Zafirlukast: Package Insert and Label Information (Page 3 of 3)

Pediatric Patients 5 through 11 years of age

Zafirlukast has been evaluated for safety in 788 pediatric patients 5 through 11 years of age. Cumulatively, 313 pediatric patients were treated with zafirlukast 10 mg twice daily or higher for at least 6 months, and 113 of them were treated for one year or longer in clinical trials. The safety profile of zafirlukast 10 mg twice daily-versus placebo in the 4- and 6-week double-blind trials was generally similar to that observed in the adult clinical trials with zafirlukast 20 mg twice daily.

In pediatric patients receiving zafirlukast in multi-dose clinical trials, the following events occurred with a frequency of ≥ 2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: headache (4.5 vs. 4.2%) and abdominal pain (2.8 vs. 2.3%).

The post-marketing experience in this age group is similar to that seen in adults, including hepatic dysfunction, which may lead to liver failure.

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 tablets 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 tablets 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 tablets 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 to 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

Zafirlukast tablets 10 mg are white to light pink, round, film coated tablets debossed with ‘R’ on one side and ‘625’ on other side and are supplied in bottles of 30, 60, 100, 500 and unit dose blister packages of 100 (10 x 10).

Bottles of 30 NDC 55111-625-30

Bottles of 60 NDC 55111-625-60

Bottles of 100 NDC 55111-625-01

Bottles of 500 NDC 55111-625-05

Unit dose packages of 100 (10 x 10) NDC 55111-625-78

Zafirlukast tablets 20 mg are white to light pink, round film coated tablets debossed with ‘R’ on one side and ‘626’ on other side and are supplied in bottles of 30, 60, 100, 500 and unit dose blister packages of 100 (10 x 10).

Bottles of 30 NDC 55111-626-30

Bottles of 60 NDC 55111-626-60

Bottles of 100 NDC 55111-626-01

Bottles of 500 NDC 55111-626-05

Unit dose packages of 100 (10 x 10) NDC 55111-626-78

STORAGE

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in air-tight container.

Rx Only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally — 500 090 INDIA

Revised: 1216

PATIENT INFORMATION

ZAFIRLUKAST TABLETS

Read the Patient Information leaflet before you start taking zafirlukast tablets 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 are zafirlukast tablets?

Zafirlukast tablets are 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 tablets are safe and effective when used in children under 5 years old.

The effect of zafirlukast tablets on growth in children has not been determined.

Do not take zafirlukast tablets 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 tablets?

Do not take zafirlukast tablets if you:

  • are allergic to zafirlukast or any of the ingredients in zafirlukast tablets. See the end of this leaflet for a complete list of ingredients in zafirlukast tablets.
  • have problems with your liver.

What should I tell my healthcare provider before taking zafirlukast tablets?

Before you take zafirlukast tablets, 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 tablets 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 tablets can pass into your milk; it is not known whether zafirlukast tablets may harm your baby. Women who are breastfeeding should not take zafirlukast tablets.

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

Zafirlukast tablets may affect the way other medicines work, and other medicines may affect how zafirlukast tablets 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 tablets?

  • Take zafirlukast tablets exactly as your healthcare provider tells you to take it.
  • Take zafirlukast tablets regularly, even if you do not have asthma symptoms. Do not change your dose or stop taking zafirlukast tablets 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 tablets by mouth at least 1 hour before or 2 hours after meals.
  • Zafirlukast tablets 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 tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of zafirlukast tablets?

Zafirlukast tablets may cause serious side effects, including:

  • Severe liver problems. In some cases, these liver problems can lead 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 tablets. 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 tablets in people 12 years and older include:

  • headache
  • infection
  • nausea
  • diarrhea
  • pain (generalized)

The most common side effects of zafirlukast tablets 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 tablets. 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.

How should I store zafirlukast tablets?

  • Store zafirlukast tablets at 68°F to 77°F (20°C -25°C ).
  • Keep zafirlukast tablets dry.
  • Keep zafirlukast tablets in a tight closed container and keep zafirlukast tablets out of the light.
  • Keep zafirlukast tablets and all medicines out of the reach of children.

General information about the safe and effective use of zafirlukast tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use zafirlukast tablets for a condition for which it was not prescribed. Do not give zafirlukast tablets 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 tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about zafirlukast tablets that is written for healthcare professionals. For more information, call 1-888-375-3784.

What are the ingredients in zafirlukast tablets?

Active ingredient: zafirlukast

Inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate (Type-A) and titanium dioxide.

What do zafirlukast tablets look like?

  • the 10 mg tablet is white to light pink, round, film coated, debossed with ‘R’ on one side and ‘625’ on other side.
  • the 20 mg tablet is white to light pink, round film coated, debossed with ‘R’ on one side and ‘626’ on other side.

Rx Only

Manufactured by:Dr. Reddy’s Laboratories Limited

Bachupally- 500 090 INDIA

Revised: 1216

Dispense with Patient Information Sheet available at:

www.drreddys.com/pi/zafirlukasttabs.pdf

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

10 mg Container label

container1
(click image for full-size original)

20 mg container label

container2
(click image for full-size original)
ZAFIRLUKAST
zafirlukast tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-625
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
hydroxypropyl cellulose
HYPROMELLOSE 2910 (5 MPA.S)
lactose monohydrate
magnesium stearate
CELLULOSE, MICROCRYSTALLINE
polyethylene glycol 400
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6mm
Flavor Imprint Code R;625
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-625-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:55111-625-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:55111-625-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:55111-625-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:55111-625-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-625-79)
5 NDC:55111-625-79 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (55111-625-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090372 11/18/2010
ZAFIRLUKAST
zafirlukast tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-626
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zafirlukast (Zafirlukast) Zafirlukast 20 mg
Inactive Ingredients
Ingredient Name Strength
hydroxypropyl cellulose
HYPROMELLOSE 2910 (5 MPA.S)
lactose monohydrate
magnesium stearate
CELLULOSE, MICROCRYSTALLINE
polyethylene glycol 400
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code R;626
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-626-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:55111-626-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:55111-626-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:55111-626-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:55111-626-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-626-79)
5 NDC:55111-626-79 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (55111-626-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090372 11/18/2010
Labeler — Dr. Reddys Laboratories Limited (650562841)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited(FTOIII) 918608162 manufacture (55111-625), analysis (55111-625), manufacture (55111-626), analysis (55111-626)

Revised: 11/2018 Dr. Reddys Laboratories Limited

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