Sodium picosulfate (Tablets, Drops) Instructions for Use
ATC Code
A06AB08 (Sodium picosulfate)
Active Substance
Sodium picosulfate (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Laxative drug
Pharmacotherapeutic Group
Drugs for the treatment of constipation; contact laxatives
Pharmacological Action
Laxative agent. 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
| ICD-10 code | Indication |
| K59.0 | Constipation |
| K60 | Fissure and fistula of anus and rectum |
| K62.8 | Other specified diseases of anus and rectum (including proctitis) |
| K64 | Hemorrhoids and perianal venous thrombosis |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| DB32.1 | Slow-transit constipation |
| DB50.Z | Fissure or fistula of anal region, unspecified |
| DB6Z | Hemorrhoids or perianal venous diseases, unspecified |
| DB70.Z | Infections of anal and rectal regions, unspecified |
| DB72.Z | Some specified diseases of the anal canal, unspecified |
| DD91.1 | Functional constipation |
| DE2Z | Diseases of the digestive system, unspecified |
| EG61 | Infections of the anus or perianal skin |
| QB9A | Preparatory procedures for subsequent treatment |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer orally. Determine the dose individually based on patient age and clinical response.
For adults and children over 10 years, the typical dose is 10-20 mg (5-10 ml of 0.2% oral solution or 1-2 tablets) once daily.
For children aged 4 to 10 years, administer 5-10 mg (2.5-5 ml of 0.2% oral solution) once daily.
For children aged 1 to 4 years, administer 2.5-5 mg (1.25-2.5 ml of 0.2% oral solution) once daily.
For infants under 1 year, use only on medical advice; the typical dose is up to 2.5 mg (1.25 ml of 0.2% oral solution) once daily.
Take the dose in the evening before bedtime to produce a laxative effect after approximately 6-12 hours.
For preparatory procedures before colonoscopy or surgery, follow the specific bowel cleansing regimen prescribed by a physician.
Adjust the dose to achieve one soft stool per day. Use the lowest effective dose.
Do not use for more than 10 consecutive days without medical supervision.
For liquid formulations, use the dropper provided and mix the dose with a small amount of water or juice if needed.
Discontinue use if severe abdominal pain, diarrhea, or dehydration occurs and consult a physician.
Adverse Reactions
From the digestive system dyspepsia, flatulence, nausea, vomiting, cramps and abdominal 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; childhood – depending on the dosage form.
With caution old age, hypokalemia, increased concentration of magnesium in the blood, 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 a deterioration in the tolerability 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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Oral drops 7.5 mg/ml: 15 ml or 25 ml dropper bottle; 10 ml, 15 ml or 25 ml bottle 1 pc.
Marketing Authorization Holder
Marbiopharm, JSC (Russia)
Dosage Form
 |
Sodium picosulfate | Oral drops 7.5 mg/ml: 15 ml or 25 ml dropper bottle; 10 ml, 15 ml or 25 ml bottle 1 pc. |
Dosage Form, Packaging, and Composition
Oral drops as a clear, slightly viscous solution from colorless to yellowish or slightly brownish-yellow, with a faint characteristic odor.
| 1 ml | |
| Sodium picosulfate monohydrate | 7.5 mg |
Excipients : sodium citrate dihydrate, citric acid monohydrate, sodium benzoate, liquid non-crystallizing sorbitol, purified water.
15 ml – dropper bottles (1) – cardboard boxes.
25 ml – dropper bottles (1) – cardboard boxes.
10 ml – bottles (1) – cardboard boxes.
15 ml – bottles (1) – cardboard boxes.
25 ml – bottles (1) – cardboard boxes.
Oral drops 7.5 mg/1 ml: bottle/dropper bottle/jar from 10 ml to 100 ml.
Marketing Authorization Holder
Stmfarm LLC (Russia)
Manufactured By
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Sodium picosulfate | Oral drops 7.5 mg/1 ml: bottle/dropper bottle/jar from 10 ml to 100 ml. |
Dosage Form, Packaging, and Composition
Oral drops as a clear, from colorless to yellowish or slightly yellowish-brown, slightly viscous solution.
| 100 ml | |
| Sodium picosulfate monohydrate | 0.75 g |
Excipients : sodium benzoate – 0.2 g, liquid sorbitol 70% (non-crystallizing) – 64.37 g (in terms of sorbitol – 45.059 g), sodium citrate dihydrate – 0.15 g, citric acid (monohydrate) – 0.14 g, purified water 49.89 g.
From 10 ml to 100 ml – bottles (1) – cardboard boxes.
From 10 ml to 100 ml – orange glass dropper bottles (1) – cardboard boxes.
From 10 ml to 100 ml – jars (1) – cardboard boxes.
Oral drops 7.5 mg/1 ml: 15 ml or 30 ml bottle
Marketing Authorization Holder
Formula-FR, LLC (Russia)
Manufactured By
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Sodium picosulfate | Oral drops 7.5 mg/1 ml: 15 ml or 30 ml bottle |
Dosage Form, Packaging, and Composition
Oral drops as a clear, from colorless to yellowish or slightly yellowish-brownish, slightly viscous solution.
| 100 ml | |
| Sodium picosulfate monohydrate | 0.75 g |
Excipients : sodium benzoate – 0.2 g, liquid sorbitol 70% (non-crystallizing) – 64.37 g (in terms of sorbitol – 45.059 g), sodium citrate dihydrate – 0.15 g, citric acid monohydrate – 0.14 g, purified water – 49.89 g.
15 ml – polymer bottles (1) – cardboard boxes.
15 ml – polymer bottles (1) with a dropper cap – cardboard boxes.
15 ml – dark glass bottles (1) with a dropper cap – cardboard boxes.
30 ml – polymer bottles (1) – cardboard boxes.
30 ml – polymer bottles (1) with a dropper cap – cardboard boxes.
30 ml – dark glass bottles (1) with a dropper cap – cardboard boxes
Tablets 5 mg: 10 or 20 pcs.
Marketing Authorization Holder
Medisorb, JSC (Russia)
Dosage Form
|
Sodium picosulfate Medisorb | Tablets 5 mg: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical, with a bevel on both sides and a score on one side.
| 1 tab. | |
| Sodium picosulfate monohydrate | 5.187 mg, |
| Which corresponds to the sodium picosulfate content | 5 mg |
Excipients : lactose monohydrate, corn starch, hydrolyzed potato starch, colloidal silicon dioxide, magnesium stearate.
10 pcs. – blister packs (1) – cardboard boxes.
10 pcs. – blister packs (2) – cardboard boxes.
Oral drops 7.5 mg/ml: 10 ml, 15 ml, 20 ml, 25 ml or 30 ml bottle
Marketing Authorization Holder
VTF, LLC (Russia)
Dosage Form
|
Sodium picosulfate-VTF | Oral drops 7.5 mg/ml: 10 ml, 15 ml, 20 ml, 25 ml or 30 ml bottle |
Dosage Form, Packaging, and Composition
Oral drops as a clear, slightly viscous solution from colorless to yellowish or slightly yellowish-brown.
| 1 ml | |
| Sodium picosulfate monohydrate | 7.5 mg |
Excipients : liquid non-crystallizing sorbitol – 643.7 mg, sodium benzoate – 2 mg, sodium citrate dihydrate – 1.5 mg, citric acid – 1.4 mg, purified water – up to 1 ml.
10 ml – bottles (1) – cardboard boxes.
15 ml – bottles (1) – cardboard boxes.
20 ml – bottles (1) – cardboard boxes.
25 ml – bottles (1) – cardboard boxes.
30 ml – bottles (1) – cardboard boxes.
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