Guttalax, tablets 5 mg 20 pcs

Laxative drug. The active ingredient – sodium picosulfate – is a laxative of triarylmethane group.

As a local laxative sodium picosulfate after bacterial cleavage in the large intestine has a stimulating effect on the mucosa of the large intestine, increasing peristalsis, promotes accumulation of water and electrolytes in the large intestine. This leads to stimulation of the act of defecation, reduced evacuation time and softening of stools.

Pharmacokinetics

After oral administration, sodium picosulfate passes unchanged through the stomach and small intestine, entering the colon. There is little absorption of the drug, which rules out 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 bloodstream.

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

Indications

Anal Fissures, Hemorrhoids, Constipation

• atonic constipation
• stool regulation (hemorrhoids, proctitis, anal fissures)
• preparation for surgical procedures, instrumental and radiological studies.

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Active ingredient

Sodium picosulfate

Composition

Associates:

Lactose monohydrate – 71 mg,

Corn starch – 41.5 mg,

colloidal silica – 1.7 mg,

potato starch hydrolyzed – 0.3 mg,

magnesium stearate – 0.5 mg.

How to take, the dosage

It is taken orally. The tablets should be swallowed with enough fluids.

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 tablet (2.5-5 mg).

To get a laxative effect in the morning, take the drug the night before.

Interaction

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

The electrolyte imbalance may increase sensitivity to cardiac glycosides.

The co-administration of the drug and antibiotics may decrease the laxative effect of the drug.

Special Instructions

Do not use the drug daily without medical advice for more than 10 days. Prolonged use of high doses of the drug may lead to fluid loss, electrolyte imbalance, hypokalemia.

Dizziness and fainting have been observed in patients taking Guttalax^®. Analysis showed that these cases were associated with fainting while defecating (or fainting caused by straining to defecate), or with a vasovagal response to abdominal pain, which may be due to constipation and not necessarily related to taking the drug.

One tablet (5 mg) contains 67.5 mg of lactose. The maximum recommended daily dose for treating 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 the drug as prescribed by their doctor.

The effect of the drug on driving and operating machinery

There have been no special clinical studies of the effect of the drug on the ability to drive vehicles or operate machinery. Despite this, patients should be informed that they may experience dizziness and/or fainting due to vasovagal reaction (i.e., during bowel spasm). If patients experience bowel spasm, they should avoid potentially dangerous activities, including driving or operating machinery.

Contraindications

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

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Side effects

Gastrointestinal disorders: discomfort, nausea, vomiting, abdominal cramps and pain, diarrhea.

Nervous system disorders: dizziness and fainting. Dizziness and fainting occurring after taking the drug appear to be associated with a vasovagal response (e.g., straining during defecation, abdominal cramps).

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

Overdose

Symptoms

In high doses, diarrhea, dehydration, decreased BP, water-electrolyte imbalance, hypokalemia, seizures are possible.

In addition, there have been reports of cases of ischemia of the colon muscles associated with administration of the drug in doses significantly higher than those recommended for normal treatment of constipation.

The drug Guttalax, like other laxatives, in chronic overdose may lead to chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and urolithiasis. Renal tubular damage, metabolic alkalosis, and muscle weakness associated with hypokalemia may develop due to chronic laxative abuse.

Treatment

In order to reduce absorption of the drug after ingestion, vomiting or gastric lavage may be induced. Fluid replenishment and correction of electrolyte balance may be necessary, and antispasmodic agents may be prescribed.

Pregnancy use

In the long-term experience of using the drug, no adverse events during pregnancy have been found. However, due to the lack of studies, the use of the drug Guttalax® during pregnancy is recommended only if the potential benefit to the mother exceeds the possible risk to the fetus. In pregnancy, the drug may be used only after consultation with a specialist.

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

There have been no studies on the effect of the drug on fertility. No teratogenic effects on fertility were found in preclinical studies.

Pediatric use

It is contraindicated in children under 4 years of age. For children from 4 to 10 years of age, use only with a doctor’s prescription.

Similarities

Regulax Picosulfate, Slabilen, Slabicap, Picodinar