Coartem

DRUG DESCRIPTION

Coartem (artemether lumefantrine tablets) Tablets contain a fixed combination of two antimalarial active ingredients, artemether, an artemisinin derivative, and lumefantrine. Both components are blood schizontocides. The chemical name of artemether is (3R,5aS,6R,8aS,9R,10S,12R,12aR)-decahydro-10-methoxy-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepine. Artemether is a white, crystalline powder that is freely soluble in acetone, soluble in methanol and ethanol, and practically insoluble in water. It has the empirical formula C16H2605 with a molecular weight of 298.4, and the following structural formula:

COARTEM (artemether/lumefantrine)  structural formula illustration

The chemical name of lumefantrine is ( )-2-dibutylamino-l-[2,7-dichloro-9-(4-chlorobenzylidene)-9H-fluorene-4-yl]ethanol. Lumefantrine is a yellow, crystalline powder that is freely soluble in N,N-dimethylformamide, chloroform, and ethyl acetate; soluble in dichloromethane; slightly soluble in ethanol and methanol; and insoluble in water. It has the empirical formula C30H32CI3NO with a molecular weight of 528.9, and the following structural formula:

Coartem (artemether lumefantrine tablets) Tablets are for oral administration. Each Coartem (artemether lumefantrine tablets) Tablet contains 20 mg of artemether and 120 mg lumefantrine. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, and polysorbate 80.

What are the possible side effects of artemether and lumefantrine (Coartem)?

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 a serious side effect such as:

  • worsening malaria symptoms;
  • dizziness, fainting, fast or pounding heartbeat;
  • severe or uncontrolled vomiting or diarrhea; or
  • stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Call your doctor if...

Read All Potential Side Effects and See Pictures of Coartem

What are the precautions when taking artemether lumefantrine tablets (Coartem)?

Before taking artemether/lumefantrine, tell your doctor or pharmacist if you are allergic to artemether or lumefantrine; 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: recent use (within the past month) of any medication to prevent or treat malaria (such as halofantrine, quinine, or quinidine), kidney problems, liver problems.

Artemether/lumefantrine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe...

Read All Potential Precautions of Coartem


Coartem Consumer (continued)

SIDE EFFECTS: Headache, dizziness, loss of appetite, weakness, fever, chills, tiredness, muscle/joint pain, nausea, vomiting, abdominal pain, cough, and trouble sleeping may occur. If any of these effects persist after stopping the medication or if these effects worsen while taking this medication, 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.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting, fast/irregular/pounding heartbeat.

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 artemether/lumefantrine, tell your doctor or pharmacist if you are allergic to artemether or lumefantrine; 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: recent use (within the past month) of any medication to prevent or treat malaria (such as halofantrine, quinine, or quinidine), kidney problems, liver problems.

Artemether/lumefantrine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using artemether/lumefantrine, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using artemether/lumefantrine safely.

This medication may make you dizzy, or cause you to feel tired, or weak. Do not drive, use machinery, or perform 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. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.


Coartem Patient Information Including Side Effects

Brand Names: Coartem

Generic Name: artemether and lumefantrine (Pronunciation: ar TEM e ther and LOO me FAN treen)

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

What is artemether and lumefantrine (Coartem)?

Artemether and lumefantrine 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 artemether and lumefantrine is used to treat non-severe malaria.

This medication is used only to treat malaria. Do not use artemether and lumefantrine to prevent malaria.

Artemether and lumefantrine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of artemether and lumefantrine (Coartem)?

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 a serious side effect such as:

  • worsening malaria symptoms;
  • dizziness, fainting, fast or pounding heartbeat;
  • severe or uncontrolled vomiting or diarrhea; or
  • stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Call your doctor if you develop fever, chills, body aches, severe headache, or flu symptoms after you have finished taking all your doses of artemether and lumefantrine.

Less serious side effects may include:

  • weakness, mild headache;
  • nausea, vomiting, loss of appetite;
  • cough;
  • joint or muscle pain; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about artemether and lumefantrine (Coartem)?

This medication is used only to treat malaria. Do not use artemether and lumefantrine to prevent malaria.

Do not use this medication if you are allergic to artemether or lumefantrine.

Before using this medication, tell your doctor if you have a history of heart disease or "Long QT syndrome," liver or kidney disease, or low levels of potassium or magnesium in your blood.

Take artemether and lumefantrine with food, milk, oatmeal, or broth. The tablet may be crushed and mixed with water for easier swallowing.

If you vomit within 1 hour after taking this medication, take another dose. If your vomiting continues or you cannot eat, call your doctor.

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

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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