MEFLOQUINE HYDROCHLORIDE- mefloquine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

West-Ward Pharmaceuticals Corp

INN (International Name):

MEFLOQUINE HYDROCHLORIDE

Composition:

MEFLOQUINE HYDROCHLORIDE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

West-Ward Pharmaceuticals Corp
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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

Summary of Product characteristics

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.