Pikodinar oral solution 7.5mg/ml, 15ml

Composition

>1 ml of the drug contains: Active ingredient: Sodium Picosulfate Monohydrate 7.5 mgm Auxiliary substances: Sorbitol liquid (non-crystallizing)643.7 mgNodium benzoate 2.0 mgNodium citrate dihydrate 1.5 mg Citric acid anhydrous 1.28 mg 10 M sodium hydroxide solution up to pH 4.5-7.5 Water for injection up to 1.0 ml

Pharmacological action

Active ingredient-sodium picosulfate is a laxative of the triarylmethane group. As a local laxative, sodium picosulfate, after bacterial breakdown in the large intestine, has a stimulating effect on the colon mucosa, increasing peristalsis, and promotes the accumulation of water and electrolytes in the large intestine. This leads to stimulation of the act of defecation, reduction of evacuation time and softening of the stool. Sodium picosulfate, being a laxative that acts at the level of the colon, stimulates the natural process of evacuation of contents from the lower gastrointestinal tract. Therefore, sodium picosulfate has no effect on the digestion or absorption of high-calorie foods or essential nutrients in the small intestine.

Indications

As a laxative in the following cases: – constipation caused by atony and hypotension of the colon (including in the elderly, in bedridden patients, after surgery, after childbirth and during lactation);- constipation caused by medication;- to regulate the stool for hemorrhoids, proctitis, anal fissures (to soften the consistency of feces);- diseases of the gallbladder, irritable bowel syndrome with a predominance of constipation; – constipation caused by intestinal dysbiosis, dietary disorders.

Recommendations for use

Inside. The following dosage regimen is recommended: Adults and children over 10 years of age: 10-20 drops (5-10 mg) per day. 4 Children 4-10 years: 5-10 drops (2.5-5 mg) per day. It is recommended to start with the lowest dose. In order to achieve a regular stool, the dose can be increased to the maximum recommended. Do not exceed the maximum recommended daily dose. The recommended dose for children under 4 years of age is 0.25 mg/kg of body weight per day. This corresponds to 1 drop of the drug (0.5 mg of sodium picosulfate) per 2 kg of body weight per day. To get a laxative effect in the morning, you should take the drug the day before at night. During use, the bottle should be held vertically. The drug does not have to be dissolved in a liquid.

Contraindications

-intestinal obstruction or obstructive bowel diseases; – acute diseases of the abdominal organs or severe abdominal pain, which may be accompanied by nausea, vomiting, fever, including appendicitis;- acute inflammatory bowel diseases; – hypersensitivity to sodium picosulfate or other components of the drug;- severe dehydration; – fructose intolerance;- pregnancy (I trimester). Use with caution in the elderly, with hypokalemia, increased blood magnesium concentrations, and patients with asthenia. Use of the drug in patients with severe renal insufficiency only under the supervision of a doctor. Use during pregnancy and lactation Data on reliable and well-controlled studies in pregnant women are not available. Long-term experience with the drug did not reveal a negative effect on pregnancy. Taking the drug in the first trimester of pregnancy is contraindicated. In the second and third trimesters of pregnancy (as with the use of other laxatives), the drug can only be taken as prescribed by a doctor. The active metabolite and its glucuronides are not excreted in breast milk. Thus, the drug can be used during breastfeeding.

Side effects

With short-term use of the drug, side effects are rarely observed. Possible side effects are classified by frequency of occurrence as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), infrequent (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (With prolonged use of the drug in significantly increased doses, the following disorders may occur: : from the skin and subcutaneous tissues frequency unknown: skin rash, urticaria, pruritus;from the side of metabolism and nutrition frequency unknown: increased excretion of potassium, sodium and other electrolytes, possible development of dehydration;from the gastrointestinal tract very often: diarrhea; often: dyspeptic phenomena, abdominal cramps and pain, flatulence; infrequently: vomiting, nausea; frequency unknown: pain in the stomach and anus, increased intestinal motility, which pass with a decrease in the dose of the drug;from the immune system, the frequency is unknown: allergic reactions, angioedema, allergic dermatitis;from the nervous system, infrequently: dizziness; frequency is unknown: headache, fatigue, drowsiness, convulsions, fainting.

Interaction

Diuretics and glucocorticosteroids increase the risk of electrolyte imbalance (hypokalemia) when taking high doses of the drug. Electrolyte imbalance can increase sensitivity to cardiac glycosides. The combined use of the drug and antibiotics may reduce the laxative effect of the drug.

Special instructions

Like other laxatives, Picodinar should not be taken daily without consulting a doctor for more than 10 days. If you need to take daily laxatives, you should find out the cause of constipation. Prolonged use of laxatives can lead to a violation of water and electrolyte balance and hypokalemia, as well as cause “addiction” and constipation due to the “rebound”effect. Picodinar should be taken under medical supervision for conditions associated with impaired water and electrolyte balance (for example, with severe renal impairment). Cases of dizziness and/or syncope were reported, which coincided with the use of sodium picosulfate. Case analysis has shown that these conditions are associated with fainting during defecation (or fainting caused by exertion during defecation) or are associated with a vasovagal reaction to abdominal pain, which may be due to constipation and is not necessarily associated with taking the drug. Picodinar is effective in eliminating constipation in cancer patients receiving high doses of opioids. Studies on the effect of the drug on fertility have not been conducted. No teratogenic effects on reproduction were detected in preclinical studies. The drug contains sorbitol, so patients with rare hereditary problems of fructose intolerance are not recommended to take it. The drug has no taste qualities, so it can be added to children’s food. Children should only take the drug as directed by their doctor. Effect on the ability to drive vehicles and mechanismspecial clinical studies of the effect of the drug on the ability to drive vehicles and work with other mechanisms have not been conducted. Despite this, patients should be warned about the possibility of developing adverse reactions such as dizziness and/or syncope due to a vasovagal reaction (in particular abdominal spasm). If abdominal cramps occur, the patient should avoid potentially dangerous activities such as driving vehicles or working with other mechanisms.

Active ingredient

Sodium Picosulfate

Dosage form

oral solution