Solirekt^® (Solution) Instructions for Use

Marketing Authorization Holder

Endocrine Technologies, LLC (Russia)

Manufactured By

Moscow Endocrine Plant FSUE (Russia)

ATC Code

A06AG11 (Lauryl sulfate, including combination preparations)

Active Substances

Sorbitol (BP British Pharmacopoeia)

Sodium citrate (Ph.Eur. European Pharmacopoeia)

Sodium lauryl sulfoacetate (Grouping name)

Dosage Form

Solirekt®

Rectal solution 9 mg+90 mg+625 mg/1 ml: microclysters 5 ml 4 or 12 pcs.

Dosage Form, Packaging, and Composition

Rectal solution as a viscous, opalescent liquid from colorless to almost white; the presence of air bubbles is allowed.

Excipients: glycerol (distilled glycerin) – 125 mg, sorbic acid – 1 mg, purified water – up to 1 ml.

5 ml – single-use microclysters (4) – cardboard packs.
5 ml – single-use microclysters (12) – cardboard packs.

Clinical-Pharmacological Group

Laxative drug

Pharmacotherapeutic Group

Laxative

Pharmacological Action

A combined medicinal product that has a laxative effect.

Sodium lauryl sulfoacetate liquefies the intestinal contents.

Sodium citrate is a peptizing agent that displaces bound water contained in the feces.

Sorbitol enhances the laxative effect by stimulating the influx of water into the intestine.

The increase in water content due to peptization and liquefaction helps to soften the feces and facilitates bowel evacuation.

The effect occurs within 5-15 minutes.

Indications

Constipation (including with encopresis); preparation for endoscopic (rectoscopy) and radiological examination of the gastrointestinal tract.

ICD codes

Dosage Regimen

Administer rectally as a microclyster.

Use a single 5 ml unit per application.

For constipation in adults and adolescents over 12 years, use once daily as needed.

For preparation for diagnostic procedures (rectoscopy, radiological examination), use one unit on the morning of the examination.

Do not use for more than 5 consecutive days without medical consultation.

Remove the protective tip cover immediately before use.

Gently insert the applicator tip completely into the rectum.

Squeeze the container firmly to expel the entire contents.

Withdraw the applicator while maintaining pressure on the container.

Dispose of the used unit appropriately.

The laxative effect typically occurs within 5 to 15 minutes.

For pediatric patients under 12 years, use only under medical supervision with appropriate dosage adjustment.

Adverse Reactions

From the digestive system very rarely – abdominal pain (including abdominal discomfort, upper abdominal pain), anorectal discomfort, loose stools.

From the immune system very rarely – hypersensitivity reactions (e.g., urticaria).

Contraindications

Increased individual sensitivity to the components of the combination; intestinal obstruction and abdominal pain of unknown etiology; simultaneous oral/rectal use of sodium/calcium polystyrene sulfonate.

With caution

It is recommended to avoid the use of this medicinal product in case of exacerbation of hemorrhoids, anal fissures, or hemorrhagic rectocolitis.

Special precautions should be observed when used in patients with inflammatory or ulcerative diseases of the colon or with acute gastrointestinal diseases.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies in pregnant women have not been conducted. Since the components of the combination are probably absorbed into the systemic circulation to an insignificant extent, no adverse effects on the fetus or breastfed infant are expected when used as recommended during pregnancy or lactation.

Special Precautions

Long-term use should be avoided; if symptoms persist, the patient should consult a doctor.

Drug Interactions

There is a risk of developing colon necrosis with the simultaneous oral/rectal use of sodium polystyrene sulfonate and sorbitol, which is part of this combination.

If it is necessary to use other rectal drugs, an interval between their use should be observed.

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.