Description

    Intra-amniotic urea is given by injection into the uterus to cause abortion. It is to be administered only by or under the immediate care of your doctor.


    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

    Although there is no specific information comparing use of urea in teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in teenagers than it does in adults.

    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 taking 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.

    • Amikacin
    • Amikacin Liposome
    • Arsenic Trioxide
    • Droperidol
    • Ephedrine
    • Levomethadyl

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Licorice

    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:

    • Diabetes mellitus (sugar diabetes)
    • Fibroid tumors of the uterus
    • Kidney disease
    • Liver disease
    • Sickle cell disease

    Proper Use

    During the abortion procedure, you should drink fluids to help prevent your body from losing too much water.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For injection dosage form:
      • For causing abortion:
        • Adults and teenagers—Up to 250 milliliters (mL) injected through the abdomen into the uterus after the same amount of fluid is taken out of the bag around the fetus (amniotic sac). The injection may be repeated 48 hours after the first dose if needed.

    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 immediately if any of the following side effects occur:

    • Pain in lower abdomen
    • weakness

    Check with your doctor as soon as possible if any of the following side effects occur:

    Rare

    • Confusion
    • irregular heartbeat
    • muscle cramps or pain
    • numbness, tingling, pain, or weakness in hands or feet
    • unusual tiredness or weakness
    • weakness and heaviness of legs

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Nausea or vomiting

    Less common or rare

    • Headache
    • diarrhea

    After the procedure is completed, this procedure may still produce some side effects that need medical attention. Check with your doctor if you notice any of the following side effects:

    • Chills or shivering
    • fever
    • foul-smelling vaginal discharge
    • increase in bleeding of the uterus
    • pain in lower abdomen

    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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