ALBUTEROL SULFATE (albuterol sulfate)

There are 0 contraindications.

There are 0 severe contraindications.

There are 12 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Cardiac arrhythmia
Chronic myocardial ischemia
Congenital long QT syndrome
Diabetes mellitus
Hypertension
Hyperthyroidism
Hypokalemia
Ketoacidosis
Metabolic acidosis
Myocardial ischemia
Prolonged QT interval
Seizure disorder

There are 10 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal ECG Angina Angioedema Cardiac arrhythmia Chest pain Erythema multiforme Paradoxical bronchospasm Pharyngeal edema ST segment changes Stevens-johnson syndrome

There are 27 less severe adverse reactions.

More Frequent	Less Frequent
Nausea Nervousness Tremor	Cough Dizziness Dry throat Dysgeusia Dyspepsia Epistaxis Excitement Flushing General weakness Headache disorder Hyperhidrosis Hyperkinesis Hypertension Increased appetite Insomnia Muscle spasm Palpitations Tachycardia Vomiting Xerostomia

Rare/Very Rare
Anorexia Pallor Skin rash Urticaria

Experts from the National Asthma Education and Prevention Program (NAEPP) state that maintaining adequate control of asthma during pregnancy is important for the health and well-being of the mother and the fetus. Because of the risks associated with asthma symptoms and exacerbations (e.g., increased perinatal mortality, preeclampsia, preterm birth, low birth weight during pregnancy, such experts consider use of antiasthmatic agents to be safer than the complications of inadequately controlled asthma. Albuterol is the preferred short-acting inhaled beta2-agonist because more data are available on use of albuterol in pregnant women than on use of other short-acting inhaled beta2-agonists, and such data indicate an excellent safety profile. The manufacturers of albuterol or levalbuterol state that the drugs should be used during pregnancy only if the possible benefits outweigh the potential risks. During marketing experience with the drug, various congenital anomalies, including cleft palate and limb defects, have been reported in the children of patients being treated with albuterol; however, some women were receiving multiple medications during their pregnancies. Because no consistent pattern of congenital abnormality development can be discerned, a relationship between albuterol use and the development of congenital anomalies cannot be established. Large IV doses of albuterol have reportedly inhibited uterine contractions, and the drug has reportedly delayed preterm labor following oral administration. Serious adverse effects, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol. There are currently no well-controlled studies to show that albuterol will stop preterm labor or prevent labor at term, and the risks versus benefits of tocolytic therapy with levalbuterol or albuterol have not been established. Albuterol or orally inhaled levalbuterol should be used with caution in pregnant women when needed for relief of bronchospasm during labor and only when the potential benefits are expected to clearly outweigh the possible risks, since the drugs may interfere with uterine contractility. Albuterol has been shown to be teratogenic in mice and rabbits. Reproduction studies in mice given subcutaneous albuterol doses of 0.025, 0.25, or 2.5 mg/kg (approximately 0.003, 0.03, or 0.3 times, respectively, the maximum recommended daily oral dosage for adults; 0.125, 1.25, and 12.5 times the maximum recommended human albuterol single-use inhalation solution via nebulization; less than the maximum recommended adult daily inhalation solution dosage on a mg/m2 basis; and up to 8 times the maximum recommended daily inhalation aerosol dosage on a mg/m2 basis) showed cleft palate formation in 4.5% of fetuses at 0.25

mg/kg and in 9.3% of fetuses at 2.5 mg/kg (approximately equal to the maximum daily nebulized levalbuterol, albuterol sulfate, or albuterol sulfate/ipratropium bromide dosage in adults on a mg/m2 basis); cleft palate did not occur in mice receiving 0.025

mg/kg of albuterol (representing less than the maximum daily adult inhalation dosage of albuterol sulfate alone via metered-dose inhalation or nebulization or in fixed combination with ipratropium bromide via nebulization on a mg/m2 basis). Cleft palate also occurred in 30.5% of fetuses treated with 2.5

mg/kg of isoproterenol (positive control). A reproduction study with oral albuterol in rabbits revealed cranioschisis in 37% of fetuses at 50 mg/kg (approximately 25, 55, 60 or 80 times the maximum recommended daily adult oral albuterol sulfate dosage, albuterol sulfate/ipratropium bromide nebulized adult dosage, nebulized pediatric albuterol dosage or nebulized albuterol sulfate adult dosage, respectively, on a mg/m2 basis; 630-680 times the maximum daily adult inhalation aerosol dosage; or 250 times the maximum albuterol inhalation solution dosage via nebulization for a 50-kg human). In a reproduction study in rats given albuterol sulfate aerosol containing a hydrofluoroalkane propellant by oral inhalation, the drug did not exhibit any teratogenic effects at 10.5

mg/kg daily (approximately 60-65 times the maximum recommended human daily inhalation dosage on a mg/m2 basis). Safe use of the drug in pregnant women has not been established. A reproduction study in rabbits given oral levalbuterol dosages of up to 25 mg/kg (approximately 110 times the maximum recommended daily adult oral inhalation dosage on a mg/m2 basis) revealed no evidence of teratogenicity.

It is not known whether albuterol, albuterol sulfate, or levalbuterol is distributed into milk. Because of the potential for tumorigenicity shown for albuterol in animal studies, a decision should be made whether to discontinue nursing or albuterol or levalbuterol, taking into account the importance of the drug to the woman.

No enhanced Geriatric Use information available for this drug.