Atovaquone and Proguanil

The combination of atovaquone and proguanil is used to treat a certain kind of malaria infection (a serious infection that is spread by mosquitoes in certain parts of the world and can cause death) and to prevent a certain kind of malaria infection in travelers who visit areas where malaria is common. Atovaquone and proguanil is in a class of medications called antimalarials. It works by killing the organisms that cause malaria.

The combination of atovaquone and proguanil comes as a tablet to take by mouth. If you are taking atovaquone and proguanil to prevent malaria, you will probably start taking it once daily 1 or 2 days before you travel to an area where malaria is common, and then continue during your time in the area and for 7 days after you return. If you are taking atovaquone and proguanil to treat malaria, you will probably take it once daily for 3 days in a row. Always take atovaquone and proguanil with food or a milky drink. Take atovaquone and proguanil at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take atovaquone and proguanil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you have trouble swallowing the tablets, they may be crushed and mixed with condensed milk just before taking them.

If you vomit within 60 minutes after you take atovaquone and proguanil, take another full dose.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking atovaquone and proguanil,

• tell your doctor and pharmacist if you are allergic to atovaquone and proguanil, any other medications, or any of the ingredients in atovaquone and proguanil tablets. Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking atovaquone and proguanil. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have kidney disease. Your doctor may tell you not to take atovaquone and proguanil.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking atovaquone and proguanil, call your doctor.
• you should know that atovaquone and proguanil decreases your risk of becoming infected with malaria but does not guarantee that you will not become infected. You still need to protect yourself from mosquito bites while you are in an area where malaria is common by wearing long sleeves and long pants and using mosquito repellant and a bed net.
• you should know that the first symptoms of malaria are fever, chills, muscle pain, and headaches. If you are taking atovaquone and proguanil to prevent malaria, call your doctor immediately if you develop any of these symptoms. Be sure to tell your doctor that you may have been exposed to malaria.
• you should plan what to do in case you experience serious side effects from atovaquone and proguanil and have to stop taking the medication, especially if you are not near a doctor or pharmacy. You will have to get another medication to protect you from malaria. If no other medication is available, you will have to leave the area where malaria is common, and then get another medication to protect you from malaria.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Atovaquone and proguanil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• stomach pain
• loss of appetite
• headache
• dizziness
• cough
• mouth sores

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• rash
• hives
• peeling or blistering skin
• fever
• swelling of the eyes, face, lips, tongue, throat, hands, feet, ankles or lower legs
• difficulty breathing or swallowing
• hoarseness or throat tightness
• yellow eyes or skin, dark urine, loss of appetite, fatigue, or pain or discomfort in right upper stomach area

Atovaquone and proguanil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• rash
• grey-bluish color of lips and/or skin
• headache
• tiredness
• shortness of breath
• vomiting
• stomach pain or discomfort
• hair loss
• dry, cracked skin on palms of hands or bottom of feet
• canker sores

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.

• Malarone^®