Malarone Pediatric

Atovaquone and proguanil are medications to treat 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.

The combination of atovaquone and proguanil is used to treat or prevent malaria.

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

You should not use this medication if you are allergic to atovaquone or proguanil. You should not use this medication to prevent malaria if you have severe kidney disease.

To make sure you can safely take atovaquone and proguanil, tell your doctor if you have any of these other conditions:

• kidney disease;

• liver disease;

• severe complications from malaria; or

• uncontrolled vomiting or diarrhea.

FDA pregnancy category C. It is not known whether atovaquone and proguanil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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.

Atovaquone and proguanil can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

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.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe or uncontrolled vomiting or diarrhea;

• fever, mouth sores;

• problems with speech, balance, or walking;

• severe skin rash;

• nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); o

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Less serious side effects may include:

• mild stomach pain or upset stomach;

• mild diarrhea;

• headache;

• mild itching;

• weakness; or

• dizziness.

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:

• a blood thinner such as warfarin (Coumadin);

• rifabutin (Mycobutin);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

• tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

• metoclopramide (Reglan).

This list is not complete and other drugs may interact with atovaquone and proguanil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

In the U.S.

• Malarone
• Malarone Pediatric

Available Dosage Forms:

• Tablet

Therapeutic Class: Ubiquinone/Biguanide Combination

Pharmacologic Class: Proguanil

Chemical Class: Ubiquinone

Antiprotozoals are medicines that are used to prevent and treat malaria, a red blood cell infection transmitted by the bite of a mosquito. This medicine is a combination of two medicines, atovaquone and proguanil.

This medicine is available only with your doctor's prescription.

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.

Pediatric

Studies on this medicine have been done only in patients who weigh more than 25 pounds (11 kilograms [kg]) for the prevention of malaria and more than 11 pounds (5 kg) for the treatment of malaria. There is no specific information comparing use of atovaquone and proguanil combination in patients of lesser weight.

Geriatric

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 atovaquone and proguanil in the elderly with use in other age groups.

Pregnancy

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.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Cholera Vaccine, Live
• Dicumarol
• Efavirenz
• Rifabutin
• Rifampin
• 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
• Indinavir
• Tetracycline
• Warfarin

Interactions with Food/Tobacco/Alcohol

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:

• Diarrhea or vomiting—The amount of atovaquone and proguanil the body can absorb may be decreased.

• Kidney disease or failure—Atovaquone and proguanil could cause your condition to become much worse.

• Return of previously treated malaria—Atovaquone and proguanil may not work in treating the malaria again; your doctor may need to give you another type of medicine