ROVAMICINE ® Spiramycin

ROVAMICINA ® is a drug based on spiramycin

THERAPEUTIC GROUP: Antibacterials - Antibiotics for systemic use

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications ROVAMICINE ® Spiramycin

ROVAMICINA ® is a drug used in the treatment of infections caused by germs sensitive to macrolides and in particular to Spiramycin.

Mechanism of action ROVAMICINA ® Spiramycin

Spiramycin, the active ingredient of ROVAMICINA ®, is a molecule extracted from cultures of Streptomyces Ambofaciens, endowed with a natural antibacterial activity also directed towards mycoplasmas.

Coming back into the category of macrolides with 16 carbon atoms, it owes its antibacterial activity to the ability to bind the 50S ribosomal subunit, preventing binding to the enzyme peptidyltransferase and thus hindering the normal elongation of the nascent peptide chain.

All this takes the form of a bacteriostatic action capable of determining a prompt regression of the symptomatology in progress.

From the pharmacokinetic point of view, Spiromycin is rapidly absorbed, with a bioavailability of around 30%, and with a peak time of about 2-3 hours, promptly spreading in the various tissues and concentrating mainly in breast milk and bile.

The latter represents the main elimination route, considering that only 10% of the drug is eliminated via the kidneys.

Different studies show the great efficacy of this antibiotic in the treatment of infections of the oral cavity especially in the periodontal and gingivitis diseases and as an adjunct also of alveolar pyorrhea.

Respiratory infections, some complications of exanthematous diseases and soft tissue infections represent other pathological manifestations in which treatment with ROVAMICINA ® is required.

Studies carried out and clinical efficacy

1 THE SPIRAMICINE IN PERIODONTITUSES

Acta Odontol Latinoam. 2011; 24 (1): 115-21.

Work demonstrating how bacterial infections associated with bacterial periodontitis can regress effectively after 7 days of systemic administration of Spiramycin.

2. HEPATOTOSSICITY FROM SPIRAMYCIN AND METRONIDAZOLE

Arab J Gastroenterol. 2011 Mar; 12 (1): 44-7.

Case report demonstrating the onset of acute fulminant hepatotoxicity in two patients receiving Spiramycin and metronidazole. Only one of them was responsive to corticosteroid therapy, guaranteeing a remission of the damage.

3. THE SPIRAMICINA IN CARDIOLOGY

Georgian Med News. 2007 Sep; (150): 11-3.

Study demonstrating that oral administration of spiramycin is effective in preventing coronary artery restenosis, the main complication of percutaneous coronary intervention.

Method of use and dosage

ROVAMICINE ®

Film-coated tablets of 3 million IU Spiramycin.

The therapeutic scheme with Spiramycin generally involves the administration of 2-3 tablets of 3 million IU daily to be taken with abundant liquid.

A correction of standard dosages could be necessary in particular populations such as pediatric and senile.

Warnings ROVAMICINA ® Spiramycin

The intake of ROVAMICINA ® should be preceded by a careful medical examination aimed at evaluating the clinical picture of the patient, his physiopathological conditions and therefore the prescriptive appropriateness.

Particular caution in the use of this drug should be reserved for elderly patients or those suffering from liver and kidney diseases, with a continuous monitoring of renal and hepatic function.

Although the drug is generally safe, its use in patients with enzyme deficiency of glucose 6 phosphate dehydrogenase is not recommended, given the increased incidence of haemolytic anemia.

PREGNANCY AND BREASTFEEDING

While the use of this drug during pregnancy has long been carried out, being generally safe and therefore not contraindicated in absolute terms, it would be advisable to avoid taking it during the period of breastfeeding, given the ability of Spiramycin to concentrate in doses rather than therapeutic in breast milk.

Interactions

It should be remembered that the therapeutic action and the safety profile of Spiramycin could be compromised by the simultaneous intake of other macrolides.

Interactions with other active ingredients seem clinically irrelevant.

Contraindications ROVAMICINE ® Spiramycin

ROVAMICINE ® is contraindicated in patients who are hypersensitive to the active ingredient or to one of its excipients.

Undesirable effects - Side effects

The use of ROVAMICINA ®, above all when prolonged in time, could determine the appearance of nausea, diarrhea, vomiting, pseudomembranous colitis, headache, hypertransaminasemia, haemolysis in patients suffering from enzymatic deficiency of glucose 6 phosphate dehydrogenase and hypersensitivity reactions above all in character dermatology.