Guttalax drops 7.5 mg/ml. 15 ml.

Description

Guttalax 15 ml Storage
active substance: sodium picosulfate, monohydrate;

1 ml contains 7.5 mg of sodium picosulfate monohydrate;

excipients: sodium benzoate (E 211); sorbitol solution that does not crystallize (E 420); citric acid, monohydrate; sodium citrate, dihydrate; purified water.

Guttalax 15 ml Dosage form
Drops.

Basic physical and chemical properties: clear solution, from colorless to yellowish color or slightly yellowish-brown color, slightly viscous solution with almost imperceptible smell.

Guttalax 15 ml Pharmacotherapeutic group
Contact laxatives. ATX code A06A B08.

Pharmacological properties

Pharmacodynamics.

Sodium picosulfate, the active substance of GUTTALAX® PICOSULFATE, is a laxative of local action of the triarylmethane group, which after bacterial cleavage in the colon stimulates its mucous membrane, accelerating peristalsis and promoting the accumulation of water and electricity in the intestine. The result is stimulation of defecation, reduction of transit time and softening of feces.

Sodium picosulfate acts in the colon and directly stimulates the process of fecal evacuation. As a result, it is ineffective in affecting the digestion or absorption of calories or essential nutrients in the small intestine.

In a randomized, double-blind, parallel-group study of 367 patients with chronic constipation, daily administration of GUTTALAX® PICOSULFATE resulted in a significant increase in the number of successful bowel movements per week compared with placebo at baseline. The advantages of GUTTALAX® PICOSULFATE over placebo were demonstrated during all 4 weeks of treatment (p <0.0001). At the end of the study, serum potassium levels remained unchanged (4.4 mm) and were within the physiological norm (3.6 – 5.3 mm).

Pharmacokinetics.

Absorption and distribution. After oral administration of sodium picosulfate reaches the colon without significant absorption.

Biotransformation. Sodium picosulfate is converted to the active compound, which has a laxative effect – bis- (p-hydroxyphenyl) -pyridyl-2-methane (BGPM) – by bacterial cleavage in the distal segment of the intestine.

Elimination. After conversion, only a small part of BGPM is absorbed. After oral administration of 10 mg of sodium picosulfate 10.4% of the total dose is excreted as glucuronide BGPM in the urine after 48 hours. In addition, BGPM is excreted as glucuronide in bile.

Relationship between pharmacokinetics and pharmacodynamics. The onset of action is usually observed 6 to 12 hours after taking the drug, depending on the release of the active metabolite (BGPM). The laxative effect of the drug does not correlate with the levels of the active metabolite in blood plasma.

Indication
Constipation or cases that require facilitation of defecation.

Like other laxatives, GUTTALAX® PICOSULFATE should not be used daily or for long periods of time without a complete diagnostic evaluation to determine the cause of constipation.

Contraindication
Hypersensitivity to the active substance, other triarylmethanes or to any of the excipients.
Dynamic or mechanical intestinal obstruction.
Severe diseases of the abdominal organs with pain and / or fever (eg appendicitis), which may be accompanied by nausea and vomiting.
Acute inflammatory bowel disease.
Severe dehydration.
Rare hereditary intolerance to any of the excipients (see section “Special warnings and precautions for use”).
GUTTALAX® PICOSULFATE should not be used in children under 4 years of age.

GUTTALAX® PICOSULFATE should not be used in patients with rare hereditary problems of fructose intolerance.

In conditions associated with water and electrolyte imbalance (eg, severe renal impairment), GUTTALAX® PICOSULFATE should only be taken under medical supervision.