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Active ingredients
Sodium picosulphate
Release form
Pills
Composition
active ingredient: botulinum toxin complex type A-hemagglutinin 300 U; excipients: human albumin - 125 mcg; lactose - 2.5 mg
Pharmacological effect
Laxative drug. The active ingredient, sodium picosulfate, is a laxative of the triarylmethane group. As a local laxative, sodium picosulphate after bacterial cleavage in the large intestine has a stimulating effect on the mucous membrane of the colon, increasing the motility, contributes to the accumulation of water and electrolytes in the colon. This leads to the stimulation of the act of defecation, reducing the time of evacuation and softening of the chair.
Pharmacokinetics
After ingestion of sodium picosulfate enters the colon. The absorption of the drug is negligible, which excludes its enterohepatic circulation. In the colon, sodium picosulfate is cleaved to form the active metabolite, bis- (p-hydroxyphenyl) -pyridyl-2-methane. The development time 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. The relationship between the laxative effect of the active metabolite and its concentration in serum is absent.
Indications
As a laxative in the following cases: - constipation caused by atony and hypotension of the colon (including in old age, in bedridden patients, after surgery, after childbirth and during lactation); - Constipation caused by taking medication; - to regulate the stool with hemorrhoids, proctitis, anal fissures (to soften the consistency of feces); - diseases of the gallbladder, irritable bowel syndrome with a predominance of constipation; - Constipation caused by intestinal dysbiosis, dietary disorders.
Contraindications
- intestinal obstruction; - obstructive bowel disease; - acute diseases of the abdominal organs or severe abdominal pain, which may be accompanied by nausea, vomiting, fever (including appendicitis); - acute inflammatory bowel disease; - severe dehydration; - Lactase deficiency, lactose intolerance, glucose-galactose malabsorption; - children's age up to 4 years; - Hypersensitivity to sodium picosulfate or other components of the drug.
Precautionary measures
not described
Use during pregnancy and lactation
During the long experience of using the drug, no adverse events were detected during pregnancy. However, due to the lack of research, the use of the drug Guttalax during pregnancy is recommended only when the intended benefit to the mother outweighs the potential risk to the fetus. In pregnancy, the drug can be used only after consulting 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 were not conducted. In the course of preclinical studies, no teratogenic effects on reproduction have been identified.
Dosage and administration
The drug is taken orally. Tablets need to drink with a sufficient amount of liquid. To get a laxative effect in the morning hours, you should take the drug the night before. Adults and children over 10 years old are prescribed 1-2 tab. (5-10 mg) / day. Children aged 4-10 years appoint 1 / 2-1 tab./day (2.5-5 mg) / day. It is recommended to start treatment with a lower dose. In order to achieve regular stools, the dose can be increased to the maximum recommended. Do not exceed the maximum recommended daily dose. In children under the age of 4 years should not use this dosage form, it is recommended to prescribe the drug in the form of drops.
Side effects
On the part of the gastrointestinal tract, discomfort, nausea, vomiting, cramps and abdominal pain, diarrhea are possible. On the part of the nervous system, dizziness and fainting are possible. Dizziness and fainting that occur after taking the drug, apparently, are associated with vasovagal response (for example, stress during defecation, abdominal cramps). Hypersensitivity reactions from the immune system are possible. Skin and subcutaneous tissues may cause skin reactions, for example, angioedema, drug rash, skin rash, pruritus.
Overdose
Symptoms When using the drug in high doses, diarrhea, dehydration, reduction of blood pressure, impaired water and electrolyte balance, hypokalemia, convulsions are possible. In addition, there are reports of cases of ischemia of the muscles of the large intestine associated with taking the drug in doses far exceeding those recommended for conventional treatment of constipation. The drug Guttalax, like other laxatives, with chronic overdose can lead to chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, urolithiasis.Due to the chronic abuse of laxatives, renal tubular damage, metabolic alkalosis and muscle weakness associated with hypokalemia may 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 correct the balance of electrolytes, as well as the appointment of antispasmodics.
Interaction with other drugs
Diuretics or GCS increase the risk of electrolyte imbalance (hypokalemia) when using the drug in high doses. Disruption of electrolyte balance may increase sensitivity to cardiac glycosides. The combined use of the drug and antibiotics can reduce the affectionate effect of the drug.
special instructions
Do not use the drug daily without consulting a doctor for more than 10 days. Prolonged use of the drug in high doses can lead to loss of fluid, electrolyte imbalance, hypokalemia. Dizziness and fainting were observed in patients taking Guttalax. The analysis showed that these cases are associated with fainting during defecation (or fainting caused by stress during defecation) or 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 old and for children 4-10 years old contains 135.0 mg and 67.5 mg of lactose, respectively. Use in pediatrics Children over the age of 4 years should take the drug only as prescribed by a doctor. Influence on the ability to drive vehicles and control mechanisms Special clinical studies of the effect of the drug on the ability to drive vehicles or work with mechanisms have not been carried out. Despite this, patients should be informed that when using the drug, due to vasovagal reaction (ie, during intestinal spasm), dizziness and / or fainting may occur. When an intestinal spasm occurs, patients should avoid potentially hazardous activities, including driving vehicles or driving arrangements.