Altaflor

Generic Name: fluoride (FLOR ide)

Brand Names: Altaflor, Ethedent Chewable, Fluor-A-Day, Fluoritab, Flura-Drops, Flura-Loz, Flura-Tab, Karidium, Lozi-Flur, Luride, Nafrinse, Pharmaflur, Pharmaflur 1.1

What is Altaflor (fluoride)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.

Fluoride is used as a medication to prevent tooth decay in people that have a low level of fluoride in their drinking water. Fluoride is also used to prevent tooth decay in people who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.

Fluoride may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Altaflor (fluoride)?

You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.

Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.

What should I discuss with my healthcare provider before taking Altaflor (fluoride)?

You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.

Talk to your doctor and dentist before taking fluoride if you are pregnant or could become pregnant during treatment. Talk to your doctor and dentist before taking fluoride if you are breast-feeding. The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age; the American Academy of Pediatrics recommends fluoride supplementation by children until the age of 16 years of age. Do not give a 1-mg tablet to a child younger than 3 years old, or when your drinking water fluoride content is equal to or greater than 0.3 ppm.

How should I take Altaflor (fluoride)?

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.

Take this medicine with a full glass of water. Do not take fluoride with milk or other dairy products. Calcium can make it harder for your body to absorb fluoride.

Suck on the fluoride lozenge until it dissolves completely in your mouth. Do not chew the lozenge or swallow it whole.

The chewable forms of fluoride can be chewed, swallowed, dissolved in the mouth, added to drinking water or fruit juice, or added to water for use in infant formula or other food.

The fluoride drops can be taken by mouth undiluted, or mixed with fluid or food.

If you mix fluoride with food or water, drink or eat this mixture right away. Do not save it for later use.

It is important to take fluoride regularly to get the most benefit.

Store fluoride at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. 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 nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).

What should I avoid while taking Altaflor (fluoride)?

Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.

Altaflor (fluoride) 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. Call your doctor if you have any of the following side effects:

• 
  

  discolored teeth;

  
  


• 
  

  weakened tooth enamel; or

  
  


• 
  

  any changes in the appearance of your teeth.

  
  

Less serious side effects may include:

• 
  

  stomach upset;

  
  


• 
  

  headache; or

  
  


• 
  

  weakness.

  
  

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 Altaflor (fluoride)?

There may be other drugs that can interact with fluoride. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Altaflor resources

• Altaflor Use in Pregnancy & Breastfeeding
• Altaflor Support Group
• 0 Reviews for Altaflor - Add your own review/rating

• Epiflur Prescribing Information (FDA)


• Fluor-A-Day Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Fluor-A-Day Advanced Consumer (Micromedex) - Includes Dosage Information


• Fluor-a-Day Prescribing Information (FDA)


• Fluorides Monograph (AHFS DI)


• Fluoritab Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Lozi-Flur Lozenges MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Altaflor with other medications

• Prevention of Dental Caries

Where can I get more information?

• Your pharmacist can provide more information about fluoride.

Tekturna

Generic Name: Aliskiren Hemifumarate
Class: Renin Inhibitors
Chemical Name: (2S,4S,5S,7S) - N - (2 - Carbamoyl - 2 - methylpropyl) - 5 - amino - 4 - hydroxy - 2,7 - diisopropyl - 8 - [4 - methoxy - 3 - (3 - methoxypropoxy)phenyl] - octanamide hemifumarate
Molecular Formula: C₃₀H₅₃N₃O₆•0.5 C₄H₄O₄
CAS Number: 173334-57-1

• 
  

  May cause fetal and neonatal morbidity and mortality if used during pregnancy.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  
  


• 
  

  If pregnancy is detected, discontinue aliskiren as soon as possible.¹

  
  

Introduction

Nonpeptide renin inhibitor.^{1 2 3 4 5 6 7 8 9 10}

Uses for Tekturna

Hypertension

Management of hypertension (alone or in combination with other antihypertensive agents).^{1 3 4 5 6 7 8 9 11 15}

Most experience with combination therapy to date has been with diuretics or an angiotensin II receptor antagonist (valsartan); concomitant use of aliskiren with either of these drugs at maximum recommended dosages produces a greater BP response than does use of each drug alone.¹

Not known whether effects of aliskiren and ACE inhibitors or aliskiren and β-adrenergic blocking agents are additive.¹ Whether aliskiren further improves BP control in patients receiving maximum dosages of an ACE inhibitor not established.¹

Tekturna Dosage and Administration

Administration

Oral Administration

Manufacturer recommends that patients establish a routine pattern for taking drug with regard to meals; administration with a high-fat meal substantially decreases absorption of the drug.^{1 9}

Dosage

Available as aliskiren hemifumarate; dosage expressed in terms of the base.¹

Adults

Hypertension

Oral

Initially, 150 mg once daily, alone or in combination with other antihypertensive agents.^{1 9 11} May increase dosage to 300 mg once daily if BP not adequately controlled.^{1 9}

Dosages >300 mg daily do not appear to further increase BP response,^{1 2 3 6} but are associated with an increased frequency of diarrhea.^{1 6}

Special Populations

Hepatic Impairment

No initial dosage adjustment required in patients with mild to severe hepatic impairment.^{1 2 18} (See Special Populations under Pharmacokinetics.)

Renal Impairment

No initial dosage adjustment required in patients with mild to severe renal impairment; however, select dosage with caution in patients with severe renal impairment (S_cr >1.7 mg/dL [women] or S_cr >2 mg/dL [men], and/or GFR <30 mL/minute) as clinical experience is limited.^{1 2 11 16} (See Special Populations under Pharmacokinetics and see Renal Effects under Cautions.)

Geriatric Patients

No initial dosage adjustment required.^{1 17} (See Geriatric Use under Cautions and see Special Populations under Pharmacokinetics.)

Volume- and/or Salt-depleted Patients

Correct volume and/or salt depletion prior to initiating therapy or initiate therapy under close medical supervision.¹

Cautions for Tekturna

Contraindications

Manufacturer states that there are no contraindications to use of aliskiren.^{1 11}

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.¹ (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.¹

Retrospective data indicate that ACE inhibitors, a class of drugs acting on the renin-angiotensin-aldosterone (RAA) system, have been associated with an increased risk of major congenital malformations when administered during the first trimester of pregnancy.¹

Discontinue as soon as possible when pregnancy is detected.¹

Hypotension

Excessive hypotension reported rarely in patients with uncomplicated hypertension receiving the drug alone and infrequently during combination therapy with other antihypertensive agents.^{1 11}

Possible symptomatic hypotension, particularly in volume- and/or salt-depleted patients (e.g., those receiving high dosages of diuretics).¹ (See Volume- and/or Salt-Depleted Patients under Dosage and Administration.)

If excessive hypotension occurs, place patient in supine position and, if necessary, administer IV infusion of 0.9% sodium chloride injection.¹ Transient hypotension is not a contraindication to further treatment, which usually may be continued without difficulty once BP is stabilized.¹

Sensitivity Reactions

Angioedema of face, extremities, lips, tongue, glottis and/or larynx reported; angioedema associated with laryngeal or tongue edema may be fatal.¹ Angioedema associated with respiratory symptoms, periorbital edema without respiratory symptoms, and edema involving the face, hands, or whole body reported rarely.¹

If angioedema occurs, promptly discontinue drug and provide appropriate therapy and monitoring until complete and sustained resolution of signs and symptoms.¹ Provide immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.¹ Antihistamines and corticosteroids may not prevent respiratory involvement; prolonged observation may be necessary.¹

General Precautions

Renal Effects

Use with caution in patients with severe renal impairment (S_cr >1.7 mg/dL [women] or S_cr >2.0 mg/dL [men], and/or GFR <30 mL/minute) or history of peritoneal or hemodialysis, nephrotic syndrome, or renovascular hypertension; safety not established and potential risk of increased S_cr or BUN associated with other drugs acting on the RAA system.^{1 11}

Minor increases in BUN or S_cr observed in patients with essential hypertension receiving the drug alone.¹

Hyperkalemia

Increases in serum potassium >5.5 mEq/L reported infrequently in patients receiving the drug alone.¹

Increased serum potassium reported more frequently during combination therapy with ACE inhibitors in diabetic patients; routinely monitor electrolytes and renal function.^{1 11}

Specific Populations

Pregnancy

Category C (first trimester); Category D (second and third trimesters).¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹ Discontinue nursing or the drug.^{1 11}

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

BP response and adverse reactions similar to those in younger adults.^{1 17} (See Geriatric Patients under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Renal Impairment

Use with caution in patients with severe renal impairment.^{1 11} (See Renal Effects under Cautions.)

Select dosage with caution in patients with severe renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Diarrhea,¹ headache,¹ dizziness,¹ fatigue,¹ upper respiratory tract infection,¹ nasopharyngitis,¹ cough,¹ back pain.¹

Interactions for Tekturna

Does not inhibit CYP isoenzymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A or induce CYP isoenzyme 3A4.^{1 2}

Metabolized by CYP3A4 in vitro.^{1 11} (See Metabolism under Pharmacokinetics.)

Specific Drugs

Drug	Interaction	Comments
Amlodipine	Clinically important pharmacokinetic interactions unlikely1 20	No initial dosage adjustment of aliskiren required20
Atenolol	Clinically important pharmacokinetic interactions unlikely1 21	Further study of long-term concomitant administration may be required21
Atorvastatin	Increased peak plasma concentration and AUC of aliskiren by about 50% following multiple dosing1 11 Pharmacokinetics of atorvastatin not substantially affected by aliskiren1
Celecoxib	Clinically important pharmacokinetic interactions unlikely1 21	Further study of long-term concomitant administration may be required21
Cimetidine	Clinically important pharmacokinetic interactions unlikely21	Further study of long-term concomitant administration may be required21
Digoxin	Pharmacokinetic interactions unlikely1
Furosemide	Concomitant administration does not appear to result in clinically important increases in systemic exposure to aliskiren1 Decreased peak plasma concentration and AUC of furosemide with concomitant administration1 11	Effects of furosemide may be reduced following initiation of aliskiren therapy1
Hydrochlorothiazide	Clinically important pharmacokinetic interactions unlikely1 20	No initial dosage adjustment of aliskiren required20
Irbesartan	May decrease peak plasma concentration of aliskiren by up to 50% following multiple dosing1 11 16
Ketoconazole	Increased plasma concentrations of aliskiren by about 80%1 11 17
Lovastatin	Clinically important pharmacokinetic interactions unlikely1 21	Further study of long-term concomitant administration may be required21
Metformin	Pharmacokinetic interactions unlikely1
Ramipril	Clinically important pharmacokinetic interactions unlikely1 20	No initial dosage adjustment of aliskiren required20
Valsartan	Clinically important pharmacokinetic interactions unlikely1 20	No initial dosage adjustment of aliskiren required20
Warfarin	Concomitant administration does not appear to result in clinically important increases in systemic exposure to aliskiren1 Effects of aliskiren on warfarin pharmacokinetics not established in a well-controlled clinical study1 19

Tekturna Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed; oral bioavailability is about 2.5%.^{1 2 9 10 16}

Peak plasma concentrations usually attained within 1–3 hours following oral administration.^{1 2 9 13}

Onset

Substantial proportion (85–90%) of antihypertensive effect attained within 2 weeks of initiation of therapy.^{1 6 9}

Food

High-fat meal decreases mean AUC and peak plasma concentration by 71 and 85%, respectively; however, in clinical studies the drug was administered without requiring a fixed relation of administration to meals.^{1 2}

Special Populations

In geriatric patients, systemic exposure to drug (measured by AUC) may be increased.^{1 17} (See Geriatric Patients under Dosage and Administration and see Geriatric Use under Cautions.)

In patients with varying degrees of renal impairment, rate and extent of systemic exposure (peak plasma concentration and AUC) to drug were increased; however, changes in exposure did not consistently correlate with severity of renal impairment.^{1 16} (See Renal Impairment under Dosage and Administration and see Renal Effects under Cautions.)

In patients with mild to severe hepatic impairment, pharmacokinetics of drug not substantially altered.^{1 18} (See Hepatic Impairment under Dosage and Administration.)

Distribution

Extent

Crosses the placenta and is distributed in the amniotic fluid and fetus in animals.¹

Distributed into milk in rats; not known whether distributed into human milk.¹

Plasma Protein Binding

Approximately 47–51%.^{2 16 20}

Elimination

Metabolism

Amount of absorbed dose that undergoes metabolism not established;¹ however, drug appears to undergo minimal hepatic metabolism.^{2 9 11 13 16} CYP3A4 appears to be main enzyme responsible for metabolism of drug based on in vitro studies.^{1 9 11} Also a substrate for p-glycoprotein.^{11 13 16 17}

Elimination Route

Unabsorbed drug excreted principally in feces as unchanged drug, and absorbed drug eliminated principally in feces via hepatobiliary clearance as unchanged drug and minimally in urine;^{1 2 9 10 11 13 16 17 20} approximately 25% of an absorbed oral dose is eliminated in urine as unchanged drug.^{1 9}

Half-life

Accumulation half-life is approximately 24 hours.^{1 11}

Terminal half-life is approximately 24–40 hours; ^{2 9 10 11 13 14 16 17} wide interpatient variability observed.¹¹

Stability

Storage

Oral

Tablets

Tight containers at 25°C (may be exposed to 15–30°C); protect from moisture.¹

ActionsActions

• 
  

  Binds with high affinity to plasma renin.⁹

  
  


• 
  

  Inhibits conversion of angiotensinogen to angiotensin I and reduces plasma renin activity (PRA) and concentrations of angiotensin I, angiotensin II, and aldosterone.^{1 2 3 4 6 8 9 10}

  
  


• 
  

  May suppress feedback inhibition of renin secretion leading to a compensatory increase in plasma renin concentrations; however, PRA does not appear to increase, unlike therapy with ACE inhibitors or angiotensin II receptor antagonists.^{1 9 10}

  
  


• 
  

  Not known whether aliskiren affects other RAA system components (e.g., ACE, non-ACE pathways).¹

  
  

Advice to Patients

• 
  

  Advise patients to take the drug once daily, at same time every day establishing a routine pattern with regard to food.^{1 11}

  
  


• 
  

  Importance of advising patient that if a dose of aliskiren is missed to take it as soon as remembered.¹ If it is almost time for the next dose, omit the missed dose and administer the next dose at the regularly scheduled time.¹

  
  


• 
  

  Risk of angioedema, including laryngeal edema; importance of discontinuing the drug and reporting suggestive manifestations (e.g., edema of face, extremities, eyes, lips, or tongue; swallowing or breathing with difficulty) to a clinician.¹

  
  


• 
  

  Risk of fetal and neonatal morbidity and death when administered to pregnant women.¹

  
  


• 
  

  Importance of women informing clinicians immediately if they are or plan to become pregnant or plan to breast-feed.¹ Advise women to discontinue aliskiren if they become pregnant.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Aliskiren Hemifumarate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	150 mg (of aliskiren)	Tekturna (with povidone)	Novartis
		300 mg (of aliskiren)	Tekturna (with povidone)	Novartis

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Tekturna 150MG Tablets (NOVARTIS): 30/$96.99 or 90/$271.96

Tekturna 300MG Tablets (NOVARTIS): 30/$119.99 or 90/$342.96

Tekturna HCT 300-25MG Tablets (NOVARTIS): 30/$120.99 or 90/$334.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Novartis. Tekturna (aliskiren) tablets prescribing information. East Hanover, NJ; 2007 Apr.

2. Van Tassell BW, Munger MA. Aliskiren for renin inhibition: a new class of antihypertensives. Ann Pharmacother. 2007; 41:456-64. [PubMed 17341529]

3. Gradman AH, Schmieder RE, Lins RL et al. Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients. Circulation. 2005; 111:1012-8. [PubMed 15723979]

4. Pool JL, Schmieder RE, Azizi M et al. Aliskiren, an orally effective renin inhibitor, provides antihypertensive efficacy alone and in combination with valsartan. Am J Hypertens. 2007; 20:11-20. [PubMed 17198906]

5. Villamil A, Chrysant SG, Calhoun D et al. Renin inhibition with aliskiren provides additive antihypertensive efficacy when used in combination with hydrochlorothiazide. J Hypertens. 2007; 25:217-26. [PubMed 17143194]

6. Oh BH, Mitchell J, Herron JR et al. Aliskiren, an oral renin inhibitor, provides dose-dependent efficacy and sustained 24-hour blood pressure control in patients with hypertension. J Am Coll Cardiol. 2007; 49:1157-63. [PubMed 17367658]

7. Munger MA, Drummond W, Essop MR et al. Aliskiren as add-on to amlodipine provides significant additional blood pressure lowering without increased oedema associated with doubling the amlodipine dose. Eur Heart J. 2006; 25(Suppl):P784. Abstract.

8. Kushiro T, Itakura H, Abo Y et al. Aliskiren, a novel oral renin inhibitor, provides dose-dependent efficacy and placebo-like tolerability in Japanese patients with hypertension. Hypertens Res. 2006; 29:997-1005. [PubMed 17378372]

9. Anon. Aliskiren (Tekturna) for hypertension. Med Lett Drugs Ther. 2007; 49:29-31. [PubMed 17415282]

10. Staessen JA, Li Y, Richart T. Oral renin inhibitors. Lancet. 2006; 368:1449-56. [PubMed 17055947]

11. Novartis, East Hanover, NJ: Personal communication.

12. Stanton A, Jensen C, Nussberger J et al. Blood pressure lowerirng in essential hypertension with an oral renin inhibitor, aliskiren. Hypertension. 2003; 42:1137-43. [PubMed 14597641]

13. Waldmeier F, Glaenzel U, Wirz B et al. Absorption, distribution, metabolism, and elimination of the direct Renin inhibitor aliskiren in healthy volunteers. Drug Metab Dispos. 2007; 35:1418-28. [PubMed 17510248]

14. Nussberger J, Wuerzner G, Jensen C et al. Angiotensin II suppression in humans by the orally active renin inhibitor aliskiren (SPP100): comparison with enalapril. Hypertension. 2002; 39:E1-8. [PubMed 11799102]

15. Oparil S, Yarows SA, Patel S et al. Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial. Lancet. 2007; 370:221-9. [PubMed 17658393]

16. Vaidyanathan S, Bigler H, Yeh CM et al. Pharmacokinetics of the oral direct renin inhibitor aliskiren alone and in combination with irbesartan in renal impairment. Clin Pharmacokinet. 2007; 46:661-75. [PubMed 17655373]

17. Vaidyanathan S, Reynolds C, Yeh CM et al. Pharmacokinetics, safety, and tolerability of the novel oral direct renin inhibitor aliskiren in elderly healthy subjects. J Clin Pharmacol. 2007; 47:453-60. [PubMed 17389554]

18. Vaidyanathan S, Warren V, Yeh CM et al. Pharmacokinetics, safety, and tolerability of the oral renin inhibitor aliskiren in patients with hepatic impairment. J Clin Pharmacol. 2007; 47:192-200. [PubMed 17244770]

19. Dieterle W, Corynen S, Mann J. Effect of the oral renin inhibitor aliskiren on the pharmacokinetics and pharmacodynamics of a single dose of warfarin in healthy subjects. Br J Clin Pharmacol. 2004; 58:433-6. [PubMed 15373937]

20. Vaidyanathan S, Valencia J, Kemp C et al. Lack of pharmacokinetic interactions of aliskiren, a novel direct renin inhibitor for the treatment of hypertension, with the antihypertensives amlodipine, valsartan, hydrochlorothiazide (HCTZ) and ramipril in healthy volunteers. Int J Clin Pract. 2006; 60:1343-56. [PubMed 17073832]

21. Dieterle W, Corynen S, Vaidyanathan S et al. Pharmacokinetic interactions of the oral renin inhibitor aliskiren with lovastatin, atenolol, celecoxib and cimetidine. Int J Clin Pharmacol Ther. 2005; 43:527-35. [PubMed 16300168]

More Tekturna resources

• Tekturna Side Effects (in more detail)
• Tekturna Dosage
• Tekturna Use in Pregnancy & Breastfeeding
• Drug Images
• Tekturna Drug Interactions
• Tekturna Support Group
• 23 Reviews for Tekturna - Add your own review/rating

• Tekturna Prescribing Information (FDA)


• Tekturna Consumer Overview


• Tekturna Advanced Consumer (Micromedex) - Includes Dosage Information


• Tekturna MedFacts Consumer Leaflet (Wolters Kluwer)


• Aliskiren Professional Patient Advice (Wolters Kluwer)

Compare Tekturna with other medications

• High Blood Pressure

Ketocon

Dosage Form: cream/gel
Ketocon

Ketocon Description

Ketoconazole cream, 2% contains the broad-spectrum synthetic antifungal agent, Ketoconazole 2%, formulated in an aqueous cream vehicle consisting of butylated hydroxyanisole (BHA), cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.

Ketoconazole is cis - 1 - acetyl - 4 - [4 - [[2 - (2,4 - dichlorophenyl) - 2 - (1H - imidazol - 1 - ylmethyl) - 1,3 - dioxolan - 4 - yl]methoxy]phenyl] piperazine and has the following structural formula:

Molecular Formula: C26H28CI2N4O4

Molecular Weight: 531.43

Ketocon - Clinical Pharmacology

When Ketoconazole cream, 2% was applied dermally to intact or abraded skin of beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/mL.

After a single topical application to the chest, back and arms of normal volunteers, systemic absorption of Ketoconazole was not detected at the 5 ng/mL level in blood over a 72-hour period.

Two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to Ketoconazole cream, 2%.

Microbiology: Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare). Only those organisms listed in the INDICATIONS AND USAGE section have been proven to be clinically affected. Development of resistance to Ketoconazole has not been reported.

Mode of Action: In vitro studies suggest that Ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. It is postulated that the therapeutic effect of Ketoconazole in seborrheic dermatitis is due to the reduction of M. ovale, but this has not been proven.

Indications and Usage for Ketocon

Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.

Contraindications

Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Warnings

Ketoconazole cream, 2% is not for ophthalmic use.

Precautions

General: If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. Hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered Ketoconazole; these effects have not been seen with topical Ketoconazole.

Carcinogenesis, Mutagenesis, Impairment of Fertility: A long-term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of Ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames’ salmonella microsomal activator assay was also negative.

Pregnancy: Teratogenic effects: Pregnancy Category C: Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.

There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether Ketoconazole cream, 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in children have not been established.

Adverse Reactions

During clinical trials 45 (5.0%) of 905 patients treated with Ketoconazole cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with Ketoconazole cream developed a painful allergic reaction.

In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with Ketoconazole cream or one of its excipients, namely propylene glycol.

Ketocon Dosage and Administration

Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor: It is recommended that Ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment.


Seborrheic dermatitis: Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until clinical clearing.


If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.

How is Ketocon Supplied

Ketoconazole cream, 2% is supplied in 60 g (NDC 23589-054-60) tubes.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].


Manufactured by:

Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1


Manufactured for:

TIBER LABORATORIES, Suwanee, GA 30024

Issued: April, 2010

Ketocon  Ketoconazole, hydrocortisone  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 23589-073

Packaging # NDC Package Description Multilevel Packaging 1 23589-073-91 1 KIT In 1 PACKAGE, COMBINATION None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 TUBE   60 g Part 2 1 TUBE   42.53 g

Part 1 of 2 KetoconAZOLE  Ketoconazole  cream

Product Information NDC Product Code (Source) 23589-054     Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KetoconAZOLE (KetoconAZOLE) KetoconAZOLE 20 mg  in 1 g

Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE   CETYL ALCOHOL   ISOPROPYL MYRISTATE   POLYSORBATE 60   POLYSORBATE 80   PROPYLENE GLYCOL   WATER   SORBITAN MONOSTEARATE   STEARYL ALCOHOL

Product Characteristics Color white Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 23589-054-60 1 TUBE In 1 CARTON contains a TUBE 1 60 g In 1 TUBE This package is contained within the CARTON (23589-054-60)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075638 04/06/2011 06/30/2012

Part 2 of 2 HYDROCORTISONE  hydrocortisone  gel

Product Information NDC Product Code (Source) 23589-063     Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES   MENTHOL   POLYOXYL 35 CASTOR OIL   PROPYLENE GLYCOL   WATER   ALCOHOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 23589-063-42 42.53 g In 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/06/2011 06/30/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075638	04/06/2011	06/30/2012

Labeler - Tiber Laboratories, LLC (008913939)

Revised: 11/2011Tiber Laboratories, LLC

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Ferrous Fumarate Controlled-Release Tablets

Pronunciation: FER-us FYOO-ma-rate
Generic Name: Ferrous Fumarate
Brand Name: Generic only. No brands available.

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Ferrous Fumarate Controlled-Release Tablets are used for:

Preventing or treating low levels of iron in the blood. It also may be used to treat other conditions as determined by your doctor.

Ferrous Fumarate Controlled-Release Tablets are an essential body mineral. It works by replacing iron in your body if your body does not produce enough on its own.

Do NOT use Ferrous Fumarate Controlled-Release Tablets if:

• you are allergic to any ingredient in Ferrous Fumarate Controlled-Release Tablets


• you have high levels of iron in your blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ferrous Fumarate Controlled-Release Tablets:

Some medical conditions may interact with Ferrous Fumarate Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have inflammation of the colon, Crohn disease, digestive problems, ulcers, certain types of anemia, or a blood disease such as porphyria


• if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Ferrous Fumarate Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Doxycycline, mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because the effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ferrous Fumarate Controlled-Release Tablets 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.

How to use Ferrous Fumarate Controlled-Release Tablets:

Use Ferrous Fumarate Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ferrous Fumarate Controlled-Release Tablets are absorbed better on an empty stomach, but may be taken with food if it upsets your stomach.


• If you are also taking a bisphosphonate (eg, alendronate), cephalosporin (eg, cephalexin), penicillamine, quinolone (eg, ciprofloxacin), or tetracycline (eg, minocycline) along with Ferrous Fumarate Controlled-Release Tablets, you may need to space the doses several hours apart. Ask your doctor or pharmacist how much time is needed between doses of Ferrous Fumarate Controlled-Release Tablets and your other medicines.


• Do not take Ferrous Fumarate Controlled-Release Tablets within 1 hour before or 2 hours after antacids, eggs, whole grain breads or cereal, milk, milk products, coffee, or tea.


• Take Ferrous Fumarate Controlled-Release Tablets with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Ferrous Fumarate Controlled-Release Tablets.


• Ferrous Fumarate Controlled-Release Tablets must be swallowed whole. Do not break, crush, or chew before swallowing.


• If you miss a dose of Ferrous Fumarate Controlled-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ferrous Fumarate Controlled-Release Tablets.

Important safety information:

• Do not take large doses of vitamins (megadoses or megavitamin therapy) unless otherwise directed by your doctor.


• Do not take Ferrous Fumarate Controlled-Release Tablets for longer than 6 months without checking with your doctor.


• Ferrous Fumarate Controlled-Release Tablets contains iron. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. In case of accidental overdose, call a doctor or poison control center immediately.


• LAB TESTS, including blood tests and iron levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Ferrous Fumarate Controlled-Release Tablets with extreme caution in CHILDREN. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Ferrous Fumarate Controlled-Release Tablets during pregnancy. Ferrous Fumarate Controlled-Release Tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Ferrous Fumarate Controlled-Release Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Ferrous Fumarate Controlled-Release Tablets:

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; green stools; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.

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: Ferrous Fumarate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include loss of consciousness; difficulty breathing; seizures; severe nausea; stomach pain; tarry stools; unusual tiredness; vomiting; weak, fast heartbeat.

Proper storage of Ferrous Fumarate Controlled-Release Tablets:

Store Ferrous Fumarate Controlled-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ferrous Fumarate Controlled-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Ferrous Fumarate Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Ferrous Fumarate Controlled-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ferrous Fumarate Controlled-Release Tablets. 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.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Zirgan

ganciclovir

Dosage Form: ophthalmic gel
FULL PRESCRIBING INFORMATION

Indications and Usage for Zirgan

Zirgan (ganciclovir ophthalmic gel) 0.15% is indicated for the treatment of acute herpetic keratitis (dendritic ulcers).

Zirgan Dosage and Administration

The recommended dosing regimen for Zirgan is 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals, and then 1 drop 3 times per day for 7 days.

Dosage Forms and Strengths

Zirgan contains 0.15% of ganciclovir in a sterile preserved topical ophthalmic gel.

Contraindications

None.

Warnings and Precautions

Topical Ophthalmic Use Only

Zirgan is indicated for topical ophthalmic use only.

Avoidance of Contact Lenses

Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with Zirgan.

Adverse Reactions

Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

USE IN SPECIFIC POPULATIONS

Pregnancy: Teratogenic Effects

Pregnancy Category C. Ganciclovir has been shown to be embryotoxic in rabbits and mice following intravenous administration and teratogenic in rabbits. Fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (approximately 10,000x and 17,000x the human ocular dose of 6.25 mcg/kg/day), respectively, assuming complete absorption. Effects observed in rabbits included: fetal growth retardation, embryolethality, teratogenicity, and/or maternal toxicity. Teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly, and brachygnathia. In mice, effects observed were maternal/fetal toxicity and embryolethality. Daily intravenous doses of 90 mg/kg/day (14,000x the human ocular dose) administered to female mice prior to mating, during gestation, and during lactation caused hypoplasia of the testes and seminal vesicles in the month-old male offspring, as well as pathologic changes in the nonglandular region of the stomach (see Carcinogenesis, Mutagenesis, and Impairment of Fertility).

There are no adequate and well-controlled studies in pregnant women. Zirgan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether topical ophthalmic ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when Zirgan is administered to nursing mothers.

Pediatric Use

Safety and efficacy in pediatric patients below the age of 2 years have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Zirgan Description

Zirgan (ganciclovir ophthalmic gel) 0.15% contains a sterile, topical antiviral for ophthalmic use. The chemical name is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine (CAS number 82410-32-0). Ganciclovir is represented by the following structural formula:

Ganciclovir has a molecular weight of 255.23, and the empirical formula is C9H13N5O4.

Each gram of gel contains: ACTIVE: ganciclovir 1.5 mg (0.15%). INACTIVES: carbopol, water for injection, sodium hydroxide (to adjust the pH to 7.4), mannitol. PRESERVATIVE: benzalkonium chloride 0.075 mg.

Zirgan - Clinical Pharmacology

Mechanism of Action

Zirgan (ganciclovir ophthalmic gel) 0.15% contains the active ingredient, ganciclovir, which is a guanosine derivative that, upon phosphorylation, inhibits DNA replication by herpes simplex viruses (HSV). Ganciclovir is transformed by viral and cellular thymidine kinases (TK) to ganciclovir triphosphate, which works as an antiviral agent by inhibiting the synthesis of viral DNA in 2 ways: competitive inhibition of viral DNA-polymerase and direct incorporation into viral primer strand DNA, resulting in DNA chain termination and prevention of replication.

Pharmacokinetics

The estimated maximum daily dose of ganciclovir administered as 1 drop, 5 times per day is 0.375 mg. Compared to maintenance doses of systemically administered ganciclovir of 900 mg (oral valganciclovir) and 5 mg/kg (IV ganciclovir), the ophthalmically administered daily dose is approximately 0.04% and 0.1% of the oral dose and IV doses, respectively, thus minimal systemic exposure is expected.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Ganciclovir was carcinogenic in the mouse at oral doses of 20 and 1,000 mg/kg/day (approximately 3,000x and 160,000x the human ocular dose of 6.25 mcg/kg/day, assuming complete absorption). At the dose of 1,000 mg/kg/day there was a significant increase in the incidence of tumors of the preputial gland in males, forestomach (nonglandular mucosa) in males and females, and reproductive tissues (ovaries, uterus, mammary gland, clitoral gland, and vagina) and liver in females. At the dose of 20 mg/kg/day, a slightly increased incidence of tumors was noted in the preputial and harderian glands in males, forestomach in males and females, and liver in females. No carcinogenic effect was observed in mice administered ganciclovir at 1 mg/kg/day (160x the human ocular dose). Except for histocytic sarcoma of the liver, ganciclovir-induced tumors were generally of epithelial or vascular origin. Although the preputial and clitoral glands, forestomach and harderian glands of mice do not have human counterparts, ganciclovir should be considered a potential carcinogen in humans. Ganciclovir increased mutations in mouse lymphoma cells and DNA damage in human lymphocytes in vitro at concentrations between 50 to 500 and 250 to 2,000 mcg/mL, respectively.

In the mouse micronucleus assay, ganciclovir was clastogenic at doses of 150 and 500 mg/kg (IV) (24,000x to 80,000x human ocular dose) but not 50 mg/kg (8,000x human ocular dose). Ganciclovir was not mutagenic in the Ames Salmonella assay at concentrations of 500 to 5,000 mcg/mL.

Ganciclovir caused decreased mating behavior, decreased fertility, and an increased incidence of embryolethality in female mice following intravenous doses of 90 mg/kg/day (approximately 14,000x the human ocular dose of 6.25 mcg/kg/day). Ganciclovir caused decreased fertility in male mice and hypospermatogenesis in mice and dogs following daily oral or intravenous administration of doses ranging from 0.2 to 10 mg/kg (30x to 1,600x the human ocular dose).

Clinical Studies

In one open-label, randomized, controlled, multicenter clinical trial which enrolled 164 patients with herpetic keratitis, Zirgan was non-inferior to acyclovir ophthalmic ointment, 3% in patients with dendritic ulcers. Clinical resolution (healed ulcers) at Day 7 was achieved in 77% (55/71) for Zirgan versus 72% (48/67) for acyclovir 3% (difference 5.8%, 95% CI -9.6%-18.3%). In three randomized, single-masked, controlled, multicenter clinical trials which enrolled 213 total patients, Zirgan was non‑inferior to acyclovir ophthalmic ointment 3% in patients with dendritic ulcers. Clinical resolution at Day 7 was achieved in 72% (41/57) for Zirgan versus 69% (34/49) for acyclovir (difference 2.5%, 95% CI -15.6%-20.9%).

How Supplied/Storage and Handling

Zirgan is supplied as 5 grams of a sterile, preserved, clear, colorless, topical ophthalmic gel containing O.15% of ganciclovir in a polycoated aluminum tube with a white polyethylene tip and cap and protective band (NDC 24208-535-35).

Storage

Store at 15°C-25°C (59°F-77°F). Do not freeze.

Patient Counseling Information

This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the gel. If pain develops, or if redness, itching, or inflammation becomes aggravated, the patient should be advised to consult a physician. Patients should be advised not to wear contact lenses when using Zirgan.

Revised: June 2010

Zirgan is a trademark of Laboratoires Théa Corporation licensed by Bausch & Lomb Incorporated.

Bausch & Lomb Incorporated

Tampa, FL 33637

© Bausch & Lomb Incorporated

9187201

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

NDC 24208-535-35

Zirgan®

ganciclovir ophthalmic gel

0.15%

Rx only

5 gm

Sterile

Bausch & Lomb

Zirgan  ganciclovir  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24208-535 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GANCICLOVIR (GANCICLOVIR) GANCICLOVIR 1.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)   BENZALKONIUM CHLORIDE   MANNITOL   WATER   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24208-535-35 1 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 1 5 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (24208-535-35) 2 24208-535-32 1 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 2 1 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (24208-535-32)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022211	04/30/2010

Labeler - Bausch & Lomb Incorporated (196603781)

Revised: 06/2010Bausch & Lomb Incorporated

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T-Athlete

Generic Name: tolnaftate topical (toll NAF tate)

Brand Names: Absorbine Athletes Foot, Absorbine Jr. Antifungal, Aftate For Athletes Foot, Blis-To-Sol, Desenex Spray, Fungatin, Fungi-Guard, Genaspor, Hongos, NP 27, Podactin, T-Athlete, Tinactin, Tinaspore, Ting

What is T-Athlete (tolnaftate topical)?

Tolnaftate topical is an antifungal medication. Tolnaftate topical prevents fungus from growing on the skin.

Tolnaftate topical is used to treat skin infections such as athlete's foot, jock itch, and ringworm infections. Tolnaftate is also used, along with other antifungals, to treat infections of the nails, scalp, palms, and soles of the feet. The powder and powder aerosol may be used to prevent athlete's foot.

Tolnaftate topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about T-Athlete (tolnaftate topical)?

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in the eyes, nose, or mouth.

What should I discuss with my healthcare provider before using T-Athlete (tolnaftate topical)?

Do not use tolnaftate topical if you have had an allergic reaction to it in the past.

It is not known whether tolnaftate topical will be harmful to an unborn baby. Do not use tolnaftate topical without first talking to your doctor if you are pregnant. It is not known whether tolnaftate topical passes into breast milk. Do not use tolnaftate topical without first talking to your doctor if you are breast-feeding a baby.

How should I use T-Athlete (tolnaftate topical)?

Use tolnaftate topical exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the gel, cream, lotion, spray, or powder twice daily as directed for 2 to 6 weeks.

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 10 days or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in the eyes, nose, or mouth. Store tolnaftate topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the dose you missed and apply only the regular amount of tolnaftate topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of tolnaftate topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that tolnaftate topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using T-Athlete (tolnaftate topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

T-Athlete (tolnaftate topical) side effects

Serious side effects of tolnaftate topical use are not expected to occur. Stop using tolnaftate topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect T-Athlete (tolnaftate topical)?

Other skin medications may affect the absorption or effectiveness of tolnaftate topical. Avoid using other topicals at the same time except under the direction of a doctor.

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• Tinea Corporis
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Where can I get more information?

• Your pharmacist has additional information about tolnaftate topical written for health professionals that you may read.

See also: T-Athlete side effects (in more detail)

Vicks 44 Cold, Flu and Cough

Generic Name: acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine (a SEET a MIN oh fen, KLOR fen EER a meen, DEX troe meth OR fan, SOO doe ee FED rin)

Brand Names: Alka-Seltzer Plus Cough and Cold Liquigel, Children's Tylenol Flu, Comtrex Cold and Flu Maximum Strength Liquid, Comtrex Cold and Flu Maximum Strength Tablet, Robitussin Flu, Robitussin Honey Flu Nighttime, Theraflu (pseudoephedrine) Cold & Cough, Theraflu Flu & Cough, Theraflu Night Cough and Cold and Flu, Theraflu Nightime Maximum Strength, Theraflu Severe Cold & Congestion, Triaminic Cold and Fever, Triaminic Flu, Cough & Fever, Vicks 44 Cold, Flu and Cough, Vicks Formula 44M

What is Vicks 44 Cold, Flu and Cough (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

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

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Dextromethorphan will not treat a cough that is caused by smoking.

Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medication?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Do not use this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.

What should I discuss with my healthcare provider before taking this medication?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use a cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

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  liver disease, cirrhosis, or a history of alcoholism;

  
  


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  a blockage in your digestive tract (stomach or intestines);

  
  


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  diabetes;

  
  


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  kidney disease;

  
  


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  epilepsy or other seizure disorder;

  
  


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  cough with mucus, or cough caused by emphysema or chronic bronchitis;

  
  


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  enlarged prostate or urination problems;

  
  


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  pheochromocytoma (an adrenal gland tumor); or

  
  


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  if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

  
  

It is not known whether acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use cold medicine without medical advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Do not use cold medicine without medical advice if you are breast-feeding a baby.

How should I take Vicks 44 Cold, Flu and Cough (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

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

The chewable tablet must be chewed thoroughly before you swallow it.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Do not give this medication to a child younger than 4 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 take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since cold medicine is taken when 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking this medication?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

This medication 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 a serious side effect such as:

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  fast or pounding heartbeats, severe restless feeling or nervousness;

  
  


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  mood changes, confusion, hallucinations, unusual thoughts or behavior;

  
  


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  tremor, seizure (convulsions);

  
  


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  easy bruising or bleeding, unusual weakness;

  
  


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  urinating less than usual or not at all;

  
  


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  feeling short of breath;

  
  


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  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


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  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

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  dizziness, drowsiness;

  
  


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  dry mouth, nose, or throat;

  
  


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  constipation or diarrhea;

  
  


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  blurred vision; or

  
  


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  feeling nervous or restless.

  
  

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 Vicks 44 Cold, Flu and Cough (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by chlorpheniramine.

Tell your doctor about all other medicines you use, especially:

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  leflunomide (Arava);

  
  


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  topiramate (Topamax);

  
  


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  zonisamide (Zonegran);

  
  


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  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


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  an antidepressant;

  
  


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  birth control pills or hormone replacement therapy;

  
  


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  bladder or urinary medications;

  
  


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  blood pressure medication;

  
  


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  a bronchodilator;

  
  


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  cancer medicine;

  
  


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  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


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  gout or arthritis medications (including gold injections);

  
  


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  HIV/AIDS medication;

  
  


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  medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;

  
  


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  medicines to treat psychiatric disorders;

  
  


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  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


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  seizure medication.

  
  

This list is not complete and other drugs may interact with acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Vicks 44 Cold, Flu and Cough resources

• Vicks 44 Cold, Flu and Cough Side Effects (in more detail)
• Vicks 44 Cold, Flu and Cough Use in Pregnancy & Breastfeeding
• Vicks 44 Cold, Flu and Cough Drug Interactions
• Vicks 44 Cold, Flu and Cough Support Group
• 1 Review for Vicks 44 Cold, Flu and Cough - Add your own review/rating

• Vicks Formula 44M Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Vicks 44 Cold, Flu and Cough with other medications

• Cold Symptoms
• Influenza

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine.

See also: Vicks 44 Cold, Flu and Cough side effects (in more detail)