MEFLOQUINE HYDROCHLORIDE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Preferred Pharmaceuticals Inc.

INN (इंटरनेशनल नाम):

MEFLOQUINE HYDROCHLORIDE

रचना:

MEFLOQUINE HYDROCHLORIDE 250 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. falciparum. Use of mefloquine hydrochloride tablets is contraindicated in patients with a known hypersensitivity to mefloquine or

उत्पाद समीक्षा:

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 68788-6833-2. 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET
Preferred 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)
•
co

उत्पाद विशेषताएं

MEFLOQUINE HYDROCHLORIDE- MEFLOQUINE HYDROCHLORIDE TABLET
PREFERRED 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.
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
17
16
6
2
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 concentr