Guttalax - instructions for use, doses, side effects, contraindications

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.

Description:

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

Pharmacotherapeutic group:Laxative

ATX: & nbsp

A.06.A.B.08 Sodium picosulphate

Pharmacodynamics:

Active substance - sodium picosulphate is laxative triarylmethane group.

As a local laxative sodium picosulphate after bacterial splitting in the large intestine has a stimulating effect on mucosal thickness of that intestine, increasing promotes accumulation water and electrolytes in the large intestine. This leads to stimulation of the act of defecation, reduction of evacuation time and softening of the stool.

Sodium picosulfate, being a laxative means acting at the level of the colon, stimulates the natural process of evacuation of the contents from the lower parts of the gastrointestinal tract. therefore sodium picosulphate does not affect the digestion or absorption of high-calorie foods or essential nutrients in the small intestine.

Pharmacokinetics:

Absorption: insignificant, the drug is almost completely metabolized in the wall of the intestine and liver to the inactive glucuronide.

After oral administration sodium picosulphate enters the large intestine; absorption of the drug is negligible, which excludes its enterohepatic circulation. In the distal part of the large intestine, sodium disintegration of picosulphate occurs to form an active metabolite, bis (p-hydroxyphenyl) -pyridyl-2-methane.The time of development of the laxative effect of the drug is determined by the release rate of the active metabolite and is usually 6-12 hours after application (on average 10 hours).

A small part of the drug enters the systemic circulation.

The relationship between the laxative effect of the active metabolite and its concentration in serum is absent.

After taking 10 mg of the drug, about 10.4% of the total dose is excreted in the urine as glucuronide after 48 hours.

When using higher doses of the drug, its excretion in the urine, in general, decreases.

Indications:

As a laxative in the following cases:

Constipation due to atony and hypotension of the colon (including elderly, in bedridden patients, after operations, after childbirth and during lactation)

- Constipation caused by taking medications means

- to regulate stool with hemorrhoids, proctitis, anal fissures (for softening consistency of feces)

- diseases of the gallbladder, syndrome irritated bowel with predominance constipation

- constipation due to dysbiosis intestines, diet disorders.

Contraindications:

- Intestinal obstruction or obstructive bowel disease;

- Acute diseases of the abdominal organs cavity or severe pain in the abdomen, which can be accompanied by nausea, vomiting, fever, including appendicitis;

- acute inflammatory diseases intestines;

- Hypersensitivity to sodium picosulphate or other components preparation;

- severe dehydration;

- intolerance to fructose.

Carefully:

In the II and III trimesters of pregnancy (as well as with the use of other laxatives), the drug is taken only by the doctor's prescription.

The active metabolite and its glucuronides are not excreted in breast milk. Thus, the drug can be used during breastfeeding.

Pregnancy and lactation:

Data on credible and good controlled studies in pregnant women women are absent. Long experience application has not revealed a negative effect preparation for pregnancy. Taking the drug in I trimester of pregnancy is contraindicated.

Studies on the effect of the drug on fertility have not been conducted. During preclinical studies of teratogenic effects on reproductive performance, no It was.

Dosing and Administration:

Inside.

Recommended the following dosing regimen:

Adults and children over 10 years of age: 10-20 drops (5-10 mg) per day

Children 4-10 years old: 5-10 drops (2.5-5 mg) per day

It is recommended to start with the lowest dose. In order to achieve a regular stool, the dose may rise to the maximum recommended. Do not exceed the maximum recommended daily dose.

The recommended dose for children younger than 4 years is 0.25 mg / kg body weight per day. This corresponds to 1 drop of the drug (0.5 mg of sodium picosulphate) per 2 kg of body weight per day. To get a laxative effect in the morning, you should take the drug the night before. The drug does not necessarily dissolve in the liquid.

Side effects:

From the gastrointestinal tract possible discomfort, nausea, vomiting, cramps and pains in the abdomen, diarrhea.

From the nervous system are possible dizziness and fainting. Dizziness and syncope arising after taking can be associated with vasovagal reaction (for example, tension during defecation, spasms in the abdominal area).

Possible reactions are increased sensitivity from the immune system system.

From the skin and subcutaneous tissues skin reactions are possible, for example, angioedema, skin rash, itching.

Overdose:

Symptoms

When taking high doses are possible: diarrhea, dehydration, lowering blood pressure, violation of water-electrolyte balance, hypokalemia, convulsions.

In addition, there are reports of cases of ischemia of the musculature of the large intestine associated with the administration of doses Guttalax®, significantly exceeding the recommended for conventional constipation treatment.

Guttalax®, like other laxatives, with chronic overdose can lead to chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, urolithiasis. In connection with chronic abuse of laxatives, renal tubular damage, metabolic alkalosis and muscle weakness associated with hypokalemia can develop.

Treatment

To reduce the absorption of the drug after ingestion, you can induce vomiting or gastric lavage. It may be necessary to replenish the fluid and balance the balance of electrolytes, as well as the appointment of antispasmodics.

Interaction:

Diuretics or glucocorticosteroids increase the risk of electrolyte imbalance (hypokalemia) with high doses Guttalax®.

Violation of electrolyte balance can increase sensitivity to cardiac glycosides.

Joint use of the drug and antibiotics can reduce the laxative effect of the drug.

Special instructions:

Do not apply the drug daily without consulting a doctor for more than 10 days. Long-term use of high doses of the drug can lead to loss of fluid, a violation of the balance of electrolytes, hypokalemia.

Dizziness and fainting were observed in patients taking Guttalax®. The analysis showed that these cases are associated with fainting during defecation (or a syncope caused by stress during defecation) or with a vasovaginal response to abdominal pain that may be caused by constipation and is not necessarily associated with taking the drug.

In 1 ml of drops contains 0.45 g of sorbitol. The maximum recommended daily intake for treatment of adults and children 4-10 years old contains 0.6 g and 0.3 g of sorbitol, respectively.

The drug does not have taste, so children can be added to food. Children should take the drug only as directed by the doctor.

Effect on the ability to drive transp. cf. and fur:Special clinical studies of the effect of the drug on the ability to control the car and mechanisms were not carried out. Despite this, patients should be informed that dizziness and / or syncope may occur due to vasovagal reaction (i.e., during intestinal spasm). If patients develop a spasm of the intestine, they should avoid potentially dangerous activities, including driving vehicles or controlling mechanisms.

Form release / dosage:

Drops for oral administration 7.5 mg / ml.

Packaging:For 15 ml or 30 ml in a plastic bottle, sealed with a stopper and a screw cap. Vial with instructions for use in a cardboard box.

Storage conditions:

At a temperature not higher than 30 ° C, do not freeze. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N015238 / 01

Date of registration:02.10.2009 / 27.01.2010

Expiration Date:Unlimited

The owner of the registration certificate:Boehringer Ingelheim International GmbHBoehringer Ingelheim International GmbH Germany

Manufacturer: & nbsp

INSTITUTO de ANGELI, S.r.L. Italy

Representation: & nbspBERINGER INGELCHAIM INTERNATIONAL GmbH BERINGER INGELCHAIM INTERNATIONAL GmbH Germany

Information update date: & nbsp14.05.2017

Illustrated instructions

Instructions

Guttalax® (Guttalax®)