Mefloquine

Mefloquine

Approved uses

• Treatment of Acute Malaria Infections Mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax.
• There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae.
• Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites.
• To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).

Forms and strengths

• Mefloquine hydrochloride tablets USP, 250 mg are available as white, oval-shaped, flat-faced, beveled-edge, scored tablets, debossed with "stylized b" 171 on the scored side and plain on the other...

How it is taken

• Malaria Treatment in Adults Treatment of mild to moderate malaria in adults caused by mefloquine-susceptible strains of P. falciparum or by P. vivax: Dosage: Five tablets (1250 mg) mefloquine hydrochloride to be given as a single oral dose.
• The drug should not be taken on an empty stomach and should be administered with at least 8 oz (240 mL) of water.
• If a full-treatment course with mefloquine does not lead to improvement within 48 to 72 hours, mefloquine should not be used for retreatment.
• An alternative therapy should be used.

Must not be used when

• Use of mefloquine hydrochloride tablets is contraindicated in patients with a known hypersensitivity to mefloquine or related compounds (e.g., quinine and quinidine) or to any of the excipients contained in the formulation.
• Mefloquine hydrochloride tablets should not be prescribed for prophylaxis in patients with active depression, a recent history of depression, generalized anxiety disorder, psychosis, schizophrenia or other major psychiatric disorders, or with a history of convulsions.

Interactions

• Drug-drug interactions with mefloquine have not been explored in detail.
• There is one report of cardiopulmonary arrest, with full recovery, in a patient who was taking a beta blocker (propranolol) (see PRECAUTIONS, Cardiac Effects).
• The effects of mefloquine on the compromised cardiovascular system have not been evaluated.
• The benefits of mefloquine therapy should be weighed against the possibility of adverse effects in patients with cardiac disease.

Warnings and precautions

• In case of life-threatening, serious or overwhelming malaria infections due to P. falciparum, patients should be treated with an intravenous antimalarial drug.
• Following completion of intravenous treatment, mefloquine may be given to complete the course of therapy.
• QTc Interval Prolongation and Drug Interactions Halofantrine should not be administered with mefloquine or within 15 weeks of the last dose of mefloquine due to the risk of a potentially fatal prolongation of the QTc interval (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elimination).

Common side effects

• Clinical At the doses used for treatment of acute malaria infections, the symptoms possibly attributable to drug administration cannot be distinguished from those symptoms usually attributable to the disease itself. Among subjects who received mefloquine for prophylaxis of malaria, the most frequently observed adverse experience was vomiting (3%).

How it acts

Microbiology Mechanism of Action: Mefloquine is an antimalarial agent which acts as a blood schizonticide. Its exact mechanism of action is not known.

Label holder:

Teva Pharmaceuticals USA, Inc.

Label version:

26 September 2025

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.