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:

NuCare Pharmaceuticals,Inc.

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 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. falciparu

Product summary:

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 (NDC 68071-4702-8) 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET
NuCare 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)
•
convu

Summary of Product characteristics

MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET
NUCARE 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.
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16
6
2
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 produces a maximum
concentrat