Artesunate (intravenous route)


    Description

    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.

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using

    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.

    Pediatric

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

    Geriatric

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

    Breastfeeding

    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.

    Drug Interactions

    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

    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

    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

    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.






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