Gramicidin S Renewal (Tablets) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

R02AB30 (Gramicidin)

Active Substance

Gramicidin S (Rec.INN registered by WHO)

Dosage Form

Gramicidin S Renewal

Buccal tablets 1.5 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Buccal tablets white or white with a yellowish tint, flat-cylindrical with a bevel, with a score on one side and with or without the marking “R” on the other.

Excipients: calcium stearate – 0.0060 g, lactose (milk sugar) – 0.44169 g, sucrose (sugar) – 0.1482 g, food flavoring – 0.00198 g, sodium saccharin (soluble saccharin) – 0.00063 g.

10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; antibiotics

Pharmacological Action

An antibiotic for external and topical use. It has a bacteriostatic and bactericidal effect. It is active against Streptococcus spp. (including Streptococcus pneumoniae), Staphylococcus spp., anaerobic bacteria.

Indications

For topical use: washing, irrigation in the treatment of purulent wounds, bedsores, ulcers; osteomyelitis; empyema, complicated appendicitis; phlegmons, carbuncles, furuncles; for gargling; as part of combination therapy: superficial bacterial eye infections accompanied by severe inflammation, infected eyelid eczema, blepharitis, stye, scleritis, episcleritis, iridocyclitis, iritis, acute and chronic external otitis.

For external use: pyoderma and other pustular skin diseases.

ICD codes

Dosage Regimen

For buccal tablets, use one tablet. Place the tablet in the mouth and allow it to dissolve slowly. Do not chew or swallow the tablet whole.

Administer the tablet three to four times daily. Maintain a regular interval between doses. The maximum daily dose is eight tablets.

Continue treatment for the full prescribed duration. Do not discontinue use prematurely even if symptoms improve.

For other dosage forms, follow the specific instructions provided. Dosage is individual and depends on the indication and formulation used.

For wound irrigation, prepare a solution of 0.8 mg per 100 ml of water or isotonic sodium chloride solution. Use the solution for washing or wet dressings.

For eye infections, apply eye drops as directed. The typical regimen is one to two drops into the conjunctival sac two to three times daily.

For external otitis, instill the solution into the external auditory canal. The usual frequency is two to three times per day.

Do not use for parenteral administration. This formulation is for topical and external use only.

Adverse Reactions

Possible allergic reactions.

Contraindications

Hypersensitivity to gramicidin C, parenteral administration.

Special Precautions

With intravenous administration, hemolysis and phlebitis are possible.

In ENT practice, it can be used in combination with framycetin and dexamethasone.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.