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In the U.S.—

Halfan

• Antimalarial

Halofantrine ( ha-loe-FAN-trin) belongs to a group of medicines known as antimalarials. It is used to treat malaria, a red blood cell infection transmitted by the bite of a mosquito.

Malaria transmission occurs in large areas of Central and South America, Hispaniola, sub-Saharan Africa, the Indian subcontinent, Southeast Asia, the Middle East, and Oceania. Country-specific information on malaria can be obtained from the Centers for Disease Control and Prevention (CDC) or from the CDC's web site at http://www.cdc.gov/travel/yellowbk.

This medicine may cause serious side effects. Therefore, it usually is used to treat serious malaria infections in areas where it is known that other medicines may not work.

Halofantrine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Oral suspension (United Kingdom)
• Tablets (U.S. and United Kingdom)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For halofantrine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to halofantrine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Halofantrine has not been studied in pregnant women. However, it has been found to cause unwanted effects, including death of the fetus, in animals. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Halofantrine may pass into breast milk and cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding while taking halofantrine. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Although there is no specific information comparing use of halofantrine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of halofantrine in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking halofantrine, it is especially important that your health care professional know if you are taking the following:

• Mefloquine (e.g., Lariam)—Recent use of mefloquine or use of mefloquine with halofantrine may cause fast and irregular heartbeat

Other medical problems—The presence of other medical problems may affect the use of halofantrine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart problems, especially abnormal heartbeat or
• Thiamine deficiency or
• Unexplained sudden fainting—These conditions increase the chance of side effects affecting the heart, including fast irregular heartbeat

Halofantrine is best taken on an empty stomach to decrease the chance of side effects.

To help clear up your infection completely, take this medicine exactly as directed by your doctor for the full time of treatment. Your symptoms may come back if you stop your treatment too early. Your doctor may instruct you to take a second course of treatment after 1 week.

Dosing—

The dose of halofantrine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of halofantrine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets or teaspoonfuls of suspension that you take depends on the strength of the medicine. For malaria:

• For oral dosage forms (oral suspension and tablets):
  • Adults and children over 37 kilograms (81 pounds) of body weight—500 mg, taken on an empty stomach every six hours three times a day for one day. Treatment may need to be repeated after one week.
  • Children—Dose is based on body weight and must be determined by your doctor. Treatment may need to be repeated after one week.
    • Up to 23 kilograms (51 pounds) of body weight: Dose must be determined by your doctor.
    • 23 to 31 kilograms (51 to 68 pounds) of body weight: 250 mg, taken on an empty stomach every six hours three times a day for one day.
    • 32 to 37 kilograms (70 to 81 pounds) of body weight: 375 mg, taken on an empty stomach every six hours three times a day for one day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is important that your doctor check your progress after treatment. This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects.

If your symptoms do not improve after you have taken this medicine for the full course of treatment, or if they become worse, check with your doctor.

Malaria is spread by the bites of certain kinds of infected female mosquitoes. If you are living in, or will be traveling to, an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

• If possible, avoid going out between dusk and dawn because it is at these times that mosquitoes most commonly bite.
• Wear long-sleeved shirts and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.
• Apply insect repellant, preferably one containing DEET, to uncovered areas of the skin from dusk through dawn when mosquitoes are out.
• If possible, sleep in a screened or air-conditioned room or under mosquito netting sprayed with insecticide to avoid being bitten by malaria-carrying mosquitoes.
• Use mosquito coils or sprays to kill mosquitoes in living and sleeping quarters during evening and nighttime hours.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Less common
  • Coughing;  noisy, rattling, or troubled breathing 
  
  

• Rare
  • Abdominal pain;  chest pain;  confusion;  convulsions (seizures);  diarrhea;  difficulty in breathing or swallowing;  hives;  itching, especially of feet or hands;  nausea;  pounding heartbeat;  reddening of skin, especially around ears;  swelling of eyes, face or inside of nose;  unusual tiredness or weakness;  vomiting 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More Common
  • Headache 
  
  

• Less common
  • Aches and pain in joints;  constipation ;  frequent urination;  indigestion ;  loss of appetite;  skin itching or rash 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 09/14/2000