Guttasil, drops for oral use 7.5mg/ml vial 30ml

Composition

Active ingredient:

sodium picosulfate monohydrate (in terms of sodium picosulfate) 7.5 mg;

Auxiliary substances:

sorbitol-460 mg;

sodium methylparahydroxybenzoate-2 mg;

1 M hydrochloric acid solution – up to pH 6-7;

water for injection – up to 1 ml

Pharmacological action

Guttasil is a laxative.

Pharmacodynamics

A contact laxative of the triarylmethane group, activated in the large intestine under the action of bacterial sulfatases; the substance that is released in this case stimulates the sensitive nerve endings of the intestinal mucosa, enhances its motility. The use of the drug is not accompanied by tenesmus and intestinal spasms.

During the course of treatment, Guttasil stimulates the growth and metabolic activity of normal intestinal microflora.

Pharmacokinetics

After ingestion, it reaches the large intestine without significant absorption, where it is broken down under the action of bacterial flora to form the active form — bis-(p-hydroxyphenyl)- pyridyl-2-methane. The laxative effect develops 6-12 hours after ingestion, the severity of the laxative effect does not correlate with the level of active bis-(p-hydroxyphenyl)- pyridyl-2-methane in blood plasma. It does not undergo hepatic-intestinal recirculation.

Indications

Constipation or cases requiring relief of defecation (hemorrhoids, proctitis, anal fissures, preparation for surgery, instrumental and X-ray examinations).

Contraindications

• hypersensitivity to sodium picosulfate and the other components of the drug;
• intestinal obstruction;
• acute inflammatory bowel disease and acute diseases of the abdominal organs (including acute appendicitis, ulcerative colitis, peritonitis);
• acute abdominal pain accompanied with nausea and vomiting, which may indicate an acute inflammatory disease, severe dehydration;
• pregnancy (I trimester);
• lactation.

With caution:  elderly patients, hypokalemia, elevated magnesium content in the blood, patients with asthenia, II-III trimesters of pregnancy.

Side effects

From the side of the skin:  skin rash, urticaria, pruritus.

From the side of the water-electrolyte balance:  loss of potassium, sodium, and other electrolytes, and possible dehydration.

From the digestive system:  dyspeptic symptoms, vomiting, nausea, abdominal cramps and pain, diarrhea, flatulence, pain in the stomach and anus, increased intestinal motility, which disappear with a decrease in the dose of the drug.

From the immune system:  allergic reactions, angioedema.

From the central nervous system:  headache, fatigue, drowsiness, convulsions.

Interaction

An electrolyte imbalance can lead to a decrease in tolerance to cardiac glycosides.

Diuretics or corticosteroids may increase the severity of hypokalemia caused by the use of Guttasil in high doses.

Simultaneous treatment with antibiotics may reduce the laxative effect of the drug.

How to take, course of use and dosage

Inside, for the night (so that the chair is ready the next morning).

The drug is dosed by the manufacturer’s dispenser. Adults and children over 10 years — 13-27 drops (5-10 mg); children from 4 to 10 years-7-13 drops (2.5-5 mg). For children under 4 years of age, a dosage of 250 mcg/kg (2 drops/3 kg) is recommended. For children, the drug can be added to food. In children, a single dose of the drug can be effective. If necessary, the child’s course of treatment can be extended, but it is preferable to limit it to three days.

To eliminate constipation in cancer patients receiving large doses of opioids, it is used as prescribed by a doctor.

Overdose

Symptoms:  high doses of Guttasil can cause liquid bowel movements, abdominal cramps (colic), and clinically significant water-electrolyte balance disorders (hypokalemia, loss of other electrolytes and fluids), and ischemia of the colon mucosa.

Prolonged overdose leads to the development of chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism, possible kidney damage and the development of nephrolithiasis, metabolic alkalosis, hypokalemia and muscle weakness as a result of hypokalemia.

Treatment:  gastric lavage, use of enterosorbents (activated charcoal), symptomatic treatment (correction of water and electrolyte balance, use of antispasmodics).

Special instructions

Like other laxatives, Guttasil should not be taken daily for a long time. If you need to take daily laxatives, you should find out the cause of constipation. Long-term use of laxatives can lead to electrolyte imbalance and hypokalemia, as well as cause addiction and constipation due to the rebound effect.

Guttasil is effective in relieving constipation in cancer patients receiving high doses of opioids.

The drug contains sorbitol, so patients with rare hereditary problems of fructose intolerance are not recommended to take it.

Influence on the ability to drive vehicles and work with mechanisms. In therapeutic doses, the drug does not affect the ability to drive vehicles and work with other mechanisms.

Form of production

Drops for oral use

Storage conditions

In a dark place, at a temperature of 15-25 °C.

Shelf life

3 years

Active ingredient

Sodium Picosulfate

Dosage form

Drops for oral use

Description

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

Indications

Hemorrhoids, Constipation