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Mefloquine Hcl 250 Mg Tabs 25 By Teva Pharma

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Mefloquine Hcl 250 Mg Tabs 25 By Teva Pharma

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Mefloquine Hcl 250 Mg Tabs 25 By Teva Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD3541729/RXB10057977/RXA317666
Size : 25
Selling UoM : EA
NDC: 00555-0171-78
UPC Barcode : 305550171782
Supplier: 0050001781 TEVA PHARMACEUTICALS USA
Supplier Material : 017178
Generic Code : 013747 MEFLOQUINE HCL ORAL TABLET 250 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic R

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Product Description.:

B 171
tablet , white , scored , oval oblong
Flat-faced beveled-edgeBeveled edge

Indications And Clinical Uses: Prophylaxis: For the prophylaxis of P. falciparum and P. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of P. falciparum.

Treatment of Acute Malaria Infections: 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 P. vivax.

Note: In case of life-threatening, serious or overwhelming malaria infections due to P. falciparum, patients should be treated with an i.v. antimalarial drug. Following completion of i.v. treatment, mefloquine may be given orally to complete the course of therapy.

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 (e.g., primaquine).

There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae.

Contra-Indications: In patients with a known hypersensitivity to mefloquine or related compounds, e.g., quinine, quinidine, chloroquine.

Patients with a history of psychiatric disturbances (including depression) or convulsions should not be prescribed mefloquine prophylactically since mefloquine may precipitate these conditions.

Manufacturers' Warnings In Clinical States: Concomitant administration of mefloquine and quinine, quinidine, chloroquine, or drugs producing beta-adrenergic blockade may produce electrocardiographic abnormalities or cardiac arrest. Because of the danger of a potentially fatal prolongation of the QTc interval, halofantrine must not be given simultaneously with or subsequent to mefloquine. Concomitant administration of mefloquine, quinine, quinidine or chloroquine may increase the risk of convulsions (see Precautions, Drug Interactions).

In patients with epilepsy, mefloquine, especially when used in high doses, may increase the risk of convulsions. Therefore, in such patients, mefloquine should be used only for curative treatment and only if there are compelling medical reasons.

In patients with impaired liver function the elimination of mefloquine may be prolonged, leading to higher plasma levels.

Pregnancy: Mefloquine crosses the placenta. Administered at 5 to 20 times the therapeutic dose in man, mefloquine was teratogenic in mice and rats and embryotoxic in rabbits. The safety of mefloquine use during the first trimester has not been established. Available data indicate that mefloquine is safe and effective in pregnancy beyond 16 weeks. Women of childbearing potential should be advised to practise contraception during malaria prophylaxis with mefloquine and for 3 months after the last dose.

Pregnancy has no clinically relevant effect on the pharmacokinetics of mefloquine.

Precautions: General: Occupational Hazards: Caution should be exercised with regard to driving, piloting airplanes, operating machines, or any other activity requiring alertness and fine motor coordination, as dizziness, a disturbed sense of balance and other disorders of the central and peripheral nervous system have been reported during and up to 3 weeks after the use of mefloquine (see Adverse Effects). During prophylactic use, if signs of unexplained anxiety, depression, restlessness or confusion are noticed, these may be considered prodromal to a more serious event. In these cases, the drug must be discontinued.

Mefloquine should be taken with caution in patients suffering from cardiac conduction disorders. Parenteral studies in animals show that mefloquine, a myocardial depressant, possesses 20% of the antifibrillatory action of quinidine and produces 50% of the increase in the PR interval reported with quinine. The effect of mefloquine on the compromised cardiovascular system has not been evaluated. In patients with cardiac disease, the benefits of mefloquine therapy should be weighed against the possibility of adverse effects.

During clinical trials, this drug was not administered for longer than 1 year. If the drug is to be administered for a prolonged period, periodic evaluations including liver function tests should be performed, if feasible. Although retinal abnormalities seen in humans with long-term chloroquine use have not been observed with mefloquine use, long-term feeding of mefloquine to rats resulted in dose-related ocular lesions (retinal degeneration, retinal edema and lenticular opacity at 12.5 mg/kg/day and higher). Therefore, periodic ophthalmic examinations are recommended.

Drug Interactions: Drug-drug interactions with mefloquine have not been explored in detail.

Concomitant administration of me