Ocuquin 300/375 Tablets

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. …

• 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
• Similarly, if previous prophylaxis with mefloquine failed, mefloquine should not be used for curative treatment (see INDICATIONS AND USAGE )
• 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)
• Malaria Prophylaxis
• In Adults Dosage: One 250 mg mefloquine hydrochloride tablet once weekly
• Prophylactic drug administration should begin 1 week before arrival in an endemic area
• Subsequent weekly doses should be taken regularly, always on the same day of each week, preferably after the main meal
• To reduce the risk of malaria after leaving an endemic area, prophylaxis must be continued for 4 additional weeks to ensure suppressive blood levels of the drug when merozoites emerge from the liver. …

• Use of mefloquine to treat acute, uncomplicated P. falciparum malaria
• In pediatric patients is supported by evidence from adequate and well-controlled studies of mefloquine
• In adults with additional data from published open-label and comparative trials using mefloquine to treat malaria caused by P. falciparum in patients younger than 16 years of age
• The safety and effectiveness of mefloquine
• For the treatment of malaria
• In pediatric patients below the age of 6 months have not been established. …

Clinical studies of mefloquine did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Medication Guide: As required by law, a mefloquine hydrochloride tablets Medication Guide is supplied to patients when mefloquine is dispensed
• An information wallet card is also supplied to patients when mefloquine is dispensed
• Patients should be instructed to read the Medication Guide when mefloquine is received and to carry the information wallet card with them when they are taking mefloquine
• The complete texts of the Medication Guide and information wallet card are reprinted at the end of this document. …

• 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

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. Halofantrine 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 WARNINGS ). …

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 ). …

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%). Dizziness, syncope, extrasystoles and other complaints affecting less than 1% were also reported. …

Pregnancy

Symptoms and Signs In cases of overdosage with mefloquine, the symptoms mentioned under ADVERSE REACTIONS may be more pronounced. Treatment Patients should be managed by symptomatic and supportive care following mefloquine overdose. There are no specific antidotes. Monitor cardiac function (if possible by ECG) and neuropsychiatric status. Provide symptomatic and intensive supportive treatment as required.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.