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VENTOLIN Syrup (albuterol sulfate syrup) contains albuterol sulfate, USP, the racemic form of albuterol, a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name a1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-a,a1-diol sulfate (2:1) (salt), and the following chemical structure:
The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2·H2SO4. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization†s recommended name for albuterol base is salbutamol.
VENTOLIN Syrup (albuterol sulfate syrup) for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). The inactive ingredients for VENTOLIN Syrup (albuterol sulfate syrup) include: citric acid, USP anhydrous; FD&C Yellow No. 6; flavor strawberry artificial F-8636; hydroxypropyl methylcellulose 2906 or 2910, USP; saccharin, NF; sodium benzoate, NF; sodium citrate, USP dihydrate; and water purified, USP. The pH of the syrup is between 3.0 and 4.5.
VENTOLIN Syrup (albuterol sulfate syrup) is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.
The following dosages of VENTOLIN Syrup (albuterol sulfate syrup) are expressed in terms of albuterol base:
Usual Dose
Adults and pediatric patients over 12 years of age: The usual starting dosage for adults and children over 12 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.
Pediatric patients 6 to 12 years of age: The usual starting dosage for children 6 to 12 years of age is 2 mg (1 teaspoonful) three or four times a day.
Pediatric patients 2 to 6 years of age: Dosing in children 2 to 6 years of age should be initiated at 0.1 mg/kg of body weight three times a day. The starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.
Dosage Adjustment
Adults and pediatric patients over 12 years of age: For adults and children over 12 years of age, a dosage above 4 mg four times a day should be used only when the patient fails to respond to this dosage. If a favorable response does not occur with the 4 mg initial dosage, it may be cautiously increased stepwise as tolerated, but not to exceed 8 mg four times a day (total daily dose should not exceed 32 mg).
Pediatric patients 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day: For children 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 as tolerated but not to exceed 6 mg four times a day (total daily dose should not exceed 24 mg).
Pediatric patients 2 to 6 years of age who do not respond satisfactorily to the initial dosage: For children 2 to 6 years of age who do not respond satisfactorily to the initial starting dosage, the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day as tolerated, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day (total daily dose should not exceed 12 mg).
Elderly patients and those sensitive to beta-adrenergic stimulators: The initial dosage should be restricted to 2 mg three or four times a day. If adequate bronchodilation is not obtained, dosage may be increased gradually as tolerated to as much as 8 mg three or four times per day (total daily dose should not exceed 32 mg).
VENTOLIN Syrup (albuterol sulfate syrup) , a clear orange-yellow liquid with a strawberry flavor, contains 2 mg albuterol as the sulfate per 5 mL; amber glass bottles of 16 fluid ounces (NDC 0173-0351-54).
Store between 2° and 30°C (36° and 86°F). Dispense in tight, light-resistant containers as defined in the USP/NF.
Manufactured for Glaxo Wellcome Inc. Research Triangle Park, NC 27709 by Schering Corporation, Kenilworth, NJ 07033 USA., Rev. 6/97, RL-788
The adverse reactions to albuterol are similar in nature to those of other sympathomimetic agents. In clinical trials, the most frequent adverse reactions to VENTOLIN Syrup (albuterol sulfate syrup) in adults and older children were:
| Percent Incidence of Adverse Reactions in Adults and Children (6-12 Years of Age) | |
| Adverse Event | Percent Incidence |
| Central Nervous System | |
| Tremor | 10 |
| Nervousness | 9 |
| Shakiness | 9 |
| Headache | 4 |
| Dizziness | 3 |
| Excitement | 2 |
| Hyperactivity | 2 |
| Sleeplessness | 1 |
| Disturbed sleep |
|
