Albuterol Sulfate (Page 2 of 3)

Drug Interactions :

Other sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol.

Albuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of albuterol on the vascular system may be potentiated.

Beta-receptor blocking agents and albuterol inhibit the effect of each other.

Carcinogenesis, Mutagenesis, Impairment of Fertility :

Albuterol sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium in a 2-year study in the rat, at oral doses of 2, 10, and 50 mg/kg corresponding to 10, 50 and 250 times, respectively, the maximum nebulization dose for a 50 kg human. In another study this effect was blocked by the coadministration of propranolol. The relevance of these findings to humans is not known. An 18-month study in mice and a lifetime study in hamsters revealed no evidence of tumorigenicity. Studies with albuterol revealed no evidence of mutagenesis. Reproduction studies in rats revealed no evidence of impaired fertility.

Pregnancy : Teratogenic Effects: Pregnancy Category C :

Albuterol has been shown to be teratogenic in mice when given subcutaneously in doses corresponding to 1.25 times the human nebulization dose (based on a 50 kg human). There are no adequate and well-controlled studies in pregnant women. Albuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A reproduction study in CD-1 mice with albuterol (0.025, 0.25, and 2.5 mg/kg subcutaneously, corresponding to 0.125, 1.25 and 12.5 times the maximum human nebulization dose, respectively) showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg. None were observed at 0.025 mg/kg. Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated with 2.5 mg/kg isoproterenol (positive control). A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses at 50 mg/kg, corresponding to 250 times the maximum nebulization dose for a 50 kg human.

During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been rarely reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established.

Labor and Delivery :

Oral albuterol has been shown to delay preterm labor in some reports. There are presently no well-controlled studies that demonstrate that it will stop preterm labor or prevent labor at term. Therefore, cautious use of albuterol sulfate inhalation solution is required in pregnant patients when given for relief of bronchospasm so as to avoid interference with uterine contractibility.

Nursing Mothers :

It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use :

The safety and effectiveness of albuterol sulfate inhalation solution have been established in children 2 years of age or older. Use of albuterol sulfate inhalation solution in these age groups is supported by evidence from adequate and well-controlled studies of albuterol sulfate inhalation solution in adults; the likelihood that the disease course, pathophysiology, and the drug’s effect in pediatric and adult patients are substantially similar; and published reports of trials in pediatric patients 3 years of age or older. The recommended dose for the pediatric population is based upon three published dose comparison studies of efficacy and safety in children aged 5 to 17 years, and on the safety profile in both adults and pediatric patients at doses equal to or higher than the recommended doses. The safety and effectiveness of albuterol sulfate inhalation solution in children below 2 years of age have not been established.

ADVERSE REACTIONS : Clinical Trial Experience:

The results of clinical trials with albuterol sulfate inhalation solution in 135 patients showed the following side effects that were considered probably or possibly drug related:

Central Nervous System: tremors (20%), dizziness (7%), nervousness (4%), headache (3%), insomnia (1%).

Gastrointestinal: nausea (4%), dyspepsia (1%).

Ear, Nose, and Throat: pharyngitis (<1%), nasal congestion (1%).

Cardiovascular: tachycardia (1%), hypertension (1%).

Respiratory: bronchospasm (8%), cough (4%), bronchitis (4%), wheezing (1%).

No clinically relevant laboratory abnormalities related to albuterol sulfate inhalation solution administration were determined in these studies.

In comparing the adverse reactions reported for patients treated with albuterol sulfate inhalation solution with those of patients treated with isoproterenol during clinical trials of three months, the following moderate to severe reactions, as judged by the investigators, were reported. This table does not include mild reactions.

*
The finding of no arrhythmias and no palpitations after albuterol administration in this clinical study should not be interpreted as indicating that these adverse effects cannot occur after the administration of inhaled albuterol.
In most cases of bronchospasm, this term was generally used to describe exacerbations in the underlying pulmonary disease.
Percent Incidence of Moderate to Severe Adverse Reactions
Reaction Albuterol N=65 Isoproterenol N=65
Central Nervous System
Tremors 10.7% 13.8%
Headache 3.1% 1.5%
Insomnia 3.1% 1.5%
Cardiovascular
Hypertension 3.1% 3.1%
Arrythmias 0% 3%
*Palpitation 0% 22%
Respiratory
Bronchospasm 15.4% 18%
Cough 3.1% 5%
Bronchitis 1.5% 5%
Wheeze 1.5% 1.5%
Sputum Increase 1.5% 1.5%
Dyspnea 1.5% 1.5%
Gastrointestinal
Nausea 3.1% 0%
Dyspepsia 1.5% 0%
Systemic
Malaise 1.5% 0%
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