Spiramycin (oral route, injection route, rectal route)


    Description

    Spiramycin is used to treat many kinds of infections. It is often used to treat toxoplasmosis in pregnant women since this medicine decreases the chance that the unborn baby will get the infection. This medicine may also be used for other problems as determined by your doctor. It will not work for colds, flu, or other virus infections.

    Spiramycin is available only with your doctor's prescription.


    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

    This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems in children than it does in adults.

    Geriatric

    Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of spiramycin in the elderly with use in other age groups.

    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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Levomethadyl

    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.

    • Acecainide
    • Ajmaline
    • Amiodarone
    • Amitriptyline
    • Amoxapine
    • Aprindine
    • Arsenic Trioxide
    • Astemizole
    • Azimilide
    • Bretylium
    • Chloral Hydrate
    • Chloroquine
    • Cholera Vaccine, Live
    • Clarithromycin
    • Desipramine
    • Dibenzepin
    • Disopyramide
    • Dofetilide
    • Dolasetron
    • Doxepin
    • Dronedarone
    • Droperidol
    • Enflurane
    • Erythromycin
    • Flecainide
    • Fluconazole
    • Fluoxetine
    • Foscarnet
    • Gemifloxacin
    • Halofantrine
    • Haloperidol
    • Halothane
    • Hydroquinidine
    • Ibutilide
    • Imipramine
    • Isoflurane
    • Isradipine
    • Lidoflazine
    • Lorcainide
    • Mefloquine

    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.

    • Carbidopa
    • Levodopa

    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:

    • Liver disease or
    • Obstruction of the bile ducts—Liver disease or obstruction of the bile ducts may increase the chance of side effects

    Proper Use

    Spiramycin is best taken on an empty stomach.

    To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

    This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

    For patients using spiramycin suppositories:

    • First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

    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 forms (capsules or tablets):
      • For treatment of infections:
        • Adults and teenagers—1 to 2 grams (3,000,000 to 6,000,000 International Units [IU]) two times a day, or 500 mg to 1 gram (1,500,000 to 3,000,000 IU) three times a day. For severe infections, the dose is 2 to 2.5 grams (6,000,000 to 7,500,000 IU) two times a day.
        • Children weighing 20 kilograms (kg) (44 pounds) or more—Dose is based on body weight. The usual dose is 25 mg (75,000 IU) per kg (11.4 mg per pound) of body weight two times a day, or 17 mg (51,000 IU) per kg (7.7 mg per pound) of body weight three times a day.
    • For injection dosage form:
      • For treatment of infections:
        • Adults and teenagers—500 mg (1,500,000 IU) injected slowly into a vein every eight hours. For severe infections, the dose is 1 gram (3,000,000 IU) injected slowly into a vein every eight hours.
        • Children—Use and dose must be determined by your doctor.
    • For rectal dosage form (suppository):
      • For treatment of infections:
        • Adults and children 12 years of age and over—Two or three 750 mg (1,950,000 IU) suppositories per day.
        • Children up to 12 years of age—Two or three 500 mg (1,300,000 IU) suppositories per day.
        • Newborns—Dose is based on body weight. The usual dose is one 250 mg (650,000 IU) suppository per 5 kg (250 mg suppository per 11 pounds) of body weight once a day.

    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.


    Precautions

    If your 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.

    Check with your doctor immediately if any of the following side effects occur:

    Less common

    • Skin rash and itching
    • unusual bleeding or bruising

    Rare

    • Pain at site of injection

    Rare

    • Bloody stools
    • chest pain
    • fever
    • heartburn
    • irregular heartbeat
    • nausea
    • recurrent fainting
    • stomach pain and tenderness
    • vomiting
    • yellow eyes or skin

    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:

    Less common

    • Diarrhea

    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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