Guttalax tablets 5mg, No. 20

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 medication;

• to regulate stool for hemorrhoids, proctitis, anal fissures (to soften the consistency of feces);

• gallbladder disease, irritable bowel syndrome with a predominance of constipation;

• constipation due to intestinal dysbiosis, diet disorders.

The drug is taken orally.

The tablets must be taken with a sufficient amount of liquid (at least half a glass of water). Adults and children over 10 years old are prescribed 1-2 tablets. (5-10 mg) / day.

The maximum daily dose is 2 tab. (With 10 mg). Children aged 4-10 years are prescribed 1 / 2-1 tab. (2.5-5 mg) / day.

The maximum daily dose is 1 tab. (With 5 mg). Children under the age of 4 years should not use the drug in the form of tablets, it is recommended to prescribe the drug in the form of drops. It is recommended to start treatment with a lower dose.

In order to achieve regular bowel movements, the dose can be increased to the maximum recommended. Do not exceed the maximum recommended daily dose. Because the drug is not addictive, the dose can be individually adjusted by the patient: the dose can be reduced depending on individual needs or the drug can be used once as needed. To obtain a laxative effect in the morning, take the drug the night before. To restore the natural rhythm of defecation, along with taking a laxative, it is recommended to increase physical activity, sufficient intake of dietary fiber (20-25 g / day) and liquid (at least 2 liters).

sodium picosulfate

• 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 under 4 years of age;

• hypersensitivity to sodium picosulfate or other components of the drug.

pharmachologic effect

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 mucous membrane of the large intestine, increasing peristalsis, promotes the accumulation of water and electrolytes in the large intestine. This leads to stimulation of the act of defecation, a decrease in evacuation time and softening of the stool. Sodium picosulfate, as a laxative that acts at the level of the colon, stimulates the natural process of evacuation of contents from the lower gastrointestinal tract. Therefore, sodium picosulfate has no effect on the digestion or absorption of high-calorie foods or essential nutrients in the small intestine.In a randomized, double-blind, parallel group study of 367 patients with chronic constipation, the effect of GuttalaxЃ was investigated. The study results showed a significant increase in intestinal motility during the week compared with placebo for all 4 weeks of therapy (p <0.0001). Serum potassium concentration levels were unchanged at the end of the study (4.4 mM) and corresponded to the physiological norm (3.6-5.3 mM).Pharmacokinetics

Absorption and distribution

After oral administration of the sodium drug, picosulfate enters the colon without significant absorption. Thus, enterohepatic circulation of the drug is excluded.

Metabolism

In the distal colon, sodium picosulfate is degraded bacterially with the formation of an active metabolite of bis- (p-hydroxyphenyl) -pyridyl-2-methane (BHPM), which has a laxative effect. The time of development of the laxative effect of the drug is determined by the rate of release of the active metabolite (BHPM) and is 6-12 hours after application (on average 10 hours).

Withdrawal

After cleavage, a small amount of BGPM is absorbed and then almost completely binds in the intestinal wall and liver with the formation of an inactive glucuronide. After oral administration of sodium picosulfate at a dose of 10 mg (about 10.4% of the total dose), the drug is excreted in the urine in the form of BGPM-glucuronide after 48 hours. When sodium picosulfate is used in higher doses, its excretion by the kidneys decreases.

Pharmacokinetic / Pharmacodynamic Relationship

The time of development of the laxative effect of the drug is determined by the rate of release of the active metabolite (BHPM) and is 6-12 hours after application (on average 10 hours). A small part of the drug enters the systemic circulation. There is no relationship between the laxative effect of the active metabolite and its serum concentration.

Side effect

From the digestive system: discomfort, nausea, vomiting, cramps and pain in the abdomen, diarrhea. From the nervous system: dizziness and fainting. Dizziness and fainting that occur after taking the drug appear to be associated with a vasovagal response (eg, straining during bowel movements, abdominal cramps). From the immune system: hypersensitivity reactions. On the part of the skin and subcutaneous tissues: skin reactions, for example, angioedema, drug rash, skin rash, itching.

Application during pregnancy and lactation

During the long-term experience of using the drug, no adverse events have been identified during pregnancy. However, due to the lack of research, the use of the drug GuttalaxЃ during pregnancy is recommended only when the intended benefit to the mother outweighs the potential 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. In the course of preclinical studies, teratogenic effects on reproduction were not identified.

Application in children

The use of the drug is contraindicated in children under 4 years of age.

special instructions

For many constipated patients, there is no need for a daily full dose, the dose can be reduced depending on the individual needs of the patient, or the drug can be used once as needed. Do not use the drug daily without consulting a doctor for more than 10 days. Long-term use of the drug in high doses can lead to fluid loss, electrolyte imbalance, hypokalemia. Dizziness and fainting were observed in patients taking GuttalaxЃ. Analysis has shown that these cases are associated with fainting during bowel movements (or fainting caused by straining during bowel movements) or with a vasovagal response to abdominal pain, which may be due to constipation, and not necessarily drug-related. 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. Pediatric use Children over 4 years of age should only take this medicine as directed by a doctor. Influence on the ability to drive vehicles and operate mechanisms Special clinical studies of the effect of the drug on the ability to drive vehicles or operate mechanisms have not been conducted. Despite this, patients should be advised that when using the drug, due to a vasovagal reaction (i.e., during intestinal spasm), dizziness and / or fainting may occur. Patients should avoid potentially hazardous activities, incl. driving vehicles or operating machinery.

Overdose

Symptoms

When using the drug in high doses, diarrhea, dehydration, a decrease in blood pressure, a violation of the water-electrolyte balance, hypokalemia, and 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 significantly higher than those recommended for the usual treatment of constipation. The drug GuttalaxЃ, like other laxatives, in chronic overdose can lead to chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, urolithiasis. Chronic laxative abuse can lead to renal tubular damage, metabolic alkalosis, and muscle weakness associated with hypokalemia.

Treatment

To reduce the absorption of the drug after ingestion, you can induce vomiting or gastric lavage. Fluid replenishment and electrolyte balance adjustments may be required, as well as antispasmodics.

Drug interactions

Diuretics or GCS increase the risk of electrolyte imbalance (hypokalemia) when using the drug in high doses. Electrolyte imbalance can increase sensitivity to cardiac glycosides. The combined use of the drug and antibiotics can reduce the laxative effect of the drug