ACCOLATE- zafirlukast tablet, coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

ZAFIRLUKAST (UNII: XZ629S5L50) (ZAFIRLUKAST - UNII:XZ629S5L50)

Dostupno od:

Par Pharmaceutical, Inc.

INN (International ime):

ZAFIRLUKAST

Sastav:

ZAFIRLUKAST 10 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

ACCOLATE is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older. ACCOLATE is contraindicated in patients who are hypersensitive to zafirlukast or any of its inactive ingredients. ACCOLATE is contraindicated in patients with hepatic impairment including hepatic cirrhosis.

Proizvod sažetak:

ACCOLATE 10 mg Tablets, (NDC 49884-589-02) 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. ACCOLATE 20 mg Tablets, (NDC 49884-590-02) white, round, biconvex, film-coated tablets debossed with “P” on one side and “20” on the other, are supplied in opaque HDPE bottles of 60 tablets. Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Protect from light and moisture. Dispense in the original air-tight container. ACCOLATE is a registered trademark of Par Pharmaceutical, Inc. Manufactured by: Par Pharmaceutical Companies, Inc. Chestnut Ridge, NY 10977 U.S.A. ACCOLATE® (ak-o-late) (zafirlukast) Tablets Read the Patient Information leaflet before you start taking ACCOLATE 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 ACCOLATE? ACCOLATE 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 ACCOLATE is safe and effective when used in children under 5 years old. The effect of ACCOLATE on growth in children has not been determined. Do not take ACCOLATE 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 ACCOLATE? Do not take ACCOLATE if you; What should I tell my healthcare provider before taking ACCOLATE? Before you take ACCOLATE, tell your healthcare provider if you: Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ACCOLATE may affect the way other medicines work, and other medicines may affect how ACCOLATE works. Especially tell your healthcare provider if you take: 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 ACCOLATE? What are the possible side effects of ACCOLATE? ACCOLATE may cause serious side effects, including: The most common side effects of ACCOLATE in people 12 years and older include: The most common side effects of ACCOLATE in children 5 to 11 years include: 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 ACCOLATE. 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 ACCOLATE? General information about the safe and effective use of ACCOLATE. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ACCOLATE for a condition for which it was not prescribed. Do not give ACCOLATE 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 ACCOLATE. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ACCOLATE 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 ACCOLATE? Active ingredient: zafirlukast Inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, hypromellose, and titanium dioxide. What do ACCOLATE tablets look like?

Status autorizacije:

New Drug Application

Svojstava lijeka

ACCOLATE- ZAFIRLUKAST TABLET, COATED
PAR PHARMACEUTICAL, INC.
----------
ACCOLATE®
(_ZAFIRLUKAST_)
TABLETS
DESCRIPTION
Zafirlukast is a synthetic, selective peptide leukotriene receptor
antagonist (LTRA), with
the chemical name
4-(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3-ylmethyl)-3-
methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of
zafirlukast is 575.7 and
the structural formula is:
The empirical formula is: C
H
N O S
Zafirlukast, a fine white to pale yellow amorphous powder, is
practically insoluble in
water. It is slightly soluble in methanol and freely soluble in
tetrahydrofuran,
dimethylsulfoxide, and acetone.
ACCOLATE is supplied as 10 and 20 mg tablets for oral administration.
INACTIVE INGREDIENTS: Film-coated tablets containing croscarmellose
sodium, lactose,
magnesium stearate, microcrystalline cellulose, povidone,
hypromellose, and titanium
dioxide.
CLINICAL PHARMACOLOGY
31
33
3
6
MECHANISM OF ACTION:
Zafirlukast is a selective and competitive receptor antagonist of
leukotriene D and E
(LTD and LTE ), components of slow-reacting substance of anaphylaxis
(SRSA).
Cysteinyl leukotriene production and receptor occupation have been
correlated with the
pathophysiology of asthma, including airway edema, smooth muscle
constriction, and
altered cellular activity associated with the inflammatory process,
which contribute to the
signs and symptoms of asthma. Patients with asthma were found in one
study to be 25-
100 times more sensitive to the bronchoconstricting activity of
inhaled LTD than
nonasthmatic subjects.
_In vitro_ studies demonstrated that zafirlukast antagonized the
contractile activity of
three leukotrienes (LTC , LTD and LTE ) in conducting airway smooth
muscle from
laboratory animals and humans. Zafirlukast prevented intradermal LTD
-induced
increases in cutaneous vascular permeability and inhibited inhaled LTD
-induced influx of
eosinophils into animal lungs. Inhalational challenge studies in
sensitized sheep showed
that zafirlukast suppressed the airway responses to antigen; this