Drug Catalog - Product Detail
ALBUTEROL SULFATE 4MG TB 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64980-0443-01 | RISING PHARMACEUTICALS | 100 | 4MG | TABLET |
PACKAGE FILES
Generic Name
ALBUTEROL
Substance Name
ALBUTEROL SULFATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207046
Description
DESCRIPTION Albuterol Tablets, USP contain albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2 -adrenergic bronchodilator. Albuterol sulfate has the chemical name 4-hydroxy- 3-hydroxymethyl-α-[(tert-butylamino) methyl]benzyl alcohol, sulfate and the following structural formula: The molecular weight of albuterol sulfate is 576, and the molecular formula is (C 13 H 21 N O 3 ) 2 • H 2 S O 4 . Albuterol sulfate, USP is a white or practically white powder, freely soluble in water and slightly soluble in alcohol, in chloroform, and ether. The World Health Organization recommended name for albuterol base is salbutamol. Each Albuterol tablet for oral administration contains 2 or 4 mg of albuterol as 2.4 mg or 4.8 mg of albuterol sulfate, USP respectively. The inactive ingredients for Albuterol tablets, 2 mg and 4 mg include: co-processed starch , lactose hydrate , magnesium stearate, partially pregelatinized maize starch and sodium lauryl sulfate. structure
How Supplied
HOW SUPPLIED Albuterol Tablets, USP for oral administration contains 2 mg or 4 mg albuterol as 2.4 mg or 4.8 mg of albuterol sulfate, USP respectively. Albuterol Tablets, USP containing 2 mg albuterol as the sulfate are white, round shaped, scored tablets debossed with “AC 2” on one side and plain on other side. They are available as follows: NDC 64980-442-01 Bottles of 100 tablets NDC 64980-442-50 Bottles of 500 tablets Albuterol Tablets, USP containing 4 mg albuterol as the sulfate are white, round shaped, scored tablets debossed with “AC 4” on one side and plain on other side. They are available as follows: NDC 64980-443-01 Bottles of 100 tablets NDC 64980-443-50 Bottles of 500 tablets Store Albuterol Tablets, USP at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: Appco Pharma LLC. Piscataway, New Jersey 08854 Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Revised: 01/2022 200229 PIR44350-00
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. Usual Dosage 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 age is 2 mg three or four times a day. Dosage Adjustment 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). Elderly Patients and Those Sensitive to Beta-adrenergic Stimulators 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 over 12 years and older.