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Ventolin Rotacaps (Albuterol Sulfate)
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Respiratory agent
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Respiratory inhalant product
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Prevention and relief the bronchospasm in persons 4 years of age or older.
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Adults and children 4 years of age and older: The usual dose is one 200 mcg capsule inhaled every 4 to 6 hours using a ROTAHALER inhalation device. Some patients need 400 mcg (two 200 mcg capsules) every 4 to 6 hours. Prevention of exercise-induced bronchospasm: Recommended dose for adults and children over 4 years of age is 200 mcg (1 capsule) via a ROTAHALER inhalation device 15 minutes before exercise.
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Category C
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Headache, nervousness, tremor, sleeplessness, dizziness, coughing, nausea, and vomiting.
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Pregnancy Risk Categories defined:
A: Studies in pregnant women failed to show a risk to the fetus in the first
trimester - with no evidence of risk in the later trimesters.
B: Animals studies indicate no adverse effect to the fetus, but there are no adequate,
clinical studies in pregnant women.
C: Animal studies have shown an adverse effect on the fetus, but there are no adequate,
clinical studies in humans. Despite potential risks, the drug may be useful in pregnant
women.
D: There is evidence of risk to the human fetus, but the potential benefits of use in
pregnant women may be acceptable, despite potential risks.
X: Studies in animals or humans show fetal abnormalities, or adverse reaction reports
indicate evidence of fetal risk. Warning: the risks involved clearly outweigh any
potential benefit from using the drug in pregnant women, regardless of trimester.
NR: Not rated (i.e., no information available at this time as to the potential
risks or benefits).
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