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USP DI Vol. II - PROGUANIL (Systemic)

PROGUANIL (Systemic)*


Some commonly used brand names are:

In Canada?

  • Paludrine

* Not commercially available in the U.S.


Category

  • Antimalarial

Description

Proguanil (pro-GWAN-il) belongs to a group of medicines called antimalarials.It is used to prevent malaria, a red blood cell infection transmitted by thebite of a mosquito.

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

This medicine may be given together with another medicine to prevent malariainfection.

Proguanil is available only with your doctor's prescription, in the followingdosage form:

    Oral
  • Tablets (Canada)


Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to proguanil. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Proguanil has not been shown to cause birth defectsor other problems in humans. However, it is best if pregnant women can avoidtraveling to areas where there is a chance of getting malaria.

Breast-feeding?Proguanil passes into the breast milk. This medicinehas not been reported to cause problems in nursing babies. However, the amountof proguanil that passes into breast milk is not sufficient to protect theinfant from malaria.

Children?Although there is no specific information comparinguse of proguanil in children with use in other age groups, this medicine isnot expected to cause different side effects or problems in children thanit does in adults. However, children should avoid traveling to areas wherethere is a chance of getting malaria, unless they can take more effectiveantimalarial medicines.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof proguanil in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of proguanil. Make sure you tell your doctor ifyou have any other medical problems, especially:

  • Kidney problems, severe?Patients with kidney problems may havean increased chance of side effects.

Proper Use of This Medicine

Take proguanilwith a glass of water after meals to lessen possible stomach upset, unlessotherwise directed by your doctor.

For young children, proguanil may be given by crushing the tablet and mixingit with milk, honey, or jam.

You may start taking proguanil at least 24 hours before you arrive in anarea where there is a chance of getting malaria. This will allow your bodyto absorb enough medicine to fight the malaria parasites. Also, keep takingthis medicine every day while you are in an area where malaria occurs andtake it every day for 6 weeks after you leave the area.

No medicine will protect you completely from malaria. However, to protectyourself as completely as possible, keep taking thismedicine for the full time your doctor ordered.

Dosing?The dose of proguanil will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of proguanil. If your dose is different,do not change it unless your doctor tells you to do so.

  • For oral dosage form (tablets):
    • For prevention of malaria:
      • Adults and children older than 12 years of age?100 milligrams(mg) (1 tablet) a day.
      • Children up to 1 year of age?25 mg (1/4 tablet) a day.
      • Children 1 to 4 years of age?50 mg (1/2 tablet) a day.
      • Children 5 to 8 years of age?75 mg (3/4 tablet) a day.
      • Children 9 to 12 years of age?100 mg (1 tablet) a day.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed 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 otherdamp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Malariais spread by the bites of certain kinds of infected female mosquitoes. Ifyou are living in, or will be traveling to, an area where there is a chanceof getting malaria, the following mosquito-control measures will help to preventinfection:

  • Remain in air-conditioned or well-screened rooms to reduce contactwith mosquitoes.
  • If possible, sleep under mosquito netting, preferably netting coatedor soaked with permethrin, to avoid being bitten by malaria-carrying mosquitoes.
  • Wear long-sleeved shirts or blouses and long trousers to protectyour arms and legs, especially from dusk through dawn when mosquitoes areout.
  • Apply mosquito repellent, preferably one containing DEET, to uncoveredareas of the skin from dusk through dawn when mosquitoes are out.
  • Use a pyrethrum-containing flying insect spray to kill mosquitoesin living and sleeping quarters during evening and nighttime hours.

If fever or ?flu-like? symptoms develop during your travelsor within a year (especially within the first 2 months) after you leave anarea where malaria occurs, check with your doctor immediately.


Side Effects of This Medicine

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 mayneed medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

    Rare

      Skin rash or itching

    Symptoms of overdose

      Abdominal or stomach pain; bloody urine; lower back pain; painor burning while urinating; vomiting

Other sideeffects may occur that usually do not need medical attention. These side effectsmay 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 arebothersome:

    More common

      Diarrhea; headache; loss of appetite; mouth sores or ulcers; nausea; vomiting

    Less common or rare

      Temporary hair loss

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


Revised: 08/18/2000