sodium picosulfate | Picodinar solution for oral administration 7.5 mg / ml 30 ml

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SKU
BID877199
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Release form

Solution for oral administration
Release form

Solution for oral administration

Pharmacological action

Active ingredient - sodium picosulfate is a laxative of the triarylmethane group. As a local laxative, sodium picosulfate, after bacterial cleavage in the large intestine, has a stimulating effect on the mucosa of the large intestine, increasing motility, and promotes the accumulation of water and electrolytes in the large intestine. This leads to stimulation of the bowel movement, a decrease in evacuation time and softening of the stool.

Sodium picosulfate, being a laxative, acting at the level of the colon, it stimulates the natural process of evacuation of contents from the lower parts of the gastrointestinal tract. Therefore, sodium picosulfate does not affect the digestion or absorption of high-calorie foods or essential nutrients in the small intestine.

Indications

As a laxative in the following cases:

- constipation due to atony and hypotension of the colon (including the elderly, in bedridden patients, after surgery, after childbirth and during lactation)

- constipation caused by taking

medicines - to regulate stool for hemorrhoids, proctitis, anal fissures (to soften stool consistency) - gall bladder disease, irritable bowel syndrome with a predominance of constipation

- constipation due to intestinal dysbiosis, naru eniyami diet.

Special instructions

Like other laxatives, Picodinar should not be taken daily without consulting a doctor for more than 10 days. If necessary, daily use of laxatives should determine 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 "rebound". Pikodinar should be taken under medical supervision in conditions associated with impaired water and electrolyte balance (for example, with severe renal impairment). Reported cases of dizziness and / or fainting, which in time coincided with the use of sodium picosulfate.

Case analysis has shown that these conditions are associated with fainting during bowel movements (or fainting, caused by stress during bowel movements) 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 large doses of opioids.

Studies on the effect of the drug on fertility have not been conducted. In the course of preclinical studies of teratogenic effects on reproduction were not detected. The drug contains sorbitol, therefore, patients with rare hereditary fructose intolerance are not recommended to take it. The drug does not have taste, so it can be added to children as food. Children should take the drug only as directed by a doctor.

Effect on the ability to drive vehicles and mechanisms

There have been no special clinical studies of the effect of the drug on the ability to drive vehicles and work with other mechanisms.

Despite this, patients should be warned of the possibility of developing adverse reactions such as dizziness and / or syncope due to a vasovagal reaction (in particular, abdominal spasm).

In the event of an abdominal cramp, the patient should avoid potentially hazardous activities such as driving or working with other mechanisms.

Composition of

1 ml of the preparation contains:

Active ingredient:

Sodium picosulphate monohydrate 7.5 mg

Excipients:

Sorbitol liquid (non-crystallizing) 643.7 mg

Sodium benzoate 2.0 mg

Sodium citrate 1.5 mg citrate

Anhydrous citric acid 1.28 mg

10 M sodium hydroxide solution up to pH 4.5-7.5

Water for injection up to 1, 0 ml

Dosage and Administration

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 that you start with the lowest dose.

In order to achieve regular stool, the dose may 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 body weight per day.

This corresponds to 1 drop of the drug (0, 5 mg sodium picosulfate) per 2 kg of body weight per day.

To obtain a laxative effect in the morning, you should take the drug the night before.

The bottle should be kept upright during use.

The drug does not have to be dissolved in a liquid.

Side effects

With short-term use of the drug, side effects are rare.

Possible side effects are classified by frequency of occurrence as follows:

very often (? 1/10),

often (? 1/100, <1/10),

infrequently (? 1/1000, <1/100),

rarely (? 1/10000, <1/1000),

very rarely (< 1/10000),

frequency is unknown (there are currently no data on the prevalence of adverse reactions).

With prolonged use of the drug at significantly higher doses, the following disorders are possible: on the part of the skin and subcutaneous tissues

, frequency is unknown: skin rash, urticaria, pruritus

on the part of the metabolism and nutrition

frequency is unknown: increased excretion of potassium, sodium and other electrolytes, possibly development of

dehydration from the gastrointestinal tract

very often: diarrhea often: dyspeptic symptoms, cramping and abdominal pain, flatulence

infrequent: vomiting, nausea

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

from the immune system

, frequency is unknown: allergic reactions, angioedema, allergic dermatitis

from the nervous system

infrequently: dizziness

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

Drug Interactions

Diuretics and glucocorticosteroids increase the risk of electrolyte imbalance (hypokalemia) when taking high doses of the drug.

Impaired electrolyte balance may increase sensitivity to cardiac glycosides.

The combined use of the drug and antibiotics may reduce the laxative effect of the drug.

Active ingredient

Sodium picosulfate

Terms of sale from pharmacies

Over-the-counter

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