Guttasil, drops 7.5 mg/ml 15 ml

Pharmacotherapeutic group: laxative.
ATX code: A06A B08
Pharmacological properties
Pharmacodynamics
Contact laxative of triarylmethane group, activated in large intestine under the action of bacterial sulfatases; substance released during this – stimulates sensitive nerve endings of intestinal mucosa, increases its motility. Administration of the drug is not accompanied by tenesmias and intestinal spasms.
In case of course treatment Guttasil stimulates the growth and metabolic activity of normal intestinal microflora.

Pharmacokinetics
After oral administration it reaches the large intestine without significant absorption where it is cleaved under the influence of bacterial flora to form the active form – bis-(p-hydroxyphenyl)-pyridyl-2-methane. Laxative effect develops 6-12 hours after intake, 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.< br>

Indications

Constipation or cases requiring the facilitation of defecation (hemorrhoids, proctitis, anal fissures, preparation for surgery, instrumental and radiological examinations).

Active ingredient

Sodium picosulfate

Composition

1 ml contains:
active ingredient: sodium picosulfate in terms of 100% anhydrous agent – 7.5 mg;
excipients: sorbitol (E 420) – 450.0 mg; sodium benzoate (E 211) – 2.0 mg; citric acid – 3.4 mg; sodium citrate dihydrate – 6.45 mg; water for injections up to 1 ml.

How to take, the dosage

The drug is dosed using the manufacturer’s dosing device. The following mode of administration is recommended: Adults and children over 10 years old: 13-27 drops (corresponding to 5-10 mg of sodium picosulfate).
Children from 4 to 10 years old (only if prescribed by doctor): 7-13 drops (corresponding to 2.5-5 mg of sodium picosulfate).
Use the drug in children aged 4 years and older only after consulting a doctor. It is recommended to start with the lowest dose. In order to achieve regular stools the dose may be increased to the maximum recommended one.
In order to obtain a laxative effect in the morning Guttasil should be taken at night. After using the drug Guttasil bowel emptying occurs after 10-12 hours. The drug can be used both with and without liquid. Guttasil should not be taken daily without medical advice for more than 10 days.

Interaction

Electrolyte imbalance may lead to decreased tolerance to cardiac glycosides. Diuretics or glucocorticosteroids may increase the severity of hypokalemia caused by the use of Guttasil in high doses. Concomitant treatment with antibiotics may decrease the laxative effect of the drug.

Special Instructions

Like other laxatives, Guttasil should not be taken daily without medical advice for more than 10 days. If daily use of laxatives is necessary, find out the cause of constipation. Prolonged use of laxatives may lead to disturbance of water and electrolyte balance, hypokalemia, and cause “addiction” and constipation due to the
“rebound” effect.
Guttasil should be taken under medical supervision in conditions associated with impaired water and electrolyte balance (e.g. severe renal dysfunction).
Cases of dizziness and/or fainting have been reported that coincided with the use of sodium picosulfate. Analysis of the cases showed that these conditions were associated with fainting during defecation (or fainting caused by straining during defecation) or were associated with a vasovagal reaction to abdominal pain, which may be due to constipation and not necessarily related to taking the drug.
Guttasil is effective in relieving constipation in cancer patients receiving high doses of opioids.
No studies have been done to evaluate effects on fertility.
The drug contains sorbitol, so patients with rare hereditary fructose intolerance are not recommended to take it.

Effect on the ability to drive and operate machinery
Studies on the effect on the ability to drive and operate other mechanisms have not been conducted.
However, patients should be warned about the possibility of adverse reactions such as dizziness and/or syncope due to vasovagal reaction (in particular abdominal spasm). In case of abdominal spasm the patient should avoid potentially dangerous activities such as driving vehicles or working with other mechanisms.

Contraindications

Intestinal obstruction or obstructive bowel disease; acute inflammatory bowel disease and acute abdominal diseases (including acute appendicitis, ulcerative colitis, peritonitis); severe abdominal pain accompanied by nausea, vomiting and fever, which may indicate acute inflammatory diseases, severe dehydration; hypersensitivity to sodium picosulfate and other drug components; sucrose intolerance, sucrose/isomaltase deficiency, glucose-galactose malabsorption (sorbitol is included). Pregnancy.

With caution
Use with caution in the elderly, hypokalemia, increased concentration of magnesium in the blood, patients with asthenia.
Use the drug in patients with severe renal insufficiency (in accordance with the section “Special directions”) only under medical supervision.

Side effects

Side effects are rare when taking the drug for short periods of time. Possible side effects are classified according to the frequency of occurrence as follows: very frequently (≥ 1/10), frequently (≥ 1/100 to < 1/10), infrequently (≥ 1/1000 to < 1/100), rarely (≥ 1/10000 to < 1/1000), very rarely (< 1/10000), frequency is unknown (at present data on the incidence of adverse reactions are missing).
With long-term use of the drug in significantly higher doses, there may be disorders:
skin and subcutaneous tissues
frequency is unknown: skin rash, urticaria, itching.
metabolism and nutrition
frequency unknown: increased excretion of potassium, sodium and other electrolytes, possible development of dehydration.
gastrointestinal tract
very common: diarrhea.
frequent: dyspeptic complaints, abdominal cramps and pain, flatulence. infrequent: vomiting, nausea.
frequency unknown: pain in the stomach and anus area, increased bowel motility, which improve with reducing the drug dose.
immune system
frequency is unknown: allergic reactions, angioedema, allergic dermatitis.
nervous system
infrequent: dizziness.
frequency unknown: headache, increased fatigue, drowsiness, seizures, fainting.
Probability 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 may cause liquid defecation, abdominal cramps (colic) and clinically significant disorders of water-electrolyte balance (hypokalemia, loss of other electrolytes and fluid), ischemia of the colon mucosa. Prolonged overdose leads to development of chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism, renal damage and development of nephrolithiasis, metabolic alkalosis, hypokalemia and muscle weakness as a result of hypokalemia are possible.
Treatment: gastric lavage, intake of enterosorbents (activated charcoal), symptomatic treatment (correction of water-electrolyte balance, use of antispasmodics).

Pregnancy use

In the absence of sufficient clinical trials, the use of Guttasil during pregnancy is not recommended.
Clinical data show that neither the active metabolite bis-(p-hydroxy-phenyl)-pyridyl-2-methane (BGPM) nor its glucuronides penetrate into the breast milk. Thus, Guttasil can be used during breastfeeding.

Similarities

Regulax Picosulfate, Guttalax, Slabilen, Slabicap, Picodinar