MAZANOR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MAZANOR (MAZANOR).
Mazanor (mazindol) is a sympathomimetic amine that acts as an anorectic agent. It likely reduces appetite by increasing norepinephrine and dopamine levels in the hypothalamic feeding centers via reuptake inhibition and possibly by blocking serotonin receptors.
| Metabolism | Hepatic metabolism primarily via CYP3A4 isoenzyme. |
| Excretion | Primarily renal (85-90% as unchanged drug), with minor biliary/fecal elimination (5-10%). |
| Half-life | Terminal half-life is 12-15 hours in adults with normal renal function; prolonged in renal impairment (up to 30 hours). |
| Protein binding | 25-30% (primarily to albumin). |
| Volume of Distribution | 3.5-5.5 L/kg (large Vd indicates extensive tissue distribution). |
| Bioavailability | Oral: 70-90% (first-pass metabolism minimal). |
| Onset of Action | Oral: 30-60 minutes; peak effect at 2-4 hours. |
| Duration of Action | 6-12 hours (dose-dependent); clinical effects may persist longer in renal impairment. |
1 mg orally once daily, titrated based on response and tolerability up to 2 mg once daily.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min; avoid use in GFR <30 mL/min. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: not recommended. |
| Pediatric use | Not approved in pediatric patients. |
| Geriatric use | Start at 0.5 mg once daily; titrate cautiously due to increased sensitivity and risk of hypotension. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MAZANOR (MAZANOR).
| Breastfeeding | Mazindol is excreted into breast milk; M/P ratio not established. Potential for serious adverse reactions in nursing infants (e.g., irritability, poor feeding). Not recommended during breastfeeding. Consider alternative treatments. |
| Teratogenic Risk | Mazanor (mazindol) is a controlled substance with limited data in human pregnancy. Animal studies have shown fetal abnormalities at high doses. First trimester: potential risk of major malformations, though specific human data are lacking. Second and third trimesters: may increase risk of preterm birth, low birth weight, and neonatal withdrawal (irritability, feeding difficulties). Drug should be avoided in pregnancy unless benefit outweighs potential risk. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to mazindol or any component of the formulation","History of drug abuse","Patients taking or within 14 days of monoamine oxidase inhibitors (MAOIs)","Thyrotoxicosis","Glaucoma","Severe hypertension or cardiovascular disease","Agitated states"]
| Precautions | ["May cause primary pulmonary hypertension (PPH) and valvular heart disease, especially with long-term use or when used with other serotonergic agents.","Risk of dependence and abuse; use with caution in patients with history of substance abuse.","May impair ability to drive or operate machinery; caution with alcohol use.","Use with caution in patients with hypertension, cardiovascular disease, diabetes mellitus, or hyperthyroidism."] |
Loading safety data…
| Fetal Monitoring | If used in pregnancy, monitor fetal growth via serial ultrasound, assess for signs of preterm labor, and evaluate neonatal withdrawal symptoms after delivery. Maternal monitoring includes blood pressure, heart rate, and signs of tolerance/dependence. |
| Fertility Effects | Mazindol may impair fertility based on animal studies (e.g., altered estrous cycles). Human data insufficient. Caution in patients planning pregnancy; discuss alternative therapies. |