Brand Name

    US Brand Name

    Humatin


    Description

    Paromomycin is used to treat acute and chronic intestinal amebiasis (bowel infection caused by a parasite in your stomach or bowels). It is also used with other medicines to help lessen the symptoms of hepatic coma (a complication of liver disease).

    Paromomycin belongs to the class of medicines known as aminoglycoside antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Capsule

    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 paromomycin to treat intestinal amebiasis in children. However, safety and efficacy of paromomycin to treat hepatic coma have not been established in children.

    Geriatric

    No information is available on the relationship of age to the effects of paromomycin in geriatric patients.

    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.

    • Aspirin
    • Cholera Vaccine, Live
    • Colistimethate Sodium
    • Emtricitabine
    • Foscarnet
    • Furosemide
    • LetibotulinumtoxinA-wlbg
    • Methotrexate
    • Tacrolimus
    • Tenofovir Alafenamide

    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:

    • Bowel blockage—Should not be used in patients with this condition.
    • Stomach or bowel problems (e.g., lesions, ulcerations)—Use with caution. May increase risk for more serious side effects.

    Proper Use

    Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

    It is best to take this medicine with food.

    To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, you must take this medicine on a regular schedule.

    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 oral dosage form (capsules):
      • For intestinal amebiasis:
        • Adults and children—Dose is based on body weight and must be determined by your doctor. The dose is usually 25 to 35 milligrams (mg) per kilogram (kg) of body weight, divided in three doses, for 5 to 10 days.
      • For management of hepatic coma:
        • Adults—4000 milligrams (mg) per day, divided in small doses, for 5 to 6 days.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly.

    If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.


    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.

    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:

    Incidence not known

    • Abdominal or stomach cramps
    • diarrhea
    • nausea

    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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