Drug Catalog - Product Detail
ALBUTEROL SULFATE TB 4MG 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 53489-0177-05 | SUN PHARMACEUTICALS | 500 | 4MG | TABLET |
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Description
DESCRIPTION Albuterol tablets contain albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2 -adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1 -[( tert -Butylamino)methyl]-4-hydroxy- m -xylene-α,α'-diol sulfate (2:1)(salt) and the following structural formula: Albuterol sulfate has a molecular weight of 576.71, and the molecular formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Each albuterol sulfate tablet, for oral administration contains 2 or 4 mg of albuterol as 2.4 or 4.8 mg of albuterol sulfate, respectively. Each tablet also contains the following inactive ingredients: anhydrous lactose, magnesium stearate, pregelatinized (corn) starch, and sodium starch glycolate. MM1
How Supplied
HOW SUPPLIED Albuterol tablets, USP; 2 mg of albuterol as the sulfate, are white, round, scored, debossed MP 47 Bottles of 50 NDC 53489-176-02 Bottles of 100 NDC 53489-176-01 Bottles of 250 NDC 53489-176-03 Bottles of 500 NDC 53489-176-05 Bottles of 1000 NDC 53489-176-10 Albuterol tablets, USP; 4 mg of albuterol as the sulfate, are white, round, scored, debossed MP 88 Bottles of 50 NDC 53489-177-02 Bottles of 100 NDC 53489-177-01 Bottles of 250 NDC 53489-177-03 Bottles of 500 NDC 53489-177-05 Bottles of 1000 NDC 53489-177-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Indications & Usage
INDICATIONS & USAGE Albuterol tablets 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 & ADMINISTRATION The following dosages of albuterol tablets are expressed in terms of albuterol base. Adults and Children Over 12 Years of Age The usual starting dosage for adults and children 12 years and older is 2 or 4 mg three or four times a day. Children 6 to 12 Years of Age The usual starting dosage for children 6 to 12 years of age is 2 mg three or four times a day. Adults and Children Over 12 Years of Age For adults and children 12 years and older, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4 mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated. Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses). An initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day. The total daily dose should not exceed 32 mg in adults and children 12 years and older.