atovaquone-proguanil (pediatric) 62.5 mg-25 mg tablet

Generic name:
Atovaquone/proguanil - oral

Pronunciation
(a-TOE-va-kwone/proe-GWAHN-il)

Brand name(s)
Malarone

This medication contains 2 medicines: atovaquone and proguanil. It is used to prevent and treat malaria caused by mosquito bites in countries where malaria is common. Malaria parasites can enter the body through these mosquito bites, and then live in body tissues such as red blood cells or the liver. This medication is used to kill the malaria parasites living inside red blood cells and other tissues. In some cases, you may need to take a different medication (such as primaquine) to complete your treatment. Both medications may be needed for a complete cure and to prevent the return of infection (relapse). Atovaquone/proguanil belongs to a class of drugs known as antimalarials.

The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication, and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food or a milky drink (such as whole milk, milkshake) that contains fat. If you vomit within 1 hour of taking a dose, repeat the dose. If you have vomiting that doesn't stop after taking atovaquone/proguanil, contact a doctor right away. You may need another medication to prevent vomiting or a different malaria medication.

Swallow the tablet whole because of its bitter taste. Do not chew. If you have trouble swallowing tablets, this medication may be crushed and mixed with condensed milk. Take the entire mixture right away. Do not save for future use.

The dosage is based on your medical condition and your response to treatment. Children's dosage is also based on weight.

To prevent illness, take atovaquone/proguanil as directed by your doctor, usually once daily. Start this medication 1 to 2 days before you enter the malarious area and keep taking the medication while in the area and for 7 days after leaving.

If needed, primaquine can be taken for 14 days starting during the last week of treatment with atovaquone/proguanil or starting immediately after you have finished treatment.

To treat malaria, take this medication as directed by your doctor, usually once daily for 3 days.

It is very important to keep taking this medication exactly as prescribed by your doctor. To help you remember, take it at the same time each day for the entire prescribed time.

Do not take more or less of this drug than prescribed. Do not stop taking this drug before completing the full treatment unless directed to do so by your doctor, even if you feel better or do not feel sick. Skipping or changing your dose without approval from your doctor may cause prevention/treatment to be ineffective, cause the amount of parasite to increase, make the infection more difficult to treat (resistant), or worsen side effects.

It is important to prevent mosquito bites (such as by using appropriate insect repellents, wearing clothes that cover most of the body, remaining in air-conditioned or well-screened areas, using mosquito nets and insect-killing sprays). Buy insect repellent before traveling. The most effective insect repellents contain diethyltoluamide (DEET). Ask your doctor or pharmacist to recommend the appropriate strengths of mosquito repellent for you/your children.

No drug treatment is completely effective in preventing malaria. Get medical help right away if you develop symptoms of malaria (such as fever, chills, headache, other flu-like symptoms). Malaria can return, even months after completing this prescription. Quick treatment of malaria infection is needed to prevent serious, possibly fatal, outcomes.

When using atovaquone/proguanil for treatment, tell your doctor if your condition lasts or gets worse.

See also How to Use section.

Nausea, vomiting, abdominal pain, headache, diarrhea, weakness, loss of appetite, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of serious liver problems (such as nausea and vomiting that are severe or don't stop, abdominal pain, unexplained tiredness, dark urine, yellowing eyes/skin)
• signs of anemia (such as worsening tiredness, rapid breathing, pale skin/lips/nails, fast heartbeat while resting)
• signs of severe infection (such as high fever, severe chills, body aches, sore throat)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking atovaquone/proguanil, tell your doctor or pharmacist if you are allergic to either atovaquone or proguanil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current diarrhea
• current vomiting
• kidney problems
• liver problems
• mental/mood problems
• seizures

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. While you are pregnant, traveling to an area with malaria places you and your infant at a much higher risk for death and other problems. Discuss the risks and benefits of malaria prevention with your doctor.

It is unknown if atovaquone passes into breast milk. The proguanil in this medication passes into breast milk and the effects of this medication on a nursing infant are not known. The CDC recommends against using this product for malaria prevention if you are breastfeeding an infant weighing less than 11 pounds (5 kilograms). Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• penicillamine
• "blood thinners" (such as warfarin)
• metoclopramide

Other medications can affect the removal of atovaquone/proguanil from your body, which may affect how atovaquone/proguanil works. Examples include efavirenz, rifampin, rifabutin, tetracycline, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood cell counts, liver function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.