Atovaquone and proguanil is a combination medicine used to treat or prevent malaria, a disease caused by parasites. These medicines work by interfering with the growth of parasites in the red blood cells of the human body.

Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Atovaquone and proguanil may also be used for purposes not listed in this medication guide.

You should not use atovaquone and proguanil to prevent malaria if you have severe kidney disease.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day.

Take atovaquone and proguanil with food or milk if it upsets your stomach.

If you vomit within 1 hour after taking this medication, take another dose.

If you are take this medicine to prevent malaria:

• Start taking the medicine 1 or 2 days before entering an area where malaria is common. Continue taking the medicine every day during your stay and for at least 7 days after you leave the area.

Use atovaquone and proguanil regularly to best prevent malaria. If you stop using the medication early for any reason, talk to your doctor about other forms of malaria prevention.

If you take this medicine to treat malaria:

• Take the medicine every day for 3 days in a row.

• Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

Call your doctor as soon as possible if you have been exposed to malaria, or if you have fever, vomiting, or diarrhea during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing all types of malaria. For best results, keep using the medication as directed.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Malaria:

1 g atovaquone/400 mg proguanil (four adult strength tablets as a single dose) orally once a day for 3 consecutive days

Usual Adult Dose for Malaria Prophylaxis:

Prophylactic therapy should start 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.

250 mg atovaquone/100 mg proguanil (one adult strength tablet) orally once a day

Usual Pediatric Dose for Malaria:

Less than 5 kg ABW (actual body weight): Safety and efficacy has not been established.

5 to 8 kg ABW: 125 mg atovaquone/50 mg proguanil (2 pediatric tablets) once daily for 3 consecutive days.

9 to 10 kg ABW: 187.5 mg atovaquone/75 mg proguanil (3 pediatric tablets) once daily for 3 consecutive days.

11 to 20 kg ABW: 250 mg atovaquone/100 mg proguanil (one adult strength or four pediatric tablets as a single dose) orally once a day for 3 consecutive days

21 to 30 kg ABW: 500 mg atovaquone/200 mg proguanil (two adult strength tablets as a single dose) orally once a day for 3 consecutive days

31 to 40 kg ABW: 750 mg atovaquone/300 mg proguanil (three adult strength tablets as a single dose) orally once a day for 3 consecutive days

Greater than 40 kg ABW: 1 g atovaquone/400 mg proguanil (four adult strength tablets as a single dose) orally once a day for 3 consecutive days

Usual Pediatric Dose for Malaria Prophylaxis:

Prophylactic treatment should start 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.

11 to 20 kg ABW (actual body weight): 62.5 mg atovaquone/25 mg proguanil (one pediatric tablet) orally once a day

21 to 30 kg ABW: 125 mg atovaquone/50 mg proguanil (two pediatric tablets as a single dose) orally once a day

31 to 40 kg ABW: 187.5 mg atovaquone/75 mg proguanil (three pediatric tablets as a single dose) orally once a day

Greater than 40 kg ABW: 250 mg atovaquone/100 mg proguanil (one adult strength tablet) orally once a day

You should not use this medicine if you are allergic to atovaquone or proguanil.

Do not use atovaquone and proguanil to prevent malaria if you have severe kidney disease.

Atovaquone and proguanil should not be used to treat malaria in a child who weighs less than 11 pounds (5 kilograms), and should not be used to prevent malaria in a child who weighs less than 24 pounds (11 kilograms).

Tell your doctor if you have ever had:

• kidney disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Malaria is more likely to cause death in a pregnant woman. If you are pregnant, talk with your doctor about the risks of traveling to areas where malaria is common.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include stomach discomfort, vomiting, mouth sores, hair loss, easy bruising or bleeding, and peeling of the skin on your hands or feet.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Atovaquone and proguanil may cause serious side effects. Call your doctor at once if you have:

• stomach pain (upper right side), loss of appetite;

• tiredness, itching;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Common side effects of atovaquone and proguanil may include:

• stomach pain, vomiting, diarrhea;

• mouth sores;

• headache, dizziness, weakness;

• strange dreams;

• itching; or

• cough

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all other medicines you use, especially:

• metoclopramide;

• rifabutin;

• rifampin;

• tetracycline; or

• a blood thinner--warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect atovaquone and proguanil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.