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|Malarone

ATOVAQUONE AND PROGUANIL (Systemic)

Some commonly used brand names are:

In the U.S.—

• Malarone

Category

• Anti-protozoal

Description

Antiprotozoals ((AN-ti-pro-to-ZO-uls)) 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 (a-TOE-va-kwone) and proguanil (pro-GWAN-il).

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Tablets (U.S.)

Before Using This Medicine

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 atovaquone and proguanil, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to atovaquone or proguanil hydrochloride. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Atovaquone and proguanil combination has not been studied in pregnant women. However, this medicine has not been shown to cause birth defects or other problems in animal studies. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant It is advisable for pregnant women to avoid traveling to areas where there is a chance of getting malaria.

Breast-feeding—It is not known if atovaquone passes into human breast milk, but it was found in the milk of rats. Proguanil passes into breast milk, but in small quantities. Be sure you have discussed the risks and benefits of this medicine with your doctor.

Children—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 and there is no specific information comparing use of atovaquone and proguanil combination in patients of lesser weight.

Older adults—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.

Other 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 atovaquone and proguanil, it is especially important that your health care professional know if you are taking any of the following:

• Rifabutin (e.g., Mycobutin) or
• Rifampin (e.g., Rifadin)—Use of rifampin may decrease the amount of atovaquone in the blood and keep it from working properly

• Metoclopramide (e.g., Reglan)—Use of metoclopramide with atovaquone and proguanil may lessen the amount of atovaquone your body absorbs
• Tetracycline (e.g., Sumycin)—Use of tetracycline lowers the amount of atovaquone in your blood.

Other medical problems—The presence of other medical problems may affect the use of atovaquone and proguanil. 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

Proper Use of This Medicine

Be sure to take this medicine at the same time each day.

Take this medicine with food or with a milky drink. This will help your body absorb the maximal amount of medicine.

If you vomit within 1 hour of taking this medicine, take the entire dose again as soon as your stomach can tolerate it.

If you or your child have trouble swallowing tablets, you may crush and mix this medicine with condensed milk just before taking it or giving it to your child.

Dosing—The dose of atovaquone and proguanil will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of atovaquone and proguanil. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking atovaquone and proguanil.

• For oral dosage form (tablets):
  • For malaria prevention:
    • Adults—250 milligrams (mg) of atovaquone and 100 mg proguanil (1 adult strength tablet) per day, starting 1-2 days before entering malarial area and continuing for 7 days following return.
    • Children weighing 25 pounds (11 kilograms [kg]) or more—Dosage is according to weight and will be determined by your doctor.
    • Children weighing less than 25 pounds (11 kg)—Use and dose must be determined by your doctor.
• • For malaria treatment:
    • Adults—1 gram of atovaquone and 400 mg of proguanil (4 adult strength tablets) once daily as a single dose taken three days in a row.
    • Children weighing 11 pounds (5 kg) or more—Dosage is based on body weight and must be determined by your doctor.
    • Children weighing less than 11 pounds (5 kg)—Use and dose must be determined by your doctor.

Missed dose— If you miss a dose of this medicine, take it as soon as possible. Contact your doctor as soon as possible for additional instructions since you may need additional protective measures.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store at room temperature.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Malaria is spread by the bites of certain kinds of infected female mosquitoes. If you are living in, or will be traveling to, an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

• Remain in air-conditioned or well-screened rooms to reduce contact with mosquitoes.
• If possible, sleep under mosquito netting, preferably netting coated or soaked with permethrin, to avoid being bitten by malaria-carrying mosquitoes.
• Wear long-sleeved shirts or blouses and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.
• Apply mosquito repellent, preferably one containing DEET, to uncovered areas of the skin from dusk through dawn when mosquitoes are out.
• Use a pyrethrum-containing flying insect spray to kill mosquitoes in living and sleeping quarters during evening and nighttime hours.

Contact your doctor right away if you experience cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, shortness of breath, skin rash, tightness in chest, unusual tiredness or weakness or wheezing. These could be symptoms of an allergic reaction.

Atovaquone and proguanil may cause your skin to be more sensitive to sunlight than it is normally. Be sure to wear protective clothing and a hat or apply a product to the skin that prevents sunburn before going outside.

Side Effects of This Medicine

However, check with your health care professional if any of the following side effects continue or are bothersome :

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 11/03/2000
Revised: 02/23/2005

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