Export: +91 9820402906   Domestic: +91 7710003340 | HR: +91 9137757219
Mefloquine Hydrochloride Tablets

Mefloquine Hydrochloride Tablets

Composition: Mefloquine Hydrochloride IP equivalent to Mefloquine 250 mg; Mefloquine Hydrochloride IP or BP equivalent to Mefloquine 500 mg; Mefloquine Hydrochloride BP equivalent to Mefloquine 750 mg.

Dosage form: Film-coated tablet

Usage: Malaria treatment or prevention where clinically appropriate and recommended for the geographic area

Category: Antimalarial Drugs

Therapeutic category: Antimalarial

SKU: Mefloquine Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Mefloquine Hydrochloride Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Manufacturer: Healthy Life Pharma Pvt. Ltd. (WHO-GMP status to be verified)
Exporter: Healthy Inc (Star Export House status to be verified)

1. Product Introduction

Mefloquine is a long-acting antimalarial used for prevention and, in selected circumstances, treatment of malaria. Its suitability depends on local parasite resistance, current national guidelines, patient history and the approved product label. It should not be presented as a universal first-line therapy for malaria.

Healthy Life Pharma Pvt. Ltd. is identified in the supplied materials as manufacturer, with Healthy Inc as exporter. Specific manufacturing, export-market and certification claims require documentary confirmation.

2. Product Specifications

Product nameMefloquine Hydrochloride Tablets
250 mg variantMefloquine Hydrochloride IP equivalent to Mefloquine 250 mg
500 mg variantsMefloquine Hydrochloride IP or BP equivalent to Mefloquine 500 mg
750 mg variantMefloquine Hydrochloride BP equivalent to Mefloquine 750 mg
Dosage formFilm-coated tablets
Therapeutic classAntimalarial
CAS number53230-10-7 (mefloquine hydrochloride)
Packaging / shelf lifeConfirm with approved specifications and stability data
Regulatory statusMarket-specific registration and approved strength must be verified

3. Manufacturing Technology

Formulation development for mefloquine hydrochloride tablets may address API particle-size distribution, blend uniformity, dissolution, taste masking, coating integrity and stability. Any claim of micronization, particular excipients or validated processes must be supported by batch records and technical data. The supplied formulations are film-coated, not uncoated.

4. Quality Assurance

Appropriate release and stability testing may include identification, assay, uniformity of dosage units, dissolution, related substances and packaging integrity against the applicable approved IP/BP monograph or product specification. Specific assay and dissolution limits, 24–36-month shelf life and GMP certification are not independently verified here.

5. Pharmacology and Clinical Use

Mefloquine is a blood-stage antimalarial active against susceptible malaria parasites. It has a long elimination half-life, supporting weekly preventive dosing in selected travelers. It does not prevent or eradicate dormant liver stages of Plasmodium vivax or P. ovale; additional treatment may be required under specialist guidance.

Use depends on destination-specific resistance patterns. Mefloquine is not appropriate in regions with significant resistance and is generally not preferred as monotherapy for uncomplicated falciparum malaria where artemisinin-based combination therapy is recommended. Severe malaria requires urgent hospital-based treatment.

6. Export and Regulatory Support

Importers may request current manufacturing licenses, GMP evidence, certificates of analysis, product registration documents, available CTD/ACTD dossiers and stability/packaging information. Availability of certificates, shipping destinations and registered strengths should be confirmed before commercial claims or tender submissions.

7. Frequently Asked Questions

Q: Which strengths are supplied?
A: The provided composition lists 250 mg (IP), 500 mg (IP/BP) and 750 mg (BP), expressed as mefloquine base equivalent. Availability and approval of each strength require confirmation.

Q: Is it suitable for every malaria destination?
A: No. Resistance patterns and patient contraindications determine suitability.

Q: Can it cause unusual dreams or mood changes?
A: Yes. Abnormal dreams, anxiety, depression and more severe psychiatric reactions can occur. Seek medical advice immediately if neuropsychiatric symptoms develop.

Q: Is it equivalent to Lariam?
A: Lariam is an established mefloquine brand. Bioequivalence of any particular generic product cannot be claimed without applicable supporting evidence.

8. Dosage and Administration

Prevention: Some approved labels use mefloquine 250 mg base once weekly for adults, started sufficiently before travel, continued during exposure and for four weeks after departure. A clinician should select the exact start date, regimen and alternatives based on local guidance and the patient's history.

Treatment: Weight-based treatment regimens and dose splitting vary by national guidance and product label. Do not infer a treatment regimen from the supplied 500 mg or 750 mg tablet strengths; those are individual tablet strengths, not instructions to take that amount. Treatment must be clinician-directed. Take with food and water if consistent with the approved label.

9. Side Effects and Precautions

  • Boxed neuropsychiatric warning: Anxiety, depression, hallucinations, psychosis and other serious symptoms may occur; some neurological or psychiatric adverse effects can persist after stopping.
  • Contraindications: Generally avoid for prophylaxis in people with active or recent depression, generalized anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders or a history of convulsions, according to applicable labeling.
  • Neurologic: Dizziness, vertigo, balance disturbance and abnormal dreams can occur. Avoid driving if impaired.
  • Cardiac: Consider conduction abnormalities and interactions with other QT-affecting or antimalarial medicines.
  • Pregnancy, children and interactions: Require individualized professional assessment; never self-medicate for malaria.

For malaria prevention, new psychiatric or neurologic symptoms warrant prompt medical review and selection of an alternative prophylactic drug where indicated. Suspected malaria with fever requires urgent testing and medical care.

10. Storage Instructions

Keep in the original packaging, protected from moisture and excessive heat, according to the approved product label. Verify any specific below-25°C storage claim from registered stability information. Keep out of reach of children.