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Halfan (Halofantrine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

HALFAN tablets are indicated for the treatment of adults who can tolerate oral medication and who have mild to moderate malaria (equal to or less than 100,000 parasites/mm3) caused by Plasmodium falciparum or Plasmodium vivax.

NOTE: Patients with acute P. vivax malaria treated with HALFAN are at risk of relapse because halofantrine does not eliminate the exoerythrocytic (hepatic phase) parasites. To avoid relapse after initial treatment of the acute P. vivax infection with HALFAN, patients should subsequently be treated with an 8-aminoquinoline to eradicate the exoerythrocytic parasites.

NOTE: THE EFFICACY OF HALFAN IN THE PROPHYLAXIS OF MALARIA HAS NOT BEEN ESTABLISHED.

DOSAGE AND ADMINISTRATION

(See INDICATIONS AND USAGE.)

HALFAN should be given on an empty stomach at least 1 hour before or 2 hours after food. (See WARNINGS.) The recommended dosage regimen to treat adults able to tolerate oral medications, who have mild to moderate malaria caused by P. falciparum or P. vivax is:

Non-immune Patients

Patients with no previous exposure or minimal exposure to malaria should be considered “non-immune.” These patients should receive 500 mg (2 x 250 mg tablets) of halofantrine hydrochloride every 6 hours for 3 doses (total first course dosage 1,500 mg). This course of therapy should be repeated 7 days after the first course.

Semi-immune Patients

Patients with a history of life-long residence in endemic areas and a clear history of recent previous malaria caused by the same Plasmodium species may be considered semi-immune. In these patients, omitting the second course of therapy may be considered. Clinical trials in semi-immune patients have utilized this one-course regimen with satisfactory efficacy and safety.

Hepatic or Renally Impaired Patients

There is no information on dosing alterations needed because of hepatic or renal impairment.

HOW SUPPLIED

HALFAN is available as a white to off-white, capsule-shaped tablet containing 250 mg of halofantrine hydrochloride in bottles of 60 tablets. The tablets are imprinted HALFAN on 1 side.

Store at controlled room temperature between 20° to 25°C (68° to 77°F) and protect from light.

250 mg 60’s: NDC 0007-4195-18

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