VENTOLIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VENTOLIN (VENTOLIN).
Selective beta-2 adrenergic receptor agonist; relaxes bronchial smooth muscle by increasing intracellular cyclic AMP
| Metabolism | Primarily hepatic via conjugation; substrate for catechol-O-methyltransferase (COMT) and sulfation; minor CYP450 metabolism |
| Excretion | Renal (60-70% as unchanged drug and metabolites), biliary/fecal (minor, <10%) |
| Half-life | Terminal elimination half-life 3-4 hours (nebulized, oral); 4-6 hours (intravenous); prolonged in renal impairment |
| Protein binding | Approximately 10-15% (primarily to albumin) |
| Volume of Distribution | 2-4 L/kg (extensive extravascular distribution, minimal CNS penetration) |
| Bioavailability | Inhalation: 10-20% (delivered dose to lungs); Oral: 40-50% (extensive first-pass metabolism) |
| Onset of Action | Inhalation: 5-15 minutes; Oral: 30-60 minutes; Intravenous: immediate |
| Duration of Action | Inhalation: 4-6 hours (short-acting beta-agonist); oral: 4-8 hours; sustained-release oral: 12 hours |
2 inhalations (100 mcg/inhalation) via metered-dose inhaler every 4-6 hours as needed for bronchospasm. For nebulization: 2.5 mg (0.5 mL of 0.5% solution) in 2.5 mL sterile normal saline, inhaled via nebulizer 3-4 times daily.
| Dosage form | SYRUP |
| Renal impairment | No specific dose adjustment required for renal impairment. Dose as in normal renal function. |
| Liver impairment | No specific dose adjustment required for hepatic impairment. Dose as in normal hepatic function. |
| Pediatric use | For acute bronchospasm: Children <12 years: 1-2 inhalations (100 mcg/inhalation) via MDI every 4-6 hours as needed, or via nebulizer: 0.15 mg/kg/dose (minimum 2.5 mg) every 4-6 hours. Maximum 10 mg/day. |
| Geriatric use | No specific dose adjustment; use caution in patients with cardiovascular disease. Start at lower end of dosing range (e.g., 1 inhalation) and titrate to effect. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VENTOLIN (VENTOLIN).
| Breastfeeding | Albuterol is excreted into breast milk in low amounts; estimated infant dose is <1% of maternal weight-adjusted dose. M/P ratio data not established. No adverse effects reported in nursing infants. Use with caution due to theoretical risk of beta-adrenergic side effects in neonates. |
| Teratogenic Risk | Inhaled short-acting beta-agonists like albuterol are not associated with increased risk of major congenital malformations. First trimester: no increased risk in observational studies. Second and third trimesters: may cause maternal tachycardia, hyperglycemia, and fetal tachycardia; no known teratogenic effects. Use during labor may delay preterm labor and cause neonatal hypoglycemia or hypokalemia. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to albuterol or any component","History of severe hypersensitivity reactions to beta-agonists (relative)","Concurrent use with non-selective beta-blockers (relative, may antagonize effects)"]
| Precautions | ["Paradoxical bronchospasm may occur; discontinue immediately","Cardiovascular effects: increased heart rate, blood pressure, QT prolongation; use caution with cardiovascular disorders","Hypokalemia may occur (especially with high doses)","Immediate hypersensitivity reactions (urticaria, angioedema, rash)","Do not exceed recommended dose; excessive use may lead to death"] |
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| Fetal Monitoring | Monitor maternal heart rate, blood pressure, and serum glucose. Fetal heart rate monitoring should be considered during acute use, especially in third trimester or preterm labor. Assess for signs of maternal hypokalemia with high-dose therapy. |
| Fertility Effects | No known adverse effects on fertility in animal or human studies. Albuterol is not associated with impairment of male or female reproductive function. |