Halofantrine (Oral Route)

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.

This product is available in the following dosage forms:

• Tablet

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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.

Geriatric

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.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aurothioglucose


• Bepridil


• Cisapride


• Dronedarone


• Levomethadyl


• Mesoridazine


• Pimozide


• Posaconazole


• Thioridazine


• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide


• Ajmaline


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Aprindine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azimilide


• Bretylium


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Clarithromycin


• Clomipramine


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Dothiepin


• Doxepin


• Droperidol


• Encainide


• Enflurane


• Erythromycin


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gemifloxacin


• Haloperidol


• Halothane


• Hydroquinidine


• Ibutilide


• Iloperidone


• Imipramine


• Isoflurane


• Isradipine


• Itraconazole


• Lapatinib


• Lidoflazine


• Lofepramine


• Lorcainide


• Lumefantrine


• Mefloquine


• Methadone


• Nortriptyline


• Octreotide


• Opipramol


• Pazopanib


• Pentamidine


• Pirmenol


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Risperidone


• Sematilide


• Sertindole


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Sunitinib


• Tedisamil


• Telavancin


• Telithromycin


• Terfenadine


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Vasopressin


• Zolmitriptan


• Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cola Nut

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following is not recommended . Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. 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 faintinga€”These conditions increase the chance of side effects affecting the heart, including fast irregular heartbeat

Proper Use

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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (oral suspension and tablets):
  
  
  
  • Adults and children over 37 kilograms (81 pounds) of body weighta€”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.
  
  
  • Childrena€”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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Keep the liquid form of this medicine from freezing.

Precautions

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.

Side Effects

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.