Important Safety Information
Comprehensive safety guidelines and precautions for Mefloquin® Tablets USP 250mg.
BOXED WARNING
PSYCHIATRIC SYMPTOMS: Mefloquine may cause neuropsychiatric adverse reactions that can persist after discontinuation. These include anxiety, depression, hallucinations, psychotic reactions, and suicidal ideation. Discontinue use and contact healthcare provider immediately if psychiatric symptoms occur.
Contraindications
Absolute Contraindications
- Known hypersensitivity to mefloquine or related compounds
- History of seizures or epilepsy
- Current or recent history of depression, generalized anxiety disorder, psychosis, or other major psychiatric disorders
- Recent use of halofantrine (within 2 weeks)
Relative Contraindications
- Cardiac conduction abnormalities
- Severe liver impairment
- Pregnancy (especially first trimester)
- Breastfeeding (consult healthcare provider)
Warnings & Precautions
Neurological Warnings
- Dizziness, vertigo, and loss of balance
- Headache and visual disturbances
- Tinnitus and hearing impairment
- Confusion and disorientation
- May impair ability to drive or operate machinery
Cardiac Warnings
- QT interval prolongation possible
- Avoid in patients with cardiac arrhythmias
- Caution with other QT-prolonging drugs
- Monitor ECG in high-risk patients
Hepatic Warnings
- Hepatotoxicity reported
- Monitor liver function in prolonged use
- Avoid in severe hepatic impairment
- Dose adjustment may be needed
Ocular Warnings
- Visual disturbances may occur
- Blurred vision and difficulty focusing
- Usually temporary but can be persistent
- Avoid activities requiring clear vision
Drug Interactions
| Drug Class |
Interaction |
Recommendation |
| Halofantrine |
Increased cardiac toxicity |
Contraindicated - avoid within 2 weeks |
| Quinidine, Quinine |
Increased cardiac risk |
Avoid concurrent use |
| Antiepileptics |
Reduced mefloquine levels |
Monitor efficacy |
| Live Vaccines |
Reduced vaccine efficacy |
Separate by 10 days |
| QT Prolonging Drugs |
Increased arrhythmia risk |
Avoid or monitor closely |
Use in Pregnancy & Lactation
Pregnancy
First Trimester:
Contraindicated - risk of fetal harm outweighs benefits
Second/Third Trimester:
Use only if benefits outweigh risks - consult healthcare provider
Note: Women of childbearing potential should use effective contraception during and for 3 months after therapy.
Breastfeeding
Mefloquine is excreted in human milk. Caution should be exercised when administered to nursing mothers. The decision should be based on the importance of the drug to the mother.
Side Effects
Common Side Effects (>10%)
- Nausea and vomiting
- Diarrhea
- Abdominal pain
- Dizziness
- Headache
- Sleep disturbances
- Unusual dreams
Serious Side Effects
- Psychiatric: Depression, anxiety, psychosis, suicidal thoughts
- Neurological: Seizures, confusion, ataxia, tremor
- Cardiac: Arrhythmias, QT prolongation
- Hepatic: Hepatitis, liver failure
- Dermatological: Severe skin reactions, Stevens-Johnson syndrome
When to Seek Medical Help
Seek Immediate Medical Attention For:
- Suicidal thoughts or self-harm
- Severe depression or anxiety
- Psychosis or hallucinations
- Seizures or convulsions
- Chest pain or irregular heartbeat
- Severe allergic reaction (swelling, difficulty breathing)
- Yellowing of skin or eyes (liver problems)
Contact Healthcare Provider For:
- Persistent dizziness or balance problems
- Visual disturbances
- Mood changes or irritability
- Sleep problems lasting more than a week
- Unusual dreams or nightmares
- Any concerning side effects