Docusate sodium (Gel) Instructions for Use

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

ATC Code

A06AG10 (Sodium docusate, including combination preparations)

Active Substance

Docusate sodium

Dosage Form

Docusate sodium

Rectal gel 120 mg: microenemas 4 or 6 pcs.

Dosage Form, Packaging, and Composition

Rectal gel colorless, transparent or slightly opalescent liquid gel.

Excipients: hyetellose, glycerol, purified water.

10 g – microenemas (4) – carton packs.
10 g – microenemas (6) – carton packs.

Clinical-Pharmacological Group

Laxative drug

Pharmacotherapeutic Group

Drugs for the treatment of constipation; laxatives in enemas

Pharmacological Action

Laxative agent, anionic surfactant. It is believed that its action is mainly associated with the ability to increase the penetration of fluid into the fecal masses, which leads to their softening and facilitates evacuation.

Indications

Symptomatic treatment of constipation, preparation for endoscopic examination of the lower colon.

ICD codes

Dosage Regimen

For rectal administration only using the provided microenema.

For adult patients with constipation, administer one 120 mg microenema rectally, once daily.

For pre-procedure bowel preparation before endoscopic examination, administer one 120 mg microenema as directed by the physician, typically on the day of the procedure.

Do not use for more than one week unless directed by a doctor.

For oral administration using other dosage forms, the typical adult daily dose is 300-500 mg in divided doses.

The typical pediatric oral daily dose is 150 mg in divided doses; use only age-appropriate formulations.

The typical rectal dose for other formulations is 50-120 mg per day.

Adverse Reactions

When taken orally rarely – diarrhea, nausea, abdominal cramps, skin rash, abdominal pain, throat irritation.

With rectal use burning in the rectum; with long-term treatment rarely – congestive phenomena in the rectum.

Contraindications

Intestinal obstruction, abdominal pain of unclear etiology, hemorrhoids in the acute phase, anal fissure, hemorrhagic proctitis and colitis.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

Use with caution in children – according to indications, in age-appropriate recommended doses and dosage forms.

Special Precautions

Not intended for long-term use. Should not be used together with liquid paraffin.

May be used as part of an antiseptic solution for topical application in combination with chlorhexidine digluconate, chlorobutanol, chloroform.

Drug Interactions

When taken orally simultaneously, Docusate sodium facilitates the absorption from the gastrointestinal tract of other drugs, which may lead to an increase in their activity and, possibly, toxic effects.

With simultaneous use with acetylsalicylic acid, the frequency of development of gastrointestinal side effects of acetylsalicylic acid increases.

Dantron, liquid paraffin – increased absorption, risk of toxic effects, liver damage with repeated doses, do not take together.

Potassium-sparing diuretics, potassium preparations – antagonism of action.

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.