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|Rovamycine 500

SPIRAMYCIN (Systemic)*

Some commonly used brand names are:

In Canada—

• Rovamycine

• Provamicina
• Rovamycina
• Rovamycine
• Rovamycine 250
• Rovamycine 500
• Spiramycine Coquelusédal

* Not commercially available in the U.S.

Category

• Antibacterial, systemic
• Antiprotozoal

Description

Spiramycin (speer-a-MYE-sin) 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, in the following dosage forms:

• Oral
• Spiramycin
  • Capsules (Canada)
  • Tablets (France, Germany, Italy, Mexico, Spain)

• Parenteral
• Spiramycin Adipate
  • Injection (France)

• Rectal
• Spiramycin Adipate
  • Suppository (France)

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 spiramycin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to spiramycin, or any related medicines, such as erythromycin, azithromycin, clarithromycin, troleandomycin, dirithromycin, or josamycin. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Spiramycin is used to treat toxoplasmosis in pregnant women since this medicine decreases the chance that the unborn baby will get the infection. If the unborn baby is already infected with toxoplasmosis, spiramycin does not treat the infection. This medicine has not been found to cause birth defects or other problems in humans.

Breast-feeding—Spiramycin passes into the breast milk. However, spiramycin has not been shown to cause problems in nursing babies to date.

Children—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.

Older adults—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.

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. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of spiramycin. 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 of This Medicine

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 spiramycin 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 spiramycin. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets that you take or the number of suppositories that you use 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 taking spiramycin .

• 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. This will help to keep a constant amount of medicine in the blood. 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 your dose.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of spiramycin in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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

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 immediately if any of the following side effects occur:

Other 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. However, check with your doctor if the following side effect continues or is bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 05/28/1996

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