Mefloquine Hydrochloride Tablets Sandoz

7271 9.5x15.75 Mefloquine FP 06-2013_Layout 1 6/17/13 1:23 PM Page 1 lar to those obtained in the same population after 6 months of Neurologic Adverse Reactions • that no chemoprophylactic regimen is 100% effective, and In clinical trials, the concomitant administration of sulfadox - vomiting (3%). Dizziness, syncope, extrasystoles and other com - drug use, which is when they reached steady state. Neurologic symptoms such as dizziness or vertigo, tinnitus, protective clothing, insect repellents, and bed nets are impor - ine and pyrimethamine did not alter the adverse reaction pro - plaints affecting less than 1% were also reported. In vitro and in vivo studies showed no hemolysis associated and loss of balance have been reported. These adverse reac - tant components of malaria prophylaxis; file of mefloquine. Two serious adverse reactions were cardiopulmonary arrest with glucose-6-phosphate dehydrogenase deficiency (see ANI - tions may occur early in the course of mefloquine use and in • to seek medical attention for any febrile illness that occurs Carcinogenesis, Mutagenesis, Impairment of Fertility in one patient shortly after ingesting a single prophylactic dose MAL TOXICOLOGY ). some cases have been reported to continue for months or after return from a malaria area and to inform their physician Carcinogenesis of mefloquine while concomitantly using propranolol (see PRE - Microbiology years after mefloquine has been stopped. Dizziness or vertigo, that they may have been exposed to malaria. The carcinogenic potential of mefloquine was studied in CAUTIONS: Drug Interactions ), and encephalopathy of unknown Mechanism of Action tinnitus, and loss of balance have been reported to be perma - Drug Interactions rats and mice in 2-year feeding studies at doses of up to 30 etiology during prophylactic mefloquine administration. The rela - Mefloquine is an antimalarial agent which acts as a blood sch - nent in some cases. During prophylactic use, if neurologic Drug-drug interactions with mefloquine have not been mg/kg/day. No treatment-related increases in tumors of any type tionship of encephalopathy to drug administration could not be izonticide. Its exact mechanism of action is not known. symptoms occur, the drug should be discontinued and an explored in detail. There is one report of cardiopulmonary were noted. clearly established. Activity In Vitro and In Vivo alternative medication should be substituted. arrest, with full recovery, in a patient who was taking a beta Mutagenesis Among subjects who received mefloquine for treatment, Mefloquine is active against the erythrocytic stages of Caution should be exercised with regard to activities requir - blocker (propranolol) (see PRECAUTIONS: Cardiac Effects ). The The mutagenic potential of mefloquine was studied in a the most frequently observed adverse experiences included: Plasmodium species (see INDICATIONS AND USAGE ). However, ing alertness and fine motor coordination, such as driving, effects of mefloquine on the compromised cardiovascular sys - variety of assay systems including: Ames test, a host-mediated dizziness, myalgia, nausea, fever, headache, vomiting, chills, the drug has no effect against the exoerythrocytic (hepatic) piloting aircraft, operating machinery, and deep-sea diving, tem have not been evaluated. The benefits of mefloquine ther - assay in mice, fluctuation tests and a mouse micronucleus assay. diarrhea, skin rash, abdominal pain, fatigue, loss of appetite, stages of the parasite. Mefloquine is effective against malaria while symptoms persist. apy should be weighed against the possibility of adverse effects Several of these assays were performed with and without prior and tinnitus. Those side effects occurring in less than 1% parasites resistant to chloroquine (see INDICATIONS AND Mefloquine may increase the risk of convulsions in patients in patients with cardiac disease. metabolic activation. In no instance was evidence obtained included bradycardia, hair loss, emotional problems, pruritus, Mefloquine Hydrochloride Tablets USP, 250 mg meets USP USAGE ). with epilepsy. The drug should therefore be prescribed only for Halofantrine for the mutagenicity of mefloquine. asthenia, transient emotional disturbances and telogen efflu - Dissolution Test 2 . Drug Resistance curative treatment in such patients and only if there are com - Halofantrine should not be administered with mefloquine or Impairment of Fertility vium (loss of resting hair). Seizures have also been reported. The inactive ingredients are crospovidone, lactose monohy - Strains of P. falciparum with decreased susceptibility to pelling medical reasons for its use (see PRECAUTIONS: Drug within 15 weeks of the last dose of mefloquine due to the risk Fertility studies in rats at doses of 5, 20, and 50 mg/kg/day Laboratory drate, low-substituted hydroxypropyl cellulose, magnesium mefloquine can be selected in vitro or in vivo . Resistance of P. Interactions ). of a potentially fatal prolongation of the QTc interval (see of mefloquine have demonstrated adverse effects on fertility in The most frequently observed laboratory alterations which stearate, microcrystalline cellulose, pregelatinized starch and falciparum to mefloquine has been reported in areas of multi- Concomitant administration of mefloquine and quinine or WARNINGS ). the male at the high dose of 50 mg/kg/day, and in the female could be possibly attributable to drug administration were talc. drug resistance in South East Asia. Increased incidences of chloroquine may increase the risk of convulsions. Other Antimalarial Drugs at doses of 20 and 50 mg/kg/day. Histopathological lesions were decreased hematocrit, transient elevation of transaminases, CLINICAL PHARMACOLOGY resistance have also been reported in other parts of the world. PRECAUTIONS Concomitant administration of mefloquine and other related noted in the epididymides from male rats at doses of 20 and leukopenia and thrombocytopenia. These alterations were Pharmacokinetics Cross Resistance Hypersensitivity Reactions antimalarial compounds (eg, quinine, quinidine and chloroquine) 50 mg/kg/day. Administration of 250 mg/week of mefloquine observed in patients with acute malaria who received treatment Absorption Cross-resistance between mefloquine and halofantrine and Hypersensitivity reactions have been reported with mefloquine may produce electrocardiographic abnormalities and increase (base) in adult males for 22 weeks failed to reveal any delete - doses of the drug and were attributed to the disease itself. The absolute oral bioavailability of mefloquine has not been cross-resistance between mefloquine and quinine have been use. the risk of convulsions (see WARNINGS ). If these drugs are to rious effects on human spermatozoa. During prophylactic administration of mefloquine to indige - determined since an intravenous formulation is not available. observed in some regions. Use in Patients with Hepatic Impairment be used in the initial treatment of severe malaria, mefloquine Pregnancy nous populations in malaria-endemic areas, the following alter - The bioavailability of the tablet formation compared with an oral INDICATIONS AND USAGE In patients with impaired liver function the elimination of administration should be delayed at least 12 hours after the last Teratogenic Effects ations in laboratory values were observed: transient elevation solution was over 85%. The presence of food significantly Treatment of Acute Malaria Infections mefloquine may be prolonged, leading to higher plasma levels dose. Clinically significant QTc prolongation has not been found Pregnancy Category B of transaminases, leukocytosis or thrombocytopenia. enhances the rate and extent of absorption, leading to about a Mefloquine hydrochloride tablets are indicated for the treat - and a higher risk of adverse reactions. with mefloquine alone. Data from published studies in pregnant women have shown Because of the long half-life of mefloquine, adverse reactions 40% increase in bioavailability. In healthy volunteers, plasma ment of mild to moderate acute malaria caused by mefloquine- Long-Term Use Ketoconazole (Potent Inhibitor of CYP3A4) no increase in the risk of teratogenic effects or adverse preg - to mefloquine may occur or persist up to several weeks after concentrations peak 6 to 24 hours (median, about 17 hours) susceptible strains of P. falciparum (both chloroquine-sus - This drug has been administered for longer than one year. Co-administration of a single 500 mg oral dose of mefloquine nancy outcomes following mefloquine treatment or prophylaxis discontinuation of the drug. after a single dose of mefloquine. In a similar group of volun - ceptible and resistant strains) or by Plasmodium vivax . There If the drug is to be administered for a prolonged period, peri - with 400 mg of ketoconazole once daily for 10 days in 8 healthy during pregnancy. Reproduction studies in mice, rats and rab - Postmarketing teers, maximum plasma concentrations in mcg/L are roughly are insufficient clinical data to document the effect of mefloquine odic evaluations including liver function tests and evaluations volunteers resulted in an increase in the mean C max and AUC bits have shown teratogenic effects at doses similar to the Postmarketing surveillance indicates that the same kind of equivalent to the dose in milligrams (for example, a single in malaria caused by P. ovale or P. malariae . for neuropsychiatric effects should be performed (see WARN - of mefloquine by 64% and 79%, respectively, and an increase clinical

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