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Drug Catalog - Product Detail

ALBUTEROL SULFATE ER TB 8MG 100

NDC Mfr Size Str Form
00378-4124-01 MYLAN 100 8MG TABLET
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Description
DESCRIPTION Albuterol extended-release tablets, USP contain albuterol sulfate, the racemic form of albuterol and a relatively selective beta 2 -adrenergic bronchodilator, in an extended-release formulation. Albuterol sulfate has the chemical name (±) a 1 -[( tert -butyl-amino)methyl]-4-hydroxy- m -xylene-a, a´-diol sulfate (2:1) (salt), and the following structural formula: Albuterol sulfate has a molecular weight of 576.7, and the molecular formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . Albuterol sulfate, USP is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Each tablet for oral administration contains 4 mg or 8 mg of albuterol as 4.8 mg or 9.6 mg, respectively, of albuterol sulfate, USP. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, triacetin and xanthan gum. The 8 mg tablets also contain the following coloring agents: FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Structural Formula
How Supplied
HOW SUPPLIED Albuterol Extended-release Tablets, USP are available containing 4.8 mg or 9.6 mg of albuterol sulfate, USP equivalent to 4 mg or 8 mg of albuterol, respectively. The 4 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 22 on the other side. They are available as follows: NDC 0378-4122-01 bottles of 100 tablets The 8 mg tablets are blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and 24 on the other side. They are available as follows: NDC 0378-4124-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED MARCH 2015 ALBER:R2
Indications & Usage
INDICATIONS AND USAGE Albuterol extended-release tablets, USP are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
Dosage and Administration
DOSAGE AND ADMINISTRATION The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base: Usual Dosage Adults and Children Over 12 Years of Age The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient. Children 6 to 12 Years of Age The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours. Dosage Adjustment in Adults and Children Over 12 Years of Age In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response. If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours). Dosage Adjustment in Children 6 to 12 Years of Age If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours). Switching From Oral Albuterol, USP Products Patients currently maintained on albuterol tablets or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply. Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.