Picodinar (Drops) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

A06AB08 (Sodium picosulfate)

Active Substance

Sodium picosulfate (Rec.INN registered by WHO)

Dosage Form

Picodinar

Oral drops 7.5 mg/1 ml: bottle 10 ml, 15 ml, 20 ml, 25 ml, 30 ml or 40 ml 1 pc.

Dosage Form, Packaging, and Composition

Oral drops as a transparent, slightly viscous, colorless or greenish-yellow, or brownish-yellow, or brown liquid.

Excipients : liquid sorbitol (non-crystallizing) – 643.7 mg, sodium benzoate – 2 mg, sodium citrate dihydrate – 1.5 mg, anhydrous citric acid – 1.28 mg, 10M sodium hydroxide solution – to pH 4.5-7.5, water for injections – to 1 ml.

10 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
15 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
20 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
25 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
30 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
40 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.

Clinical-Pharmacological Group

Laxative drug

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Laxative. Under the action of intestinal microorganisms, it is hydrolyzed to form an active form, which irritates the receptors of the intestinal mucosa and enhances its peristalsis.

It promotes the accumulation of water and electrolytes in the large intestine, which leads to stimulation of defecation, reduction of evacuation time, and softening of stool.

Pharmacokinetics

After oral administration, it is not absorbed from the gastrointestinal tract and does not undergo enterohepatic circulation.

In the distal part of the large intestine, sodium picosulfate is cleaved to form the active metabolite bis-(p-hydroxyphenyl)-pyridyl-2-methane. The time to onset of the laxative effect is determined by the rate of release of the active metabolite and is 6-12 hours.

Approximately 10.4% of the total dose is excreted by the kidneys as a glucuronide within 48 hours.

Indications

Constipation due to atony and hypotension of the colon (including in the elderly, in bedridden patients, after surgery, after childbirth and during lactation); constipation caused by medication; constipation due to intestinal dysbiosis, dietary violations; for regulating stool in hemorrhoids, proctitis, anal fissures; gallbladder diseases, irritable bowel syndrome with predominant constipation.

ICD codes

Dosage Regimen

Administer orally. Determine the dose individually based on the patient’s age and clinical response.

For adults and children over 10 years, the usual dose is 13 to 27 drops (0.5 to 1.0 ml) containing 10 to 20 mg of sodium picosulfate. Take once daily, preferably in the evening.

For children aged 4 to 10 years, the usual dose is 7 to 13 drops (0.25 to 0.5 ml) containing 5 to 10 mg of sodium picosulfate. Take once daily.

For children under 4 years, determine the dose strictly by a physician. The typical dose is 1 drop per 2 kg of body weight.

Measure the dose precisely using the dropper provided. Dilute the drops in a small amount of water immediately before administration. The solution is tasteless and can be added to food or drink for children.

Do not use for more than 10 consecutive days without medical supervision. The onset of the laxative effect typically occurs after 6 to 12 hours.

Adjust the dosage to achieve one soft stool per day. If the nature of the stool does not change, discontinue use and consult a physician to determine the cause of constipation.

In cases of severe or chronic constipation, use the lowest effective dose for the shortest possible duration to avoid electrolyte imbalance and dependence.

Adverse Reactions

From the digestive system dyspepsia, flatulence, nausea, vomiting, abdominal cramps and pain, diarrhea.

From the nervous system dizziness, fainting, drowsiness, increased fatigue.

From the immune system allergic reactions, angioedema, allergic dermatitis.

From the skin and subcutaneous tissues skin rash, urticaria, itching.

From metabolism increased excretion of potassium, sodium and other electrolytes, dehydration.

Contraindications

Hypersensitivity to sodium picosulfate; intestinal obstruction or obstructive bowel diseases; acute diseases of the abdominal organs or severe abdominal pain that may be accompanied by nausea, vomiting, fever, including appendicitis; acute inflammatory bowel diseases; severe dehydration; first trimester of pregnancy; pediatric age – depending on the dosage form.

With caution elderly age, hypokalemia, increased blood magnesium concentration, asthenia, renal failure.

Use in Pregnancy and Lactation

Contraindicated for use in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy should only be if the intended benefit to the mother outweighs the potential risk to the fetus.

The active metabolite and its glucuronides are not excreted in breast milk. It is possible to use during lactation (breastfeeding) according to indications in recommended doses.

Use in Renal Impairment

Should be used with caution in patients with impaired renal function.

Pediatric Use

It is possible to use in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the sodium picosulfate drug labels regarding contraindications for the use of specific sodium picosulfate dosage forms in children of different ages.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

The product is tasteless, so it can be added to food for children. Do not use daily without medical supervision for more than 10 days.

Dizziness and fainting that occur after taking sodium picosulfate may be associated with a vasovagal reaction (e.g., straining during defecation, abdominal cramps).

The possibility of spontaneous defecation cannot be excluded. If the nature of the stool does not change for a long time while taking sodium picosulfate, it is necessary to consult a doctor to determine the cause of constipation.

Studies on the effect of sodium picosulfate on fertility have not been conducted. No teratogenic effects were identified.

Effect on ability to drive vehicles and operate machinery

If vasovagal reactions occur in patients while taking the product, they should avoid driving vehicles and engaging in other activities that require high concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with broad-spectrum antibiotics, a decrease in the laxative effect of sodium picosulfate is possible.

With simultaneous use with diuretics, with corticosteroids, an increased risk of electrolyte disturbances is possible.

Electrolyte imbalance that occurs while taking sodium picosulfate in high doses may lead to worsened tolerance of cardiac glycosides with their simultaneous use.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.