BRONCHITOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BRONCHITOL (BRONCHITOL).
Increases mucociliary clearance by reducing mucus viscosity and facilitating cough; may also stimulate surfactant production and have anti-inflammatory effects.
| Metabolism | Not metabolized; excreted unchanged primarily by the kidneys. |
| Excretion | Primarily renal excretion of unchanged drug; approximately 80-90% of the inhaled dose is recovered in urine within 24 hours, with less than 5% in feces. |
| Half-life | Terminal elimination half-life is approximately 1.6 hours, indicating rapid clearance from plasma; however, the residence time in airways is prolonged due to mucoadhesion. |
| Protein binding | Less than 10% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Vd is approximately 0.3 L/kg, indicating distribution mainly in extracellular fluids; not extensively distributed into tissues. |
| Bioavailability | Inhalation: systemic bioavailability is approximately 10-20% of the delivered dose, with the majority swallowed and excreted unchanged in feces. |
| Onset of Action | Inhalation: improvement in pulmonary function tests observed within 30-60 minutes post-dose. |
| Duration of Action | Clinical effects on mucociliary clearance persist for up to 24 hours after a single inhalation, but effects on FEV1 may wane after 8-12 hours, supporting once-daily dosing. |
400 mg (2 capsules) inhaled twice daily via a dry powder inhaler.
| Dosage form | POWDER |
| Renal impairment | No adjustment required as BRONCHITOL is not systemically absorbed and is primarily eliminated unchanged in the urine without significant systemic exposure. Caution in severe renal impairment due to potential bronchospasm risk. |
| Liver impairment | No adjustment required as BRONCHITOL is not systemically absorbed and undergoes negligible hepatic metabolism. |
| Pediatric use | Not recommended for use in children below 18 years of age due to lack of safety and efficacy data. For pediatric cystic fibrosis patients (≥18 years): same as adult dosing (400 mg twice daily). |
| Geriatric use | No specific dose adjustment; use with caution due to age-related decline in renal function and increased risk of bronchospasm. Monitor for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BRONCHITOL (BRONCHITOL).
| Breastfeeding | Unknown if excreted in human milk; no M/P ratio available. Consider developmental benefits of breastfeeding vs. potential drug exposure. |
| Teratogenic Risk | No adequate human studies; animal studies show no fetal harm at doses up to 2.6 times MRHD. Risk cannot be excluded; use only if clearly needed. |
| Fetal Monitoring | Monitor pulmonary function and oxygen saturation; fetal heart rate monitoring if severe respiratory compromise. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to mannitol or any excipient; severe hemoptysis; untreated hypokalemia; patients with severe hyperosmolar states.
| Precautions | Bronchospasm (risk of severe bronchospasm, require pre- and post-dose spirometry), hemoptysis, hypersensitivity reactions, potential for airway irritation. |
| Food/Dietary | No clinically significant food interactions. Maintain adequate hydration to enhance mucus clearance. |
| Clinical Pearls |
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| Fertility Effects | No data on human fertility; animal studies show no adverse effects on male or female fertility. |
| BRONCHITOL (mannitol dry powder for inhalation) is used to improve mucociliary clearance in cystic fibrosis (CF). Administer via low-resistance inhaler (e.g., R501) after a bronchodilator to reduce risk of bronchospasm. Perform baseline spirometry; contraindicated if FEV1 < 30% predicted. Monitor for coughing, hemoptysis, or acute bronchospasm. |
| Patient Advice | Take one capsule twice daily using the provided inhaler device. · Always use a bronchodilator (e.g., salbutamol) 5-15 minutes before BRONCHITOL to prevent airway narrowing. · Do not swallow the capsules; inhale the powder only. · Do not use if you have severe lung function (FEV1 less than 30% predicted) or a history of severe blood in sputum. · Report sudden worsening of breathlessness or chest tightness. |