MEFLOQUINE HYDROCHLORIDE tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

MEFLOQUINE HYDROCHLORIDE (UNII: 5Y9L3636O3) (MEFLOQUINE - UNII:TML814419R)

Доступно од:

Hikma Pharmaceuticals USA Inc.

INN (Међународно име):

MEFLOQUINE HYDROCHLORIDE

Састав:

MEFLOQUINE HYDROCHLORIDE 250 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Mefloquine is 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 is indicated for the prophylaxis of P. falciparum and P. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of P. falciparum . Use of Mefloquine is contraindicated in patients with a known hypersensitivity to mefloquine or related compounds (e.g., quinine and quinidine) or to any of th

Резиме производа:

Mefloquine Hydrochloride Tablets, USP 250 mg tablet is supplied as a speckled off-white to yellow, round flat faced beveled edge tablet with product identification “54 111” debossed on one side and scored on the other side. Each tablet contains 250 mg of mefloquine hydrochloride, USP. NDC 0054-0025-11: Bottle of 25 Tablets Mefloquine hydrochloride should be stored at 20° to 25°C (68° to 77°F); with excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

MEFLOQUINE HYDROCHLORIDE- mefloquine hydrochloride tablet
Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Mefloquine Hydrochloride Tablets,
USP
(mef'-loe-kwin HYE-droe-KLOR-ide)
Rx Only
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

Карактеристике производа

MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET
HIKMA PHARMACEUTICALS USA INC.
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MEFLOQUINE HYDROCHLORIDE TABLETS, USP
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 is an antimalarial agent
available as 250 mg
tablets of mefloquine hydrochloride, USP (equivalent to 228 mg of the
free base) for oral
administration.
Mefloquine Hydrochloride is a 4-quinolinemethanol derivative with the
specific chemical
name of
(RS)-[2,8-Bis(trifluoromethyl)quinolin-4-yl][(SR)-piperidin-2-yl]methanol
hydrochloride. It is a 2-aryl substituted chemical structural analog
of quinine. The drug is
a white to slightly yellow, crystalline powder.
Mefloquine hydrochloride has a calculated molecular weight of 414.8
and the following
structural formula:
The inactive ingredients are ammonium-calcium alginate blend,
colloidal silicon dioxide,
crospovidone, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
poloxamer 331, povidone and pregelatinized starch.
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 mcg/L are roughly equivalent to the
dose in
milligrams (for example, a single 1000 mg dose pr