Benzocaine (Suppositories) Instructions for Use

Marketing Authorization Holder

Avva Rus, JSC (Russia)

ATC Code

C05AD03 (Benzocaine)

Active Substance

Benzocaine (Rec.INN registered by WHO)

Dosage Form

Benzocaine

Rectal suppositories 206 mg

Dosage Form, Packaging, and Composition

Rectal suppositories

3 pcs. – contour cell packaging (2 pcs.) – cardboard packs (6 pcs.) – Over-the-Counter
3 pcs. – contour cell packaging (4 pcs.) – cardboard packs (12 pcs.) – Over-the-Counter
5 pcs. – contour cell packaging (2 pcs.) – cardboard packs (10 pcs.) – Over-the-Counter
6 pcs. – contour cell packaging – cardboard packs (6 pcs.) – Over-the-Counter
6 pcs. – contour cell packaging (2 pcs.) – cardboard packs (12 pcs.) – Over-the-Counter

Clinical-Pharmacological Group

A drug with anti-inflammatory, wound-healing, and local anesthetic effects for local use in proctology

Pharmacotherapeutic Group

Angioprotectors; agents for the treatment of hemorrhoids and anal fissures for topical use; local anesthetics

Pharmacological Action

A local anesthetic for superficial anesthesia. It prevents the occurrence of pain sensations in the endings of sensory nerves and the conduction of pain impulses along nerve fibers.

It does not have a resorptive effect.

When applied to the oral mucosa, the effect develops within 1 minute.

It is believed that when taken orally, Benzocaine has an anorexigenic effect, which may be due to its effect on the gastrointestinal mucosa.

Pharmacokinetics

Benzocaine is poorly soluble in water, which causes its slow absorption. Like all ester derivatives of para-aminobenzoic acid, it is cleaved by esterase in blood plasma and the liver.

As a result, para-aminobenzoic acid and ethyl alcohol are formed, the latter being metabolized to acetyl coenzyme A. Para-aminobenzoic acid undergoes conjugation with glycine or is excreted by the kidneys unchanged.

Indications

As part of combination therapy for oral administration: anesthesia of mucous membranes during spasms and pain in the stomach (including peptic ulcer disease); hypersensitivity of the esophagus.

As part of combination therapy for external and topical use: pain in superficial lesions of the skin and mucous membranes, in myositis, diseases of superficial veins, hemorrhoids, and perianal fissures.

ICD codes

Dosage Regimen

For rectal administration only.

Adults and children over 12 years: administer one suppository (206 mg) into the rectum after bowel movements.

Use up to 3 times daily or as directed by a physician.

The maximum daily dosage is 3 suppositories (618 mg of Benzocaine).

Duration of treatment should not exceed 7-10 days without medical supervision.

For severe acute pain, use only as a short-term measure until a physician consultation.

Discontinue use and consult a physician if symptoms persist or worsen.

Do not exceed the recommended dosage.

Adverse Reactions

Possible allergic reactions.

Contraindications

Hypersensitivity to benzocaine.

Special Precautions

The correspondence of the used dosage form to the indications for use should be observed.

Drug Interactions

With simultaneous use with analgesic-antipyretics, cholinesterase inhibitors, the effect of benzocaine is enhanced.

With simultaneous use with benzocaine, the antibacterial activity of sulfonamides is reduced.

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.