Guttalax - drops 30 ml, laxative, anti- constipation

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SKU
FL102010352
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Dosage:

7.5mg / ml x 15ml

7.5mg / ml x 30ml

sodium picosulfate monohydrate 0.75 g

Release form:

Drops

Tablet

Category

Laxatives

Scope of the medicinal product

Gastrointestinal tract

Release form

Drops

Manufacturer country

Italy

Package quantity, pcs

one

Description

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 GuttalaxВ® 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.

INN / Active ingredient

sodium picosulfate

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

- lactase deficiency, lactose intolerance, glucose-galactose malabsorption

- children under 4 years old.

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.

30 ml

Brand name

Istituto de Angeli Srl

The amount of the dosage form in the primary package

30 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

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

750 mg

Package weight, g

fifty

Mode of application

:

The medication is taken before bedtime, inside.

What is the scheme for drinking Guttalax drops?

Instructions for use recommend starting treatment with 10 drops, followed by an increase in the dose in the absence of the expected therapeutic effect. < br> < br> With persistent, severe constipation, a single dosage of the medication can be increased to 30 drops. < br> < br> How to take Guttalax in drops: dilute the required amount of medication in warm water, apply inside.

Information on technical characteristics, delivery set, country of manufacture

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