Proctostesol (Suppositories) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

C05AD03 (Benzocaine)

Dosage Form

Proctostesol

Rectal suppositories: 4, 5, 6, 8, 10, or 12 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories of yellow or greenish-yellow color, torpedo-shaped.

Excipients: macrogol 1500 (polyethylene oxide 1500) – 95%, macrogol 400 – 5%.

4 pcs. – contour cell packs (1) – cardboard packs.
4 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory, astringent, drying, and local anesthetic action for topical use in proctology

Pharmacotherapeutic Group

Hemorrhoid treatment agent

Pharmacological Action

A combined medicinal product that has a local anesthetic, antiseptic, astringent, and drying effect.

Pharmacokinetics

Benzocaine, Zinc oxide are practically not absorbed.

Bismuth subgallate – absorption is insignificant. Elimination of the absorbed portion is mainly by the kidneys, but a certain amount can be retained in the bones and tissues (capable of accumulating, causing an intoxication syndrome).

Bismuth penetrates the placental barrier.

Indications

• For the symptomatic relief and management of hemorrhoids.
• For the treatment of anal fissures.

ICD codes

Dosage Regimen

Administer rectally after a cleansing enema or spontaneous bowel movement.

The standard dosage is one suppository inserted into the anal canal. Apply once or twice daily as directed by a physician.

Ensure thorough hand hygiene before and after the application procedure.

Adverse Reactions

Local reactions may include a transient burning sensation in the anus or a laxative effect.

Systemic reactions are rare but can manifest as allergic reactions, including skin rash, itching, or urticaria.

Discontinue use immediately and consult a physician if any signs of a hypersensitivity reaction occur.

Drug Interactions

Formal studies of drug interactions have not been conducted.

Exercise caution with concurrent use of other local anesthetics, as the effects may be additive.

Avoid concomitant use with sulfonamides, as benzocaine may antagonize their antibacterial action.

Contraindications

• Hypersensitivity to benzocaine, other ester-type local anesthetics, bismuth subgallate, zinc oxide, levomenthol, or any of the excipients.
• Do not use in patients with a known history of methemoglobinemia.

Overdose

Systemic absorption is low with rectal use, making overdose unlikely.

Excessive use could theoretically lead to systemic effects of bismuth, including neurotoxicity.

In case of suspected overdose, discontinue treatment immediately and initiate symptomatic and supportive measures.

Use in Pregnancy and Lactation

The use of the medicinal product during pregnancy and breastfeeding is possible if the potential benefit to the mother outweighs the risk to the child and fetus.

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.