Atovaquone (a-TOE-va-kwone), Proguanil Hydrochloride (proe-GWAHN-il hye-droe-KLOR-ide)

Treats and prevents malaria.

Brand Name(s):

Malarone, Malarone Pediatric

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk. You may also take this medicine with milk. Take your medicine at the same time every day.
• If you vomit within 1 hour after taking this medicine, take another dose.
• If you are giving this medicine to a child who cannot swallow the tablet, you may crush it and mix it in milk. Then have the child drink this milk mixture right away.
• Keep taking this medicine for the full treatment time, even if you feel better after the first few doses. When it is used to prevent malaria, this medicine is usually used before, during, and after your trip.

If a dose is missed:

• Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using tetracycline, metoclopramide, rifampin, rifabutin, Mycobutin®, Reglan®, or Rifadin®. Make sure your doctor knows if you are using other medicines that contain proguanil.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breast feeding, or if you have kidney problems or liver problems.
• You may still catch malaria while taking this medicine. If you become ill or have a fever, call your doctor.
• Because malaria is spread through insect bites, you can help prevent malaria by keeping your skin covered with clothing. Use bug spray and place mosquito netting over your bed while you sleep.
• This medicine may not work as well if you are vomiting or have diarrhea. Talk with your doctor if this occurs while you are using this medicine. Your doctor may prescribe medicine to keep you from vomiting.
• You must use this medicine for the entire treatment time in order for it to be effective. Tell your doctor right away if you stop using the medicine early for any reason.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash.
• Fever, chills, headache, cough, sore throat, body aches.
• Seeing or hearing things that are not there.
• Seizures.
• Sores or white patches on your lips, mouth, or throat.

If you notice these less serious side effects, talk with your doctor:

• Cough.
• Headache.
• Mild skin rash or itching.
• Nausea, vomiting, diarrhea, stomach pain, loss of appetite.
• Weakness, dizziness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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