VOSPIRE ER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VOSPIRE ER (VOSPIRE ER).
Vospire ER (albuterol sulfate) is a beta2-adrenergic receptor agonist that relaxes bronchial smooth muscle by increasing cyclic AMP production via activation of adenylyl cyclase, leading to bronchodilation.
| Metabolism | Primarily hepatic metabolism via conjugation (sulfation) by SULT1A3 and to a lesser extent by CYP450 (CYP3A4). |
| Excretion | Primarily renal (approximately 75% as unchanged drug and metabolites) and biliary/fecal (approximately 25%). |
| Half-life | Terminal elimination half-life of vospire ER is approximately 12-15 hours. This prolonged half-life supports once-daily dosing and provides sustained bronchodilation over the dosing interval. |
| Protein binding | Approximately 90% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is approximately 3-4 L/kg, indicating extensive tissue distribution and penetration into extravascular spaces. |
| Bioavailability | Oral bioavailability is approximately 60-70% due to first-pass metabolism; for the extended-release formulation, bioavailability is similar but with a prolonged absorption phase. |
| Onset of Action | Bronchodilation is detectable within 30 minutes to 1 hour after oral administration. |
| Duration of Action | Duration of bronchodilation is approximately 12-24 hours, with the extended-release formulation providing control of asthma symptoms for the full 24-hour period with once-daily dosing. |
Oral: 30-60 mg once daily in the morning, with or without food. Maximum dose: 60 mg/day.
| Dosage form | TABLET, EXTENDED RELEASE |
| Renal impairment | eGFR 30-89 mL/min/1.73m²: No adjustment. eGFR 15-29 mL/min/1.73m²: Reduce dose to 30 mg once daily. eGFR <15 mL/min/1.73m² or dialysis: Not recommended. |
| Liver impairment | Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce dose to 30 mg once daily. Child-Pugh Class C: Not recommended. |
| Pediatric use | Not approved for pediatric patients under 18 years. |
| Geriatric use | No specific dose adjustment required based on age alone; monitor renal function and consider starting at 30 mg once daily in patients with frailty or comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VOSPIRE ER (VOSPIRE ER).
| Breastfeeding | Methamphetamine is excreted into breast milk. M/P ratio is approximately 2.8-7.5, indicating significant accumulation. Breastfeeding is contraindicated due to potential for infant toxicity (irritability, poor feeding, seizures) and long-term neurodevelopmental harm. |
| Teratogenic Risk | VOSPIRE ER (methamphetamine hydrochloride) is classified as FDA Pregnancy Category C. First trimester: increased risk of premature delivery, low birth weight, and congenital anomalies (e.g., cardiac, cleft palate) based on animal data and limited human reports. Second and third trimesters: risk of fetal toxicity, including intrauterine growth restriction, placental abruption, and neonatal withdrawal syndrome (irritability, poor feeding). |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to albuterol or any component of the formulation"]
| Precautions | ["Paradoxical bronchospasm may occur; discontinue immediately.","Cardiovascular effects: tachycardia, arrhythmias, increased blood pressure, especially with excessive use.","Hypokalemia may occur with high doses.","Patients with hyperthyroidism, diabetes, or seizure disorders should use with caution."] |
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| Fetal Monitoring | Regular monitoring of maternal blood pressure, heart rate, and signs of tachycardia or hypertension. Fetal surveillance includes serial ultrasound for growth restriction, amniotic fluid index assessment, and fetal heart rate monitoring starting at 28 weeks gestation. Assess for signs of preterm labor. |
| Fertility Effects | Methamphetamine use can impair fertility in both males (reduced sperm count, motility) and females (menstrual irregularities, anovulation). Recovery may occur with cessation. No specific human studies on VOSPIRE ER. |