Spiramycin ......................................................................... 3,000,000 IU
Excipients q.s.............................................................................. 1 tablet
Film coated tablets
Box of 2 blisters x 5 tablets.
Rovas contains Spiramycin which is a macrolide antibiotic. Spiramycin is bacteriostatic at serum concentrations but may be bactericidal at tissue concentrations. Mechanism of action of spiramycin is to bind reversibly to the 50S subunits of bacterial ribosome resulting in inhibition of protein synthesis. Spiramycin is active against Gram-positive organisms, Coccus spp. including Staphylococcus, Pneumococcus, Meningococcus, etc.
Spiramycin is incompletely absorbed from the gastrointestinal tract. Drug absorption is approximately 20 - 50% of the dose. Peak plasma concentrations attained within 2 - 4 hrs after oral administration. Peak blood concentrations of a single dose may be maintained 4 - 6 hrs. Bioavailability of spiramycin may be significantly reduced when the presence of food is in the stomach. Cmax is decreased by 70% and Tmax is delayed by 2 hours in the presence of food. Spiramycin is widely distributed in the body. Spiramycin achieves high concentrations in lungs, tonsils, bronchi, and sinuses. Penetration of spiramycin into cerebrospinal fluid is reported to be poor. The mean half-life is 5 to 8 hours. Spiramycin is mainly excreted in the bile. Only 2% of the total drug is found in the urine after 36 hrs of oral administration.
The effect of spiramycin on the ability to drive and use machines is rarely reported.
The drug should be used with caution in patients with hepatic dysfunction because it may cause hepatotoxicity.
Spiramycin crosses the placenta; however, fetal blood concentrations are lower than maternal serum concentrations. Spiramycin does not cause bad effects in pregnant women. High concentrations are distributed into breast milk; therefore, breast-feeding is not recommended for women taking spiramycin.
Concomitant use of spiramycin with oral contraceptives causes ineffective contraception.
Common: nausea, vomiting, diarrhea, dyspepsia (following oral route).
Uncommon: General disorders: fatigue, nosebleeds, sweating, chest pains; transient paresthesia, unsteadiness, muscle and joint contractures or pains, burning sensation, flushing (following intravenous injection); Gastrointestinal disorders: acute colitis; Skin disorders: skin rash, urticaria.
Rare: anaphylactic reactions, surinfections due to prolonged use of spiramycin.
Inform your physician about any adverse effects occur during the treatment.
No documents have been reported. In the event of overdosage, inform your doctor immediately.
Store in dry places, not exceeding 30oC, protect from light.
36 months from the manufacturing date.
Spiramycin is suggested to be the second choice in treatment of respiratory tract infections, skin and genital infections caused by susceptible to bacteria.
Preventive treatment of meningitis caused by Meningococcus when patients contra-indicated in the prescription of rifampicin
Prevention of innate toxoplasmosis during pregnant period.
Prophylaxis of recurrences of acute rheumatism in penicillin-allergic patients.
A known history of hypersensitivity to spiramycin, erythromycin.
Treatment dose:
Adults and children aged > 12 years: oral dose of 3,000,000 IU 3 times for 24 hours (1 tablet 3 times daily).
Prevention of meningitis caused by Meningococcus:
Adults and children aged > 12 years: oral dose of 3,000,000 IU every 12 hours (1 tablet twice daily).
Prophylaxis of innate toxoplasmosis in pregnancy:
Oral dose of 9,000,000 IU/day (3 tablets/day), in divided doses for 3 weeks. The dosage should be repeated every 2 weeks.
Alternate or coordinate administration with pyrimethamine/sulfonamide therapy should be given to get a better result.
Bioavailability of spiramycin may be decreased when the presence of food is in the stomach; so the drug should be taken at least 2 hours before a meal or 3 hours after a meal.
The therapy must be completely pursued.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
Register an account - receive thousands of information
You will be one of the first to receive information, news, recruitment news... from Hau Giang Pharmaceutical as soon as possible. Register today to enjoy thousands of incentives from Hau Giang Pharmaceutical.
