ALBUTEROL SULFATE inhalant

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)

Fáanlegur frá:

Cipla USA Inc.

Stjórnsýsluleið:

RESPIRATORY (INHALATION)

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other Albuterol sulfate inhalation aerosol components.

Vörulýsing:

Albuterol sulfate inhalation aerosol is supplied as a pressurized aluminum canister with an attached dose indicator, a white plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations (NDC 69097-142-60). Rx only. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Store the inhaler with the mouthpiece  down. For best results, canister should be at room temperature before use. SHAKE WELL BEFORE USING. The white actuator supplied with Albuterol sulfate inhalation aerosol should not be used with any other product canisters, and actuator from other products should not be used with an Albuterol sulfate inhalation aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations and when the dose indicator display window shows zero , even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used. WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children. Albuterol sulfate inhalation aerosol does not contain chlorofluorocarbons (CFCs) as the propellant. Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Disclaimer: Other brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited. Revised: 11/2021

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

ALBUTEROL SULFATE - ALBUTEROL SULFATE INHALANT
CIPLA USA INC.
----------
ALBUTEROL SULFATE INHALATION AEROSOL, WITH DOSE INDICATOR
FOR ORAL INHALATION ONLY
PRESCRIBING INFORMATION
DESCRIPTION
The active component of Albuterol sulfate inhalation aerosol is
albuterol sulfate, USP
racemic α
[(_tert-_Butylamino)methyl]-4-hydroxy-_m_-xylene-α,α'-diol sulfate
(2:1)(salt), a
relatively selective beta -adrenergic bronchodilator having the
following chemical
structure:
Albuterol sulfate is the official generic name in the United States.
The World Health
Organization recommended name for the drug is salbutamol sulfate. The
molecular
weight of albuterol sulfate is 576.7, and the empirical formula is (C
H
NO ) •H SO .
Albuterol sulfate is a white to off-white crystalline solid. It is
soluble in water and slightly
soluble in ethanol. Albuterol sulfate inhalation aerosol is a
pressurized metered-dose
aerosol unit for oral inhalation. It contains a microcrystalline
suspension of albuterol
sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol,
and oleic acid.
Each actuation delivers 120 mcg albuterol sulfate, USP from the valve
and 108 mcg
albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of
albuterol base from
the mouthpiece). Each canister provides 200 inhalations. It is
recommended to prime
the inhaler before using for the first time and in cases where the
inhaler has not been
used for more than 2 weeks by releasing four "test sprays" into the
air, away from the
face.
This product does not contain chlorofluorocarbons (CFCs) as the
propellant.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION _In vitro _studies and _in vivo _pharmacologic
studies have
demonstrated that albuterol has a preferential effect on beta
-adrenergic receptors
1
2
13
21
3 2
2
4
2
compared with isoproterenol. While it is recognized that beta
-adrenergic receptors are
the predominant receptors on bronchial smooth muscle, data indicate
that there is a
population of beta -receptors in the human heart existing in a
concentration bet