COMPOSITION :

Each f/c tablet contains : Spiramycin Eur.P. 750.000 I.U

Metronidazole B.P. 125 mg.

DESCRIPTION :

Spiramycin is a macrolide bacteriostatic antibiotic, it has a wide spectrum of activity for the treatment of

infections caused by susceptible organisms such as Streptococcus Pyogenes, Methicillin sensitive

Staphylococcus Aureus, Chlamydia Trachomatis and Mycoplasma Pneumonia. Metronidazole , an

imidazole derivatives has marked activity against anaerobic bacteria and protozoa. Metronidazole is well

absorbed after oral administration, it is excreted with its metabolites mainly in the urine (60 - 80%) and in

the feces (6 - 15%) of the dose. It has a half-life of 8 hours. Spiramycin absorption from the

gastro-intestinal tract is irregular and is metabolized in the liver to active metabolites, substantial

amounts are excreted in the bile and 10% in the urine. It has a half-ife of 8 hours.

INDICATIONS :

- Treatment of buccodental infections such as dental abscesses, aphthous ulcers, premaxillary cellulitis,

pericoronitis, periodonitis, gingivitis and stomatitis.

- Prophylaxis of pre - and post- operative infections in buccodental surgery.

- Pharyngitis, tonsilitis, sinusitis and otitis media.

- Parotiditis and submaxilaritis.

- It is used in patients with AIDs and diarrhea caused by cryptospordium.

DOSAGE & ADMINISTRATION :

Daily dose should be taken during meals as follow :

Adults : 2 tablets twice to three times daily.

children 10 to 15 years : 1 tablet three times daily.

5 to 10 years : 1 tablet twice daily.

RESTRICTIONS ON USE :

Contraindications

Hypersensitivity to Metronidazole or spiramycin.

Precautions

- Patients with blood dyscrasias or with active diseases of the central nervous system or liver

impairment.

- Consumption of alcoholic drinks during treatment should be avoided.

- Consult your doctor in case of ataxia or vertigo.

Use in pregnancy and lactation

Spirazine should be avoided in pregnancy especially during the first trimester and during lactation.

DRUG INTERACTIONS :

- Concomitant administration of Spirazine with sulfiram, ethanol, lithium, barbiturates, cimetidine,

ergotamine.

- The effect of oral anticoagulant ( e.g. warfarin ) is enhanced when adminstered with Spirazine,

so the dosage of warfarin should be adjusted.

- Spirazine may increase serum theophylline concentration.

ADVERSE EFFECTS :

- Gastrointestinal disturbances as nausea , vomiting and diarrhea.

- Rare cases of skin rash, vertigo, ataxia and leukopenia.

STORAGE INSTRUCTIONS:

Tablets : Store below 30oC, in a dry place.

PRESENTATION :

Spirazine Tablet : pack of 20 film coated tablets and hospital packs of different sizes