Picoprep, effervescent powder for preparation of oral solution 16.1g

Composition

1 package contains:

Active ingredients:

sodium picosulfate 10 mg,

magnesium oxydalight 3.5 g,

citric acid anhydrous 12 g;

Auxiliary substances:

potassium bicarbonate,

sodium saccharin,

natural dry orange flavor (gum arabic (E 414),

lactose,

ascorbic acid (E 300),

butylhydroxyanisole (E 320).

Pharmacological action

Pharmacokinetics

The active ingredients act topically in the colon, but none of them is absorbed in significant amounts.

The time of passage through the gastrointestinal tract for each person is individual, but most often the time of orocecal passage is 4-5 hours, and passage through the colon is 12-24 hours. The osmotic effect of Picoprep begins to develop in the small intestine, meaning that within 2 hours after taking the drug, a significant amount of fluid is excreted into 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 emptying the intestines, which is from 6 to 18 hours.

Pharmacodynamics

Picoprep is a laxative, the active ingredients of the drug are sodium picosulfate, which stimulates a laxative effect and acts in the colon, and magnesium citrate, which shows a laxative effect due to osmotic phenomena of moisture retention in the colon. The effect of the drug is manifested in a strong washing effect, which is combined with the effect of stimulating intestinal motility, which determines its use for cleaning the intestines before conducting radiographic studies, colonoscopy or surgical procedures.

Indications

Cleaning of the bowel before X-ray examinations, endoscopy or before surgery

Contraindications

• Hypersensitivity
• congestive heart failure
• impaired gastric emptying, gastrointestinal ulcers, toxic colitis, toxic megacolon, intestinal obstruction, nausea and vomiting, acute abdominal pathologies requiring surgery, such as acute appendicitis, and diagnosed or suspected gastrointestinal obstruction or perforation
• renal failure (due to accumulation of magnesium in the blood plasma)
• children under 1 year of age

Side effects

• hypersensitivity, anaphylactic reaction
• hyponatremia
• headache, confusion, epilepsy, clonic-tonic convulsions, convulsions
• nausea, vomiting, abdominal pain, diarrhea, proctalgia
• rash (including erythematous and maculopapular rash), pruritus, urticaria, purpura

Interaction

Since Picoprep is a laxative, it increases the rate of gastrointestinal transit. Therefore, the use of the drug may alter the absorption of other oral medications(for example, antiepileptic and antidiabetic drugs, contraceptives and antibiotics).

The effectiveness of the drug Picoprep decreases when taken simultaneously with laxatives that increase the volume of intestinal contents.

The drug should be used with caution in patients who are already taking drugs that cause hypokalemia (such as diuretics or corticosteroids, as well as drugs that are associated with a particular risk of hypokalemia, for example, cardiac glycosides). Caution should be exercised when prescribing Picoprep to patients taking nonsteroidal anti-inflammatory drugs or drugs that induce the syndrome of inadequate antidiuretic hormone secretion, such as tricyclic antidepressants, selective serotonin reuptake inhibitors, antipsychotics, and carbamazepine medications, as these may increase the risk of water retention and/or electrolyte imbalance.

How to take, course of use and dosage

The day before hospitalization, it is recommended to switch to a low-calorie diet. To prevent dehydration during the use of the drug, it is recommended to drink a sufficient amount of water (about 250 ml per hour). The drug is used internally.

Powder preparation rules

The contents of one package are diluted in a glass of water at room temperature (about 150 ml), stirred for 2-3 minutes and drink the resulting solution. If the solution is hot, wait until the solution has cooled to a temperature suitable for drinking.

Adults (including the elderly)

The contents of one package are diluted with water, as described above, and taken in the evening the day before the procedure, repeated in 6-8 hours.

Children

1-2 years: 1/4 of the contents of the package in the morning and 1/4 of the contents of the package in the afternoon;

2-4 years: 1/2 of the contents of the package in the morning and 1/2 of the contents of the package in the afternoon;

4-9 years: contents of 1 package in the morning and 1/2 of the contents of the package in the afternoon;

9 years and older: dosage as adults.

The remaining solution is poured out. The prepared solution is not stored.

Overdose

Symptoms: profuse diarrhea may occur.

Treatment:  conduct general supportive care and ensure adequate fluid intake.

Special instructions

With extreme caution, 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 diseases.

The drug should be used with caution in patients using drugs that may affect the water and / or electrolyte balance, for example, diuretics, corticosteroids, lithium.

Since Picoprep may alter the absorption of drugs intended for regular oral use, it should be used with caution in such cases; for example, there have been isolated reports of convulsive seizures in patients taking antiepileptic drugs that previously allowed for successful control of the course of epilepsy.

Insufficient oral intake of water and electrolytes can lead to clinically significant deficiencies, especially in debilitated patients. Therefore, elderly and debilitated patients, as well as patients at risk of developing hypokalemia, should be under medical supervision. In patients with signs or symptoms of hyponatremia, rapid corrective measures may be required to restore fluid and electrolyte balance. You should consume a sufficient amount of fluids.

The period of bowel cleansing should not exceed 24 hours, since a longer procedure can increase the risk of water or electrolyte imbalance.

The drug contains lactose, so it should not be used in patients with lactose intolerance.

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

Children

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

Use during pregnancy or lactation

Clinical experience with the use of Picoprep during pregnancy is limited, so the drug should be used with caution, especially in the first trimester of pregnancy.

Sodium picosulfate and magnesium citrate are not excreted in breast milk.

Features of the drug’s influence on the ability to drive vehicles and maintain moving mechanisms

Given the possibility of convulsions, convulsions or confusion of consciousness, during the use of the drug, you should refrain from driving vehicles or working with other mechanisms.

Form of production

Powder for oral solution

Storage conditions

Store at a temperature not exceeding 25 °C.

Shelf life

3 years

Active ingredient

Sodium Picosulfate, Magnesium Oxide, Citric Acid

Dosage form

solution for oral use

Description

Pregnant women in the second and third trimester as prescribed by a doctor, Children over 9 years of age, For adults, Children as prescribed by a doctor, Nursing mothers as prescribed by a doctor

Indications

Preparation for ultrasound and X-ray of the abdominal cavity