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 preventand treat malaria, a red blood cell infection transmitted by the bite of amosquito. 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 thefollowing 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 willdo. 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 unusualor allergic reaction to atovaquone or proguanil hydrochloride. Also tell yourhealth care professional if you are allergic to any other substances, suchas preservatives or dyes.

Pregnancy?Atovaquone and proguanil combination has not beenstudied in pregnant women. However, this medicine has not been shown to causebirth 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 thereis a chance of getting malaria.

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

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

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof 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 casestwo different medicines may be used together even if an interaction mightoccur. In these cases, your doctor may want to change the dose, or other precautionsmay be necessary. When you are taking atovaquone and proguanil, it is especiallyimportant that your health care professional know if you are taking any ofthe following:

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

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

Other medical problems?The presence of other medical problems may affect the use of atovaquoneand proguanil. Make sure you tell your doctor if you have any other medicalproblems, especially:

• Diarrhea or vomiting?The amount of atovaquone and proguanilthe body can absorb may be decreased.

• Kidney disease or failure?Atovaquone and proguanilcould cause your condition to become much worse.

• Return of previously treated malaria?Atovaquone and proguanilmay not work in treating the malaria again; your doctor may need to give youanother type of medicine

Proper Use of This Medicine

Be sureto 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 andmix this medicine with condensed milk just before taking it or giving it toyour child.

Dosing?The dose of atovaquone and proguanil willbe different for different patients. Follow your doctor'sorders or the directions on the label. The following information includesonly the average doses of atovaquone and proguanil. If your dose is different, do not change it unless your doctor tellsyou 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 timeallowed between doses, and the length of time you take the medicine dependon 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 enteringmalarial area and continuing for 7 days following return.
    • Children weighing 25 pounds (11 kilograms [kg]) or more?Dosageis according to weight and will be determined by your doctor.
    • Children weighing less than 25 pounds (11 kg)?Use and dosemust be determined by your doctor.
• • For malaria treatment:
    • Adults?1 gram of atovaquone and 400 mg of proguanil (4 adultstrength tablets) once daily as a single dose taken three days in a row.
    • Children weighing 11 pounds (5 kg) or more?Dosage is basedon body weight and must be determined by your doctor.
    • Children weighing less than 11 pounds (5 kg)?Use and dose mustbe determined by your doctor.

Missed dose? If you miss a dose of this medicine, take itas soon as possible. Contact your doctor as soon as possible for additionalinstructions 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 otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Malariais spread by the bites of certain kinds of infected female mosquitoes. Ifyou are living in, or will be traveling to, an area where there is a chanceof getting malaria, the following mosquito-control measures will help to preventinfection:

• Remain in air-conditioned or well-screened rooms to reduce contactwith mosquitoes.
• If possible, sleep under mosquito netting, preferably netting coatedor soaked with permethrin, to avoid being bitten by malaria-carrying mosquitoes.
• Wear long-sleeved shirts or blouses and long trousers to protectyour arms and legs, especially from dusk through dawn when mosquitoes areout.
• Apply mosquito repellent, preferably one containing DEET, to uncoveredareas of the skin from dusk through dawn when mosquitoes are out.
• Use a pyrethrum-containing flying insect spray to kill mosquitoesin 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 eyelidsor around the eyes, face, lips or tongue, shortness of breath, skin rash,tightness in chest, unusual tiredness or weakness or wheezing. These couldbe symptoms of an allergic reaction.

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

Side Effects of This Medicine

Along with its neededeffects, a medicine may cause some unwanted effects. Side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine.

Check with your doctor as soon as possible if any of thefollowing side effects occur:

Incidence not known

Blistering, peeling, loosening of skin; chills; convulsions; difficultyswallowing; fast heartbeat; hives or welts; increased sensitivity of skin tosunlight; itching, redness or other discolorationof skin; joint or muscle pain; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs,feet, sex organs; loss of bladder control; muscle spasm or jerking of all extremities; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; rash; red, irritated eyes; red skin lesions, often with a purple center; seeing, hearing, or feeling things that are not there; severe mental changes; severe sunburn; shortness of breath; skin rash; sores, ulcers or white spots in mouthor on lips; sudden loss of consciousness; tightness in chest; unusual tirednessor weakness; wheezing

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

More common

Abdominal pain; back pain; coughing; diarrhea; dreams; fever; headache; itching skin ; lack ofor loss of strength; nausea; muscle pain; sore throat; sores in mouth; sneezing; vomiting

Less common

Acid or sour stomach; belching; blurred or loss of vision; disturbedcolor perception; dizziness; double vision; flu like symptoms; halos around lights; heartburn; indigestion; loss of appetite; night blindness; overbright appearance of lights; sleeplessness; stomachdiscomfort, upset or pain; trouble sleeping; tunnel vision; unable to sleep; weight loss

Rare

Discouragement; fear; feeling sad or empty; irritability; lack of appetite; loss of interest orpleasure; nervousness; trouble concentrating

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