Guttalax, tablets 5 mg 50 pcs

Pharmgroup:

Laxative.

Pharmic action:

The active ingredient of Guttalax is sodium picosulfate, it 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, contributes to water and electrolytes accumulation 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 into the large intestine.

The absorption of the drug is insignificant, which rules out its enterohepatic circulation. In the large intestine, 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 systemic blood flow.
There is no correlation between the laxative effect of active metabolite and its serum concentration.

Indications

As a laxative in the following cases:
– constipation caused by atony and hypotonia of the large intestine (including the elderly, bedridden patients, after surgery, after childbirth and during lactation)
– constipation caused by taking medicines
– to regulate stool at hemorrhoids, proctitis, anal fissures (to soften the stool consistency)
– gall bladder diseases, irritable bowel syndrome with predominant constipation
– constipation due to dysbacteriosis of the intestines, violations of the diet.

Active ingredient

Composition

1 tablet:

– sodium picosulfate 5 mg (as sodium picosulfate monohydrate 5.187 mg)

Ancillary substances:

Lactose monohydrate 71.0 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

Ingestion. The tablets should be swallowed with enough fluids.

Unless otherwise prescribed by the doctor, the following dosing regimen is recommended:

Adults and children over 10 years of age: 1 – 2 tablets (5 – 10 mg)

Children ages 4 – 10 years: ½ – 1 tablet (2.5 – 5 mg)

To obtain a laxative effect in the morning hours, Guttalax should be taken the night before.

Interaction

Diuretics or glucocorticosteroids increase the risk of electrolyte imbalance (hypokalemia) when taking high doses of the drug. 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 treated with Guttalax®. Analysis showed that these cases were associated with fainting during defecation (or fainting caused by straining during defecation), or with a vasovagal response to abdominal pain, which may be due to constipation and is 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 take the drug only by prescription.

Impact on the ability to drive or operate machinery:

There have been no specific clinical studies of the effect of Guttalax on the ability to drive 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 hazardous activities, including driving or operating machinery.

Contraindications

Intestinal obstruction, obstructive bowel disease, acute abdominal diseases including appendicitis, acute inflammatory bowel disease, severe abdominal pain accompanied by nausea and vomiting, which may be a sign of the above mentioned severe conditions.

The drug Guttalax is also contraindicated in severe dehydration and in patients with hypersensitivity to the drug or its components.

Patients with rare hereditary disorders, such as intolerance to galactose, e.g. galactosemia, lactase deficiency, glucose-galactose malabsorption, should not take the drug.

Side effects

Gastrointestinal tract disorders may include discomfort, nausea, vomiting, abdominal cramps and pain, diarrhea.

Nervous system disorders may cause dizziness and fainting. Dizziness and fainting after taking Guttalax appear to be related to a vasovagal response (e.g., straining during defecation, abdominal cramps).

Possible immune system hypersensitivity reactions, including angioedema and skin reactions.

Overdose

Symptoms:

In high doses, diarrhea, dehydration, decreased blood pressure, water-electrolyte imbalance, hypokalemia, and seizures may occur. In addition, there are reports of cases of ischemia of the colon muscles associated with taking doses of the drug significantly higher than those recommended for the usual treatment of constipation. Guttalax®, like other laxatives, in chronic overdose may cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, urolithiasis.

Chronic abuse of laxatives can lead to renal tubular damage, metabolic alkalosis, and muscle weakness associated with hypokalemia.

Treatment:

In order to reduce absorption of the drug after ingestion, vomiting or gastric lavage may be induced. It may be necessary to replenish fluids and correct electrolyte balance, as well as prescription of antispasmodic agents.

Pregnancy use

In the long-term experience of using the drug no adverse events during pregnancy have been identified. However, due to
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. During pregnancy the drug can 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.

Studies on the effect of the drug on fertility have not been conducted.

In preclinical studies, no teratogenic effects on fertility have been identified.

Similarities