Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Mefloquine hydrochloride tablets USP, 250 mg are round, white to off white tablets, scored, debossed GP 118 on one side and plain on the reverse side, and are supplied as follows: Bottle of 5 tablets – NDC 62135-973-11 Bottle of 25 tablets – NDC 62135-973-25 Dispense in tight, light-resistant container as determined in the USP using a child-resistant closure. Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).; PRINCIPAL DISPLAY PANEL Mefloquine Hydrochloride Tablets, USP 250 mg - NDC 62135-973-11 - 5s Bottle Label Mefloquine Hydrochloride Tablets, USP 250 mg - NDC 62135-973-25 - 25s Bottle Label "Image Description" "Image Description"
- HOW SUPPLIED Mefloquine hydrochloride tablets USP, 250 mg are round, white to off white tablets, scored, debossed GP 118 on one side and plain on the reverse side, and are supplied as follows: Bottle of 5 tablets – NDC 62135-973-11 Bottle of 25 tablets – NDC 62135-973-25 Dispense in tight, light-resistant container as determined in the USP using a child-resistant closure. Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).
- PRINCIPAL DISPLAY PANEL Mefloquine Hydrochloride Tablets, USP 250 mg - NDC 62135-973-11 - 5s Bottle Label Mefloquine Hydrochloride Tablets, USP 250 mg - NDC 62135-973-25 - 25s Bottle Label "Image Description" "Image Description"
Overview
Mefloquine hydrochloride is an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration. Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. Mefloquine hydrochloride has a calculated molecular weight of 414.78 and the following structural formula: Mefloquine Hydrochloride Tablets USP, 250 mg meets USP Dissolution Test 2. The inactive ingredients are crospovidone, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. "Image Description"
Dosage & Administration
Not available
Warnings & Precautions
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.
Boxed Warning
Mefloquine may cause neuropsychiatric adverse reactions that can persist after mefloquine has been discontinued. Mefloquine should not be prescribed for prophylaxis in patients with major psychiatric disorders. During prophylactic use, if psychiatric or neurologic symptoms occur, the drug should be discontinued and an alternative medication should be substituted (see WARNINGS ).
Contraindications
Use of mefloquine hydrochloride tablets is contraindicated in patients with a known hypersensitivity to mefloquine or related compounds (eg, 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.
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