Mikrolax solution for rectal administration 5 ml, microclysters # 4

Release form, composition and packaging

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Solution for rectal administration is colorless, opalescent, viscous.

1 ml

sodium citrate 90 mg

sodium lauryl sulfoacetate 70% 12.9 mg,

which corresponds to the content of sodium lauryl sulfoacetate 9 mg

sorbitol solution 70% 893 mg,

which corresponds to the content of sorbitol 625 mg

sorbic acid - 1 mg, glycerol - 125 mg, purified water - up to 1 ml.

5 ml - microclysters for single use (polyethylene tubes with a tip and a breakable seal) (4) - cardboard packs.

5 ml - microclysters for single use (polyethylene tubes with a tip and a breakable seal) (12) - cardboard packs.

pharmachologic effect

Combined drug with a laxative effect.

The preparation contains sodium citrate (a peptizing agent that displaces bound water contained in feces), sodium lauryl sulfoacetate (dilutes the contents of the intestine) and sorbitol (enhances the laxative effect by stimulating the flow of water into the intestine).

An increase in the amount of water due to peptization and liquefaction promotes softening of feces and facilitates bowel movement.

The laxative effect occurs within 5-15 minutes after taking the drug.

Pharmacokinetics

Data on the pharmacokinetics of MicrolaxВ® are not available.

Indications for use

- constipation (including with encopresis)

- preparation for endoscopic (rectoscopy) and X-ray examination of the gastrointestinal tract.

Contraindications for use

- increased individual sensitivity to drug components.

Dosage regimen

The drug is administered rectally. Adults and children over the age of 3 years should inject the contents of 1 micro enema (5 ml) by inserting the tip full length (the length of the universal tip is 60.6 mm). Newborns and children under 3 years of age should inject the contents of 1 micro enema by inserting the tip halfway (see the mark on the tip). For children under 3 years of age, it is also possible to use a micro enema with a shortened tip (the length of the shortened tip is 47.3 mm). In this case, it is necessary to enter the entire contents of one micro enema rectally, inserting the tip to the full length. The patient should be warned that if the complaints persist for a long time, it is necessary to see a doctor. Directions for use of the preparation 1. Break off the seal on the tip of the tube. 2. Press lightly on the tube so thatso that a drop of the drug smears the tip of the enema (to facilitate the administration process). 3. While squeezing the tube, squeeze out its contents completely. 4. Remove the tip while still squeezing the tube slightly.

Overdose

Overdose cases are not described at present.

Side effect

According to spontaneous reports of adverse events Adverse reactions arising from the use of the drug, which were identified during the post-marketing period, were classified as follows: very often (�10%), often (�1%, but < 10%), infrequently ( ? 0.1%, but < 1%), rarely (? 0.01%, but < 0.1%), very rare (< 0.01%) and adverse reactions with an unknown frequency of occurrence (the frequency of occurrence cannot be estimated based on the available data).

On the part of the digestive system: very rarely - pain in the abdomen (including abdominal discomfort, pain in the upper abdomen), discomfort in the anorectal region, loose stools.

Allergic reactions: very rarely - hypersensitivity reactions (for example, urticaria).

Drug interactions

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

Application during pregnancy and lactation

There are no adequate and well-controlled studies in pregnant women.

Because

the drug is probably absorbed

Name ENG

MICROLAX

Clinical and pharmacological group

Laxative drug

ATX code

Sodium lauryl sulfoacetate (including in combination with other drugs)

Dosage

12.9mg / ml + 90mg / ml + 893mg / ml x 5ml

Structure

Active ingredients: sodium citrate 90 mg

sodium lauryl sulfoacetate 70% 12.9 mg

sorbitol solution 70% 893 mg (corresponds to 625 mg sorbitol)

Excipients: sorbic acid

glycerol

water

Indications

Constipation (including with encopresis)

preparation for endoscopic (rectoscopy) and X-ray examination of the gastrointestinal tract.

Contraindications

Increased individual sensitivity to the components of Mikrolax.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 5 years

INN / Active ingredient

Sorbitol, Sodium Citrate, Sodium Lauryl Sulfoacetate

Specifications

Category

Laxatives

Scope of the medicinal product

Gastrointestinal tract

Release form

Solution

Manufacturer country

France

Package quantity, pcs

4

Scope of application

Gastroenterology

Minimum age from

3 years old

Way of introduction

Rectally

Vacation conditions

Without recipe

Brand name

Microlax

The amount of the dosage form in the primary package

5 ml

Primary packaging type

Microclysters

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Laxative

Dosage form

Rectal solution

Expiration date in days

1825

The target audience

Children

Package weight, g

35

Mode of application

:

Rectally.

< br> Adults and children over 3 years old - 1 micro enema (5 ml).

The tip should be inserted all the way into the rectum.

< br> For newborns and children under 3 years of age, insert the tip halfway (see the mark on the tip).

< br> Directions for use < br> 1. Break off the seal on the tip of the tube.

< br> 2. Press lightly on the tube so that the drop of the drug smears the tip of the enema (to facilitate the administration process).

< br> 3. Insert the tip of the micro enema for the entire length (for children under 3 years old - half the length) into the rectum.

< br> 4. While squeezing the tube, squeeze out its contents completely.

< br> 5. Remove the tip while still squeezing the tube slightly.

Anatomical and therapeutic characteristics

:

A06AG11 Lauryl sulfate, including in combination with other drugs

Dosage (volume) of the substance in the preparation

:

Sodium citrate 90 mg

sodium lauryl sulfoacetate 70% 12.9 mg

sorbitol solution 70% 893 mg (corresponds to 625 mg sorbitol)

Information on technical characteristics, delivery set, country of manufacture