Malarone

DRUG DESCRIPTION

MALARONE (atovaquone and proguanil hydrochloride) is a fixed-dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is trans-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula:

Atovaquone Structural Formula Illustration

The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula C11H16ClN5•HCl. The compound has the following structural formula:

MALARONE (atovaquone and proguanil hcl) Tablets and MALARONE (atovaquone and proguanil hcl) Pediatric Tablets are for oral administration. Each MALARONE (atovaquone and proguanil hcl) Tablet contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride and each MALARONE (atovaquone and proguanil hcl) Pediatric Tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride. The inactive ingredients in both tablets are low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, and sodium starch glycolate. The tablet coating contains hypromellose, polyethylene glycol 400, polyethylene glycol 8000, red iron oxide, and titanium dioxide.

What are the possible side effects of atovaquone and proguanil (Malarone, Malarone Pediatric)?

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 any of these serious side effects:

  • severe or uncontrolled vomiting or diarrhea;
  • fever;
  • nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • mouth sores;
  • unusual aches and pains, tired...

Read All Potential Side Effects and See Pictures of Malarone »

What are the precautions when taking atovaquone and proguanil hcl (Malarone)?

Before taking atovaquone/proguanil, tell your doctor or pharmacist if you are allergic to either atovaquone or proguanil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current diarrhea, current vomiting, kidney problems, liver problems, mental/mood problems, seizures.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use...

Read All Potential Precautions of Malarone »


Malarone Consumer (continued)

SIDE EFFECTS: See also How to Use section.

Side effects may include nausea, vomiting, abdominal pain, headache, diarrhea, weakness, loss of appetite, and dizziness. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of serious liver problems (such as persistent/severe nausea and vomiting, abdominal pain, unexplained tiredness, dark urine, yellowing eyes/skin), signs of anemia (such as worsening tiredness, rapid breathing, pale skin/lips/nails, fast heartbeat while resting), signs of severe infection (such as high fever, severe chills, body aches, sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking atovaquone/proguanil, tell your doctor or pharmacist if you are allergic to either atovaquone or proguanil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current diarrhea, current vomiting, kidney problems, liver problems, mental/mood problems, seizures.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. While you are pregnant, traveling to an area with malaria places you and your infant at a much higher risk for death and other problems. Discuss the risks and benefits of malaria prevention with your doctor.

It is not known if atovaquone passes into breast milk and may have undesirable effects on a nursing infant. The proguanil in this medication passes into breast milk and the effects of this medication on a nursing infant are not known. The CDC recommends against using this product for malaria prevention if you are breastfeeding an infant weighing less than 11 pounds (5 kilograms). Consult your doctor before breast-feeding.


Malarone Patient Information Including Side Effects

Brand Names: Malarone, Malarone Pediatric

Generic Name: atovaquone and proguanil (Pronunciation: a TOE va kwone and pro GWAHN il)

  • What is atovaquone and proguanil (Malarone)?
  • What are the possible side effects of atovaquone and proguanil (Malarone)?
  • What is the most important information I should know about atovaquone and proguanil (Malarone)?
  • What should I discuss with my healthcare provider before taking atovaquone and proguanil (Malarone)?
  • How should I take atovaquone and proguanil (Malarone)?
  • What happens if I miss a dose (Malarone)?
  • What happens if I overdose (Malarone)?
  • What should I avoid while taking atovaquone and proguanil (Malarone)?
  • What other drugs will affect atovaquone and proguanil (Malarone)?
  • Where can I get more information?

What is atovaquone and proguanil (Malarone)?

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 other purposes not listed in this medication guide.

What are the possible side effects of atovaquone and proguanil (Malarone)?

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 any of these serious side effects:

  • severe or uncontrolled vomiting or diarrhea;
  • fever;
  • nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • mouth sores;
  • unusual aches and pains, tired feeling, weight loss;
  • severe skin rash; or
  • easy bruising or bleeding.

Less serious side effects may include:

  • cough;
  • headache;
  • weakness;
  • dizziness; or
  • itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about atovaquone and proguanil (Malarone)?

Do 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.

Before using this medication, tell your doctor if you have liver or kidney disease, severe complications from infection with malaria, or uncontrolled vomiting or diarrhea.

Take atovaquone and proguanil at the same time each day with food or a milky drink.

If you vomit within 1 hour after taking this medication, take another dose. If your vomiting continues, call your doctor.

If you are taking this medicine to prevent malaria, start taking it 1 or 2 days before entering an area where malaria is common. Take the medication every day during your stay and for at least 7 days after you leave. If you stop taking the medicine early for any reason, contact a healthcare professional about another form of malaria prevention.

If you are taking this medicine to treat malaria, take the medication every day for 3 days in a row.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

In addition to taking atovaquone and proguanil, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

Contact your doctor as soon as possible if you have been exposed to malaria, or if you have a fever or other symptoms of illness during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

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