Dulcolax tab. p / o ksh / sol. 5mg No. 30

Release form, composition and packaging

Enteric-coated tablets of beige-yellow color, round, biconvex, with an even, smooth, shiny surface and a white core.

1 tab.

bisacodyl 5 mg

corn starch - 8.3 mg, glycerol 85% - 0.2 mg, soluble corn starch - 1.5 mg, lactose - 34.9 mg, magnesium stearate - 0.1 mg.

The composition of the enteric coating: sucrose - 23.3819 mg, talc - 16.1608 mg, acacia gum - 1.9354 mg, titanium dioxide - 0.3995 mg, copolymer of methacrylic acid and methyl methacrylate (1: 2) (Eudragit S100) - 2.2147 mg, copolymer of methacrylic acid (methyl methacrylate) 1: 1) (Eudragit L100) - 0.9866 mg, castor bean seed oil (castor oil) - 0.9762 mg, magnesium stearate - 3.8225 mg, macrogol (polyethylene glycol) 6000 - 0.0462 mg, iron dye yellow oxide (E172) - 0.0657 mg, white beeswax - 0.0015 mg, carnauba wax - 0.003 mg, shellac - 0.006 mg.

10 pieces.

- blisters (3) - cardboard packs.

pharmachologic effect

Laxative drug derived from diphenylmethane.

As a local laxative with an antiresorptive effect, bisacodyl, after hydrolysis in the colon, increases the secretion of water and electrolytes in the colon, accelerates and increases its peristalsis.

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

The time for the development of the laxative effect of the drug is 6-12 hours.

Bisacodyl, as a laxative at the level of the colon, stimulates the natural evacuation process in the lower gastrointestinal tract.

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

Pharmacokinetics

Absorption and distribution

Absorption is negligible.

Enteric-coated tablets are resistant to the action of gastrointestinal juice.

Bisacodyl is released in the colon to form the active metabolite, bis- (p-hydroxyphenyl) -pyridyl-2-methane, which is irritating to the colon mucosa.

Cmax of the active metabolite in plasma after taking the drug is achieved after 4-10 hours, the laxative effect develops after 6-12 hours. There is no relationship between the laxative effect of bisacodyl and the concentration of the active metabolite in plasma.

Metabolism and excretion

The drug is almost completely metabolized in the intestinal wall and liver to inactive glucuronide.

Metabolism occurs under the action of enzymes in the mucous membrane of the large intestine.

T1 / 2 is about 16.5 hours. The active metabolite is excreted mainly in the feces (up to 51.8%), about 10.5% is excreted in the urine.

Indications for use

As a laxative in the following cases:

- constipation caused by hypotension of the colon (including chronic)

- preoperative preparation, postoperative treatment

- preparation for instrumental and X-ray examinations

- medical conditions requiring relief of bowel movements.

Contraindications for use

- intestinal obstruction

- obstructive bowel disease

- acute diseases of the abdominal organs, including appendicitis

- acute inflammatory bowel disease

- severe abdominal pain associated with nausea and vomiting, which may be a symptom of a more severe condition

- severe dehydration

- children under 4 years old

- hypersensitivity to bisacodyl or excipients.

One tablet (5 mg) contains 33.2 mg of lactose.

The maximum recommended daily dose of tablets for adults and children over 10 years of age for the treatment of constipation and for x-ray examination contains 66.4 mg and 132.8 mg of lactose, respectively.

Patients with rare hereditary galactose intolerance, for example, ha

Name ENG

DULCOLAX

Clinical and pharmacological group

Laxative drug that stimulates intestinal peristalsis

ATX code

Bisacodyl

Dosage

5mg

Structure

Active ingredients: bisacodyl 5 mg.

Excipients: corn starch - 8.3 mg, glycerol 85% - 0.2 mg, soluble corn starch - 1.5 mg, lactose - 34.9 mg, magnesium stearate - 0.1 mg.

The composition of the enteric shell: sucrose - 23.3819 mg, talc - 16.1608 mg, acacia gum - 1.9354 mg, titanium dioxide - 0.3995 mg, copolymer of methacrylic acid and methyl methacrylate (1: 2) (Eudragit S100) - 2 , 2147 mg, copolymer of methacrylic acid and methyl methacrylate (1: 1) (Eudragit L100) - 0.9866 mg, castor bean seed oil (castor oil) - 0.9762 mg, magnesium stearate - 3.8225 mg, macrogol (polyethylene glycol) 6000 - 0.0462 mg, iron dye yellow oxide (E172) - 0.0657 mg, white beeswax - 0.0015 mg, carnauba wax - 0.003 mg, shellac - 0.006 mg.

Indications

As a laxative in the following cases: - constipation caused by hypotension of the large intestine (including chronic), - preoperative preparation, postoperative treatment, preparation for instrumental and X-ray examinations, medical conditions requiring easier bowel movements.

Contraindications

Hypersensitivity to bisacodyl or excipients

intestinal obstruction

obstructive bowel disease

acute diseases of the abdominal organs, including appendicitis

acute inflammatory bowel disease

severe abdominal pain associated with nausea and vomiting, which may be a symptom of a more severe condition

severe dehydration

children under 4 years of age

one tablet (5 mg) contains 33.2 mg of lactose.

The maximum recommended daily dose of tablets for adults and children over 10 years of age for the treatment of constipation and for x-ray examination contains 66.4 mg and 132.8 mg of lactose, respectively.

Patients with rare hereditary galactose intolerance, such as galactosemia, should not take the drug

one tablet (5 mg) contains 23.4 mg of sucrose.

The maximum recommended daily dose of tablets for adults and children over 10 years of age for the treatment of constipation and for X-ray examination contains 46.8 mg and 93.6 mg of sucrose, respectively.

Patients with rare hereditary fructose intolerance should not take the drug.

With caution: the drug should be prescribed to patients with hepatic and / or renal insufficiency.

Storage conditions and periods

In a dry place, at a temperature not exceeding 25 degrees.

Expiration date: 3 years

INN / Active ingredient

bisacodyl

Specifications

Category

Preparations for the gastrointestinal tract

Scope of the drug

General

Release form

Tablet

Manufacturer country

France

Package quantity, pcs

thirty

Scope of application

Gastroenterology

Minimum age from

4 years old

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Boehringer ingelheim

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Laxative

Anatomical and therapeutic characteristics

A06AB02 Bisacodyl

Dosage form

Enteric-coated tablets

Dosage (volume) of the substance in the preparation

bisacodyl 5 mg

Expiration date in days

1095

The target audience

Children

Package weight, g

40

Mode of application

:

The tablets are taken orally with plenty of liquid.

For constipation, adults and children over 10 years old are prescribed 1-2 tablets.

(5-10 mg).

It is recommended to start with the lowest dose.

In order to achieve regular bowel movements, the dose may be increased to the maximum recommended (10 mg).

Do not exceed the maximum recommended daily dose.

Children aged 4-10 years old - 1 tab.

(With 5 mg).

Do not exceed the maximum recommended daily dose (5 mg).

To obtain a laxative effect in the morning, it is recommended to take the drug the night before.

Information on technical characteristics, delivery set, country of manufacture