Lavacole^® (Powder) Instructions for Use

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

Contact Information

MOSCOW PHARMACEUTICAL FACTORY CJSC (Russia)

ATC Code

A06AD15 (Macrogol)

Active Substance

Macrogol (Rec.INN registered by WHO)

Dosage Form

Lavacole®

Powder for oral solution 12 g: sachet 15 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of oral solution white or white with a yellowish or grayish tint; the prepared solution is a colorless or slightly colored liquid, slight opalescence is allowed.

Excipients: sodium sulfate – 1 g, sodium bicarbonate – 0.6 g, sodium chloride – 0.2 g, potassium chloride – 0.2 g.

14 g – thermowelded sachets made of combined material (15) – cardboard packs.

Clinical-Pharmacological Group

Laxative drug with osmotic properties

Pharmacotherapeutic Group

Drugs for the treatment of constipation; osmotic laxatives

Pharmacological Action

Osmotic laxative. A high-molecular-weight substance representing long linear polymers capable of retaining water molecules through hydrogen bonds.

It increases osmotic pressure and the volume of fluid in the intestine, enhancing peristalsis. It increases the volume of chyme and prevents the loss of electrolytes with feces. It restores the evacuation reflex and does not change the pH of the chyme.

The action of the drug is based on the combination of a high-molecular polymer with an isotonic electrolyte solution. Macrogol prevents the absorption of water from the stomach and intestines and promotes accelerated evacuation of intestinal contents through frequent defecation.

The electrolytes contained in the drug prevent disruption of the body’s water-electrolyte balance.

Pharmacokinetics

Pharmacokinetic studies confirm the absence of absorption and metabolism of macrogol when taken orally.

Indications

• Preparation for endoscopic or radiological examination of the colon, as well as for surgical interventions requiring the absence of contents in the intestine;
• Symptomatic treatment of constipation in adults.

ICD codes

Dosage Regimen

The drug is taken orally. The drug can only be used in adult patients.

Preparation for endoscopic or radiological examination of the colon, as well as for surgical interventions

The drug is taken on an empty stomach. The contents of the sachet (14 g) are dissolved in 200-250 ml of water immediately before use.

If the procedure (examination or surgical intervention) is scheduled for the first half of the day (before 12:00), the solution should be taken the evening before – based on 15 sachets (approximately 200-250 ml each) at 20-minute intervals. The recommended hours for taking the drug are from 17:00 to 22:00.

If the procedure is scheduled for the second half of the day (after 12:00), the intake of the solution should be divided into 2 stages (the evening before, the patient takes the solution based on 10 sachets and 5 sachets in the morning). The recommended hours for intake: the evening before the procedure from 19:00 to 22:00 (10 sachets), in the morning before the procedure from 6:00 to 9:00 (5 sachets).

Intake of the drug must be completed 3-4 hours before the procedure. During and after intake, only liquid food is consumed. Food intake is not indicated after 22:00.

Symptomatic treatment of constipation in adults

The contents of each sachet should be dissolved in a glass of water immediately before intake. 1 sachet in the morning or 1 sachet in the morning and 1 sachet in the evening in case of taking 2 sachets per day. The daily dose should be adjusted according to the clinical effect and can vary from 1 sachet every day to 2 sachets per day.

The effect of the drug intake is pronounced within 24-48 hours after its intake. The recommended course of treatment is 1 month.

Maintenance of the effect after restoration of normal bowel function should be carried out through an active lifestyle and a diet rich in plant fiber. If constipation symptoms persist for more than 1 month, a repeated extended diagnostic examination is necessary.

Adverse Reactions

From the digestive system sensation of stretching of the anterior abdominal wall, abdominal pain, nausea, diarrhea, vomiting, strong urge to defecate, fecal incontinence, irritation of the perianal area, flatulence.

Allergic reactions urticaria, skin itching, skin rash, facial swelling, angioedema, anaphylactic shock, fulminant and acute pulmonary edema.

If any of the side effects mentioned in the instructions worsen or any other side effects not mentioned in the instructions are noted, the patient should inform the doctor.

Contraindications

• Hypersensitivity to macrogol or any of the excipients included in the drug;
• Dehydration;
• Chronic heart failure;
• Gastric ulcer;
• Intestinal obstruction;
• Perforation or risk of intestinal wall perforation;
• Severe inflammatory bowel diseases;
• Impaired gastric emptying (including gastroparesis);
• Age under 18 years (efficacy and safety not established).

With caution ulcerative colitis, patients with impaired swallowing reflex, reflux esophagitis, depressed consciousness, impaired renal function, tendency to develop water-electrolyte imbalance, neurological disorders, impaired motor functions, tendency to aspiration, pregnancy, elderly age.

Use in Pregnancy and Lactation

Use of the drug during pregnancy is possible if the expected benefit to the mother outweighs the potential risk to the fetus (due to insufficient data to assess the effect of macrogol on the fetus).

Since Macrogol is not absorbed from the gastrointestinal tract, use of the drug during breastfeeding is possible in consultation with the attending physician.

Use in Renal Impairment

The drug should be used with caution in case of impaired renal function.

Pediatric Use

Use of the drug is contraindicated under the age of 18 years (efficacy and safety not established).

Geriatric Use

The drug should be used with caution in elderly patients.

Special Precautions

Elderly patients with various concomitant diseases are recommended to use the drug under medical supervision.

The patient should be warned about the need to inform the doctor about all concurrently used drugs.

In case of diarrhea development, special control and monitoring of blood electrolyte composition is necessary in patients prone to developing electrolyte disturbances.

It is recommended to use the drug with caution in patients with ulcerative colitis due to the high risk of perforation.

Influence on the ability to drive vehicles and mechanisms

Considering the possibility of adverse reactions, caution should be exercised when driving vehicles and working with mechanisms.

Overdose

Exceeding the dose may lead to disruption of water-electrolyte balance, development of diarrhea, which, as a rule, stops on its own within 1-2 days after discontinuation of the drug.

Drug Interactions

Diarrhea caused by the use of the drug Lavacole^® may lead to impaired absorption of other concurrently taken medicines. In case of simultaneous use of the drug Lavacole^® with other medicines, it is recommended to administer it 2 hours after their intake.

Concomitant use of macrogol and digoxin leads to a decrease in the degree of absorption of the latter in the intestine.

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 – 5 years.

Dispensing Status

The drug is available without a prescription.

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.