Pronunciation:

ar-TES-u-nate

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antimalarial

Uses of This Medicine:

Artesunate injection is used to treat severe malaria. This medicine is also used together with other medicines (eg, 8-aminoquinoline medicine) to treat severe malaria caused by Plasmodium ovale or Plasmodium vivax.

Artesunate belongs to a group of medicines known as antimalarials. It treats malaria, a red blood cell infection transmitted by the bite of a mosquito. However, this medicine is not used to prevent malaria.

This medicine is to be given only by or under the immediate supervision of your doctor.

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—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of artesunate injection in children.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of artesunate injection in the elderly.

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 receiving 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.

• Carbamazepine

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:

• Kidney disease or
• Liver disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to stay in place for 1 to 2 minutes.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any questions about this, talk to your doctor.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed for 4 weeks after treatment with this medicine to check for unwanted effects (eg, delayed hemolysis).

Using this medicine while you are pregnant can harm your unborn baby. if you think you have become pregnant while using this medicine, tell your doctor right away.

Blood problems (eg, hemolytic anemia) may occur after you receive treatment with this medicine. Check with your doctor right away if you or your child have back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty breathing, fever, general body swelling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, unusual tiredness or weakness, or yellow eyes or skin.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening. Call your doctor right away if you or your child have blurred vision, chest tightness, confusion, cough, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, hoarseness, redness of the skin, skin rash, itching, hives or welts, sweating, swelling of your hands, face, or mouth, trouble breathing or swallowing, or unusual tiredness or weakness after you receive this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 or nurse immediately if any of the following side effects occur:

More common

Agitation

clay-colored stools

coma

confusion

dark urine

decreased urine output

depression

dizziness

fever

headache

loss of appetite

muscle twitching

nausea or vomiting

rapid weight gain

seizures

skin rash or itching

stomach pain

stupor

swelling of the face, ankles, or hands

unpleasant breath odor

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Incidence not known

Back, leg, or stomach pains

bleeding gums

bloating

blurred vision

chest tightness

chills

constipation

cough

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast heartbeat

general body swelling

hives or welts

hoarseness

indigestion

nosebleeds

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

sore throat

sweating

trouble breathing or swallowing

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.