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:

Rebel Distributors Corp

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, 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

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET
Rebel Distributors Corp
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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

Summary of Product characteristics

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 _