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:

H.J. Harkins Company, Inc.

INN (International Name):

MEFLOQUINE HYDROCHLORIDE

Composition:

MEFLOQUINE HYDROCHLORIDE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Mefloquine Hydrochloride Tablets 250 mg, are supplied as White Round Scored Tablets, Debossed 'WW 282' and available in: Bottles of 25 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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MEFLOQUINE HYDROCHLORIDE - MEFLOQUINE HYDROCHLORIDE TABLET
H.J. Harkins Company, Inc.
----------
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

Summary of Product characteristics

MEFLOQUINE HYDROCHLORIDE - MEFLOQUINE HYDROCHLORIDE TABLET
H.J. HARKINS COMPANY, INC.
----------
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 appa