Guttalax pills 5mg, 20pcs

Composition

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Auxiliary substances:

lactose monohydrate-71 mg,

corn starch-41.5 mg,

colloidal silicon dioxide-1.7 mg,

hydrolyzed potato starch-0.3 mg,

magnesium stearate-0.5 mg

Pharmacological action

A laxative drug. 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 colon mucosa, increasing peristalsis, and promotes the accumulation of 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.

Pharmacokinetics

After oral use, sodium picosulfate passes unchanged through the stomach and small intestine, entering the large intestine. Absorption of the drug is insignificant, which excludes its enterohepatic circulation.

In the colon, sodium picosulfate is broken down to form the active metabolite, bis – (p-hydroxyphenyl)- pyridyl-2-methane. The time of development of the laxative effect of the drug is determined by the rate of release of the active metabolite and is 6-12 hours.

A small part of the drug enters the systemic circulation.

There is no correlation between the laxative effect of the active metabolite and its concentration in the blood serum.

Indications

• atonic constipation;
• regulation of stool (hemorrhoids, proctitis, anal fissures);
• preparation for surgical operations, instrumental and X-ray examinations.

Use during pregnancy and lactation

During the long-term experience of using the drug, no adverse events were detected during pregnancy. However, due to the lack of research, the use of Guttalax® during pregnancy is recommended only in cases where the potential benefit to the mother exceeds the possible risk to the fetus. During pregnancy, the drug can be used only after consultation with a specialist.

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

Studies on the effect of the drug on fertility have not been conducted. No teratogenic effects on reproduction were detected in preclinical studies.

Use in children

Contraindicated in children under 4 years of age. Children from 4 to 10 years of age should only be used as directed by a doctor.

Contraindications

• hypersensitivity to sodium picosulfate or other ingredients of the drug;
• intestinal obstruction;
• pinched hernia;
• acute inflammatory diseases of the abdominal cavity;
• peritonitis;
• abdominal pain of unknown origin;
• severe dehydration;
• bleeding from the gastrointestinal tract;
• metrorrhagia;
• cystitis;
• spastic constipation;
• children under 4 years of age;
• pregnancy (I trimester).

Side effects

From the gastrointestinal tract: discomfort, nausea, vomiting, abdominal cramps and pain, diarrhea.

Nervous system disorders: dizziness and fainting. Dizziness and fainting that occur after taking the drug seem to be associated with a vasovagal response (for example, tension during bowel movements, abdominal cramps).

Immune system disorders: hypersensitivity reactions, including angioedema and skin reactions.

Interaction

Diuretics or glucocorticosteroids increase the risk of electrolyte imbalance (hypokalemia) when taking the drug in high doses.

Electrolyte imbalance can increase sensitivity to cardiac glycosides.

The combined use of the drug and antibiotics may reduce the laxative effect of the drug.

How to take, course of use and dosage

They are taken orally. Tablets should be washed down with a sufficient amount of liquid.

Adults and children over 10 years of age are prescribed 1-2 tablets (5-10 mg).

Children aged 4-10 years are prescribed 1/2-1 tab. (2.5-5 mg).

To get a laxative effect in the morning, you should take the drug the day before at night.

Overdose

Symptoms

When taken in high doses, diarrhea, dehydration, a decrease in blood pressure, a violation of the water-electrolyte balance, hypokalemia, convulsions are possible.

In addition, there are reports of cases of ischemia of the musculature of the large intestine associated with taking the drug at doses significantly higher than those recommended for the usual treatment of constipation.

The drug Guttalax, like other laxatives, with a chronic overdose can lead to chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, urolithiasis. Chronic laxative abuse can lead to renal tubule damage, metabolic alkalosis, and muscle weakness associated with hypokalemia.

Treatment

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

Special instructions

Do not use the drug daily without consulting a doctor for more than 10 days. Prolonged use of high doses of the drug can lead to fluid loss, electrolyte imbalance, and hypokalemia.

Dizziness and syncope were observed in patients taking Guttalax®. Analysis showed that these cases were associated with fainting during defecation (or fainting caused by exertion during defecation), or with a vasovagal response to abdominal pain, which may be due to constipation, and is not necessarily associated with taking the drug.

One tablet (5 mg) contains 67.5 mg of lactose. The maximum recommended daily dose for the treatment of adults and children over 10 years of age and for children 4-10 years of age contains 135.0 mg and 67.5 mg of lactose, respectively.

Children over 4 years of age should only take this medicine as directed by their doctor.

Influence on the ability to drive motor vehicles and manage mechanisms

Special clinical studies of the effect of the drug on the ability to drive vehicles or work with mechanisms have not been conducted. However, patients should be advised that they may experience dizziness and/or fainting due to a vasovagal reaction (i. e., during a bowel spasm). If patients experience bowel spasms, they should avoid potentially dangerous activities, including driving vehicles or operating machinery.

Form of production

Guttalax tablets.

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Sodium Picosulfate

Dosage form

Tablets

Description

For adults, Children over 4 years of age, Nursing mothers as prescribed by a doctor, Pregnant women in the second and third trimester as prescribed by a doctor

Indications

Hemorrhoids, Constipation