📌 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 derivative, 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 faeces (6-15%) of the dose. It has a half‑life of 8 hours. Spiramycin absorption from the gastrointestinal tract is irregular and is metabolised in the liver to active metabolites; substantial amounts are excreted in the bile and 10% in the urine. It has a half‑life 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, tonsillitis, sinusitis and otitis media.
• Parotiditis and submaxillaritis.
• It is used in patients with AIDS and diarrhoea caused by Cryptosporidium.

📌 DOSAGE & ADMINISTRATION

The daily dose should be taken during meals as follows:

• Adults: 2 tablets twice to three times daily.
• Children 10 to 15 years: 1 tablet three times daily.
• Children 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 hepatic 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 anticoagulants (e.g., warfarin) is enhanced when administered with Spirazine, so the dosage of warfarin should be adjusted.
• Spirazine may increase serum theophylline concentration.

📌 ADVERSE EFFECTS

• Gastrointestinal disturbances such as nausea, vomiting and diarrhoea.
• Rare cases of skin rash, vertigo, ataxia and leukopenia.

📌 STORAGE INSTRUCTIONS

Tablets: Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Spirazine Tablets: Pack of 20 film‑coated tablets and hospital packs of different sizes.