Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
MEFLOQUINE HYDROCHLORIDE (UNII: 5Y9L3636O3) (MEFLOQUINE - UNII:TML814419R)
Preferred Pharmaceuticals Inc.
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 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 with a known hypersensitivity to mefloquine or
Mefloquine Hydrochloride Tablets USP, 250 mg are available as white, oval-shaped, flat-faced, beveled-edge, scored tablets, debossed with “stylized b” 171 on the scored side and plain on the other side, packaged in unit-dose cartons of 25 tablets 68788-6833-2. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET Preferred Pharmaceuticals Inc. ---------- 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: • severe 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) • co read_full_document
MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET PREFERRED PHARMACEUTICALS INC. ---------- MEFLOQUINE HYDROCHLORIDE TABLETS USP RX ONLY 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 mg of the free base) for oral administration. Mefloquine Hydrochloride USP 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. The structural formula is as follows: C H F N O.HCl M.W.: 414.78 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 17 16 6 2 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 mcg/L are roughly equivalent to the dose in milligrams (for example, a single 1000 mg dose produces a maximum concentr read_full_document