Ardinex may be available in the countries listed below.
Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Ardinex in the following countries:
Ibuprofen is reported as an ingredient of Ardinex in the following countries:
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Quinace may be available in the countries listed below.
Quinapril hydrochloride (a derivative of Quinapril) is reported as an ingredient of Quinace in the following countries:
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Etacin may be available in the countries listed below.
Ciprofloxacin is reported as an ingredient of Etacin in the following countries:
Ciprofloxacin lactate (a derivative of Ciprofloxacin) is reported as an ingredient of Etacin in the following countries:
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Unasyn is a brand name of ampicillin/sulbactam, approved by the FDA in the following formulation(s):
Yes. The following products are equivalent to Unasyn:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Unasyn. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Unasyn.
Stamonevrol may be available in the countries listed below.
Sulpiride is reported as an ingredient of Stamonevrol in the following countries:
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Famotidin Alkaloid may be available in the countries listed below.
Famotidine is reported as an ingredient of Famotidin Alkaloid in the following countries:
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Vilbinitan may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Vilbinitan in the following countries:
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Vilbinitan in the following countries:
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Minurin Singad Pharma may be available in the countries listed below.
Desmopressin acetate (a derivative of Desmopressin) is reported as an ingredient of Minurin Singad Pharma in the following countries:
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Zolpidex GMP may be available in the countries listed below.
Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Zolpidex GMP in the following countries:
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Antispasmin may be available in the countries listed below.
Oxyphenonium Bromide is reported as an ingredient of Antispasmin in the following countries:
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For topical use only. Not for oral, ophthalmic, or intravaginal use.
Rx only
Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum.
The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-.
Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2.
The structural formula is:
Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Pharmacokinetic studies in men with Desoximetasone Ointment USP, 0.25% with tagged desoximetasone showed no detectable level (limit of sensitivity: 0.003 µg/mL) in 1 subject and 0.004 and 0.006 µg/mL in the remaining 2 subjects in the blood when it was applied topically on the back followed by occlusion for 24 hours. The extent of absorption for the ointment was 7% based on radioactivity recovered from urine and feces. Seven days after application, no further radioactivity was detected in urine or feces. Studies with other similarly structured steroids have shown that predominant metabolite reaction occurs through conjugation to form the glucuronide and sulfate ester.
Desoximetasone Ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Desoximetasone Ointment USP, 0.25% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Keep out of reach of children.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.
Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids.
Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.
Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.
Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Desoximetasone Ointment USP, 0.25% should be discontinued until the infection has been adequately treated.
Patients using topical corticosteroids should receive the following information and instructions:
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.
The following tests may be helpful in evaluating the hypothalamic-pituitary-adrenal (HPA) axis suppression:
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Desoximetasone was nonmutagenic in the Ames test.
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 3 to 30 times the human dose of Desoximetasone Ointment USP, 0.25%.
There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, Desoximetasone Ointment USP, 0.25% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients. Safety and effectiveness of Desoximetasone Ointment USP, 0.25% in pediatric patients below the age of 10 have not been established.
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:
Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
In controlled clinical studies the incidence of adverse reactions was low (0.3%) for Desoximetasone Ointment USP, 0.25% and included mild burning sensation at the site of application.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
Apply a thin film of Desoximetasone Ointment USP, 0.25% to the affected skin areas twice daily. Rub in gently.
Desoximetasone Ointment USP, 0.25% is supplied in 15 gram (NDC 51672-1262-1), 60 gram (NDC 51672-1262-3) and 100 gram (NDC 51672-1262-7) tubes.
Store at controlled room temperature between 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: November, 2010
PK-6353-1
85
NDC 51672-1262-7
100 g
Desoximetasone
Ointment USP, 0.25%
FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE.
Rx only
Keep this and all medications out of the reach of children.
TARO
| DESOXIMETASONE desoximetasone ointment | ||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA074286 | 06/07/1996 | |
| Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE | |
Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.
Dimetapp DM Cold/Cough Elixir is a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing while the cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Dimetapp DM Cold/Cough Elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Dimetapp DM Cold/Cough Elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Dimetapp DM Cold/Cough Elixir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Dimetapp DM Cold/Cough Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Dimetapp DM Cold/Cough Elixir.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Dimetapp DM Cold/Cough side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.
Store Dimetapp DM Cold/Cough Elixir at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dimetapp DM Cold/Cough Elixir out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Dimetapp DM Cold/Cough Elixir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
In some countries, this medicine may only be approved for veterinary use.
In the US, Nalbuphine (nalbuphine systemic) is a member of the drug class narcotic analgesics and is used to treat Anesthesia and Pain.
US matches:
Rec.INN
N02AF02
0020594-83-6
C21-H27-N-O4
357
Opioid analgesic
Partial opioid receptor antagonist
Morphinan-3,6,14-triol, 17-(cyclobutylmethyl)-4,5-epoxy-, (5α,6α)-
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Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Folifem may be available in the countries listed below.
Folic Acid is reported as an ingredient of Folifem in the following countries:
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Glimcare Plus may be available in the countries listed below.
Glimepiride is reported as an ingredient of Glimcare Plus in the following countries:
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Glimcare Plus in the following countries:
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Antiscabiosum may be available in the countries listed below.
Benzyl Benzoate is reported as an ingredient of Antiscabiosum in the following countries:
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