Rovamycine (Spiramycin)

ROVAMYCINE®

Rhône-Poulenc Rorer

Spiramycin

Antibiotic

Action And Clinical Pharmacology: It is active against the following gram-positive organisms: S. aureus (including penicillin resistant strains), beta-hemolytic streptococci, S. viridans, S. faecalis and S. pneumoniae, C. diphtheriae, clostridia.

Except for B. pertussis, H. influenzae (approximately 50% of strains) and neisseria, gram-negative organisms are generally considered as resistant to spiramycin.

Bacterial resistance to spiramycin has been reported to develop, including cross resistance between spiramycin and erythromycin. However, most of the erythromycin resistant strains of S. aureus are still sensitive to spiramycin.

Indications And Clinical Uses: The treatment of infections of the respiratory tract, buccal cavity, skin and soft tissues due to susceptible organisms.

N. gonorrhoeae: as an alternate choice of treatment for gonorrhea in patients allergic to the penicillins. Before treatment of gonorrhea, the possibility of concomitant infection due to T. pallidum should be excluded.

Contra-Indications: Hypersensitivity to the drug.

The levels of spiramycin attained in the CSF are much lower than those in the blood and are too low to be clinically useful. Therefore spiramycin must not be used in patients with meningitis.

Precautions: Administer antibiotics, including spiramycin cautiously to any patient who has demonstrated some form of allergy, particularly to drugs.

The possibilty of superinfection caused by overgrowth of nonsusceptible organisms should be kept in mind during prolonged or repeated therapy. If superinfection occurs, discontinue the drug and take appropriate measures.

Pregnancy: Safety of this product for use during pregnancy has not been established.

Adverse Reactions: Spiramycin has a low toxicity and rarely produces serious adverse effects; these include epigastric pain and abdominal discomfort, nausea, vomiting, diarrhea and skin sensitization.

Symptoms And Treatment Of Overdose: Symptoms: No case of accidental overdosage has been reported. In oral doses over 4 g/day, abdominal discomfort, nausea or diarrhea may occur.

Treatment: No specific treatment has been proposed. Management should be symptomatic.

Dosage And Administration: Adults: 6 000 000 to 9 000 000 U (4 to 6 capsules of Rovamycine ‘500’) per 24 hours, in 2 divided doses. In severe infections, the daily dosage may be increased to 12 000 000 to 15 000 000 U (8 to 10 capsules of Rovamycine ‘500’ per day).

Gonorrhea: 12 000 000 to 13 500 000 U (8 or 9 capsules) in a single dose.

Children: The usual daily dosage is based on 150 000 U/kg body weight in 2 or 3 divided doses; the following calculated dosages are given as a guide.

Spiramycin is stable in gastric juices and absorption is not affected by food. In severe infections, the daily dosage may be increased by one half.

In the treatment of beta-hemolytic streptococcal infections, adequate spiramycin dosage should be administered for 10 days.

Availability And Storage: Rovamycine ‘250’: Each orange and red capsule contains: spiramycin 750 000 U. Nonmedicinal ingredients: FD&C Blue No. 1, FD&C Red No. 28, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, sodium croscarmellose and titanium dioxide. Tartrazine-free. Bottles of 50.

Rovamycine ‘500’: Each gray and red capsule contains: spiramycin 1 500 000 U. Nonmedicinal ingredients: FD&C Blue No. 1, FD&C Red No. 28, FD&C Red No. 40, gelatin, iron oxides, lactose, magnesium stearate, sodium croscarmellose and titanium dioxide. Tartrazine-free. Bottles of 50.

ROVAMYCINE® Rhône-Poulenc Rorer Spiramycin Antibiotic

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