Atovaquone Proguanil

Atovaquone/Proguanil is a prescription medicine used to prevent and treat the symptoms of Malaria.

• Atovaquone/Proguanil is available under the following different brand names: Malarone

Adult dosage

Tablet

• 250mg/100mg

Pediatric dosage

Tablet

• 62.5mg/25mg

Malaria Prophylaxis

Adult dosage

• 250 mg/100 mg (1 tablet) orally daily,  beginning 1-2 days before travel to the malaria-endemic area and continued until 7 days after return

Pediatric dosage

• Children weighing less than 11 kg: Safety and efficacy not established
• Children weighing between 11-20 kg: 62.5 mg/25 mg (1 pediatric tablet) orally daily
• Children weighing between 21-30 kg: 125 mg/50 mg (2 pediatric tablets) orally daily
• Children weighing between 31-40 kg: 187.5 mg/75 mg (3 pediatric tablets) orally daily
• Children weighing more than 40 kg: 250 mg/100 mg (1 adult tablet) orally daily, beginning 1-2 days before travel to the malaria-endemic area and continued until 7 days after return

Malaria Treatment

Adult dosage

• 1 g/400 mg (4 tablets) orally daily for 3 days

Pediatric dosage

• Children weighing less than 5 kg: Safety and efficacy not established
• Children weighing between 5-8 kg: 125 mg/50 mg (2 pediatric tablets) orally daily  for 3 days
• Children weighing between 9-10 kg: 187.5 mg/75 mg (3 pediatric tablets) orally daily for 3 days
• Children weighing between 11-20 kg:  250 mg/100 mg (1 adult tablet) orally daily for 3 days
• Children weighing between 21-30 kg: 500 mg/200 mg (2 adult tablets) orally daily for 3 days
• Children weighing between 31-40 kg: 750 mg/300 mg (3 adult tablets) orally daily for 3 days
• Children weighing more than 40 kg: 1 g/400 mg (4 adult tablets) orally daily for 3 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages.”

Common side effects of Atovaquone/Proguanil include:

• stomach pain,
• vomiting,
• diarrhea,
• mouth sores,
• headache,
• dizziness,
• weakness,
• strange dreams,
• itching, and
• cough.

Serious side effects of Atovaquone/Proguanil include:

• stomach pain (upper right side),
• loss of appetite,
• tiredness,
• itching,
• dark urine,
• clay-colored stools, and
• yellowing of the skin or eyes (jaundice).

Rare side effects of Atovaquone/Proguanil include:

• none 

This is not a complete list of side effects and other serious side effects, or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Atovaquone/Proguanil has severe interactions with no other drugs.
• Atovaquone/Proguanil has serious interactions with the following drugs:
  • dapsone topical
  • efavirenz
• Atovaquone/Proguanil has moderate interactions with the following drugs:
  • bupivacaine implant
  • efavirenz
  • indinavir
  • metoclopramide intranasal
• Atovaquone/Proguanil has minor interactions with the following drugs:
  • metoclopramide
  • tetracycline

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Prophylaxis in severe renal impairment (CrCl less than 30 mL/min)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Atovaquone/Proguanil?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Atovaquone/Proguanil?”

Cautions

• Administration does not provide a radical cure, nor does it prevent delayed primary attacks of P vivax and P ovale
• Patients with severe malaria are not candidates for oral therapy; not evaluated in the treatment of cerebral malaria or severe manifestations of malaria (e.g., hyperparasitemia, pulmonary edema, renal failure)
• Hepatitis and increased transaminase levels reported with prophylactic use; monitor closely; use caution with existing hepatic impairment; hepatic enzyme elevations may persist for four weeks after treatment has ended
• Not for the treatment of cerebral malaria or other severe manifestations of complicated malaria
• Absorption may be reduced in patients with diarrhea or vomiting; monitor closely, and consider antiemetic use; if severe, use alternative antimalarial
• Monotherapy may result in parasite relapse of P vivax malaria
• Recrudescent P falciparum infection or chemoprophylactic failure after monotherapy should be treated with different schizonticide
• Prophylaxis should not be prematurely discontinued; delayed cases of P. falciparum malaria may occur
• Complete prophylaxis includes therapy, protective clothing, insect repellents, and bed nets
• No chemoprophylactic regimen is 100% effective; the patient should seek medical care for any febrile illness that occurs
• Treatment failure was reported in patients weighing above 100 kg; monitoring and follow up recommended in this patient group
• P falciparum malaria carries a higher risk of death and serious complications in pregnant women; the patient should discuss the risks and benefits of travel, and if travel cannot be avoided, additional prophylaxis, including protective clothing, must be employed

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy.
• Lactation
  • Proguanil is excreted into milk in small quantities, but excretion of atovaquone is unknown; use with caution