Saturday, 8 September 2012

Estraderm


Generic Name: estrogen (Oral route, Parenteral route, Topical application route, Transdermal route)


Commonly used brand name(s)

In the U.S.


  • Alora

  • Cenestin

  • Climara

  • Divigel

  • Elestrin

  • Emcyt

  • Enjuvia

  • Esclim

  • Estinyl

  • EstroGel

  • Evamist

  • Femtrace

  • Gynodiol

  • Menest

  • Menostar

  • Ogen .625

  • Ogen 1.25

  • Ogen 2.5

  • Premarin

  • Vivelle

  • Vivelle-Dot

In Canada


  • Estraderm

  • Estradot Transdermal

  • Estradot Transdermal Therapeutic System

  • Estradot Transdermal Therapeutic System

  • Estrogel

  • Oesclim

  • Rhoxal-Estradiol Derm 50

  • Rhoxal-Estradiol Derm 75

  • Roxal-Estradiol Derm 100

  • Vivelle 100 Mcg

  • Vivelle 25 Mcg

Available Dosage Forms:


  • Tablet

  • Patch, Extended Release

  • Gel/Jelly

  • Spray

  • Emulsion

  • Tablet, Enteric Coated

  • Capsule

Uses For Estraderm


Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.


The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.


Estrogens are prescribed for several reasons:


  • To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).

  • To help prevent weakening of bones (osteoporosis) in women past menopause.

  • In the treatment of selected cases of breast cancer in men and women.

  • In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.


There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.


Estrogens are available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, estrogen is used in certain patients with the following medical conditions:


  • Gender identity disorder, male-to-female transsexualism (person who is born as a man but adapts to a woman's lifestyle, sees himself as a woman, and feels like a woman instead of a man.

  • Osteoporosis caused by lack of estrogen before menopause.

  • Turner's syndrome (a genetic disorder).

Before Using Estraderm


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Use of this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.


This medicine may be used to start puberty in teenagers with some types of delayed puberty.


Geriatric


Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.


Pregnancy


Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.


Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.


Breast Feeding


Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.


  • Rotavirus Vaccine, Live

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Adenovirus Vaccine Type 4, Live

  • Adenovirus Vaccine Type 7, Live

  • Bacillus of Calmette and Guerin Vaccine, Live

  • Boceprevir

  • Felbamate

  • Influenza Virus Vaccine, Live

  • Isotretinoin

  • Measles Virus Vaccine, Live

  • Mumps Virus Vaccine, Live

  • Paclitaxel

  • Paclitaxel Protein-Bound

  • Rotavirus Vaccine, Live

  • Rubella Virus Vaccine, Live

  • Smallpox Vaccine

  • St John's Wort

  • Theophylline

  • Tizanidine

  • Tranexamic Acid

  • Typhoid Vaccine

  • Varicella Virus Vaccine

  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


For all patients


  • Asthma or

  • Calcium, too much or too little in blood or

  • Diabetes or

  • Epilepsy or seizures or

  • Heart problems or

  • Kidney problems or

  • Liver tumors, benign or

  • Lupus erythematosus, systemic or

  • Migraine headaches—Estrogens may worsen these conditions.

  • Blood clotting problems, or history of during previous estrogen therapy—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use.

  • Breast cancer or

  • Bone cancer or

  • Cancer of the uterus or

  • Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.

  • Bulging eyes or

  • Double vision or

  • Migraine headache or

  • Vision changes, sudden onset including or

  • Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).

  • Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.

  • Endometriosis or

  • Gallbladder disease or gallstones, or history of or

  • High cholesterol or triglycerides, or history of or

  • Liver disease, or history of or

  • Pancreatitis (inflammation of pancreas) or

  • Porphyria—Estrogens may worsen these conditions. Although estrogens can improve blood cholesterol, they can worsen blood triglycerides for some people.

  • Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

For males treated for breast or prostate cancer:


  • Blood clots or

  • Heart or circulation disease or

  • Stroke—Males with these medical problems may be more likely to have clotting problems while taking estrogens; the high doses of estrogens used to treat male breast or prostate cancer have been shown to increase the chances of heart attack, phlebitis (inflamed veins) caused by a blood clot, or blood clots in the lungs.

Proper Use of estrogen

This section provides information on the proper use of a number of products that contain estrogen. It may not be specific to Estraderm. Please read with care.


Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. For patients taking any of the estrogens by mouth, try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.


This medicine usually comes with patient information or directions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.


For patients taking any of the estrogens by mouth or by injection:


  • Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch):


  • Wash and dry your hands thoroughly before and after handling the patch.

  • Apply the patch to a clean, dry, non-oily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.

  • Do not apply to the breasts. Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.

  • Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.

  • If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.

  • Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion):


  • Washing and drying hands thoroughly before each application.

  • Apply while you are sitting comfortably. Apply one pouch to each leg every morning.

  • Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.

  • Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.

  • Rub any remaining emulsion on both hands on the buttocks.

  • Washing and drying hands thoroughly after application.

  • To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

If you are using the Evamist® transdermal spray:


  • Spray the medicine on your skin on the inside of your forearm, between the elbow and the wrist.

  • Do not allow your child to touch the area of the arm where the medicine was sprayed. If you cannot avoid to come nearer with your child, wear clothes with long sleeves to cover the application site.

  • If your child comes in direct contact with the arm where the medicine was sprayed, wash your child's skin right away with soap and water.

  • Do not allow your pets to lick or touch the arm where the medicine was sprayed.

Dosing


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For conjugated estrogens

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least 3 months.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.


    • For treating ovary problems (female hypogonadism or for starting puberty):
      • Adults and teenagers—0.3 to 0.625 milligram (mg) a day. Your doctor may want you to take the medicine only on certain days of the month.


    • For treating ovary problems (failure or removal of both ovaries):
      • Adults—1.25 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—1.25 to 2.5 milligram (mg) three times a day.



  • For injection dosage form:
    • For controlling abnormal bleeding of the uterus:
      • Adults—25 milligrams (mg) injected into a muscle or vein. This may be repeated in six to twelve hours if needed.



  • For esterified estrogens

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least three months.


    • For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
      • Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (failure or removal of both ovaries):
      • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (female hypogonadism):
      • Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating symptoms of menopause:
      • Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—1.25 to 2.5 mg three times a day.



  • For estradiol

  • For oral dosage form:
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least 3 months.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
      • Adults—At first, 1 to 2 milligrams (mg) one time per day for at least 3 months. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may also need to change the dose based on how your body responds to the medication.


    • For treating prostate cancer:
      • Adults—1 to 2 milligrams (mg) three times a day.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.5 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.



  • For topical emulsion dosage form (skin lotion):
    • For treating symptoms of menopause:
      • Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.



  • For transdermal dosage form (skin patches):
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
      • For the Climara patches

      • Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.

      • For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches

      • Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.



  • For estradiol cypionate

  • For injection dosage form:
    • For treating ovary problems (female hypogonadism):
      • Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.


    • For treating symptoms of menopause:
      • Adults—1 to 5 milligrams (mg) injected into a muscle every 3 to 4 weeks.



  • For estradiol valerate

  • For injection dosage form:
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—10 to 20 milligrams (mg) injected into a muscle every 4 weeks as needed.


    • For treating prostate cancer:
      • Adults—30 milligrams (mg) injected into a muscle every 1 or 2 weeks.



  • For estrone

  • For injection dosage form:
    • For controlling abnormal bleeding of the uterus:
      • Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.1 to 0.5 milligram (mg) injected into a muscle 2 or 3 times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—0.1 to 1 milligram (mg) a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.


    • For treating prostate cancer:
      • Adults—2 to 4 milligrams (mg) injected into a muscle 2 or 3 times a week.



  • For estropipate

  • For oral dosage form (tablets):
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—1.5 to 9 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.75 milligram (mg) a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one–day cycle.



  • For ethinyl estradiol

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—1 milligram (mg) three times a day.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—0.05 milligram (mg) one to three times a day for 3 to 6 months. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—0.15 to 3 milligrams (mg) a day.


    • For treating symptoms of menopause:
      • Adults—0.02 to 0.05 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.



  • For ethinyl estradiol and norethindrone

  • For oral dosage form (tablets):
    • For treating symptoms of menopause:
      • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.


    • To prevent loss of bone (osteoporosis):
      • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Estraderm


It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.


In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.


Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb). Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.


If your menstrual periods have stopped, they may start again. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.


Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.


Tell the doctor in charge that you are using this medicine before having any laboratory test because some results may be affected.


Check with your child's doctor right away if your child starts to have the following symptoms: nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to Evamist® transdermal spray.


Do not allow your pets to lick or touch the arm where Evamist® transdermal spray was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have the following symptoms: nipple or breast enlargement, swelling of the vulva, or any signs of illness.


Estraderm Side Effects


Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:


The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.


Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Breast pain (in females and males)

  • fast heartbeat

  • fever

  • hives

  • hoarseness

  • increased breast size (in females and males)

  • irritation of the skin

  • itching of the skin

  • joint pain, stiffness, or swelling

  • rash

  • redness of the skin

  • shortness of breath

  • swelling of the eyelids, face, lips, hands, or feet

  • swelling of the feet and lower legs

  • tightness in the chest

  • troubled breathing or swallowing

  • weight gain (rapid)

  • wheezing

Less common or rare
  • Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)

  • chest pain

  • chills

  • cough

  • heavy non-menstrual vaginal bleeding

  • lumps in, or discharge from, breast (in females and males)

  • pains in the stomach, side, or abdomen

  • yellow eyes or skin

Rare - for males being treated for breast or prostate cancer only
  • Headache (sudden or severe)

  • loss of coordination (sudden)

  • loss of vision or change of vision (sudden)

  • pains in the chest, groin, or leg, especially in the calf of leg

  • shortness of breath (sudden and unexplained)

  • slurring of speech (sudden)

  • weakness or numbness in the arm or leg

Incidence not known
  • Abdominal or stomach bloating

  • abdominal or stomach cramps

  • acid or sour stomach

  • anxiety

  • backache

  • belching

  • blindness

  • blistering, peeling, or loosening of the skin

  • blue-yellow color blindness

  • blurred vision

  • change in vaginal discharge

  • changes in skin color

  • changes in vision

  • chest discomfort

  • clay-colored stools

  • clear or bloody discharge from nipple

  • confusion

  • constipation

  • convulsions

  • dark urine

  • decrease in the amount of urine

  • decreased vision

  • depression

  • diarrhea

  • difficulty with breathing

  • difficulty with speaking

  • dimpling of the breast skin

  • dizziness

  • double vision

  • dry mouth

  • eye pain

  • fainting

  • fluid-filled skin blisters

  • full feeling in upper abdomen or stomach

  • full or bloated feeling or pressure in the stomach

  • headache

  • heartburn

  • inability to move the arms, legs, or facial muscles

  • inability to speak

  • incoherent speech

  • increased urination

  • indigestion

  • inverted nipple

  • irregular heartbeats

  • light-colored stools

  • lightheadedness

  • loss of appetite

  • loss of bladder control

  • lump under the arm

  • metallic taste

  • migraine headache

  • mood or mental changes

  • muscle cramps in the hands, arms, feet, legs, or face

  • muscle pain

  • muscle spasm or jerking of all extremities

  • muscle weakness

  • nausea

  • noisy breathing

  • numbness or tingling of the hands, feet, or face

  • pain in the ankles or knees

  • pain or discomfort in the arms, jaw, back or neck

  • pain or feeling of pressure in the pelvis

  • pain, tenderness, swelling of the foot or leg

  • painful or tender cysts in the breasts

  • painful, red lumps under the skin, mostly on the legs

  • pains in the chest, groin, or legs, especially calves of the legs

  • partial or complete loss of vision in the eye

  • pelvic pain

  • persistent crusting or scaling of nipple

  • pinpoint red or purple spots on the skin

  • prominent superficial veins over affected area

  • red, irritated eyes

  • redness or swelling of the breast

  • sensitivity to the sun

  • severe headaches of sudden onset

  • skin thinness

  • skin warmth

  • slow speech

  • sore on the skin of the breast that does not heal

  • sore throat

  • sores, ulcers, or white spots in the mouth or on the lips

  • stomach discomfort, upset, or pain

  • sudden loss of consciousness

  • sudden loss of coordination

  • sudden onset of shortness of breath for no apparent reason

  • sudden onset of slurred speech

  • sudden vision changes

  • swelling of the abdominal or stomach area

  • swelling of the fingers or hands

  • thirst

  • tremor

  • unpleasant breath odor

  • unusual tiredness or weakness

  • vomiting

  • vomiting of blood

  • weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Abnormal growth filled with fluid or semisolid material

  • accidental injury

  • bladder pain

  • bloated full feeling

  • bloody or cloudy urine

  • body aches or pain

  • coating or white patches on tongue

  • congestion

  • cough producing mucus

  • decrease in amount of urine

  • difficult, burning, or painful urination

  • discouragement

  • dryness of the throat

  • ear congestion or pain

  • excess air or gas in the stomach or intestines

  • fear

  • feeling of warmth

  • feeling sad or empty

  • frequent urge to urinate

  • general feeling of discomfort or illness

  • headache, severe and throbbing

  • increased clear or white vaginal discharge

  • irritability

  • itching of the vaginal, rectal or genital areas

  • lack of appetite

  • lack or loss of strength

  • loss of interest or pleasure

  • mild dizziness

  • neck pain

  • nervousness

  • pain

  • pain during sexual intercourse

  • painful or difficult urination

  • pain or tenderness around the eyes and cheekbones

  • passing gas

  • redness of the face, neck, arms, and occasionally, upper chest

  • runny nose

  • skin irritation or redness where skin patch was worn

  • shivering

  • sleeplessness

  • sneezing

  • sore mouth or tongue

  • stuffy nose

  • sudden sweating

  • tender, swollen glands in the neck

  • thick, white vaginal discharge with no odor or with a mild odor

  • tiredness

  • trouble concentrating

  • trouble sleeping

  • unable to sleep

  • voice changes

Less common
  • Blemishes on the skin

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • burning or stinging of the skin

  • diarrhea (mild)

  • difficulty with moving

  • dizziness (mild)

  • increased hair growth, especially on the face

  • lower abdominal or stomach pain or pressure

  • mood or mental changes

  • muscle stiffness

  • painful cold sores or blisters on the lips, nose, eyes, or genitals

  • pimples

  • pounding in the ears

  • problems in wearing contact lenses

  • slow heartbeat

  • tooth or gum pain

  • unusual decrease in sexual desire (in males)

  • unusual increase in sexual desire (in females)

  • white or brownish vaginal discharge

Incidence not known
  • Abnormal turning out of cervix

  • changes in appetite

  • dull ache or feeling of pressure or heaviness in the legs

  • flushed, dry skin

  • fruit-like breath odor

  • increased hunger

  • irritability

  • large amount of triglyceride in the blood

  • leg cramps

  • patchy brown or dark brown discoloration of the skin

  • poor insight and judgment

  • problems with memory or speech

  • trouble recognizing objects

  • trouble thinking and planning

  • trouble walking

  • twitching, uncontrolled movements of the tongue, lips, face, arms, or legs

  • unexpected or excess milk flow from the breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).


This medicine may cause loss or thinning of the scalp hair in some people.


Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Friday, 7 September 2012

Mucobid DM


Generic Name: dextromethorphan and guaifenesin (DEX troe me THOR fan and gwye FEN e sin)

Brand Names: Allfen DM, Altarussin DM, Aquatab DM, Benylin Expectorant, Drituss DM, Extuss LA, Fenesin DM IR, Glycotuss-DM, Guaifen DM, Mucinex Children's Cough, Mucinex DM, MucusRelief DM, Naldecon DX Liquigel, Relacon LAX, Respa-DM, Robitussin Cough & Congestion, Tussi-Bid, Tussi-Organidin DM NR, Vicks 44E


What is Mucobid DM (dextromethorphan and guaifenesin)?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.


Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.


The combination of dextromethorphan and guaifenesin is used to treat cough and chest congestion caused by the common cold, infections, or allergies.


Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan and guaifenesin may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Mucobid DM (dextromethorphan and guaifenesin)?


Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking Mucobid DM (dextromethorphan and guaifenesin)?


Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have emphysema or chronic bronchitis.


FDA pregnancy category C. It is not known whether dextromethorphan and guaifenesin is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.


How should I take Mucobid DM (dextromethorphan and guaifenesin)?


Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Dextromethorphan and guaifenesin granules should be sprinkled directly onto the tongue and swallowed right away.


Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.


Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?


Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous.


What should I avoid while taking Mucobid DM (dextromethorphan and guaifenesin)?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.


Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Dextromethorphan and guaifenesin are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin.

Mucobid DM (dextromethorphan and guaifenesin) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • severe dizziness, anxiety, restless feeling, or nervousness;




  • confusion, hallucinations; or




  • slow, shallow breathing.



Less serious side effects may include:



  • dizziness;




  • headache;




  • skin rash or itching; or




  • nausea, vomiting, or stomach upset.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Mucobid DM (dextromethorphan and guaifenesin)?


Before taking this medication, tell your doctor if you are using any of the following drugs:



  • celecoxib (Celebrex);




  • cinacalcet (Sensipar);




  • darifenacin (Enablex);




  • imatinib (Gleevec);




  • quinidine (Quinaglute, Quinidex);




  • ranolazine (Ranexa);




  • ritonavir (Norvir);




  • sibutramine (Meridia);




  • terbinafine (Lamisil);




  • medicines to treat high blood pressure; or




  • an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.



This list is not complete and there may be other drugs that can interact with dextromethorphan and guaifenesin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Mucobid DM resources


  • Mucobid DM Side Effects (in more detail)
  • Mucobid DM Use in Pregnancy & Breastfeeding
  • Mucobid DM Drug Interactions
  • Mucobid DM Support Group
  • 0 Reviews for Mucobid DM - Add your own review/rating


  • Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Bidex-A Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

  • Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer)

  • Mucinex DM Prescribing Information (FDA)

  • Mucinex DM Maximum Strength Prescribing Information (FDA)

  • Robitussin DM infant drops

  • Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tussin DM Prescribing Information (FDA)



Compare Mucobid DM with other medications


  • Cough
  • Expectoration


Where can I get more information?


  • Your pharmacist can provide more information about dextromethorphan and guaifenesin.

See also: Mucobid DM side effects (in more detail)


Thursday, 6 September 2012

Good Neighbor ClearLax



polyethylene glycol 3350

Dosage Form: powder, for solution
Amerisource Bergen ClearLax™ Drug Facts

Active ingredient (in each dose)


Polyethylene Glycol 3350, 17 g (cap filled to line)



Purpose


Laxative



Uses


  • relieves occasional constipation (irregularity)

  • generally produces a bowel movement in 1 to 3 days


Warnings


Allergy alert: Do not use if you are allergic to polyethylene glycol



Do not use


if you have kidney disease, except under the advice and supervision of a doctor



Ask a doctor before use if you have


  • nausea, vomiting or abdominal pain

  • a sudden change in bowel habits that lasts over 2 weeks

  • irritable bowel syndrome


Ask a doctor or pharmacist before use if you are


taking a prescription drug



When using this product


you may have loose, watery, more frequent stools



Stop use and ask a doctor if


  • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.

  • you get diarrhea

  • you need to use a laxative for longer than 1 week


If pregnant or breast-feeding,


ask a health professional before use.



Keep out of reach of children.


In case of overdose, get medical help or contact a Poison Control Center right away.



Directions


  • do not take more than directed unless advised by your doctor

  • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)

  • adults and children 17 years of age and older:

  • fill to top of white section in cap which is marked to indicate the correct dose (17 g)

  • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink

  • use once a day

  • use no more than 7 days

  • children 16 years of age or under: ask a doctor


Other information


  • store at 20°-25°C (68°-77°F)

  • tamper-evident: do not use if printed foil seal under cap is missing, open or broken


Inactive ingredients


none



Questions or comments?


1-800-719-9260



Principal Display Panel


Compare to MiraLAX® active ingredient


ClearLax™


Polyethylene Glycol 3350


Powder for Solution, Laxative


Original Prescription Strength


Relieves Occasional Constipation


Softens Stool


# Once-Daily Doses {Replace "#" with number daily doses}


ClearLax(tm) Label










GOOD NEIGHBOR PHARMACY CLEARLAX 
polyethylene glycol 3350  powder, for solution










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)46122-014
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350)POLYETHYLENE GLYCOL 335017 g  in 17 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
146122-014-31119 g In 1 BOTTLENone
246122-014-33238 g In 1 BOTTLENone
346122-014-71510 g In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09068510/19/2009


Labeler - Amerisource Bergen (007914906)
Revised: 10/2009Amerisource Bergen




More Good Neighbor ClearLax resources


  • Good Neighbor ClearLax Side Effects (in more detail)
  • Good Neighbor ClearLax Use in Pregnancy & Breastfeeding
  • Good Neighbor ClearLax Drug Interactions
  • Good Neighbor ClearLax Support Group
  • 2 Reviews for Good Neighbor ClearLax - Add your own review/rating


Compare Good Neighbor ClearLax with other medications


  • Bowel Preparation
  • Constipation
  • Constipation, Acute

epinephrine Ophthalmic



ep-i-NEF-rin


Commonly used brand name(s)

In Canada


  • Epifrin

  • Glaucon

Available Dosage Forms:


  • Solution

Uses For epinephrine


Ophthalmic epinephrine is used to treat certain types of glaucoma. It may also be used in eye surgery.


epinephrine is available only with your doctor's prescription.


Before Using epinephrine


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Studies on epinephrine have been done only in adult patients, and there is no specific information comparing use of epinephrine in children with use in other age groups


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of epinephrine in the elderly with use in other age groups, epinephrine is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy


Ophthalmic epinephrine may be absorbed into the body. However, studies on effects in pregnancy have not been done in either humans or animals.


Breast Feeding


Ophthalmic epinephrine may be absorbed into the body. However, it is not known whether epinephrine passes into the breast milk.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Bronchial asthma or

  • Type 2 diabetes mellitus or

  • Eye disease (other) or

  • Heart or blood vessel disease or

  • High blood pressure or

  • Overactive thyroid—Epinephrine may make the condition worse.

  • Dental surgery on gums—Dental surgery may include the use of epinephrine in topical or injection form. Use of ophthalmic epinephrine during this time may increase blood levels of the medicine and increase the chance of side effects.

Proper Use of epinephrine


Use epinephrine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.


To use:


  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.

  • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.

  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients using epinephrine ophthalmic solution:


  • Do not use if the solution turns pinkish or brownish in color, or if it becomes cloudy.

For patients using epinephryl borate ophthalmic solution:


  • The color of this solution may vary from colorless to amber yellow. Do not use if the solution turns dark brown or becomes cloudy.

Dosing


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For epinephrine and epinephryl borate

  • For ophthalmic solution (eye drops) dosage forms:
    • For glaucoma:
      • Adults and teenagers—One drop one or two times a day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of epinephrine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Keep out of the reach of children.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using epinephrine


Your doctor should check your eye pressure at regular visits.


epinephrine may cause blurred vision or other vision problems for a short time after it is applied. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well.


epinephrine Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Less common
  • Blurred or decreased vision

Symptoms of too much medicine being absorbed into the body
  • Fast, irregular, or pounding heartbeat

  • feeling faint

  • increased sweating

  • paleness

  • trembling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Headache or browache

  • stinging, burning, redness, or other eye irritation

  • watering of eyes

Less common
  • Eye pain or ache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More epinephrine Ophthalmic resources


  • Epinephrine Ophthalmic Use in Pregnancy & Breastfeeding
  • Epinephrine Ophthalmic Drug Interactions
  • Epinephrine Ophthalmic Support Group
  • 0 Reviews for Epinephrine Ophthalmic - Add your own review/rating


  • epinephrine ophthalmic Concise Consumer Information (Cerner Multum)



Compare epinephrine Ophthalmic with other medications


  • Glaucoma, Open Angle

Sunday, 2 September 2012

Serevent Diskus





Dosage Form: inhalation powder, oral powder
FULL PRESCRIBING INFORMATION

WARNING: ASTHMA-RELATED DEATH


Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT® DISKUS®, increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT® Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA.


Because of this risk, use of Serevent Diskus for the treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use Serevent Diskus only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Serevent Diskus) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Serevent Diskus for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.


Pediatric and Adolescent Patients: Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g., inhaled corticosteroid) and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA is recommended.



Indications and Usage for Serevent Diskus

Treatment of Asthma


Serevent Diskus is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in patients aged 4 years and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma. LABA, such as salmeterol, the active ingredient in Serevent Diskus, increase the risk of asthma-related death [see Warnings and Precautions (5.1)]. Use of Serevent Diskus for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated [see Contraindications (4)]. Use Serevent Diskus only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Serevent Diskus) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Serevent Diskus for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.


Pediatric and Adolescent Patients: Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g., inhaled corticosteroid) and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA is recommended.


Important Limitation of Use: Serevent Diskus is NOT indicated for the relief of acute bronchospasm.



Prevention of Exercise-Induced Bronchospasm


Serevent Diskus is also indicated for prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. Use of Serevent Diskus as a single agent for the prevention of EIB may be clinically indicated in patients who do not have persistent asthma. In patients with persistent asthma, use of Serevent Diskus for the prevention of EIB may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.



Maintenance Treatment of Chronic Obstructive Pulmonary Disease


Serevent Diskus is indicated for the long-term twice-daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) (including emphysema and chronic bronchitis).


Important Limitation of Use: Serevent Diskus is NOT indicated for the relief of acute bronchospasm.



Serevent Diskus Dosage and Administration


Serevent Diskus should be administered by the orally inhaled route only.


For both asthma and COPD, adverse effects are more likely to occur with higher doses of salmeterol, and more frequent administration or administration of a larger number of inhalations (more than 1 inhalation twice daily) is not recommended. Patients using Serevent Diskus should not use additional LABA for any reason. [See Warnings and Precautions (5.4, 5.6).]



Asthma


LABA, such as salmeterol, the active ingredient in Serevent Diskus, increase the risk of asthma-related death [see Warnings and Precautions (5.1)].


Because of this risk, use of Serevent Diskus for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid is contraindicated. Use Serevent Diskus only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Serevent Diskus) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Serevent Diskus for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.


Pediatric and Adolescent Patients: Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For patients with asthma less than 18 years of age who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g., inhaled corticosteroid) and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA is recommended.


For bronchodilatation and prevention of symptoms of asthma, including the symptoms of nocturnal asthma, the usual dosage for adults and children aged 4 years and older is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart). If a previously effective dosage regimen fails to provide the usual response, medical advice should be sought immediately as this is often a sign of destabilization of asthma. Under these circumstances, the therapeutic regimen should be reevaluated. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.



Exercise-Induced Bronchospasm


Use of Serevent Diskus as a single agent for the prevention of EIB may be clinically indicated in patients who do not have persistent asthma. In patients with persistent asthma, use of Serevent Diskus for the prevention of EIB may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid. One inhalation of Serevent Diskus at least 30 minutes before exercise has been shown to protect patients against EIB. When used intermittently as needed for prevention of EIB, this protection may last up to 9 hours in adolescents and adults and up to 12 hours in patients aged 4 to 11 years. Additional doses of SEREVENT should not be used for 12 hours after the administration of this drug. Patients who are receiving Serevent Diskus twice daily should not use additional SEREVENT for prevention of EIB.



Chronic Obstructive Pulmonary Disease


For maintenance treatment of bronchospasm associated with COPD (including chronic bronchitis and emphysema), the dosage for adults is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart).



Dosage Forms and Strengths


Disposable teal green device with 60 blisters containing salmeterol (50 mcg) as an oral inhalation powder formulation. An institutional pack containing 28 blisters is also available.



Contraindications


Because of the risk of asthma-related death and hospitalization, use of Serevent Diskus for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated [see Warnings and Precautions (5.1)].


Serevent Diskus is contraindicated as primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required [see Warnings and Precautions (5.2)].


Serevent Diskus is contraindicated in patients with severe hypersensitivity to milk proteins [see Warnings and Precautions (5.7), Adverse Reactions (6.3), Description (11)].



Warnings and Precautions



Asthma-Related Death


LABA, such as salmeterol, the active ingredient in Serevent Diskus, increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA.


Because of this risk, use of Serevent Diskus for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use Serevent Diskus only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Serevent Diskus) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Serevent Diskus for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.


Pediatric and Adolescent Patients:Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g., inhaled corticosteroid) and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA is recommended.


The Salmeterol Multi-center Asthma Research Trial (SMART) was a large 28-week placebo-controlled US study comparing the safety of salmeterol (SEREVENT Inhalation Aerosol) with placebo, each added to usual asthma therapy, that showed an increase in asthma-related deaths in patients receiving salmeterol [see Clinical Studies (14.1)]. Given the similar basic mechanisms of action of beta2-agonists, the findings seen in the SMART study are considered a class effect.


A 16-week clinical study performed in the United Kingdom, the Salmeterol Nationwide Surveillance (SNS) study, showed results similar to the SMART study. In the SNS study, the rate of asthma-related death was numerically, though not statistically significantly, greater in patients with asthma treated with salmeterol (42 mcg twice daily) than those treated with albuterol (180 mcg 4 times daily) added to usual asthma therapy.


The SNS and SMART studies enrolled patients with asthma. No studies have been conducted that were adequate to determine whether the rate of death in patients with COPD is increased by LABA.



Deterioration of Disease and Acute Episodes


Serevent Diskus should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Serevent Diskus has not been studied in patients with acutely deteriorating asthma or COPD. The initiation of Serevent Diskus in this setting is not appropriate.


Serious acute respiratory events, including fatalities, have been reported when salmeterol has been initiated in patients with significantly worsening or acutely deteriorating asthma. In most cases, these have occurred in patients with severe asthma (e.g., patients with a history of corticosteroid dependence, low pulmonary function, intubation, mechanical ventilation, frequent hospitalizations, previous life-threatening acute asthma exacerbations) and in some patients with acutely deteriorating asthma (e.g., patients with significantly increasing symptoms; increasing need for inhaled, short-acting beta2-agonists; decreasing response to usual medications; increasing need for systemic corticosteroids; recent emergency room visits; deteriorating lung function). However, these events have occurred in a few patients with less severe asthma as well. It was not possible from these reports to determine whether salmeterol contributed to these events.


Increasing use of inhaled, short-acting beta2-agonists is a marker of deteriorating asthma. In this situation, the patient requires immediate reevaluation with reassessment of the treatment regimen, giving special consideration to the possible need for adding additional inhaled corticosteroid or initiating systemic corticosteroids. Patients should not use more than 1 inhalation twice daily (morning and evening) of Serevent Diskus.


Serevent Diskus should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta2-agonist, not Serevent Diskus, should be used to relieve acute symptoms such as shortness of breath. When prescribing Serevent Diskus, the physician must also provide the patient with an inhaled, short-acting beta2-agonist (e.g., albuterol) for treatment of acute symptoms.


When beginning treatment with Serevent Diskus, patients who have been taking oral or inhaled, short-acting beta2-agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.



Serevent Diskus is Not a Substitute for Corticosteroids


There are no data demonstrating that Serevent Diskus has a clinical anti-inflammatory effect such as that associated with corticosteroids. When initiating and throughout treatment with Serevent Diskus in patients receiving oral or inhaled corticosteroids for treatment of asthma, patients must continue taking a suitable dosage of corticosteroids to maintain clinical stability even if they feel better as a result of initiating Serevent Diskus. Any change in corticosteroid dosage should be made ONLY after clinical evaluation.



Excessive Use of Serevent Diskus and Use With Other Long-Acting Beta2-Agonists


As with other inhaled beta2-adrenergic drugs, Serevent Diskus should not be used more often or at higher doses than recommended, or in conjunction with other medications containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using Serevent Diskus should not use an additional LABA (e.g., formoterol fumarate, arformoterol tartrate) for any reason.



Paradoxical Bronchospasm and Upper Airway Symptoms


As with other inhaled medications, Serevent Diskus can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Serevent Diskus, it should be treated immediately with an inhaled, short-acting bronchodilator; Serevent Diskus should be discontinued immediately; and alternative therapy should be instituted. Upper airway symptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have been reported in patients receiving Serevent Diskus.



Cardiovascular and Central Nervous System Effects


Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia [see Overdosage (10)]. Therefore, Serevent Diskus, like all products containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.


Salmeterol can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of salmeterol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Large doses of inhaled or oral salmeterol (12 to 20 times the recommended dose) have been associated with clinically significant prolongation of the QTc interval, which has the potential for producing ventricular arrhythmias. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.



Immediate Hypersensitivity Reactions


Immediate hypersensitivity reactions may occur after administration of Serevent Diskus, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm. There have been reports of anaphylactic reactions in patients with severe milk protein allergy; therefore, patients with severe milk protein allergy should not take Serevent Diskus [see Contraindications (4)].



Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors


Because of the potential for drug interactions and the potential for increased risk of cardiovascular adverse events, the concomitant use of Serevent Diskus with strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) is not recommended [see Drug Interactions (7.1)].



Coexisting Conditions


Serevent Diskus, like all medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines. Doses of the related beta2-adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.



Hypokalemia and Hyperglycemia


Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects [see Clinical Pharmacology (12.2)]. The decrease in serum potassium is usually transient, not requiring supplementation. Clinically significant and dose-related changes in blood glucose and/or serum potassium were seen infrequently during clinical studies with Serevent Diskus at recommended doses.



Adverse Reactions


LABA, including salmeterol, the active ingredient in Serevent Diskus, increase the risk of asthma-related death. Data from a large 28-week placebo-controlled US study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see Warnings and Precautions (5.1), Clinical Studies (14.1)].


Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.



Clinical Trials Experience in Asthma


Adult and Adolescent Patients Aged 12 Years and Older: Two multicenter, 12-week, controlled studies evaluated twice-daily doses of Serevent Diskus in patients aged 12 years and older with asthma. Table 1 reports the incidence of adverse reactions in these 2 studies.














































Table 1. Adverse Reaction Incidence in Two 12-Week Clinical Trials in Adult and Adolescent Patients With Asthma
Adverse EventPercent of Patients

Placebo


(N = 152)

Serevent Diskus


50 mcg


Twice Daily


(N = 149)

Albuterol Inhalation Aerosol


180 mcg


4 Times Daily


(N = 150)
 
Ear, nose, and throat
Nasal/sinus congestion, pallor698
Rhinitis454
Neurological
Headache91312
Respiratory
Asthma13<1
Tracheitis/bronchitis473
Influenza255

Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving Serevent Diskus and were more common than in the placebo group.


Pharyngitis, sinusitis, upper respiratory tract infection, and cough occurred at ≥3% but were more common in the placebo group. However, throat irritation has been described at rates exceeding that of placebo in other controlled clinical trials.


Additional Adverse Reactions: Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by patients with asthma treated with Serevent Diskus compared with patients treated with placebo include the following: contact dermatitis, eczema, localized aches and pains, nausea, oral mucosal abnormality, pain in joint, paresthesia, pyrexia of unknown origin, sinus headache, and sleep disturbance.


Pediatric Patients Aged 4 to 11 Years: Two multicenter, 12-week, controlled studies have evaluated twice-daily doses of Serevent Diskus in patients aged 4 to 11 years with asthma. Table 2 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving Serevent Diskus and were more common than in the placebo group.


















































Table 2. Adverse Reaction Incidence in Two 12-Week Pediatric Clinical Trials in Patients With Asthma
Adverse EventPercent of Patients

Placebo


(N = 215)

Serevent Diskus


50 mcg


Twice Daily


(N = 211)

Albuterol


Inhalation Aerosol


200 mcg


4 Times Daily


(N = 115)
 
Ear, nose, and throat
Ear signs and symptoms349
Pharyngitis363
Neurological
Headache141720
Respiratory
Asthma24<1
Skin
Skin rashes342
Urticaria032

The following events were reported at an incidence of >1% in the salmeterol group and with a higher incidence than in the albuterol and placebo groups: gastrointestinal signs and symptoms, lower respiratory signs and symptoms, photodermatitis, and arthralgia and articular rheumatism.


In clinical trials evaluating concurrent therapy of salmeterol with inhaled corticosteroids, adverse events were consistent with those previously reported for salmeterol, or with events that would be expected with the use of inhaled corticosteroids.


Laboratory Test Abnormalities: Elevation of hepatic enzymes was reported in ≥1% of patients in clinical trials. The elevations were transient and did not lead to discontinuation from the studies. In addition, there were no clinically relevant changes noted in glucose or potassium.



Clinical Trials Experience in Chronic Obstructive Pulmonary Disease


Two multicenter, 24-week, controlled studies have evaluated twice-daily doses of Serevent Diskus in patients with COPD. For presentation (Table 3), the placebo data from a third trial, identical in design, patient entrance criteria, and overall conduct but comparing fluticasone propionate with placebo, were integrated with the placebo data from these 2 studies (total N = 341 for salmeterol and 576 for placebo).





































































Table 3. Adverse Reactions With ≥3% Incidence in US Controlled Clinical Trials With Serevent Diskus in Patients With Chronic Obstructive Pulmonary Diseasea
Adverse EventPercent of Patients

Placebo


(N = 576)

Serevent Diskus


50 mcg Twice Daily


(N = 341)
 
Cardiovascular
Hypertension24
Ear, nose, and throat
Throat irritation67
Nasal congestion/blockage34
Sinusitis24
Ear signs and symptoms13
Gastrointestinal
Nausea and vomiting33
Lower respiratory
Cough45
Rhinitis24
Viral respiratory infection45
Musculoskeletal
Musculoskeletal pain1012
Muscle cramps and spasms13
Neurological
Headache1114
Dizziness24
Average duration of exposure (days)128.9138.5

aTable 3 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving Serevent Diskus and were more common in the group receiving Serevent Diskus than in the placebo group.


Additional Adverse Reactions: Other events occurring in the group receiving Serevent Diskus that occurred at a frequency of ≥1% and were more common than in the placebo group were as follows: anxiety; arthralgia and articular rheumatism; bone and skeletal pain; candidiasis mouth/throat; dental discomfort and pain; dyspeptic symptoms; edema and swelling; gastrointestinal infections; hyperglycemia; hyposalivation; keratitis and conjunctivitis; lower respiratory signs and symptoms; migraines; muscle pain; muscle stiffness, tightness, and rigidity; musculoskeletal inflammation; pain; and skin rashes.


Adverse reactions to salmeterol are similar in nature to those seen with other selective beta2-adrenoceptor agonists, e.g., tachycardia; palpitations; immediate hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm; headache; tremor; nervousness; and paradoxical bronchospasm.


Laboratory Abnormalities: There were no clinically relevant changes in these trials. Specifically, no changes in potassium were noted.



Postmarketing Experience


In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of salmeterol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to salmeterol or a combination of these factors.


In extensive US and worldwide postmarketing experience with salmeterol, serious exacerbations of asthma, including some that have been fatal, have been reported. In most cases, these have occurred in patients with severe asthma and/or in some patients in whom asthma has been acutely deteriorating [see Warnings and Precautions (5.2)], but they have also occurred in a few patients with less severe asthma. It was not possible from these reports to determine whether salmeterol contributed to these events.


Cardiovascular: Arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) and anaphylaxis.


Non-Site Specific: Very rare anaphylactic reaction in patients with severe milk protein allergy.


Respiratory: Reports of upper airway symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking; oropharyngeal irritation.



Drug Interactions



Inhibitors of Cytochrome P450 3A4


In a drug interaction study in 20 healthy subjects, coadministration of salmeterol (50 mcg twice daily) and ketoconazole (400 mg once daily) for 7 days resulted in greater systemic exposure to salmeterol (AUC increased 16-fold and Cmax increased 1.4-fold). Three (3) subjects were withdrawn due to beta2-agonist side effects (2 with prolonged QTc and 1 with palpitations and sinus tachycardia). Although there was no statistical effect on the mean QTc, coadministration of salmeterol and ketoconazole was associated with more frequent increases in QTc duration compared with salmeterol and placebo administration. Due to the potential increased risk of cardiovascular adverse events, the concomitant use of salmeterol with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) is not recommended.



Monoamine Oxidase Inhibitors and Tricyclic Antidepressants


Serevent Diskus should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of salmeterol on the vascular system may be potentiated by these agents.



Beta-Adrenergic Receptor Blocking Agents


Beta-blockers not only block the pulmonary effect of beta-agonists, such as Serevent Diskus, but may also produce severe bronchospasm in patients with asthma or COPD. Therefore, patients with asthma or COPD should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.



Diuretics


The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical relevance of these effects is not known, caution is advised in the coadministration of Serevent Diskus with nonpotassium-sparing diuretics.



USE IN SPECIFIC POPULATIONS



Pregnancy


Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies with Serevent Diskus in pregnant women. Serevent Diskus should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


No teratogenic effects occurred in rats at oral doses approximately 160 times the maximum recommended daily inhalation dose (MRHD) on an mg/m2 basis. In pregnant Dutch rabbits administered oral doses approximately 50 times the MRHD based on comparison of the AUCs, salmeterol exhibited fetal toxic effects characteristically resulting from beta-adrenoceptor stimulation. These included precocious eyelid openings, cleft palate, sternebral fusion, limb and paw flexures, and delayed ossification of the frontal cranial bones. No such effects occurred at an oral dose approximately 20 times the MRHD based on comparison of the AUCs.


New Zealand White rabbits were less sensitive since only delayed ossification of the frontal cranial bones was seen at an oral dose approximately 1,600 times the MRHD on an mg/m2 basis. Extensive use of other beta-agonists has provided no evidence that these class effects in animals are relevant to their use in humans.



Labor and Delivery


There are no well-controlled human studies that have investigated effects of salmeterol on preterm labor or labor at term. Because of the potential for beta-agonist interference with uterine contractility, use of Serevent Diskus during labor should be restricted to those patients in whom the benefits clearly outweigh the risks.



Nursing Mothers


Plasma levels of salmeterol, a component of Serevent Diskus, after inhaled therapeutic doses are very low. In rats, salmeterol xinafoate is excreted in the milk. Since there are no data from controlled trials on the use of salmeterol by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue Serevent Diskus, taking into account the importance of Serevent Diskus to the mother. Caution should be exercised when Serevent Diskus is administered to a nursing woman.



Pediatric Use


Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA should ordinarily be used to ensure adherence with both drugs [see Indications and Usage (1.1), Warnings and Precautions (5.1)].


The safety and efficacy of Serevent Diskus in adolescents (aged 12 years and older) has been established based on adequate and well-controlled trials conducted in adults and adolescents [see Clinical Studies (14.1)]. A large 28-week placebo-controlled US study comparing salmeterol (SEREVENT Inhalation Aerosol) and placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol [see Clinical Studies (14.1)]. Post-hoc analyses in pediatric patients aged 12 to 18 years were also performed. Pediatric patients accounted for approximately 12% of patients in each treatment arm. Respiratory-related death or life-threatening experience occurred at a similar rate in the salmeterol group (0.12% [2/1,653]) and the placebo group (0.12% [2/1,622]; relative risk: 1.0 [95% CI: 0.1, 7.2]). All-cause hospitalization, however, was increased in the salmeterol group (2% [35/1,653]) versus the placebo group (<1% [16/1,622]; relative risk: 2.1 [95% CI: 1.1, 3.7]).


The safety and efficacy of Serevent Diskus have been evaluated in over 2,500 patients aged 4 to 11 years with asthma, 346 of whom were administered Serevent Diskus for 1 year. Based on available data, no adjustment of dosage of Serevent Diskus in pediatric patients is warranted for either asthma or EIB.


In 2 randomized, double-blind, controlled clinical trials of 12 weeks’ duration, Serevent Diskus 50 mcg was administered to 211 pediatric patients with asthma who did and who did not receive concurrent inhaled c