ROVAS 750000

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Description

ROVAS 0.75M

COMPOSITION:

Spiramycin ...................................................................................... 750,000 IU

Excipients q.s....................................................................................... 1 sachet

(Orange-flavored powder, tutti frutti flavor, PVP K30, sunett sugar, sucrose).

DOSAGE FORM: Powder for oral suspension.

PRESENTATION: Box of 24 sachets x 3 g. 

PHARMACODYNAMICS:

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.

PHARMACOKINETICS:

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 maintain 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 lung, 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 total drug is found in the urine after 36 hrs of oral administration.  

INDICATIONS:

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.

CONTRAINDICATIONS:

A known history of hypersensitivity to spiramycin, erythromycin.

PRECAUTIONS:

The drug should be used with caution in patients with hepatic dysfunction because it may cause hepatotoxicity.

PREGNANCY AND LACTATION:

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 to women taking spiramycin.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

The effect of spiramycin on the ability to drive, use machines is rarely reported.

INTERACTIONS:

Concomitant use of spiramycin with oral contraceptives causes ineffective contraception.

ADVERSE EFFECTS:

Common: nausea, vomiting, diarrhea, dyspepsia (following oral route).

Uncommon: General disorders: fatigue, nosebleed, 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.

OVERDOSE:

No documents have been reported. In the event of overdosage, inform your doctor immediately.

DOSAGE & ADMINISTRATION:

Treatment dose:

Infants and children: oral dose of 150,000 IU/ kg of body-weight/24 hrs, in 2-3 divided doses.

- Or: Neonates and children weighing < 10 kg: oral dose of 1 - 2 sachets/24 hrs, in 2-3 divided doses.

- Children weighing from 10 - 20 kg: oral dose of 2 - 4 sachets/24 hrs, in 2-3 divided doses.

Prevention of meningitis caused by Meningococcus:

Children: oral dose of 75,000 IU/ kg of body-weight once every 12 hrs for 5 days.

Prophylaxis of innate toxoplasmosis in pregnancy: oral dose of 9,000,000 IU/ 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.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

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