Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
MEFLOQUINE HYDROCHLORIDE (UNII: 5Y9L3636O3) (MEFLOQUINE - UNII:TML814419R)
West-Ward Pharmaceuticals Corp
MEFLOQUINE HYDROCHLORIDE
MEFLOQUINE HYDROCHLORIDE 250 mg
ORAL
PRESCRIPTION DRUG
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). Prevention of Malaria : Mefloquine hydrochloride tablets are indicated for the prophylaxis of P. falciparum and P. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of P. falciparum. Use of Mefloquine hydrochloride tablets is contraindica
Mefloquine Hydrochloride Tablets, USP 250 mg, are supplied as White Round Scored Tablets, Debossed “WW 282” and available in: Bottles of 25 tablets Store at 20˚ to 25°C (68˚ to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
West-Ward Pharmaceuticals Corp ---------- MEDICATION GUIDE Mefloquine Hydrochloride Tablets, USP Important: Your doctor or pharmacist will give you an Information Wallet Card along with this Medication Guide. It has important information about mefloquine and should be carried with you at all times while you take mefloquine. What is the most important information I should know about mefloquine? Mefloquine can cause serious side effects, including: 1. Heart Problems. Do not take halofantrine (used to treat malaria) or ketoconazole (used for fungal infections) with mefloquine or within 15 weeks of your last dose of mefloquine. You may get serious heart problems (problems with the electrical system of your heart called QT prolongation) that can lead to death. Do not take quinine (Qualaquin) or quinidine (used to treat malaria or irregular heart beat) with mefloquine. You may get serious heart problems. 2. Mental Problems. Symptoms of serious mental problems may include: wsevere anxiety • paranoia (feelings of mistrust towards others) • hallucinations (seeing or hearing things that are not there) • depression • feeling restless • unusual behavior • feeling confused Some people who take mefloquine think about suicide (putting an end to their life). Some people who were taking mefloquine committed suicide. It is not known if mefloquine was responsible for those suicides. If you have any of these serious mental problems, or you develop other serious side effects or mental problems, you should contact your doctor right away as it may be necessary to stop taking mefloquine and use a different medicine to prevent malaria. 3. Problems with your body’s nervous system. Symptoms of serious nervous system problems may include: • dizziness • a feeling that you or things around you are moving or spinning (vertigo) • loss of balance • ringing sound in your ears (tinnitus) • convulsions (seizures) in people who already have seizures (epilepsy) • convulsions (seizures) in people who take quinine or chloroqui Baca dokumen lengkap
MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET WEST-WARD PHARMACEUTICALS CORP ---------- MEFLOQUINE HYDROCHLORIDE TABLETS MEFLOQUINE HYDROCHLORIDE TABLETS RX ONLY REV. 09/16 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). DESCRIPTION Mefloquine Hydrochloride Tablets, USP are 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: Each tablet, for oral administration, contains 250 mg mefloquine hydrochloride and the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, lactose spray dried, magnesium stearate, microcrystalline cellulose, polysorbate 80, polyvinylpyrrolidone and talc. CLINICAL PHARMACOLOGY PHARMACOKINETICS ABS ORPTION: The absolute oral bioavailability of mefloquine has not been determined since an intravenous formulation is not available. The bioavailability of the tablet formation compared with an oral solution was over 85%. The presence of food significantly enhances the rate and extent of absorption, leading to about a 40% increase in bioavailability. In healthy volunteers, plasma concentrations peak 6 to 24 hours (median, about 17 hours) after a single dose of mefloquine. Baca dokumen lengkap