Guttasil - instructions for use, dose, side effects, contraindications

The contact laxative of the triarylmethane group is activated in the large intestine by bacterial sulfatases; a substance that is released while stimulating, the sensitive nerve endings of the mucous membrane. intestines, strengthens his motor skills.The use of the drug is not accompanied by tenesmus and intestinal spasms.

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

Pharmacokinetics:

After ingestion, it reaches the large intestine without significant absorption, where, under the action of the bacterial flora, it is cleaved to form the active form-bis (p-hydroxyphenyl) -pyridyl-2-methane. The laxative effect develops after 6-12 hours after administration, the laxative effect is not correlated with the level of active bis (p-hydroxyphenyl) -pyridyl-2-methane in blood plasma. Not subject to hepatic intestinal recirculation.

Indications:

Constipation or cases requiring relief of defecation (hemorrhoids, proctitis, anal fissures, preparation for surgical operations, instrumental and radiographic studies).

Contraindications:

Intestinal obstruction or obstructive bowel disease;

acute inflammatory bowel diseases and acute diseases of the abdominal cavity (including acute appendicitis, ulcerative colitis, peritonitis);

severe pain in the abdomen, accompanied by nausea, vomiting and fever,which can indicate acute inflammatory diseases, severe dehydration; hypersensitivity to sodium picosulphate and other components of the drug; intolerance to sucrose, sugarase / isomaltase deficiency, glucose-galactose malabsorption (the composition includes sorbitol). Pregnancy. Children under 4 years.

Carefully:

Use with caution to the elderly, with hypokalemia, increased magnesium concentration in the blood, patients with asthenia.

The use of the drug in patients with severe renal insufficiency (in accordance with the section "Special instructions") is only under the supervision of a doctor.

Pregnancy and lactation:

In view of the lack of sufficient clinical studies, the use of the drug Guttasil during pregnancy is not recommended.

Clinical data show that neither the active metabolite bis- (p-hydroxyphenyl) -pyridyl-2-methane (BHPM) nor its glucuronides penetrate into breast milk. Thus, the drug Guttasil can be used during breastfeeding.

Dosing and Administration:

Inside.

The drug is dosed by the manufacturer's dispenser. The following reception mode is recommended:

Adults and children older than 10 years: 13-27 drops (corresponding to 5-10 mg sodium picosulfate).

Children from 4 to 10 years (only as prescribed by the doctor): 7-13 drops (corresponding to 2.5-5 mg sodium picosulfate).

Use the drug in children aged 4 years only after consulting a doctor.

It is recommended to start with the lowest dose. In order to achieve a regular stool, the dose may rise to the maximum recommended.

To obtain a laxative effect in the morning, the drug Guttasil must be taken at night. After using Guttasil, the bowel is emptied after 10-12 hours. The drug can be used with or without a liquid. The drug Guttasil should not be taken daily without a doctor's consultation for more than 10 days.

Side effects:

When the drug is taken for a short time, side effects are rarely observed.

Possible side effects are classified according to the frequency of occurrence as follows: very often (≥1/10), often (≥1 / 100 to <1/10), infrequently (≥ 1/1000 to <1/100), rarely (≥ 1/10000 to <1/1000), very rarely (<1/10000), the frequency is unknown (there is currently no evidence of a prevalence of adverse reactions).

With prolonged use of the drug in significantly increased doses, there may be violations:

from the skin and subcutaneous tissues

frequency unknown: skin rash, hives, itching.

from the side of metabolism and nutrition

frequency is unknown: increased excretion of potassium, sodium and other electrolytes, dehydration may develop.

from the gastrointestinal tract

very often: diarrhea.

often: dyspeptic phenomena, spasms and abdominal pain, flatulence.

infrequently: vomiting, nausea.

frequency unknown: pain in the stomach and anus areas, increased intestinal motility, which occur with a decrease in the dose of the drug.

from the immune system

frequency unknown: allergic reactions, angioedema, allergic dermatitis.

from the nervous system

infrequently: dizziness.

frequency unknown: headache, fatigue, drowsiness, convulsions, fainting.

The likelihood of dizziness and fainting may be associated with vasovagal reaction (such as spastic abdominal pain or tension during defecation).

Overdose:

Symptoms: high doses of Guttasil can cause liquid bowel movements, spasms (colic). in the abdomen and clinically significant violations of water-electrolyte balance (hypokalemia, loss of other electrolytes and fluids), ischemia of the mucous membrane of the large intestine.A prolonged overdose leads to the development of chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism, kidney damage and the development of nephrlithiasis, metabolic alkalosis, hypokalemia and muscular weakness as a result of hypokalemia.

Treatment: gastric lavage, intake of enterosorbents (Activated carbon), symptomatic treatment (correction of water-electrolyte balance, use of antispasmodics).

Interaction:

Electrolyte imbalance can lead to a decrease in tolerance to cardiac glycosides. Diuretics or glucocorticosteroids may increase the severity Hypokalemia caused by the use of Guttasil in high doses. Simultaneous treatment with antibiotics can reduce the laxative effect of the drug.

Special instructions:

Like other laxatives, the drug Guttasil should not be taken daily without a doctor's consultation for more than 10 days. If you need daily intake of laxatives, you should find out the cause of constipation. Long-term use of laxatives can lead to disruption of water and electrolyte balance and hypokalemia, as well as cause "addiction" and constipation due to the effect of "bounce".Guttasil should be taken under medical supervision in conditions associated with a violation of water and electrolyte balance (for example, with severe renal dysfunction).

Reported cases of dizziness and / or syncope, which coincided in time with the use of sodium picosulphate. Case analysis showed that these conditions are associated with syncope in defecation (or a syncope caused by stress during defecation) or are associated with a vasovagal response to abdominal pain that may be caused by constipation and is not necessarily associated with taking the drug. Guttasil is effective in eliminating constipation in cancer patients receiving large doses of opioids.

Studies to assess the effect on fertility have not been conducted.

The preparation contains sorbitol, so patients with a rare hereditary intolerance to fructose to take it is not recommended.

Effect on the ability to drive transp. cf. and fur:

Studies of the impact on the ability to drive vehicles and work with other mechanisms have not been carried out.

However, patients should be warned about the possibility of development due to vasovagal reaction (in particular, abdominal spasm), such adverse reactions as dizziness and / or syncope.In the event of abdominal spasm, the patient should avoid such potentially hazardous activities as driving a vehicle or working with other mechanisms.

Form release / dosage:

Drops for ingestion 7.5 mg / ml.

Packaging:

For 15 ml or 30 ml in polyethylene bottles with dispensers, sealed with lids with seals (control of the first opening).

Each bottle, along with instructions for medical use, is placed in a pack of cardboard.

Storage conditions:In the original packaging at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001138

Date of registration:08.11.2011 / 09.11.2016

Expiration Date:Unlimited

The owner of the registration certificate:FARMAK, PAO FARMAK, PAO Ukraine

Manufacturer: & nbsp

FARMAK, PAO Ukraine

Information update date: & nbsp14.05.2017

Illustrated instructions

Instructions

Guttasil (Guttasil)