Zafirlukast (Page 4 of 4)

OVERDOSAGE

No deaths occurred at oral zafirlukast doses of 2000 mg/kg in mice (approximately 210 times the maximum recommended daily oral dose in adults and children on a mg/m2 basis), 2000 mg/kg in rats (approximately 420 times the maximum recommended daily oral dose in adults and children on a mg/m2 basis), and 500 mg/kg in dogs (approximately 350 times the maximum recommended daily oral dose in adults and children on a mg/m2 basis).

Overdosage with zafirlukast has been reported in four patients surviving reported doses as high as 200 mg. The predominant symptoms reported following zafirlukast overdose were rash and upset stomach. There were no acute toxic effects in humans that could be consistently ascribed to the administration of zafirlukast. It is reasonable to employ the usual supportive measures in the event of an overdose; eg, remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

DOSAGE AND ADMINISTRATION

Because food can reduce the bioavailability of zafirlukast, zafirlukast should be taken at least 1 hour before or 2 hours after meals.

Adults and Children 12 years of age and older

The recommended dose of zafirlukast in adults and children 12 years and older is 20 mg twice daily.

Pediatric Patients 5 through 11 years of age

The recommended dose of zafirlukast in children 5 through 11 years of age is 10 mg twice daily.

Elderly Patients

Based on cross-study comparisons, the clearance of zafirlukast is reduced in elderly patients (65 years of age and older), such that Cmax and AUC are approximately twice those of younger adults. In clinical trials, a dose of 20 mg twice daily was not associated with an increase in the overall incidence of adverse events or withdrawals because of adverse events in elderly patients.

Patients with Hepatic Impairment

Zafirlukast is contraindicated in patients with hepatic impairment including hepatic cirrhosis (see Contraindications). The clearance of zafirlukast is reduced in patients with stable alcoholic cirrhosis such that the Cmax and AUC are approximately 50 — 60% greater than those of normal adults. Zafirlukast has not been evaluated in patients with hepatitis or in long-term studies of patients with cirrhosis.

Patients with Renal Impairment

Dosage adjustment is not required for patients with renal impairment.

HOW SUPPLIED

NDC: 63629-2102-1 white, round, biconvex, film-coated tablets debossed with “P” on one side and “10” on the other, are supplied in opaque HDPE bottles of 60 tablets

PATIENT INFORMATION

Zafirlukast Tablets

Read the Patient Information leaflet before you start taking zafirlukast and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is Zafirlukast?

Zafirlukast is a prescription medicine used to help prevent asthma attacks and for the long-term treatment of asthma symptoms in adults and children 5 years and older.

It is not known if zafirlukast is safe and effective when used in children under 5 years old. The effect of zafirlukast on growth in children has not been determined.

Do not take zafirlukast if you need relief right away for a sudden asthma attack. If you get an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.

Who should not take Zafirlukast?

Do not take zafirlukast if you:

· are allergic to zafirlukast or any of the ingredients in zafirlukast. See the end of this leaflet for a complete list of ingredients in zafirlukast.

· have problems with your liver.

What should I tell my healthcare provider before taking Zafirlukast?

Before you take Zafirlukast , tell your healthcare provider if you:

· have liver problems

· have any other medical conditions

· are pregnant or plan to become pregnant. It is not known if zafirlukast will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

· are breastfeeding or plan to breastfeed. Zafirlukast can pass into your milk; it is not known whether zafirlukast may harm your baby. Women who are breastfeeding should not take zafirlukast.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Zafirlukast may affect the way other medicines work, and other medicines may affect how zafirlukast works.

Especially tell your healthcare provider if you take:

· warfarin sodium (Coumadin, Jantoven)

· erythromycin (ERYC, ERY-TAB, PCE)

· theophylline (Elixophyllin, Theo-24, Theochron, Theolair, Uniphyl)

· fluconazole (Diflucan)

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Zafirlukast?

  • Take zafirlukast exactly as your healthcare provider tells you to take it.
  • Take zafirlukast regularly, even if you do not have asthma symptoms. Do not change your dose or stop taking zafirlukast without talking to your healthcare provider.
  • Do not stop taking or change the dose of your other asthma medicines unless your healthcare provider tells you to.
  • Take your prescribed dose of zafirlukast by mouth at least 1 hour before or 2 hours after meals.
  • Zafirlukast does not treat the symptoms of a sudden asthma attack. Always have a short-acting beta2 -agonist medicine (rescue inhaler) with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, talk to your healthcare provider to have one prescribed for you.
  • If you take too much zafirlukast, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Zafirlukast?

Zafirlukast may cause serious side effects, including:

  • Severe liver problems. In some cases, these liver problems canlead to liver failure, the need for a liver transplant or death.Tell your healthcare provider right away if you have:
  • pain or tenderness in the right upper side of your stomach area (abdomen)
  • nausea
  • tiredness
  • itchiness
  • yellowing of your skin or the whites of your eyes
  • flu-like symptoms
  • loss of appetite
  • dark (tea colored) urine
  • Inflammation of your blood vessels. Rarely, this can happen in people with asthma who take zafirlukast.This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. Tell your healthcare provider right away if you have:
  • a feeling of pins and needles or numbness of your arms or legs
  • flu like symptoms
  • rash
  • pain and swelling of your sinuses
  • Changes in behaviour or mood. Tell your healthcare provider if you have changes in your behaviour, problems sleeping or feel very sad.
  • Hypersensitivity reactions. Tell your healthcare provider if you have severe itching, breathing problems, skin rash, skin blisters, or skin redness, or swelling.

    The most common side effects of zafirlukast in people 12 years and older include:

    · headache

    · infection

    · nausea

    · diarrhea

    · pain (generalized)

    The most common side effects of zafirlukast in children 5 to 11 years include:

    · headache

    · stomach pain

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all of the possible side effects of zafirlukast. For more information, ask your healthcare provider or pharmacist.

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

    You may also report side effects to Par Pharmaceutical, Inc. at 1-800-828-9393.

    How should I store Zafirlukast?

· Store zafirlukast at 68°F to 77°F(20°C -25°C ).

· Keep zafirlukast tablets dry.

· Keep zafirlukast in a tight closed container and keep zafirlukast out of the light.

· Keep zafirlukast and all medicines out of the reach of children.

General information about the safe and effective use of Zafirlukast.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use zafirlukast for a condition for which it was not prescribed. Do not give zafirlukast to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about zafirlukast. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about zafirlukast that is written for healthcare professionals.

For more information, go to www.parpharm.com, or call 1-800-828-9393.

What are the ingredients in Zafirlukast?

Active ingredient: zafirlukast

Inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, hypromellose, and titanium dioxide.

What do Zafirlukast tablets look like?

· the 10 mg tablet is white and round with “P” marked on one side, and “10” on the other.

· the 20 mg tablet is white and round with “P” marked on one side, and “20” on the other.

ACCOLATE is a registered trademark of Par Pharmaceutical, Inc.

Manufactured by:

Par Pharmaceutical

Chestnut Ridge, NY 10977 U.S.A.

R12/16

Zafirlukast 10 mg Tablet, #60

Label
(click image for full-size original)
ZAFIRLUKAST
zafirlukast tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-2102(NDC:49884-549)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZAFIRLUKAST (ZAFIRLUKAST) ZAFIRLUKAST 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-2102-1 60 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020547 11/19/2010 04/30/2024
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-2102), RELABEL (63629-2102)

Revised: 02/2023 Bryant Ranch Prepack

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