Citric acid, Magnesium oxide, Sodium picosulfate

Pharmacological properties

active substances of the drug picoprep are sodium picosulfate and magnesium citrate.

Sodium picosulfate is a local substance that irritates the intestinal mucosa, after being split by bacteria in the colon, it turns into the active form of the laxative - bis- (p-hydroxyphenyl) -pyridyl-2-methane (BHPM), which acts as a local irritant like in the colon and in the rectum.

Magnesium citrate has an osmotic and laxative effect, causing the release of fluid into the intestinal lumen. The action of the drug is a powerful flushing effect, which is combined with the effect of stimulating intestinal motility.

Pharmacokinetics Both active components act locally in the colon, and not one of them is absorbed in significant quantities. The passage in the gastrointestinal tract is individual for each person, but often the period of the orocecal passage is 4–5 hours, and the passage through the colon is 12–24 hours. The osmotic effect of the drug Picoprep begins to develop in the small intestine, which means that within 2 hours after taking the drug, a significant amount of fluid is excreted in the intestine. The motor effect of the drug develops only in the colon and depends on how much fluid was excreted, and how much fluid the patient took additionally. The effect of the drug completely stops after bowel movement, is from 6 to 18 hours

Indications

For bowel cleansing before an X-ray, endoscopy, or before surgery.

Application

The day before hospitalization, it is recommended to switch to a low-calorie diet. to avoid dehydration with the use of picoprep, it is recommended to use a sufficient amount of water or another clear liquid. the drug is taken orally.

Powder Dilution Instructions. The contents of the sachets are dissolved in a cup of water at room temperature (approximately 150 ml). The mixture is stirred for 2-3 minutes. The solution acquires a whitish color, becomes cloudy with a faint smell of orange. This solution is ready for use.

Adults (including the elderly): (if the study / operation is scheduled for the second half of the next day, it is recommended to use a separate regimen)

Separate intake regimen (on the evening before and on the day of the procedure). The first sachet is taken in the evening before the procedure, the second - in the morning on the day of the procedure.

The day before the procedure - 1 sachet:

• the contents of one sachet are dissolved with water, as described above, and taken in the evening, approximately between 17:00 and 21:00 the day before the procedure, after which at least 5 glasses of a clear liquid of 250 ml are drunk.

On the day of the procedure - 1 sachet:

• the contents of the second sachet is taken in the morning (5–9 hours before the procedure), after which they drink at least 3 glasses of clear liquid with a volume of 250 ml.

Transparent liquid can be boiled no later than one hour before the procedure

or

Reception mode on the eve (only in the evening on the eve of the procedure). The first sachet is taken in the afternoon or early evening and the second sachet - after about 6 hours at night.

The day before the procedure - 2 sachets:

• the first sachet is taken in the afternoon or at the beginning of the evening (for example, from 16: 00-18: 00), after which they drink at least 5 glasses of clear liquid with a volume of 250 ml;
• the second sachet is taken late in the evening (22: 00-24: 00), after which they drink at least 3 glasses of clear liquid with a volume of 250 ml.

Transparent liquid can be boiled no later than 1 hour before the procedure.

Children: the drug is used in children under the age of 9 years under the supervision of a doctor in a hospital.

The first dose is dissolved in water, as indicated above, is taken until 8:00 on the day of the procedure. The second dose is taken 6-8 hours after the first.

1-2 years: ¼ volume of the prepared solution in the morning and ¼ volume of the prepared solution in the afternoon;

2–4 years: ½ volume of cooked solution in the morning and ½ volume of cooked solution in the afternoon;

4–9 years: cooked solution containing 1 sachet in the morning and ½ volume of the prepared solution in the afternoon;

9 years: dose for adults.

At preparation of solution it is recommended to use measured ware.

The remains of solution are poured. Cooked rr do not save.

Contraindications

Hypersensitivity to any of the components of the drug, congestive heart failure, impaired gastric emptying, gastrointestinal ulcers, toxic colitis, toxic megacolon, intestinal obstruction, nausea and vomiting, acute abdominal pathology requiring surgical intervention, for example, acute appendicitis, as well as diagnosed or suspected gastrointestinal obstruction or perforation, severe dehydration, rhabdomyolysis, hypermagnesemia, an active inflammatory process in the intestine.

Side effects

Organ System Classification often (≥1 / 100 to ≤1 / 10) infrequently (≥1 / 1000 to ≤1 / 100) from the immune system anaphylactic reactions, hypersensitivity from the side of metabolism hyponatremia, hypokalemia from the nervous system headache epilepsy, clonic-tonic convulsions, convulsions, confusion from the gastrointestinal tract nausea, proctalgia vomiting, abdominal pain, aphthous ileal ulcers * diarrhea, fecal incontinence on the part of the skin and subcutaneous tissue rash (including erythematous and maculopapular), urticaria, pruritus, purpura

* Some cases of development of aphthoid ileal ulcers in a mild reversible form have been reported.

Diarrhea and fecal incontinence are the main clinical manifestations of Picoprep. According to post-marketing observations, isolated cases of acute diarrhea were noted. Cases of hyponatremia, both associated with seizures and isolated, have been reported. In patients with a history of epilepsy, the development of “small” and “large” seizures was detected even in the absence of hyponatremia. There have also been isolated cases of anaphylactic reactions.

special instructions

Bowel cleansing should only be done when there are clear preoperative indications, since the clinically relevant benefits of bowel cleansing before planned colorectal surgery cannot be proven. the relationship between risk and benefit requires careful evaluation depending on the procedure.

With special care, the drug should be used after recently performed surgical procedures on the gastrointestinal tract, as well as in patients with impaired renal function, heart disease or inflammatory bowel disease in history.

Caution should be prescribed to patients who use drugs that affect the water and / or electrolyte balance, such as diuretics, GCS, lithium.

Since Picoprep may change the absorption of drugs intended for regular oral use, in such cases it should be used with caution. Thus, separate reports have been received about seizures of convulsions in patients taking antiepileptic drugs, which previously made it possible to successfully control the course of epilepsy.

Insufficient oral intake of water and electrolytes can lead to their clinically significant deficiency, especially in debilitated patients. Therefore, elderly patients and debilitated patients, as well as those at risk of developing hypokalemia, should be monitored. Patients with signs or symptoms of hyponatremia may need to take quick corrective measures to restore fluid and electrolyte balance. Adequate fluids should be taken.

The period of intestinal cleansing should not exceed 24 hours, since a long procedure can increase the risk of disturbing the water-electrolyte balance.

Each sachet containing the drug contains 5 mmol (or 195 mg) of potassium. This information should be considered when prescribing the drug to patients with impaired renal function or in patients on a diet with a limited intake of potassium.

The drug contains lactose, therefore, it should not be used in patients with hereditary disorders of galactose metabolism, such as Lapp lactase deficiency or impaired absorption of glucose-galactose.

The drug is not intended for use as a regular laxative.

Use during pregnancy and lactation. There is no clinical experience with the use of the drug Pikoprep during pregnancy. For safety reasons, this drug should not be used during pregnancy, since sodium picosulfate has a laxative effect and stimulates peristalsis.

There is no clinical experience with the use of the drug Pikoprep during breastfeeding. However, given the pharmacokinetic properties of the drug, it is possible to use the drug Picoprep during lactation.

Children. The drug is used in children from the age of 1 year under the supervision of a doctor in a hospital.

The ability to influence the reaction rate when driving vehicles and working with other mechanisms. For the period of use of the drug, one should refrain from classes requiring the speed of psychomotor reactions, given the possibility of convulsions, convulsions or confusion.

Interactions

Since picoprep is a laxative, it increases the rate of gastrointestinal transit. in this regard, taking the drug may alter the absorption of other oral medications (e.g. antiepileptic