AZMACORT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AZMACORT (AZMACORT).
Corticosteroid that binds to glucocorticoid receptors, modulating gene transcription to produce anti-inflammatory and immunosuppressive effects.
| Metabolism | Primarily hepatic via CYP3A4 to less active metabolites. |
| Excretion | Primarily fecal (60-80%) and renal (10-20%) as metabolites; unchanged drug <5% in urine. |
| Half-life | Terminal elimination half-life of 3-4 hours for the inhaled route; prolonged in hepatic impairment. |
| Protein binding | Approximately 95% bound to corticosteroid-binding globulin and albumin. |
| Volume of Distribution | Vd approximately 0.4 L/kg; indicates moderate tissue distribution. |
| Bioavailability | Inhalation: approximately 20% (range 10-30%) due to extensive first-pass metabolism; oral bioavailability <1%. |
| Onset of Action | Inhalation: 1-2 weeks for maximal therapeutic effect; some improvement within 24 hours. |
| Duration of Action | Duration of action approximately 12 hours after inhalation; requires twice-daily dosing for asthma control. |
Two inhalations (200 mcg) three to four times daily or four inhalations (400 mcg) twice daily via oral inhalation.
| Dosage form | AEROSOL, METERED |
| Renal impairment | No dosage adjustment required for renal impairment. |
| Liver impairment | No formal studies; caution advised in severe hepatic impairment due to potential increased systemic exposure. |
| Pediatric use | Children 6-12 years: One to two inhalations (100-200 mcg) three to four times daily or two to four inhalations (200-400 mcg) twice daily. |
| Geriatric use | No specific dose adjustment; use lowest effective dose due to potential increased systemic sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AZMACORT (AZMACORT).
| Breastfeeding | Excreted in breast milk at low concentrations; M/P ratio not established. Use caution, especially with high doses, due to potential for adrenal suppression in the infant. |
| Teratogenic Risk | FDA Pregnancy Category C. In first trimester, no adequate studies in humans; animal studies show cleft palate at high doses. Second and third trimesters: risk of fetal adrenal suppression with chronic high doses. Monitor for intrauterine growth restriction. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Primary treatment of status asthmaticus or acute asthma attacks","Hypersensitivity to triamcinolone or any component"]
| Precautions | ["Not for acute bronchospasm or status asthmaticus","May cause adrenal insufficiency during stress or withdrawal","Monitor for systemic corticosteroid effects (e.g., hypercorticism, growth suppression in children)","Risk of oral candidiasis: rinse mouth after use","Caution in patients with tuberculosis, infections, or ocular herpes simplex"] |
| Food/Dietary | No significant food interactions. However, avoid grapefruit and grapefruit juice as they may increase systemic exposure to corticosteroids. |
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| Monitor maternal adrenal function if on chronic therapy. Assess fetal growth via ultrasound if prolonged use. For high doses, monitor neonatal adrenal function after delivery. |
| Fertility Effects | No known adverse effects on fertility in humans. Animal studies show no impairment. |
| Clinical Pearls | AZMACORT (triamcinolone acetonide) is an inhaled corticosteroid for maintenance therapy of asthma. Not for acute bronchospasm. Rinse mouth after use to prevent oral candidiasis. Titrate to lowest effective dose to minimize systemic effects. Monitor for adrenal suppression in patients on high doses or long-term therapy. |
| Patient Advice | Use AZMACORT regularly as prescribed, not for sudden asthma attacks. · Rinse mouth with water after each use to reduce risk of thrush. · Do not stop use abruptly; consult doctor before stopping. · Keep inhaler clean; follow device instructions. · Report worsening symptoms or increased use of rescue inhaler. |