Guttasil drops for oral administration 7.5 mg/ml №1

Name:
Guttasil to-li d / vn.prim.7.5 mg / ml in p / e vial. 30 ml with drops in pack No. 1
Description:
Transparent colorless or yellowish liquid The main active ingredient Sodium picosulfate Release form Drops Dosage (20 drops) Pharmacological properties Contact laxatives. Sodium picosulfate. ATC code A06AB08 Pharmacodynamics Contact laxative of the triarylmethane group, activated in the large intestine by the action of bacterial sulfatases; the substance that is released at the same time stimulates the sensitive nerve endings of the intestinal mucosa, enhances its motility, promotes the accumulation of water and electrolytes in the lumen of the large intestine. The result of this is stimulation of defecation, reduction of transit time and softening of the stool. Pharmacokinetics After oral administration of sodium, picosulfate enters the large intestine, while its absorption is negligible, which excludes the circulation of the substance in the intestine and liver. As a result of bacterial cleavage in the large intestine, the active form is formed – bis-(p-hydroxyphenyl)-pyridyl-2-methane. As a result, the action of the drug begins after 6-12 hours, depending on the release of the active substance from the drug. After oral administration, only a small part of the drug enters the systemic circulation. There is no relationship between the laxative effect and the concentration of the active substance in the blood plasma. Indications for use Constipation or cases requiring relief of bowel movements. As with other laxatives, Guttasil should not be used daily or for long periods without determining the cause of constipation. Method of application and doses The drug is dosed by the manufacturer’s dispenser. Adults: 13-27 drops (equivalent to 5-10 mg sodium picosulfate). Children from 4 years of age only as prescribed by a doctor: 7-13 drops (corresponding to 2.5-5 mg of sodium picosulfate). It is recommended to start treatment with the lowest dose. To achieve the desired effect, the dose can be adjusted upwards to the maximum recommended. Do not exceed the maximum daily dose of 27 drops for adults and 13 drops for children over 4 years of age. Guttasil must be taken orally, preferably at night. After the use of Guttasil, bowel movement usually occurs within 10-12 hours. The drug can be used with or without liquid. Guttasil should not be used daily or for a long period without determining the cause of constipation. Use during pregnancy and lactation There are no sufficient studies of the use of sodium picosulfate in pregnant women. Preclinical studies have shown reproductive toxicity. For safety reasons, Guttasil should not be taken during pregnancy. Clinical data show that neither the active metabolite bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM) nor its glucuronides pass into breast milk. Thus, Guttasil can be used during breastfeeding. Before using the drug during pregnancy and lactation, you should consult your doctor. Studies evaluating the effect on fertility have not been conducted. Precautions Patients suffering from chronic constipation should be fully diagnosed and the cause of constipation determined. Prolonged use of the drug can lead to a violation of the water and electrolyte balance and hypokalemia. Cases of dizziness and/or syncope have been reported, which coincided in time with the use of sodium picosulfate. Dizziness and/or fainting that occurs after taking the drug may be associated with straining during bowel movements (Valsalva effect) or a vasovagal reaction to abdominal pain. Patients with rare hereditary fructose intolerance should not take this medicine because it contains sorbitol. Symptoms may recur after discontinuation of the drug. In chronic constipation after prolonged use of the drug, symptoms may recur and constipation may worsen. This medicinal product contains less than 1 mmol/dose of sodium, i.e. practically free of sodium. Interaction with other drugs The simultaneous use of large doses of Guttasil and diuretics or corticosteroids may increase the risk of electrolyte imbalance, which may lead to increased sensitivity to cardiac glycosides. Simultaneous use with antibiotics may reduce the laxative effect of Guttasil. Contraindications – Hypersensitivity to the active substance, other trialmethanes or any of the excipients. – Intestinal stenosis or intestinal obstruction. – Severe abdominal pain, which may be accompanied by fever, nausea and vomiting (eg appendicitis). – Acute inflammatory diseases of the gastrointestinal tract. – Severe dehydration. – Rare hereditary intolerance to any of the excipients of the drug (for example, rare hereditary fructose intolerance). -Children’s age up to 4 years. In diseases associated with impaired water and electrolyte balance (for example, severe renal impairment), the drug can be used only under the supervision of a physician. Active ingredient: sodium picosulfate; 1 ml of the drug contains sodium picosulfate 7.5 mg (20 drops); excipients: sorbitol (E 420); sodium benzoate (E 211); citric acid, monohydrate; sodium citrate; water for injections. Overdose Overdose can result in loose bowel movements (diarrhea), intestinal cramps, and clinically significant loss of fluid, potassium, and other electrolytes. In acute overdose, the consequences can be minimized or eliminated by forced vomiting or gastric lavage shortly after taking Guttasil. It may be necessary to replenish fluids and correct electrolyte balance. Anticonvulsants may be used. Colonic mucosal ischemia has been reported with large doses of Guttasil, significantly higher than those usually recommended for constipation. Guttasil, like other laxatives, in prolonged overdose can lead to chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism, and possibly kidney stones. With prolonged abuse of laxatives, renal tubular damage, metabolic alkalosis, and muscle weakness associated with hypokalemia have been reported. Side effect Evaluation of undesirable effects is based on the following data on the frequency of occurrence: very often (? 1/10), often (? 1/100 to < 1/10), infrequently (? 1/1000 to < 1/100), rarely (? 1/10000 to < 1/1000), very rare (< 1/10000), not known (cannot be estimated from the available data). On the part of the skin and subcutaneous fat: unknown: skin reactions (angioneurotic edema, toxidermia, rash, itching). From the immune system: unknown: hypersensitivity reactions. From the nervous system: infrequently: dizziness; unknown: fainting. Available information suggests that dizziness and / or fainting that occurs after taking the drug is associated with a vasovagal reaction (for example, with abdominal pain or defecation) (see section "Precautions"). From the gastrointestinal tract: very often: diarrhea; often: abdominal colic, abdominal pain, abdominal discomfort; infrequently: vomiting, nausea. Prolonged and excessive use of the drug can lead to loss of fluid, potassium and other electrolytes. This, in turn, can lead to muscle weakness and impaired cardiac function, especially when used simultaneously with diuretics or corticosteroids. Storage conditions Store in a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Guttasil drops for oral administration 7.5 mg/ml №1 Price for Guttasil drops for oral administration 7.5 mg/ml №1 Instructions for use for Guttasil drops for oral administration 7.5 mg/ml №1