Picodinar drops 7.5mg/ml 30ml

Instruction for Picodinar

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Release form and composition

They release the drug in the form of drops for oral administration: a slightly viscous, transparent, slightly colored or colorless liquid (10, 15, 20, 25, 30, or 40 ml each in a bottle with a dropper made of polyethylene and a lid with a first opening control, in a cardboard pack 1 bottle and instructions for the use of Picodinar).
1 ml drops contain:
    active substance: sodium picosulfate monohydrate - 7.5 mg;
    additional components: sodium citrate dihydrate, sorbitol liquid (not crystallizing), anhydrous citric acid, sodium benzoate, sodium hydroxide solution 10M, water for injection.

Pharmacodynamics

Sodium picosulfate belongs to the stimulators of intestinal motility of the triarylmethane group. Being a local laxative, the drug after bacterial cleavage in the colon promotes the activation of the mucous membrane of the latter, increasing motility, leads to the accumulation of electrolytes and water in the colon. These effects stimulate the act of defecation, reduce the period of evacuation and soften feces.
Picodinar, acting at the level of the colon, provides a natural course of evacuation of contents from the lower parts of the gastrointestinal tract (GIT). As a result, sodium picosulfate does not affect the digestion or absorption of essential nutrients from the small intestine.

Pharmacokinetics

The absorption of the drug is insignificant, because it undergoes almost complete metabolic transformation in the wall of the intestine and liver, as a result of which it is converted into inactive glucuronide. Since sodium picosulfate, after oral administration, enters the colon and is absorbed in minimal amounts, its enterohepatic circulation can be ruled out. After cleavage of the active substance in the distal colon, an active metabolite is formed - bis- (p-hydroxyphenyl) -pyridyl-2-methane. The rate of release of this metabolite determines the period of development of the laxative effect, which can range from 6 to 12 hours.
A small amount of sodium picosulfate is detected in the systemic circulation. No relationship was found between the serum concentration of the active metabolite in the blood and its laxative effect. After oral administration of Picodinar at a dose of 10 mg, approximately 10.4% of the administered dose is excreted after 48 hours in the form of glucuronide. When using higher doses of the drug, its excretion by the kidneys ultimately decreases.

Indications for use

Picodinar is recommended for use as a laxative in the following diseases:
    constipation associated with hypotension and atony of the colon (including in elderly patients, bedridden patients, in patients after surgery, after childbirth and during lactation);
    constipation due to the use of drugs;
    gallbladder disease, irritable bowel syndrome with a predominance of constipation;
    hemorrhoids, proctitis, anal fissures - with the aim of regulating the stool (softening the consistency of feces);
    constipation caused by dietary disorders, intestinal dysbiosis.

Contraindications

Absolute:
    acute inflammatory bowel disease;
    obstructive bowel disease or intestinal obstruction;
    intense abdominal pain or acute lesions of the abdominal organs, which can occur with an increase in body temperature, nausea, vomiting (including appendicitis);
    severe dehydration;
    pregnancy (I trimester);
    fructose intolerance (since picodinar contains sorbitol);
    hypersensitivity to any component of a laxative.
Relative contraindications, conditions / diseases in which Picodinar drops should be used with caution: severe renal failure, increased levels of magnesium in the blood, hypokalemia, asthenia, advanced age.

Instructions for use: method and dosage

The drops are taken orally.
Recommended daily doses depending on the age of the patients:
    adults, adolescents, and children over 10 years of age: 5–10 mg (10–20 drops);
    children 4-10 years old: 2.5-5 mg (5-10 drops);
    children under 4 years: 0.25 mg per 1 kg of body weight, i.e. 0.5 mg (1 drop) per 2 kg of child’s weight.
Children from 4 years of age and adults should start taking the drug with the lowest recommended dose. In order to achieve regular stool, you can increase the daily dose without exceeding the maximum recommended dosage of Picodinar.
In order to get a laxative effect in the morning, the drug should be taken the night before.
Drops before administration can not be diluted in liquids. For a more accurate dosage of the drug, the vial should be held upright.

Side effects

With short-term use of Picodinar, adverse events are rarely recorded.
Against the background of prolonged therapy with the drug in significantly higher doses, the following adverse reactions can be observed:
    metabolism: with an unknown frequency - increased excretion of potassium, sodium and other electrolytes, dehydration may occur;
    skin and subcutaneous tissue: with an unknown frequency - skin rash, itching, urticaria;
    immune system: with an unknown frequency - allergic reactions, allergic dermatitis, angioedema;
    nervous system: infrequently - dizziness: with an unknown frequency - drowsiness, increased fatigue, headache, fainting, convulsions;
    Gastrointestinal tract: very often - diarrhea; often - dyspeptic symptoms, flatulence, cramping and abdominal pain; infrequently - vomiting, nausea; with an unknown frequency - pain in the epigastrium and perianal region, increased intestinal motility (pass with a decrease in the dose of the drug).

Overdose

Due to the use of high doses of sodium picosulfate, the following disorders may occur: dehydration, decreased blood pressure (BP), hypokalemia, diarrhea, impaired water-electrolyte balance, and convulsions. Also, cases of the occurrence of ischemia of the muscles of the large intestine caused by the use of Picodinar doses far exceeding the recommended ones were recorded.
Against the background of a chronic overdose of sodium picosulfate, as well as other laxatives, the development of pain in the abdomen, chronic diarrhea, hypokalemia, urolithiasis, and secondary hyperaldosteronism are likely. Damage to the renal tubules, muscle weakness, metabolic alkalosis due to hypokalemia may also be noted.
In order to reduce Picodinar absorption after oral administration of high doses, induction of vomiting or gastric lavage is recommended. If necessary, restoration of fluid volume, correction of electrolyte disturbances, and the use of antispasmodic drugs are indicated.

Special instructions

Picodinar can not be taken daily for more than 10 days without consulting your doctor. If you need to constantly take laxatives, you need to establish the cause of constipation.
A long course of treatment with the drug can cause hypokalemia and disturbances in the water-electrolyte balance, as well as lead to addiction and constipation resulting from the rebound effect.
Against the background of conditions associated with a violation of the water-electrolyte balance (including with severe renal impairment), a medication should be taken under medical supervision.
While taking Picodinar, cases of dizziness and / or fainting were recorded. Analysis of these cases showed that they are associated with fainting during bowel movements, or fainting due to tension during bowel movements, or are caused by a vasovagal reaction to abdominal pain due to constipation and possibly not related to taking the drug.
Picodinar has been shown to be effective in treating constipation in cancer patients using high-dose opioids.
The effect of the drug on fertility has not been studied. In the process of preclinical studies, no teratogenic effect of the drug on reproductive function was revealed.
Since the laxative has a neutral taste, it is allowed to add to food for children.

Influence on the ability to drive vehicles and complex mechanisms

Special studies to study the influence of Picodinar on the ability to drive a car and control complex equipment have not been conducted. However, during the treatment period, the risk of dizziness and / or syncope during intestinal spasm (due to a vasovagal reaction) should be considered. If patients experience abdominal cramping, they need to avoid driving vehicles or working with other potentially dangerous and complex mechanisms.

Pregnancy and lactation

Taking the drug in the first trimester of pregnancy is contraindicated.
Data on reliable and adequate studies in pregnant women are not available. Long-term experience using the drug indicates that it does not have a negative effect on pregnancy. Take Picodinar in the II and III trimesters of pregnancy, like other laxatives, is allowed only on the recommendation of a doctor.
The active metabolite of sodium picosulfate and its glucuronides are not excreted in breast milk, so Picodinar can be used during breastfeeding.

Use in childhood

The use of the drug in children is possible only as directed by the attending physician, subject to the recommended dosage regimen of Picodinar.

With impaired renal function

In the presence of a severe degree of renal failure, Picodinar therapy is required only under medical supervision.

Use in old age

Elderly patients should take picodinar with caution.

Drug interaction

    cardiac glycosides: there may be an increase in sensitivity to these drugs due to an electrolyte imbalance that occurs with sodium picosulfate;
    antibiotics: a possible decrease in the laxative effect of Picodinar;
    glucocorticosteroids (GCS), diuretics: the risk of developing hypokalemia with a combination of these drugs with sodium picosulfate in high doses may be aggravated.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C, out of the reach of children.
Shelf life is 3 years.

Reviews

The few reviews about Picodinar that occur on specialized sites mainly indicate the effectiveness of the drug in the treatment of constipation of a different nature. Drops show a good laxative effect for problems with bowel movements caused by drugs, constipation with hemorrhoids, after operations, childbirth, as well as chronic constipation in the elderly (including in severe form). The advantages of the drug also include the possibility of its use during pregnancy (except for the first trimester), during breastfeeding and in children, including newborns.
However, some patients indicate severe cramping, abdominal pain and diarrhea that occur after taking the drug.

Terms of sell

You can buy Picodinar without a prescription.