Proctosedyl^® (Ointment) Instructions for Use

Marketing Authorization Holder

Sanofi India, Limited (India)

Manufactured By

Encube Ethicals, Pvt. Ltd. (India)

ATC Code

C05AX03 (Preparations for the treatment of hemorrhoids and anal fissures in combination)

Dosage Form

Proctosedyl®

Ointment for topical use: 10 g tube with applicator cannula

Dosage Form, Packaging, and Composition

Ointment for topical use as an almost white mass with a greenish-yellowish tint.

Excipients: cholesterol, liquid paraffin, white soft paraffin, polysorbate 80, propylene glycol, macrogol (polyethylene glycol) 400, macrogol (polyethylene glycol) 4000, macrogol (polyethylene glycol) 1540.

10 g – aluminum tubes (1) with a plastic applicator nozzle (applicator cannula) – cardboard packs.

Clinical-Pharmacological Group

Drug with anti-inflammatory, antibacterial, antithrombotic and local anesthetic action for topical use in proctology

Pharmacotherapeutic Group

Antihemorrhoidal agent

Pharmacological Action

A combined drug for the treatment of hemorrhoids and other diseases of the anorectal area.

Hydrocortisone is a glucocorticoid that has an anti-inflammatory effect. It eliminates the signs and symptoms of inflammation, such as redness, swelling, pain, and others.

Framycetin sulfate is a broad-spectrum antibiotic for topical use from the aminoglycoside group. Framycetin is produced by some species of streptomycetes and was first isolated from Streptomyces lavendulae. In vitro experiments have shown that framycetin, like other aminoglycosides, affects protein synthesis by specific and irreversible inhibition of the 30S subunits of bacterial ribosomes, leading to misreading of mRNA, which is why framycetin has bactericidal activity against a number of gram-negative microorganisms (Escherichia coli, Klebsiella pneumoniae, Aerobacter spp., Salmonella typhimurium, Salmonella paratyphi B, Shigella spp., Pasteurella multocida, Brucella spp., Proteus spp. (including Proteus vulgaris), Pseudomonas spp. (including Pseudomonas aeruginosa), Serratia marcescens, Alcaligenes spp. and Bacillus subtilis), as well as gram-positive cocci (Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus faecalis, Streptococcus pneumoniae), with streptococci being less sensitive to framycetin. Framycetin does not act on pathogenic fungi, viruses, or anaerobic flora. Clinical studies have shown the slow development of microbial resistance to framycetin sulfate.

Heparin sodium (heparin sodium salt) is an anticoagulant. It prevents thrombotic complications of hemorrhoids.

Esculoside is a substance similar in its chemical structure to rutoside; it reduces increased capillary fragility.

Benzocaine and Butamben have a local anesthetic and antipruritic effect, reducing spasm of the anal sphincter.

The effect of the drug appears a few minutes after application.

Pharmacokinetics

Pharmacokinetic data for the drug are not provided.

Indications

• Internal and external hemorrhoids (acute and chronic);
• Prevention of recurrence of internal and external hemorrhoids;
• Perianal eczema;
• Proctitis;
• Acute and chronic anal fissures;
• Preoperative and postoperative treatment of patients with hemorrhoids;
• Postpartum hemorrhoids.

ICD codes

Dosage Regimen

For external use. A small amount of the ointment should be applied with a finger to the areas of itching or pain in the morning and evening, as well as after each bowel movement.

For deeper introduction into the rectum, the applicator should be attached to the tube with the ointment, inserted into the rectum, ensuring it is inserted deep enough into the rectum, and then, gently pressing the tube from the bottom end, introduce the ointment into the rectum, gradually withdrawing the applicator.

The ointment can be used alone or in combination with Proctosedyl^® M rectal capsules.

Proctosedyl^® is used for a short time (no more than 7 days).

Adverse Reactions

Local reactions: feeling of discomfort in the rectal area, burning in the rectum, dryness of the rectal mucosa.

Other: addition of a secondary infection, allergic reactions and other hypersensitivity reactions.

When using the drug in high doses and for a long time, there is a risk of systemic side effects associated with the presence of hydrocortisone in the drug composition.

Contraindications

• Tuberculous, viral, fungal lesions of the anorectal zone;
• Pregnancy;
• Lactation period (breastfeeding);
• Childhood (due to lack of clinical data on the use of the drug).
• Hypersensitivity to the components of the drug;

With caution, the drug should be used in patients with arterial hypertension, heart failure.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

The use of the drug is contraindicated in childhood (due to lack of clinical data).

Special Precautions

The drug should not be used after the expiration date.

Overdose

Overdose data are not provided.

Drug Interactions

Drug interaction data for Proctosedyl^® are not provided.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.