Guttalax - drops of 15 ml, laxative, anti- constipation

Transparent, colorless to yellowish or slightly yellowish brown, slightly viscous solution.

Pharmacodynamics

The active ingredient, sodium picosulfate, is a laxative of the triarylmethane group.

As a local laxative, sodium picosulfate, after bacterial breakdown in the large intestine, has a stimulating effect on the mucous membrane of the large intestine, increasing peristalsis, promotes the accumulation of water and electrolytes in the large intestine.

This leads to the stimulation of the act of defecation, a decrease in the evacuation time and softening of the stool.

Sodium picosulfate, as a laxative at the level of the colon, stimulates the natural process of evacuation of contents from the lower gastrointestinal tract.

Therefore, sodium picosulfate has no effect on the digestion or absorption of high-calorie foods or essential nutrients in the small intestine.

In a randomized, double-blind, parallel group study of 367 patients with chronic constipation, the effect of Guttalax® was investigated.

The study results showed a significant increase in intestinal motility during the week compared with placebo for all four weeks of therapy (p < 0.0001).

Serum potassium levels were unchanged at the end of the study (4.4 mM) and corresponded to the physiological norm (3.6-5.3 mM).

Pharmacokinetics

Absorption and distribution

After oral administration of sodium, picosulfate enters the colon without significant absorption.

Thus, enterohepatic circulation of the drug is excluded.

Biotransformation

In the distal colon, sodium picosulfate is degraded by bacteria to form an active metabolite of bis- (p-hydroxyphenyl) -pyridyl-2-methane (BHPM), which has a laxative effect.

Withdrawal

After cleavage, a small amount of BGPM is absorbed and then almost completely binds in the intestinal wall and liver with the formation of an inactive glucuronide.

After oral administration of sodium picosulfate in a dose of 10 mg (about 10.4% of the total dose), the drug is excreted in the urine as BGPM-glucuronide after 48 hours.

With the use of sodium picosulfate in higher doses, its excretion by the kidneys decreases.

Name ENG

GUTTALAX

Clinical and pharmacological group

Laxative drug that stimulates intestinal motility

ATX code

A06AB08

Dosage

sodium picosulfate monohydrate 0.75 g

Structure

100 ml of the preparation contains:

Active substance: sodium picosulfate monohydrate 0.75 g

Excipients: sodium benzoate 0.20 g

sodium citrate dihydrate 0.15 g

sorbitol liquid (non-crystallizing) 64.37 g

citric acid monohydrate

0.14 g

purified water 49.89 g

Indications

As a laxative in the following cases:

- constipation due to atony and hypotension of the colon (including in the elderly

age, in bedridden patients, after surgery, after childbirth and during lactation)

- constipation caused by taking medications

- to regulate stool with hemorrhoids, proctitis, anal fissures (to soften

stool consistency)

- diseases of the gallbladder, irritable bowel syndrome with a predominance

constipation

- constipation due to intestinal dysbiosis, diet disorders.

Storage conditions and periods

At a temperature not exceeding 30 degrees. (Do not freeze).

Expiration date: 3 years

Contraindications

Intestinal obstruction or obstructive bowel disease

- acute diseases of the abdominal organs or severe pain in the abdomen,

which may be accompanied by nausea, vomiting, fever,

including appendicitis

- acute inflammatory bowel disease

- hypersensitivity to sodium picosulfate or other components

drug

- severe dehydration

- fructose intolerance.

INN / Active ingredient

sodium picosulfate monohydrate

Specifications

Category

Laxatives

Scope of the medicinal product

Gastrointestinal tract

Release form

Drops

Manufacturer country

Italy

Package quantity, pcs

one

Minimum age from

No restrictions

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Volume, ml.

15 ml

Brand name

Sanofi

The amount of the dosage form in the primary package

15 ml

Primary packaging type

Dropper bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Laxative

Anatomical and therapeutic characteristics

A06AB08 Sodium picosulfate

Dosage form

Drops for oral administration

The target audience

Children

Dosage (volume) of the substance in the preparation

5 mg

Expiration date in days

1095

Package weight, g

thirty

Mode of application

:

Guttalax is taken orally, before bedtime.

For adults, the initial dose is 10 drops, for severe and persistent constipation - up to 30 drops.

For children over 4 years old, the initial dose is 5-10 drops.

Depending on the effect obtained, the dose is increased or decreased with subsequent doses.

Information on technical characteristics, delivery set, country of manufacture