Pronunciation:

a-TOE-va-kwone, proe-GWAHN-il hye-droe-KLOR-ide

Brand Names:

• Malarone
• Malarone Pediatric

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Ubiquinone/Biguanide Combination

Pharmacologic—

Proguanil

Chemical—

Ubiquinone

Uses of This Medicine:

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.

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 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.

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. 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.

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.

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 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 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.

• Bupropion
• Carbamazepine
• Cholera Vaccine, Live
• Dicumarol
• Efavirenz
• Fedratinib
• Fluconazole
• Levoketoconazole
• Mavacamten
• Methotrexate
• Nirogacestat
• Quizartinib
• Rifabutin
• Rifampin
• Ritonavir
• Sapropterin
• Typhoid Vaccine, Live
• 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.

• Tetracycline
• Warfarin

Other interactions—

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

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 has 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine 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 using the medicine.

• 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 to 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. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Call your doctor or pharmacist for instructions.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Incidence not known

Blistering, peeling, loosening of skin

chills

convulsions

difficulty swallowing

fast heartbeat

hives or welts

increased sensitivity of skin to sunlight

itching, redness or other discoloration of 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 mouth or on lips

sudden loss of consciousness

tightness in chest

unusual tiredness or weakness

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal pain

back pain

coughing

diarrhea

dreams

fever

headache

itching skin

lack of or 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

disturbed color perception

dizziness

double vision

flu like symptoms

halos around lights

heartburn

indigestion

loss of appetite

night blindness

overbright appearance of lights

sleeplessness

stomach discomfort, 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 or pleasure

nervousness

trouble concentrating

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

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