BRONITIN MIST
Clinical safety rating
cautionComprehensive clinical and safety monograph for BRONITIN MIST (BRONITIN MIST).
BRONITIN MIST contains isoproterenol, a non-selective beta-adrenergic agonist that stimulates beta-1 and beta-2 receptors, leading to bronchodilation via relaxation of bronchial smooth muscle, increased heart rate, and increased contractility.
| Metabolism | Primarily metabolized by catechol-O-methyltransferase (COMT) and monoamine oxidase (MAO) in the liver and other tissues; also undergoes sulfation. |
| Excretion | Primarily renal (approximately 70-80% as unchanged drug and metabolites); biliary/fecal excretion accounts for 20-30%. |
| Half-life | Terminal elimination half-life is 3-4 hours in adults; may be prolonged in hepatic or renal impairment, requiring dose adjustment. |
| Protein binding | Approximately 40-60% bound to plasma albumin. |
| Volume of Distribution | 1.5-2.5 L/kg, indicating extensive distribution into tissues beyond plasma volume. |
| Bioavailability | Inhalation: 10-20% (depends on device and technique); Oral: 40-60% due to first-pass metabolism. |
| Onset of Action | Inhalation: 5-15 minutes; Oral: 30-60 minutes. |
| Duration of Action | Inhalation: 4-6 hours; Oral: 6-8 hours. Tolerance may develop with prolonged use, reducing duration. |
| Molecular Weight | 360.44 |
For acute bronchospasm: 1-2 inhalations (0.1 mg per inhalation) via aerosol inhaler every 4-6 hours as needed.
| Dosage form | AEROSOL, METERED |
| Renal impairment | No dose adjustment required for renal impairment; drug is primarily hepatically metabolized. |
| Liver impairment | Child-Pugh Class A: no adjustment. Class B: reduce dose by 50%. Class C: avoid use or use with extreme caution. |
| Pediatric use | Children 2-12 years: 1 inhalation (0.05 mg per inhalation) via aerosol inhaler every 4-6 hours; maximum 4 inhalations per day. |
| Geriatric use | Use with caution due to increased sensitivity; start at lower end of dosing range, monitor for tachycardia and hypertension. |
| 1st trimester | Contraindicated: increased risk of congenital malformations (e.g., cleft palate, cardiac defects). |
| 2nd trimester | Contraindicated: potential for fetal adrenal suppression and anabolic effects. |
| 3rd trimester | Contraindicated: may cause neonatal HPA axis suppression, anemia, and infections. |
Clinical note
Comprehensive clinical and safety monograph for BRONITIN MIST (BRONITIN MIST).
| Placental transfer | Prednisolone/metabolites cross placental barrier; fetal concentrations lower than maternal but significant. |
| Breastfeeding | Excreted into breast milk; may cause HPA axis suppression, growth suppression, and hypoglycemia in nursing infants. Decision to discontinue drug or breastfeed should consider importance of drug to mother. |
| Lactation Rating | L4 - Possibly Hazardous |
| Teratogenic Risk | Pregnancy category C. First trimester: No adequate studies; potential risk based on animal studies showing fetal anomalies. Second/third trimester: Possible fetal tachycardia; avoid near term due to risk of uterine relaxation and delayed labor. |
| Fetal Monitoring | Monitor maternal heart rate, blood pressure, and fetal heart rate. Assess for signs of preterm labor suppression. Evaluate uterine activity if used for tocolysis. |
| Fertility Effects | Beta-2 agonists may inhibit uterine contractility during labor; no significant impact on fertility reported in humans. Animal studies show no impairment. |
■ FDA Black Box Warning
None
| Serious Effects |
Systemic fungal infectionsHypersensitivity to prednisolone or any componentAdministration of live or live attenuated vaccines
| Precautions | May cause paradoxical bronchospasm, Risk of myocardial ischemia and cardiac arrhythmias, Use with caution in patients with hyperthyroidism, diabetes, and hypertension, May produce significant tachycardia and palpitations |
| Food/Dietary | Avoid caffeine (coffee, tea, cola, chocolate) as it may increase stimulant effects (tremor, palpitations). No specific food restrictions; however, maintain adequate hydration. Grapefruit juice may affect metabolism of some components (if includes corticosteroid); consult label. |
| Clinical Pearls | BRONITIN MIST delivers a fixed-dose combination of bronchodilators (beta-2 agonist and anticholinergic) via aerosol. Instruct patients to shake the canister well before each use and to prime it with 2 test sprays if not used for >24 hours. Monitor for paradoxical bronchospasm, oropharyngeal irritation, and cardiovascular effects (tachycardia, palpitations). Advise patients to rinse mouth after use to reduce oral candidiasis risk (if contains corticosteroid). Not for acute severe asthma attacks; short-acting rescue inhaler should be available. |
| Patient Advice | Shake the inhaler vigorously before each use. · Prime the inhaler with 2 test sprays into the air if new or not used for more than 24 hours. · Exhale fully, then place mouthpiece in mouth and seal lips around it. Inhale slowly and deeply while pressing the canister down once. · Hold breath for 10 seconds after inhalation, then exhale slowly. · Wait at least 30 seconds between puffs (if more than one is prescribed). · Rinse mouth with water (do not swallow) after each use to prevent thrush and hoarseness. · Do not exceed prescribed dose; overuse may cause increased side effects or worsening symptoms. · Seek emergency medical help if breathing does not improve or worsens after use. · Keep inhaler at room temperature; do not puncture or burn canister even when empty. · Inform your doctor if you have heart disease, high blood pressure, seizures, thyroid problems, or diabetes. |
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