Spiramycin (Oral, Injection, Rectal)

Spiramycin is used to treat various infections. It is commonly used to treat toxoplasmosis in pregnant women because this medicine lowers the risk of the unborn baby getting the infection. This medicine may also be used for other issues as decided by your doctor. It will not work for colds, flu, or other viral infections.

Spiramycin is available only with your doctor's prescription.

If your symptoms do not improve within a few days, or if they get worse, contact your doctor.

In deciding to use a medicine, it's important to consider the risks against the benefits. This is a choice you will make with your doctor. For this medicine, please think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare provider know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, check the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and has not shown different side effects or problems in children compared to adults when used at effective doses.

Geriatric

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

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the medicines listed below while using this medicine. The following interactions have been chosen for their potential significance and are not completely exhaustive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication to you or change some of your other medications.

• Levomethadyl

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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
• Methotrexate
• Nortriptyline
• Octreotide
• Pentamidine
• Pirmenol
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Quinidine
• Risperidone
• Sematilide
• Sertindole
• Sotalol
• Sulfamethoxazole
• Sultopride
• Tedisamil
• Telithromycin
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Zolmitriptan
• Zotepine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best option for you. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both of the medicines.

• Carbidopa
• Levodopa

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may impact the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Liver disease or
• Obstruction of the bile ducts—Liver disease or bile duct obstruction may increase the risk of 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, 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

with spiramycin injection only

• Pain at the 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, 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.

Chemical Class: Macrolide

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.