Pronunciation:

proe-GWAHN-il

Dosage Forms:

• Tablet

Classifications:

Pharmacologic

Folic Acid Antagonist

Chemical

Biguanide

Uses of This Medicine:

Proguanil belongs to a group of medicines called antimalarials. It is used to prevent 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.

This medicine may be given together with another medicine to prevent malaria infection.

Proguanil is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children

Although there is no specific information comparing use of proguanil 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. However, children should avoid traveling to areas where there is a chance of getting malaria, unless they can take more effective antimalarial medicines.

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 proguanil in the elderly with use in other age groups.

Breast-feeding

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.

Other medicines

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

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.

• Dicumarol
• Warfarin

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.

• Chloroquine
• Typhoid Vaccine

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.

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:

• Kidney problems, severe Patients with kidney problems may have an increased chance of side effects.

Proper Use of This Medicine:

Take proguanil with a glass of water after meals to lessen possible stomach upset, unless otherwise directed by your doctor.

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

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

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

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 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 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.

Precautions While Using This Medicine:

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:

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

If fever or “flu-like” symptoms develop during your travels or within a year (especially within the first 2 months) after you leave an area 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 may need medical attention.

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

Rare

Skin rash or itching

Symptoms of overdose

Abdominal or stomach pain

bloody urine

lower back pain

pain or burning while urinating

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

Diarrhea

headache

loss of appetite

mouth sores or ulcers

nausea

vomiting

Less common or rare

Temporary hair loss

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.