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Lariam

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Lariam

Indications
Dosage
How Supplied

INDICATIONS

Treatment of Acute Malaria Infections

Lariam (mefloquine) is 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 Lariam (mefloquine) , are at high risk of relapse because Lariam (mefloquine) does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with Lariam (mefloquine) , patients should subsequently be treated with an 8-aminoquinoline derivative (eg, primaquine).

Prevention of Malaria

Lariam (mefloquine) is indicated for the prophylaxis of P. falciparum and P. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of P. falciparum.

DOSAGE AND ADMINISTRATION

(see INDICATIONS)

Adult Patients

Treatment of mild to moderate malaria in adults caused by P. vivax or mefloquine-susceptible strains of P. falciparum

Five tablets (1250 mg) mefloquine hydrochloride to be given as a single oral dose. The drug should not be taken on an empty stomach and should be administered with at least 8 oz (240 mL) of water.

If a full-treatment course with Lariam (mefloquine) does not lead to improvement within 48 to 72 hours, Lariam (mefloquine) should not be used for retreatment. An alternative therapy should be used. Similarly, if previous prophylaxis with mefloquine has failed, Lariam (mefloquine) should not be used for curative treatment.

Note: Patients with acute P. vivax malaria, treated with Lariam (mefloquine) , are at high risk of relapse because Lariam (mefloquine) does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse after initial treatment of the acute infection with Lariam (mefloquine) , patients should subsequently be treated with an 8-aminoquinoline derivative (eg, primaquine).

Malaria Prophylaxis

One 250 mg Lariam (mefloquine) tablet once weekly.

Prophylactic drug administration should begin 1 week before arrival in an endemic area. Subsequent weekly doses should be taken regularly, always on the same day of each week, preferably after the main meal. To reduce the risk of malaria after leaving an endemic area, prophylaxis must be continued for 4 additional weeks to ensure suppressive blood levels of the drug when merozoites emerge from the liver. Tablets should not be taken on an empty stomach and should be administered with at least 8 oz (240 mL) of water.

In certain cases, eg, when a traveler is taking other medication, it may be desirable to start prophylaxis 2 to 3 weeks prior to departure, in order to ensure that the combination of drugs is well tolerated (see PRECAUTIONS: DRUG INTERACTIONS).

When prophylaxis with Lariam (mefloquine) fails, physicians should carefully evaluate which antimalarial to use for therapy.

Pediatric Patients

Treatment of mild to moderate malaria in pediatric patients caused by mefloquine-susceptible strains of P. falciparum

Twenty (20) to 25 mg/kg body weight. Splitting the total therapeutic dose into 2 doses taken 6 to 8 hours apart may reduce the occurrence or severity of adverse effects. Experience with Lariam (mefloquine) in pediatric patients weighing less than 20 kg is limited. The drug should not be taken on an empty stomach and should be administered with ample water. The tablets may be crushed and suspended in a small amount of water, milk or other beverage for administration to small children and other persons unable to swallow them whole.

If a full-treatment course with Lariam (mefloquine) does not lead to improvement within 48 to 72 hours, Lariam (mefloquine) should not be used for retreatment. An alternative therapy should be used. Similarly, if previous prophylaxis with mefloquine has failed, Lariam (mefloquine) should not be used for curative treatment.

In pediatric patients, the administration of Lariam (mefloquine) for the treatment of malaria has been associated with early vomiting. In some cases, early vomiting has been cited as a possible cause of treatment failure (see PRECAUTIONS). If a significant loss of drug product is observed or suspected because of vomiting, a second full dose of Lariam (mefloquine) should be administered to patients who vomit less than 30 minutes after receiving the drug. If vomiting occurs 30 to 60 minutes after a dose, an additional half-dose should be given. If vomiting recurs, the patient should be monitored closely and alternative malaria treatment considered if improvement is not observed within a reasonable period of time.

The safety and effectiveness of Lariam (mefloquine) to treat malaria in pediatric patients below the age of 6 months have not been established.

Malaria Prophylaxis

The recommended prophylactic dose of Lariam (mefloquine) is approximately 5 mg/kg body weight once weekly. One 250 mg Lariam (mefloquine) tablet should be taken once weekly in pediatric patients weighing over 45 kg. In pediatric patients weighing less than 45 kg, the weekly dose decreases in proportion to body weight:

30 to 45 kg: 3/4 tablet
20 to 30 kg: 1/2 tablet

Experience with Lariam (mefloquine) in pediatric patients weighing less than 20 kg is limited.

HOW SUPPLIED

Lariam (mefloquine) is available as scored, white, round tablets, containing 250 mg of mefloquine hydrochloride in unit-dose packages of 25 (NDC 0004-0172-02). Imprint on tablets: LARIAM (mefloquine) 250 ROCHE

Tablets should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Manufactured by: F. HOFFMANN-LA ROCHE LTD, Basel, Switzerland. Distributed by: Roche Laboratories Inc. 340 Kingsland Street, Nutley, New Jersey 07110-1199.

Last reviewed on RxList: 8/10/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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