Naftin Topical

Generic Name: naftifine (Topical route)

NAF-ti-feen

Commonly used brand name(s)

In the U.S.

• Naftin


• Naftin-MP

Available Dosage Forms:

• Gel/Jelly


• Cream

Therapeutic Class: Antifungal

Chemical Class: Allylamine

Uses For Naftin

Naftifine is used to treat fungus infections. It works by killing the fungus or preventing its growth.

Naftifine is applied to the skin to treat:

• athlete's foot (ringworm of the foot; tinea pedis);


• jock itch (ringworm of the groin; tinea cruris); and


• ringworm of the body (tinea corporis).

This medicine may also be used for other fungus infections of the skin as determined by your doctor.

Naftifine is available with or without your doctor's prescription.

Before Using Naftin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 this medicine have been done only in adult patients, and there is no specific information comparing use of naftifine 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 or if they cause different side effects or problems in older people. There is no specific information comparing use of naftifine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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.

Proper Use of naftifine

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

Keep this medicine away from the eyes and mucous membranes such as the inside of the nose, mouth, or vagina.

The area to which you have applied naftifine should not be covered with an occlusive dressing (airtight covering such as plastic wrap or bandage) unless otherwise directed by your doctor.

To use:

• Apply enough naftifine to cover the affected skin and surrounding areas, and rub in gently.


• After applying naftifine, wash your hands to remove any medicine that may be on them.

To help clear up your skin infection completely, keep using naftifine for the full time of treatment. You should keep using this medicine for 1 to 2 weeks after your symptoms have disappeared. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

Dosing

The dose of this medicine 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 this medicine. 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 fungus infections:
  
  • For cream dosage form:
    
    • Adults—Apply to the affected area(s) of the skin once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For gel dosage form:
    
    • Adults—Apply to the affected area(s) of the skin two times a day, morning and evening.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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.

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.

Precautions While Using Naftin

If your skin infection does not improve within 4 weeks, or if it becomes worse, check with your doctor.

To help clear up your skin infection completely and to help make sure it does not return, the following good health habits are important:

• For patients using naftifine for athlete's foot , these measures will help keep the feet cool and dry:
  
  • Carefully dry the feet, especially between the toes, after bathing.
  
  
  • Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if your feet sweat very much.
  
  
  • Wear well-ventilated shoes (for example, shoes with holes on top or on the side) or sandals.
  
  
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder freely between the toes, on the feet, and in socks and shoes once or twice a day. Be sure to use the powder after naftifine has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.
  
  


• For patients using naftifine for jock itch, these measures will help reduce chafing and irritation and will also help keep the groin area cool and dry:
  
  • Carefully dry the groin area after bathing.
  
  
  • Avoid wearing underwear that is tight-fitting or made from synthetic materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.
  
  
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder freely once or twice a day. Be sure to use the powder after naftifine has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.
  
  


• For patients using naftifine for ringworm of the body, these measures will help keep the affected areas cool and dry:
  
  • Carefully dry yourself after bathing.
  
  
  • Avoid too much heat and humidity if possible. Try to keep moisture from building up on affected areas of the body.
  
  
  • Wear well-ventilated clothing.
  
  
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder freely once or twice a day. Be sure to use the powder after naftifine has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.
  
  

If you have any questions about this, check with your health care professional.

Naftin 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.

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

• Burning or stinging feeling on treated area(s)

Less common

• Dry skin


• itching, redness, or other sign of skin irritation not present before use of this medicine

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.

See also: Naftin Topical side effects (in more detail)

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• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Hydrocortisone 1% In Absorbase

Generic Name: hydrocortisone topical (hye droe KOR ti sone)

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

What is Hydrocortisone 1% In Absorbase (hydrocortisone topical)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

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

What is the most important information I should know about Hydrocortisone 1% In Absorbase (hydrocortisone topical)?

There are many brands and forms of hydrocortisone topical available and not all brands are listed on this leaflet.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using Hydrocortisone 1% In Absorbase (hydrocortisone topical)?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone topical 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. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use Hydrocortisone 1% In Absorbase (hydrocortisone topical)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Hydrocortisone 1% In Absorbase (hydrocortisone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Hydrocortisone 1% In Absorbase (hydrocortisone topical) 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 hydrocortisone topical and call your doctor at once if you have any of these serious side effects:

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  feeling tired.

  
  

Less serious side effects may include:

• 
  

  skin redness, burning, itching, or peeling;

  
  


• 
  

  thinning of your skin;

  
  


• 
  

  blistering skin; or

  
  


• 
  

  stretch marks.

  
  

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 Hydrocortisone 1% In Absorbase (hydrocortisone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. 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 Hydrocortisone 1% In Absorbase resources

• Hydrocortisone 1% In Absorbase Side Effects (in more detail)
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• 0 Reviews for Hydrocortisone% In Absorbase - Add your own review/rating

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• Hydrocortisone Acetate Monograph (AHFS DI)


• Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hytone Prescribing Information (FDA)


• Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Lipocream Prescribing Information (FDA)


• Locoid Lotion Prescribing Information (FDA)


• Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Pandel Prescribing Information (FDA)


• Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctocort Prescribing Information (FDA)


• Texacort Prescribing Information (FDA)


• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

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• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Hemorrhoids
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone topical.

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Letrozole

Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: 4,4′-(1H-1,2,4-triazol-1-ylmethylene)bis-benzonitrile
Molecular Formula: C₁₇H₁₁N₅
CAS Number: 112809-51-5
Brands: Femara

Introduction

Antineoplastic agent; selective aromatase inhibitor.^{1 2 3 6 11 13 15}

Uses for Letrozole

Breast Cancer

Adjuvant treatment in postmenopausal women with ER-positive early breast cancer.^{a c} Efficacy based on analysis of disease-free survival in women treated with letrozole for a median of 24 months.^a Follow-up analysis needed to determine long-term safety and efficacy.^a

Extended adjuvant treatment in postmenopausal women with early-stage breast cancer who have received 5 years of adjuvant tamoxifen therapy.^{a 9 25 38} Efficacy based on analysis of disease-free survival in women treated with letrozole for a median of 24 months.^a Further data needed to determine long-term outcome.^a

First-line therapy for hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer in postmenopausal women; superior to tamoxifen in producing objective tumor response and delaying tumor progression.^{1 9 18 20}

Second-line therapy for advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy (e.g., tamoxifen).^{1 9 10}

Female Infertility

Has been used to induce ovulation† in anovulatory women desiring pregnancy.^d Letrozole is not approved by FDA for this indication;^e manufacturer states that the drug should not be given to women who may become or are pregnant.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Letrozole Dosage and Administration

General

• 
  

  Administration of corticosteroid replacement therapy not necessary.¹ (See Actions.)

  
  

Administration

Oral Administration

Administer orally once daily without regard to meals.¹

Dosage

Adults

Breast Cancer

Adjuvant Treatment of Early-stage Breast Cancer

Oral

2.5 mg once daily.^a Optimal duration unknown.^a Planned duration of treatment in clinical study was 5 years; median duration of treatment at time of analysis was 24 months; median duration of follow-up was 26 months.^a Discontinue if relapse occurs.^a

Extended Adjuvant Treatment of Early-stage Breast Cancer

Oral

2.5 mg once daily.^a Optimal duration unknown.^a Planned duration of treatment in clinical study was 5 years; median duration of treatment at time of analysis was 24 months; median duration of follow-up was 28 months.^a Discontinue if relapse occurs.^a

First-line Treatment of Locally Advanced or Metastatic Breast Cancer

Oral

2.5 mg once daily.¹ Continue therapy until tumor progresses.¹

Second-line Treatment of Advanced Breast Cancer

Oral

2.5 mg once daily.¹ Continue therapy until tumor progresses.¹

Special Populations

Hepatic Impairment

Cirrhosis and severe hepatic impairment (Child-Pugh class C): Decrease dosage to 2.5 mg every other day.¹

Mild to moderate hepatic impairment: No dosage adjustment recommended.¹

Renal Impairment

Cl_cr ≥10 mL/minute: No dosage adjustment necessary.¹

Geriatric Patients

No dosage adjustment necessary.¹

Cautions for Letrozole

Contraindications

• 
  

  Known hypersensitivity to letrozole or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.¹ Embryotoxic, fetotoxic, and teratogenic in animals.¹ If inadvertently used during pregnancy or patient becomes pregnant, apprise of fetal hazard and potential risk of pregnancy loss.¹

General Precautions

CNS Effects

Fatigue and dizziness reported; somnolence reported uncommonly.¹ Caution advised when driving or using machinery.¹

Hepatic Effects

Abnormal liver function test results not associated with documented liver metastases reported in women receiving second-line therapy.¹

Lipid Effects

Increases in total serum cholesterol reported in women receiving adjuvant treatment.^a

Effects on Bone

Risk of osteoporosis.^{a 29} Use of letrozole in women receiving calcium and vitamin D who were not receiving bisphosphonates has been associated with loss of bone mineral density (BMD) in the hip and/or lumbar spine.^a Consider monitoring BMD.^{29 37 a}

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether letrozole is distributed into human milk; caution advised.¹

Pediatric Use

Safety and efficacy not established in children of any age.¹

Geriatric Use

No substantial differences in safety or efficacy relative to younger patients when used for adjuvant therapy.^a Possibility exists of greater sensitivity in some older individuals.^a

In all studies of first- and second-line treatment, median patient age was 64–65 years; one-third were ≥70 years of age.¹ In the first-line clinical study, patients ≥70 years of age experienced longer time to tumor progression and higher response rates than patients <70 years of age.¹

Premenopausal Women

Not approved by FDA for use in premenopausal women.^{a e}

Hepatic Impairment

Dosage reduction recommended in patients with cirrhosis and severe hepatic impairment.¹ Effect of hepatic impairment on drug exposure in noncirrhotic cancer patients with increased bilirubin concentrations not determined.¹

Common Adverse Effects

Bone pain, hot flushes, back pain, nausea, arthralgia, dyspnea.¹

Interactions for Letrozole

Metabolized by CYP3A4 and CYP2A6.¹ Inhibits CYP2A6 and, to a lesser extent, CYP2C19 in vitro.¹

Specific Drugs

Drug	Interaction	Comments
Antineoplastic agents	No clinical experience with concomitant use to date1
Cimetidine	No clinically important effect on letrozole pharmacokinetics1
Diazepam	No substantial effect on letrozole or diazepam metabolism in vitro1
Estrogens	Antagonistic pharmacologic effectsb	Concomitant use not recommendedb
Tamoxifen	Decreased plasma letrozole concentrations1	Therapeutic effect of letrozole not impaired if used immediately after tamoxifen1
Warfarin	No clinically important effects on warfarin pharmacokinetics1

Letrozole Pharmacokinetics

Absorption

Bioavailability

Rapidly and completely absorbed after oral administration.¹

Onset

Plasma estradiol, estrone, and estrone sulfate reduced by 75–95% within 2–3 days with daily dosages of 0.1–5 mg.¹

Duration

Estrogen suppression maintained throughout therapy in patients receiving ≥0.5 mg daily.¹

Food

Food does not affect absorption.¹

Distribution

Extent

Not known if distributed into milk.¹

Plasma Protein Binding

Weakly bound.¹

Elimination

Metabolism

Principally metabolized to inactive carbinol metabolite by CYP3A4 and CYP2A6.¹

Elimination Route

Excreted in urine as glucuronide of carbinol metabolite (≥75%), unidentified metabolites (about 9%), and unchanged drug (6%).¹

Half-life

2 days.¹

Special Populations

Renal function did not affect the pharmacokinetics of a single 2.5-mg dose in adults with varying renal function.¹ Renal impairment (Cl_cr 20–50 mL/minute) did not affect steady-state plasma concentrations in patients with advanced breast cancer.¹

AUC was increased twofold and clearance was decreased in adults with cirrhosis and severe hepatic impairment (Child-Pugh class C); higher letrozole concentrations are expected in breast cancer patients with severe hepatic impairment compared with patients with normal liver function.¹

AUC was increased (37%) in adults with moderate hepatic impairment (e.g., cirrhosis, Child-Pugh class A and B); drug exposure was within range observed in patients without hepatic impairment.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Selectively inhibits conversion of androgens to estrogens.^{1 2 6}

  
  


• 
  

  Decreased serum and tumor concentrations of estrogen inhibit breast tumor growth and delay disease progression.^{1 4}

  
  


• 
  

  Does not affect synthesis of adrenal corticosteroid, aldosterone, or thyroid hormone.^{1 6}

  
  

Advice to Patients

• 
  

  Risk of dizziness, fatigue, or somnolence; use caution when driving or operating machinery.¹

  
  


• 
  

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

  
  


• 
  

  Risk of osteoporosis.^{a 29} Life-style changes (e.g., weight-bearing exercise, abstinence from smoking, moderation of alcohol consumption) and dietary supplementation with calcium and vitamin D advised.^{25 29 37}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; warn of potential hazard to the fetus in cases of inadvertent exposure of pregnant women to letrozole.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.

Letrozole

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	2.5 mg	Femara	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.

Femara 2.5MG Tablets (NOVARTIS): 10/$188.98 or 30/$516.96

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 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Novartis. Femara (letrozole) tablets prescribing information. East Hanover, NJ; 2003 Feb.

2. Ingle JN, Johnson PA, Suman VJ et al. A randomized phase II trial of two dosage levels of letrozole as third-line hormonal therapy for women with metastatic breast carcinoma. Cancer. 1997; 80:218-24. [IDIS 391347] [PubMed 9217033]

3. Lonning PE. Aromatase inhibition for breast cancer treatment. Acta Oncol. 1996; 35(Suppl 5):38-43. [PubMed 9142963]

4. Higa GM, AlKhouri N. Anastrazole: a selective aromatase inhibitor for the treatment of breast cancer. Am J Health-Syst Pharm. 1998; 55:445-52. [IDIS 401376] [PubMed 9522927]

5. Winer EP, Morrow M, Osborne CK et al. Malignant tumors of the breast. In: DeVita VT Jr, Hellman S, Rosenberg SA eds. Cancer: principles and practice of oncology. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2001:1651-717.

6. Iveson TJ, Smith IE, Ahern J et al. Phase I study of the oral nonsteroidal aromatase inhibitor CGS 20267 in postmenopausal patients with advanced breast cancer. Cancer Res. 1993; 53:266-70. [IDIS 308191] [PubMed 8417819]

7. Dombernowsky P, Smith I, Falkson G et al. Letrozole, a new oral aromatase inhibitor for advanced breast cancer: double-blind randomized trial showing a dose effect and improved efficacy and tolerability compared with megestrol acetate. J Clin Oncol. 1998; 16:453-61. [IDIS 401174] [PubMed 9469328]

8. Gershanovich M, Chaudri HA, Campos D et al. Letrozole, a new oral aromatase inhibitor: randomised trial comparing 2.5 mg daily, 0.5 mg daily and aminoglutethimide in postmenopausal women with advanced breast cancer. Letrozole International Trial Group (AR/BC3). Ann Oncol. 1998; 9:639-45. [PubMed 9681078]

9. Breast cancer. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2004 May 19.

10. Anon. Toremifene and letrozole for advanced breast cancer. Med Lett Drugs Ther. 1998; 40:43-5. [PubMed 9580744]

11. Bisagni G, Scaglione F et al. Letrozole, a new non-steroidal aromatase inhibitor in treating postmenopausal patients with advanced breast cancer. A pilot study. Ann Oncol. 1996; 7:99-102.

12. Bhatnagar AS, Hausler A, Schieweck K et al. Highly selective inhibition of estrogen biosynthesis by CGS 20267, a new non-steroidal aromatase inhibitor. J Steroid Biochem Mol Biol. 1990; 37:1021-7. [PubMed 2149502]

13. Ibrahim NK, Budar AU. Aromatase inhibitors: current status. Am J Clin Oncol. 1995; 18:407-17. [IDIS 354571] [PubMed 7572758]

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

15. Smith IE. Pivotal trials of letrozole: a new aromatase inhibitor. Oncology. 1998; 12(Suppl 5):41-4. [PubMed 9556791]

16. Food and Drug Administration. Labeling and prescription drug advertising; content and format for labeling for human prescription drugs. 21 CFR Parts 201 and 202. Final Rule. [Docket No. 75N-0066] Fed Regist. 1979; 44:37434-67.

17. Department of Health and Human Services, Food and Drug Administration. Subpart B—Labeling requirements for prescription drugs and/or insulin. (21 CFR Ch. 1 (4-1-87 Ed.)). 1987:18-24.

18. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52. [PubMed 15529105]

19. Food and Drug Administration. Center for Drug Evaluation and Research: Application number 020726: Medical Reviews. From FDA web site.

20. Mouridsen H, Gershanovich M, Sun Y et al. Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International Letrozole Breast Cancer Group. J Clin Oncol. 2001; 19:2596-606. [IDIS 464670] [PubMed 11352951]

21. Mouridsen H, Gershanovich M, Sun Y et al. Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group. J Clin Oncol. 2003; 21:2101-9. [IDIS 498882] [PubMed 12775735]

22. Buzdar A, Douma J, Davidson N et al. Phase III, multicenter, double-blind, randomized study of letrozole, an aromatase inhibitor, for advanced breast cancer versus megestrol acetate. J Clin Oncol. 2001; 19:3357-66. [IDIS 466492] [PubMed 11454883]

23. Dowsett M, Pfister C, Johnston SR et al. Impact of tamoxifen on the pharmacokinetics and endocrine effects of the aromatase inhibitor letrozole in postmenopausal women with breast cancer. Clin Cancer Res. 1999; 5:2338-43. [IDIS 432914] [PubMed 10499602]

24. Ingle JN, Suman VJ, Johnson PA et al. Evaluation of tamoxifen plus letrozole with assessment of pharmacokinetic interaction in postmenopausal women with metastatic breast cancer. Clin Cancer Res. 1999; 5:1642-9. [IDIS 431256] [PubMed 10430063]

25. Goss PE, Ingle JN, Martino S et al. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003; 349: 1793-802. [IDIS 506722] [PubMed 14551341]

26. Winer EP, Hudis C, Burstein HJ et al. American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for women with hormone receptor-positive breast cancer: status report 2002. J Clin Oncol. 2002; 20:3317-27. [IDIS 486566] [PubMed 12149306]

27. Bryant J, Wolmark N. Letrozole after tamoxifen for breast cancer;—what is the price of success? N Engl J Med. 2003; 349:1855-7. Editorial.

28. Burstein HJ. Beyond tamoxifen—extending endocrine treatment for early-stage breast cancer. N Engl J Med. 2003; 349:1857-9. [IDIS 506724] [PubMed 14551340]

29. Hilner BE, Ingle JN, Chelbowski RT et al. American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer. J Clin Oncol. 2003; 21:4042-57. [IDIS 513063] [PubMed 12963702]

30. Mackey JR, Joy AA. Letrozole in second-line therapy of advanced breast cancer: more questions than answers. J Clin Oncol. 2001; 19:4353-4. [IDIS 473674] [PubMed 11731524]

31. Buzdar AU, Chaudri HA, Trunet PF. Letrozole: which dose to be used? J Clin Oncol. 2000; 18:1802-3. Letter.

32. Simpson D, Curran MP, Perry CM. Letrozole: a review of its use in postmenopausal women with breast cancer. Drugs. 2004; 641:1213-30.

33. Geisler J, Haynes B, Anker G et al. Influence of letrozole and anastrozole on total body aromatization and plasma estrogen levels in postmenopausal breast cancer patients evaluated in a randomized, cross-over study. J Clin Oncol. 2002; 20:751-7. [IDIS 478622] [PubMed 11821457]

34. Rose C, Vtoraya O, Pluzanska A et al. An open randomised trial of second-line endocrine therapy in advanced breast cancer: comparison of the aromatase inhibitors letrozole and anastrozole. Eur J Cancer. 2003; 39:2318-27. [PubMed 14556923]

35. Twombly R. Critics question price of success in halted clinical trial of aromatase inhibitor letrozole. J Natl Cancer Inst. 2003; 95:1738-9. [PubMed 14652229]

36. Sperone P, Gorzegno G, Berruti A et al. Reversible pancytopenia caused by oral letrozole assumption in a patient with recurrent breast cancer. J Clin Oncol. 2002; 20:3747-8. [IDIS 485996] [PubMed 12202678]

37. Reviewers’ comments (personal observations).

38. Gilardi J, Fox K (Novartis). Femara gains U.S. FDA approval as only post-tamoxifen treatment for early breast cancer. Basel, Switzerland; 2004 Oct 29. Press release.

a. Novartis Pharmaceuticals Corporation. Femara (letrozole) tablets prescribing information. East Hanover, NJ; 2005 Dec.

b. Smith IE, Dowsett M. Aromatase inhibitors in breast cancer. N Engl J Med. 2003; 348:2431-42. [PubMed 12802030]

c. Thurlimann B, Keshaviah A, Coates AS et al. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005; 353:2747-57. [PubMed 16382061]

d. Holzer H, Casper R, Tulaudi T. A new era in ovulation induction. Fertil Seril. 2006; 85:277-84.

e. Hohneker JA and Prestifilippo J. Dear healthcare provider letter- Femara. East Hanover, NJ: Novartis Oncology; 2005 Dec 5.

More Letrozole resources

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

• Letrozole Prescribing Information (FDA)


• Letrozole MedFacts Consumer Leaflet (Wolters Kluwer)


• Letrozole Professional Patient Advice (Wolters Kluwer)


• letrozole Advanced Consumer (Micromedex) - Includes Dosage Information


• Femara Consumer Overview


• Femara Prescribing Information (FDA)

Compare Letrozole with other medications

• Breast Cancer
• Breast Cancer, Adjuvant
• Breast Cancer, Metastatic
• Female Infertility

chlorpheniramine/phenindamine/phenylpropanolamine

Generic Name: chlorpheniramine/phenindamine/phenylpropanolamine (klor fen IR a meen/fen in DA meen/fen ill proe pa NOLE a meen)

Brand Names: Amilon, Nolamine

What is chlorpheniramine/phenindamine/phenylpropanolamine?

Chlorpheniramine and phenindamine are antihistamines. They block the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine and phenindamine prevent sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal and respiratory (breathing) passages to open up.

Chlorpheniramine/phenindamine/phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Chlorpheniramine/phenindamine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about chlorpheniramine/phenindamine/phenylpropanolamine?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine/phenindamine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine/phenindamine/phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take chlorpheniramine/phenindamine/phenylpropanolamine?

Do not take chlorpheniramine/phenindamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure;

  
  


• 
  

  thyroid disease;

  
  


• 
  

  emphysema or chronic bronchitis; or

  
  


• 
  

  difficulty urinating or have an enlarged prostate.

  
  

You may not be able to take chlorpheniramine/phenindamine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Chlorpheniramine/phenindamine/phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from chlorpheniramine/phenindamine/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take chlorpheniramine/phenindamine/phenylpropanolamine?

Take chlorpheniramine/phenindamine/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow it whole. If you are unsure about the formulation of the medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of the medication.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take chlorpheniramine/phenindamine/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store chlorpheniramine/phenindamine/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a chlorpheniramine/phenindamine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.

What should I avoid while taking chlorpheniramine/phenindamine/phenylpropanolamine?

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine/phenindamine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine/phenindamine/phenylpropanolamine.

Chlorpheniramine/phenindamine/phenylpropanolamine side effects

Serious side effects are unlikely to occur. Stop taking chlorpheniramine/phenindamine/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine/phenindamine/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

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.

What other drugs will affect chlorpheniramine/phenindamine/phenylpropanolamine?

Do not take chlorpheniramine/phenindamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking chlorpheniramine/phenindamine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, phenindamine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Chlorpheniramine/phenindamine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine/phenindamine/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with chlorpheniramine/phenindamine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More chlorpheniramine/phenindamine/phenylpropanolamine resources

• Chlorpheniramine/phenindamine/phenylpropanolamine Drug Interactions
• Chlorpheniramine/phenindamine/phenylpropanolamine Support Group
• 0 Reviews for Chlorpheniramine/phenindamine/phenylpropanolamine - Add your own review/rating

Compare chlorpheniramine/phenindamine/phenylpropanolamine with other medications

• Cold Symptoms

Where can I get more information?

• Your pharmacist has additional information about chlorpheniramine/phenindamine/ phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Chlorpheniramine/phenindamine/phenylpropanolamine is available with a prescription under the brand name Nolamine. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 
  

  Nolamine 4 mg of chlorpheniramine, 24 mg of phenindamine and 50 mg of phenylpropanolamine--pink, round tablets

  
  

Capstar

Dosage Form: FOR ANIMAL USE ONLY
Capstar

Capstar®

(nitenpyram)              

Capstar® is an oral tablet for dogs, puppies, cats and kittens 4 weeks of age and older and 2 pounds of body weight or greater.

Active Ingredients

Capstar Tablets contain 11.4 or 57.0 mg of  nitenpyram, which belongs to the chemical class of neonicotinoids. Nitenpyram kills adult fleas.

Warnings

Not for human use. Keep this and all drugs out of the reach of children.

Directions

Capstar Tablets kill adult fleas and are indicated for the treatment of flea infestations on dogs, puppies, cats and kittens 4 weeks of age and older and 2 pounds of body weight or greater.

A single dose of Capstar should kill the adult fleas on your pet. If your pet gets re-infested with fleas, you can safely give another dose as often as once per day.  

To give Capstar Tablets, place the pill directly in your pet’s mouth or hide it in food. If you hide the pill in food, watch closely to make sure your pet swallows the pill. If you are not sure that your pet swallowed the pill, it is safe to give a second pill.

Treat all infested pets in the household. Fleas can reproduce on untreated pets and allow infestations to persist.

Dosage

Capstar Tablets should be administered according to the following schedule. Weigh your pet prior to administration to ensure proper dosage. Do not administer to pets under 2 pounds.

*Please see separate insert in this package for concurrent dosing of Capstar Tablets and PROGRAM® (lufenuron) Flavor Tabs®.

Adverse Reactions

Laboratory and clinical studies showed that Capstar Tablets are safe for use in dogs and cats, puppies and kittens 4 weeks of age and older and 2 pounds of body weight or greater.

Other Information

Capstar Tablets begin working within 30 minutes. In studies, Capstar achieved greater than 90% effectiveness against adult fleas on dogs within 4 hours and cats within 6 hours.

Capstar Tablets are safe for pregnant or nursing dogs and cats.

When using this product, you may notice that your dog or cat will start scratching itself as fleas begin to die. The scratching behavior is temporary and is a reaction to the fleas, not the drug. In very rare cases in cats, this may present as transient signs of hyperactivity, panting, vocalization and excessive grooming.

Capstar Tablets kill adult fleas that cause flea allergy dermatitis (FAD).

Capstar Tablets may be used together with other products, including heartworm preventives, corticosteroids, antibiotics, vaccines, de-worming medications, shampoos and other flea products.

Flea Infestations on Dogs and Cats

In addition to the common nuisance irritations associated with infestations, fleas can be responsible for skin conditions in your pet such as flea allergy dermatitis (FAD) in the dog and miliary dermatitis in the cat. Also, fleas transmit other parasites, including tapeworms. The control of flea infestations is important to your pet’s health and also reduces the problems associated with these parasites.

Capstar Tablets do not have an effect on fleas in the pet’s environment. You may need to treat more than one time because immature fleas in and around the home will continue to develop into adults that can reinfest your pet.

In addition to killing adult fleas with Capstar, you can treat your pet with an insect development inhibitor like PROGRAM Flavor Tabs to prevent and control flea populations. Please see the separate PROGRAM Flavor Tabs/Capstar Tablets FLEA MANAGEMENT SYSTEM insert included in this package for information on how to use these two

products together to kill adult fleas and prevent flea eggs from hatching. For information on how to use SENTINEL® (milbemycin oxime/lufenuron) Flavor Tabs® (for dogs only) with Capstar Tablets, see your veterinarian.

The following diagram illustrates the flea’s life cycle and where Capstar Tablets work:

Life Cycle of the Flea

Fleas can be a problem because they reproduce so rapidly. A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and can develop into adults within only three weeks. Adult female fleas feed by ingesting blood from your pet and subsequently lay eggs, which drop off your pet’s coat. Within days, larvae hatch from the eggs and live undetected in your pet’s surroundings, such as the carpet, bedding and other protected areas. Flea larvae spin a cocoon, and, when appropriately stimulated, a young adult flea emerges and jumps onto your pet to continue the life cycle. When these new fleas are seen on your pet, treat with Capstar Tablets.

After reading this insert, if you have any questions about flea control or medical problems associated with flea infestations, consult your veterinarian, who is your pet’s health care expert.

Storage Conditions

Store at controlled room temperature, between 59° and 77°F (15°-25°C).

Questions? Comments?

Please Call 1-800-332-2761

Visit our web site at www.petwellness.com 

Manufactured for: Novartis Animal Health US, Inc.

Greensboro, NC 27408

NADA #141-175, Approved by FDA.

U.S. Patent # 5,750,548

©2008 Novartis Animal Health US, Inc.

Capstar, PROGRAM, SENTINEL and Flavor Tabs are registered trademarks of Novartis AG.

NAH/CAP-FMS/PI/302/08

Capstar® (nitenpyram) PROGRAM® (lufenuron) Flavor Tabs®

FLEA MANAGEMENT SYSTEM

Supplemental Product Information

Information for Dosing Dogs

This insert describes the concurrent use of PROGRAM® (lufenuron) Flavor Tabs® and Capstar® (nitenpyram)Tablets for the management of fleas on dogs and puppies.

Please read the insert contained in each package for complete information on the individual products prior to dosing.

Warnings

Not for human use. Keep this and all drugs out of reach of children.

Directions

In dogs and puppies the concurrent use of PROGRAM Flavor Tabs and Capstar Tablets is indicated to kill adult fleas and prevent eggs from hatching. The effects of PROGRAM Flavor Tabs, which prevent and control flea populations, and Capstar Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM.

Step 1: Prevention and Control

Give PROGRAM Flavor Tabs once per month to prevent and control flea populations. PROGRAM Flavor Tabs contain lufenuron. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. If a dog currently has a flea infestation, more rapid relief can be accomplished by adding Capstar to the treatment as follows.

Step 2: Kill Adult Fleas

If your pet currently has a flea infestation, use Capstar Tablets to kill adult fleas. Capstar Tablets contain nitenpyram and are effective for the treatment of flea infestations. Nitenpyram starts killing adult fleas within 30 minutes of administration.

• Administer Capstar Tablets once per week until adult fleas are no longer observed.
  


• For a severe flea infestation, administer Capstar Tablets twice per week until adult fleas are no longer observed.
  


• Additional Capstar Tablets may be administered as needed to kill the occasional adult flea picked up from infested environments.
  


• It is important to treat all cats (see reverse side of this insert) and dogs in the household. Fleas can reproduce on untreated pets and allow infestations to persist.

Dosage

The combination of PROGRAM Flavor Tabs and Capstar Tablets should be administered according to the following schedule. Weigh the dog prior to administration to ensure proper dosage. Do not administer to dogs under 2 pounds.

*If adult fleas are seen

** Dogs over 90 lbs. are provided the appropriate combination of PROGRAM Flavor Tabs.

Adverse Reactions

The following adverse reactions have been reported in dogs after giving PROGRAM Flavor Tabs: vomiting, depression/lethargy, pruritus (itchy, scratchy skin), urticaria (wheals, hives), diarrhea, anorexia (loss of appetite), and skin congestion (red skin).

Other Information

The safety of the concurrent use of lufenuron, the active ingredient in PROGRAM Flavor Tabs, and Capstar Tablets has not been evaluated in puppies less than 11 weeks old.

Flea Infestations on Dogs

In addition to the common nuisance irritations associated with infestations, fleas can be responsible for skin conditions in the dog such as flea allergy dermatitis. Fleas also transmit other parasites, including tapeworms. The control of flea infestations is important to the pet’s health and reduces the problems associated with these parasites.

PROGRAM Flavor Tabs break the flea life cycle by inhibiting egg development. Capstar Tablets kill adult fleas on the dog. The concurrent use of these two products provides an effective flea management system.

The following diagram illustrates the flea’s life cycle and where the combination of PROGRAM Flavor Tabs and Capstar Tablets work:

Life Cycle of the Flea

A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and can develop into adults within only three weeks. Adult female fleas feed by ingesting blood from the pet and subsequently lay eggs, which drop off the pet’s coat. Within days, larvae hatch from the eggs and live undetected in the pet’s surroundings, such as the carpet and bedding. Flea larvae spin a cocoon, and, when appropriately stimulated, a young adult flea emerges and jumps onto the pet to continue the life cycle.

After reading this insert, if you have any questions about the concurrent use of PROGRAM Flavor Tabs and Capstar Tablets in your dogs, please call Novartis Animal Health US, Inc. Veterinary Product Support at 1(800)-332-2761.

Storage Conditions

Store PROGRAM Flavor Tabs and Capstar as described on the individual product inserts.

Questions? Comments?

Please Call 1-800-332-2761

Visit our website at www.petwellness.com 

Manufactured for: Novartis Animal Health US, Inc.

Greensboro, NC 27408

NADA #141-205, Approved by FDA.

U.S. Patent # 5,750,548

©2008 Novartis Animal Health US, Inc.

Capstar, PROGRAM, SENTINEL and Flavor Tabs are registered trademarks of Novartis AG.

Capstar® (nitenpyram)

Capstar® is an oral tablet for dogs, puppies, cats and kittens 4 weeks of age and older and 2 pounds of body weight or greater.

Active Ingredients

Capstar Tablets contain 11.4 or 57.0 mg of nitenpyram, which belongs to the chemical class of neonicotinoids. Nitenpyram kills adult fleas.

Warnings

Not for human use. Keep this and all drugs out of the reach of children.

Directions

Capstar Tablets kill adult fleas and are indicated for the treatment of flea infestations on dogs, puppies, cats and kittens 4 weeks of age and older and 2 pounds of body weight or greater.

A single dose of Capstar should kill the adult fleas on your pet. If your pet gets re-infested with fleas, you can safely give another dose as often as once per day.

To give Capstar Tablets, place the pill directly in your pet’s mouth or hide it in food. If you hide the pill in food, watch closely to make sure your pet swallows the pill. If you are not sure that your pet swallowed the pill, it is safe to give a second pill.

Treat all infested pets in the household. Fleas can reproduce on untreated pets and allow infestations to persist.

Dosage

Capstar Tablets should be administered according to the following schedule. Weigh your pet prior to administration to ensure proper dosage. Do not administer to pets under 2 pounds.

 

*Please see separate insert in this package for concurrent dosing of Capstar Tablets and PROGRAM® (lufenuron) Flavor Tabs®.

Adverse Reactions

Laboratory and clinical studies showed that Capstar Tablets are safe for use in dogs and cats, puppies and kittens 4 weeks of age and older and 2 pounds of body weight or greater.

Other Information

Capstar Tablets begin working within 30 minutes. In studies, Capstar achieved greater than 90% effectiveness against adult fleas on dogs within 4 hours and cats within 6 hours.

Capstar Tablets are safe for pregnant or nursing dogs and cats.

When using this product, you may notice that your dog or cat will start scratching itself as fleas begin to die. The scratching behavior is temporary and is a reaction to the fleas, not the drug. In very rare cases in cats, this may present as transient signs of hyperactivity, panting, vocalization and excessive grooming.

Capstar Tablets kill adult fleas that cause flea allergy dermatitis (FAD).

Capstar Tablets may be used together with other products, including heartworm preventives, corticosteroids, antibiotics, vaccines, de-worming medications, shampoos and other flea products.

Flea Infestations on Dogs and Cats

In addition to the common nuisance irritations associated with infestations, fleas can be responsible for skin conditions in your pet such as flea allergy dermatitis (FAD) in the dog and miliary dermatitis in the cat. Also, fleas transmit other parasites, including tapeworms. The control of flea infestations is important to your pet’s health and also reduces the problems associated with these parasites.

Capstar Tablets do not have an effect on fleas in the pet’s environment. You may need to treat more than one time because immature fleas in and around the home will continue to develop into adults that can reinfest your pet.

In addition to killing adult fleas with Capstar, you can treat your pet with an insect development inhibitor like PROGRAM Flavor Tabs to prevent and control flea populations. Please see the separate PROGRAM Flavor Tabs/Capstar Tablets FLEA MANAGEMENT SYSTEM insert included in this package for information on how to use these two products together to kill adult fleas and prevent flea eggs from hatching. For information on how to use SENTINEL® (milbemycin oxime/lufenuron) Flavor Tabs® (for dogs only) with Capstar Tablets, see your veterinarian.

The following diagram illustrates the flea’s life cycle and where Capstar Tablets work:

Life Cycle of the Flea

Fleas can be a problem because they reproduce so rapidly. A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and can develop into adults within only three weeks. Adult female fleas feed by ingesting blood from your pet and subsequently lay eggs, which drop off your pet’s coat. Within days, larvae hatch from the eggs and live undetected in your pet’s surroundings, such as the carpet, bedding and other protected areas. Flea larvae spin a cocoon, and, when appropriately stimulated, a young adult flea emerges and jumps onto your pet to continue the life cycle. When these new fleas are seen on your pet, treat with Capstar Tablets.

After reading this insert, if you have any questions about flea control or medical problems associated with flea infestations, consult your veterinarian, who is your pet’s health care expert.

Storage Conditions

Store at controlled room temperature, between 59° and 77°F (15°-25°C).

Questions? Comments?

Please Call 1-800-332-2761

Visit our web site at www.petwellness.com 

Manufactured for: Novartis Animal Health US, Inc.

Greensboro, NC 27408

NADA #141-175, Approved by FDA.

U.S. Patent # 5,750,548

©2008 Novartis Animal Health US, Inc.

Capstar, PROGRAM, SENTINEL and Flavor Tabs are registered trademarks of Novartis AG.

NAH/CAP-FMS/PI/30

2/08

FLEA MANAGEMENT SYSTEM

Supplemental Product Information

Information for Dosing Cats

This insert describes the concurrent use of PROGRAM® (lufenuron) Flavor Tabs® and Capstar® (nitenpyram)Tablets for the management of fleas on cats and kittens.

Please read the insert contained in each package for complete information on the individual products prior to dosing.

Warnings

Not for human use. Keep this and all drugs out of reach of children.

Directions

In cats and kittens the concurrent use of PROGRAM Flavor Tabs and Capstar Tablets is indicated to kill adult fleas and prevent eggs from hatching. The effects of PROGRAM Flavor Tabs, which control flea populations, and Capstar Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM.

Step 1: Control

Give PROGRAM Flavor Tabs once per month to control flea populations. PROGRAM Flavor Tabs contain lufenuron. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. If a cat currently has a flea infestation, more rapid relief can be accomplished by adding Capstar to the treatment as follows.

Step 2: Kill Adult Fleas

If your pet currently has a flea infestation, use Capstar Tablets to kill adult fleas. Capstar Tablets contain nitenpyram and are effective for the treatment of flea infestations. Nitenpyram starts killing adult fleas within 30 minutes of administration.

• Administer Capstar Tablets once per week until adult fleas are no longer observed.
  


• For a severe flea infestation, administer Capstar Tablets twice per week until adult fleas are no longer observed.
  


• Additional Capstar Tablets may be administered as needed to kill the occasional adult flea picked up from infested environments.
  


• It is important to treat all dogs (see reverse side of this insert) and cats in the household. Fleas can reproduce on untreated pets and allow infestations to persist.

Dosage

The combination of PROGRAM Flavor Tabs and Capstar Tablets should be administered according to the following schedule. Weigh the cat prior to administration to ensure proper dosage. Do not administer to cats under 2 pounds.

*If adult fleas are seen

** Cats over 15 lbs. are provided the appropriate combination of PROGRAM Flavor Tabs.

Adverse Reactions

The following adverse reactions have been reported in cats after giving PROGRAM Flavor Tabs: vomiting, depression/lethargy, anorexia (loss of appetite), diarrhea, hyperactivity, dyspnea (labored breathing), pruritus (itchy skin), and skin eruptions (rash).

Other Information

The safety of the concurrent use of PROGRAM Flavor Tabs and Capstar Tablets has not been evaluated in kittens less than 7 months of age.

Flea Infestations on Cats

In addition to the common nuisance irritations associated with infestations, fleas can be responsible for skin conditions in the cat such as miliary dermatitis. Fleas also transmit other parasites, including tapeworms. The control of flea infestations is important to the pet’s health and reduces the problems associated with these parasites.

PROGRAM Flavor Tabs break the flea life cycle by inhibiting egg development. Capstar Tablets rapidly kill adult fleas on the cat. The concurrent use of these two products provides an effective flea management system.

The following diagram illustrates the flea’s life cycle and where the combination of PROGRAM Flavor Tabs and Capstar Tablets work:

Life Cycle of the Flea

A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and can develop into adults within only three weeks. Adult female fleas feed by ingesting blood from the pet and subsequently lay eggs, which drop off the pet’s coat. Within days, larvae hatch from the eggs and live undetected in the pet’s surroundings, such as the carpet and bedding. Flea larvae spin a cocoon, and, when appropriately stimulated, a young adult flea emerges and jumps onto the pet to continue the life cycle.

After reading this insert, if you have any questions about the concurrent use of PROGRAM Flavor Tabs and Capstar Tablets in your cats, please call Novartis Animal Health US, Inc. Veterinary Product Support at 1(800)-332-2761.

Storage Conditions

Store PROGRAM Flavor Tabs and Capstar as described on the individual product inserts.

Questions? Comments?

Please Call 1-800-332-2761

Visit our website at www.petwellness.com 

Manufactured for: Novartis Animal Health US, Inc.

Greensboro, NC 27408

NADA #141-205, Approved by FDA.

U.S. Patent # 5,750,548

©2008 Novartis Animal Health US, Inc.

Capstar, PROGRAM, SENTINEL and Flavor Tabs are registered trademarks of Novartis AG.

Principal Display Panel

For treatment of flea

infestations on dogs and cats

Capstar® 

(nitenpyram)

For Dogs

And Cats

2-25 lbs.

6 Tablets

(11.4 mg nitenpyram)

FAST ACTING

Begins Working

Within 30 Minutes

For Oral Use

NOVARTIS

ANIMAL HEALTH

NADA #141-175

Approved by FDA

Product# 61011

Principal Display Panel

For treatment of flea

infestations on dogs

Capstar® 

(nitenpyram)

For Dogs

Over 25 lbs.

6 Tablets

(57.0 mg nitenpyram)

FAST ACTING

Begins Working

Within 30 Minutes

For Oral Use

NOVARTIS

ANIMAL HEALTH

NADA #141-175

Approved by FDA

Product# 61021

Capstar  nitenpyram  tablet

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 58198-6101 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITENPYRAM (NITENPYRAM) NITENPYRAM 11.4 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE   CELLULOSE, MICROCRYSTALLINE   STARCH, CORN   COLLOIDAL SILICON DIOXIDE   MAGNESIUM STEARATE

Product Characteristics Color WHITE (to light yellow) Score no score Shape ROUND (biconvex beveled edges) Size 6mm Flavor Imprint Code RB;CG Contains

Packaging # NDC Package Description Multilevel Packaging 1 58198-6101-1 1 BLISTER PACK In 1 BOX contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the BOX (58198-6101-1) 2 58198-6101-5 100 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 1 TABLET In 1 BLISTER PACK This package is contained within the CARTON (58198-6101-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141175	10/20/2000

Capstar  nitenpyram  tablet

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 58198-6102 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITENPYRAM (NITENPYRAM) NITENPYRAM 57 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE   CELLULOSE, MICROCRYSTALLINE   STARCH, CORN   COLLOIDAL SILICON DIOXIDE   MAGNESIUM STEARATE

Product Characteristics Color WHITE (to light yellow) Score no score Shape ROUND (biconvex beveled edges) Size 11mm Flavor Imprint Code HIH;CG Contains

Packaging # NDC Package Description Multilevel Packaging 1 58198-6102-1 1 BLISTER PACK In 1 BOX contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the BOX (58198-6102-1) 2 58198-6102-5 100 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 1 TABLET In 1 BLISTER PACK This package is contained within the CARTON (58198-6102-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141175	10/20/2000

Labeler - Novartis Animal Health US, Inc. (966985624)

Revised: 10/2000Novartis Animal Health US, Inc.