Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
MEFLOQUINE HYDROCHLORIDE (UNII: 5Y9L3636O3) (MEFLOQUINE - UNII:TML814419R)
Rebel Distributors Corp
ORAL
PRESCRIPTION DRUG
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 Hydrochloride Tablets, are at high risk of relapse because Mefloquine Hydrochloride Tablets do 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). 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 contraindicated in patients
Mefloquine Hydrochloride Tablets 250 mg, are supplied as White Round Scored Tablets, Debossed 'WW 282' and available in: Bottles of 10 tablets. Store at 20-25°C (68-77°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. Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised July 2011 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Abbreviated New Drug Application
MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET Rebel Distributors Corp ---------- MEDICATION GUIDE Read this entire Medication Guide before you start taking Mefloquine Hydrochloride Tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information I should know about Mefloquine Hydrochloride Tablets? Your doctor or pharmacist will give you an Information Wallet Card along with this Medication Guide. It has important information about Mefloquine Hydrochloride Tablets and should be carried with you at all times while you take Mefloquine Hydrochloride Tablets. Mefloquine Hydrochloride Tablets can cause serious mental problems. • Some people who take mefloquine have sudden serious mental problems, including: • severe anxiety • paranoia (feelings of mistrust towards others) • hallucinations (seeing or hearing things that are not there) • depression • feeling restless • unusual behavior • feeling confused In some patients these serious side effects can go on after Mefloquine is stopped. • Some people who take Mefloquine Hydrochloride Tablets think about suicide (putting an end to their life). Some people who were taking Mefloquine Hydrochloride Tablets committed suicide. It is not known whether Mefloquine Hydrochloride Tablets were 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 call your doctor right away as it may be necessary to stop taking Mefloquine Hydrochloride Tablets and use another medicine to prevent malaria. You need to take malaria prevention medicine before you travel to a malaria area, while you are in a malaria area, and after you return from a malaria area. If you are told by a doctor to stop taking Mefloquine Hydrochloride Tablets because of the side effects or for other reasons, you will need to take another mal Baca dokumen lengkap
MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET REBEL DISTRIBUTORS CORP ---------- MEFLOQUINE HYDROCHLORIDE TABLETS REV. 07/11 DESCRIPTION Mefloquine Hydrochloride Tablets 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 Absorption 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 Hydrochloride Tablets. In a similar group of volunteers, maximum plasma concentrations in μg/L are roughly equivalent to the dose in milligrams (for example, a single 1000 mg dose produces a maximum concentration of about 1000 μg/L). In healthy volunteers, a dose of 250 mg once weekly produces maximum steady-state plasma concentrations of 1000 to 2000 μg/L, which are reached after 7 to 10 weeks. Distribution In healthy adults, the apparent Baca dokumen lengkap