Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
mefloquine hydrochloride (UNII: 5Y9L3636O3) (mefloquine - UNII:TML814419R)
Rebel Distributors Corp
mefloquine hydrochloride
mefloquine hydrochloride 250 mg
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, 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). 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 are contraindicated in patients with a known hypersensitivity to mefloquine or related c
Mefloquine Hydrochloride Tablets are available as: 250 mg: White, oval-shaped, flat-faced, beveled-edge, scored tablet containing 250 mg of mefloquine hydrochloride. Debossed with stylized B 171 on the scored side and plain on the other side. Available in bottle of: 7 tablets NDC 21695-449-07 25 tablets NDC 21695-449-25 Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP].
Abbreviated New Drug Application
MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET Rebel Distributors Corp ---------- MEDICATION GUIDE Mefloquine Hydrochloride Tablets to Prevent Malaria This Medication Guide is intended only for travelers who are taking mefloquinehydrochloride tablets (mefloquine) to prevent malaria. The information may not apply to patients who are sick with malaria and who are taking mefloquine to treat malaria. An information wallet card is provided at the end of this Medication Guide. Cut it out and carry it with you when you are taking mefloquine. This Medication Guide was revised in September 2003. Please read it before you start taking mefloquine and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your prescriber (doctor or other health care provider) about mefloquine and malaria prevention. Only you and your prescriber can decide if mefloquine is right for you. If you cannot take mefloquine, you may be able to take a different medicine to prevent malaria. What is the most important information I should know about Mefloquine? 1. Take Mefloquine exactly as prescribed to prevent malaria. Malaria is an infection that can cause death, and is spread to humans through mosquito bites. If you travel to parts of the world where the mosquitoes carry the malaria parasite, you must take a malaria prevention medicine. Mefloquine is one of a small number of medications approved to prevent and to treat malaria. If taken correctly, mefloquine is effective at preventing malaria but, like all medications, it may produce side effects in some patients. 2. Mefloquine can rarely cause serious mental problems in some patients. The most frequently reported side effects with mefloquine, such as nausea, difficulty sleeping, and bad dreams are usually mild and do not cause people to stop taking the medicine. However, people taking mefloquine occasionally experience severe anxiety, feelings that people are against them, hallucinations (seeing or hearing things that are Izlasiet visu dokumentu
MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET REBEL DISTRIBUTORS CORP ---------- MEFLOQUINE HYDROCHLORIDE TABLETS 1001710105 RX ONLY DES CRIPTION: 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. C H F N O.HCL MOLECULAR WEIG HT: 4 14 .78 The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer 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. 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: 17 16 6 2 In healthy adults, the apparent volume of distribution is approximately 20 L/kg, indicating extensive tissue distribution. Mefloquine may accumulate in parasitized erythrocytes. Experiments conducted _in_ _vitro _ Izlasiet visu dokumentu