Pikoprep® (Pikoprep®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsppowder effervescent for solution for oral administration
Composition:

1 sachet contains:

active substances: citric acid anhydrous 12 g, magnesium oxide 3.5 g, sodium picosulfate monohydrate 10.0 mg;

Excipients: potassium hydrogen carbonate 0.5 g, sodium saccharinate dihydrate 0.06 g, orange flavor * 0.06 g

* The orange flavoring includes dry extract of orange, lactose, xanthine gum, ascorbic acid and butylhydroxyanisole (E320).

Description:

BA white crystalline powder with a faint orange smell.

Description of the solution: White or white with a yellowish tinge opaque solution with a characteristic orange odor.

Pharmacotherapeutic group:laxative
ATX: & nbsp
  • Sodium picosulphate in combination with other drugs
    • Pharmacodynamics:

    The active components of Pikoprep® are sodium picosulphate, which has a local laxative effect in the large intestine, and magnesium citrate, which is formed from citric acid and magnesium oxide when the powder dissolves and acts as an osmotic laxative by retaining water in the large intestine. Purification of the intestine is due to a powerful "washout" effect in combination with stimulation of peristalsis,which is necessary for carrying out X-ray or endoscopic (colonoscopy) studies and surgical manipulations.

    Pharmacokinetics:

    All active components have a local action in the colon and are not practically absorbed.

    Indications:

    Purification of the intestine before performing X-ray or endoscopic (colonoscopy) studies and surgical manipulations.

    The drug is not used as a regular laxative!

    Contraindications:

    - Hypersensitivity to one of the components of the drug,

    - chronic heart failure,

    - dehydration,

    - weakness of gastric motility,

    - peptic ulcer of the stomach and duodenum,

    - toxic colitis,

    - toxic megacolon,

    - intestinal obstruction,

    - nausea and vomiting,

    - severe renal dysfunction,

    - rhabdomyolysis,

    - hypermagnesia,

    - acute surgical abdominal states: acute appendicitis, diagnosed or suspected obstruction or perforation of the gastrointestinal tract,

    - The recently transferred surgical intervention on the gastrointestinal tract,

    - lactose intolerance, lactase deficiency and glucose-galactose malabsorption,

    - pregnancy (I trimester),

    - children's age till 9 years.

    If you have any of these diseases, consult a doctor before taking the drug.

    Carefully:

    It should be used with caution in patients with impaired renal function, heart disease, inflammatory bowel disease, in patients taking drugs that affect the water-electrolyte balance (diuretics, corticosteroids, lithium preparations), in the elderly (65 years and older) and weakened patients , during breastfeeding, during pregnancy (II and III trimesters), as well as in patients at risk of hypokalemia.

    Pregnancy and lactation:

    Clinical data on the use of Pikoprep® in pregnancy are absent. But since sodium picosulfate has a stimulating effect on intestinal peristalsis, it is not recommended to apply the drug in the first trimester of pregnancy. The drug intake during the II and III trimesters of pregnancy is possible only after a thorough assessment of the need and risks.

    Caution is prescribed during breastfeeding, although neither sodium picosulphate nor magnesium citrate do not penetrate into breast milk.

    Dosing and Administration:

    For oral administration. The day before the procedure is recommended to reduce the number of meals. To avoid dehydration while drinking Pikoprep®, drinking is recommended.

    The contents of one sachet are dissolved in 150 ml of water, stirred for 2-3 minutes, cooled to an acceptable temperature and drunk.

    Adults and children over 9 years of age

    If the procedure is scheduled for the first half of the day:

    - The contents of the first bag are taken after lunch or in the early evening (16-18 hours), with at least 5 glasses of 250 ml of water or clear liquid (water, non-carbonated soft drinks, tea, coffee, fruit juice without pulp).

    - The contents of the second packet are taken at night (22-24 hours), at least 3 glasses with 250 ml water or clear liquid. The last glass can be drunk no later than 1 hour before the procedure.

    If the procedure is scheduled for the afternoon:

    - The contents of the first packet are taken in the evening (at 17-21 hours) on the day preceding the procedure, with at least 5 glasses of 250 ml of water or clear liquid.

    - The contents of the second packet are taken in the morning (5-9 hours before the procedure), with at least 3 glasses of 250 ml water or clear liquid. The last glass can be drunk no later than 1 hour before the procedure.

    Side effects:

    Adverse reactions after taking Pikoprep® are given in the table:

    Classification by systems of organs

    Often

    (> 1/100 to <1/10)

    Rarely

    (> 1/1000 to <1/100)

    Single cases

    The immune system

    Anaphylactic reactions, hypersensitivity

    Metabolism

    Hyponatremia, hypokalemia

    Nervous system

    Headache

    Epilepsy, a large seizure (without hyponatremia), convulsions, confusion

    Gastrointestinal tract

    Nausea, procalgia

    Vomiting, diarrhea, abdominal pain

    Transient aphthoid ileal ulcers

    Skin and subcutaneous tissue

    Rash (including erythematous and maculopapular), hives, itching, purpura

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:

    Overdose can lead to profuse diarrhea and, as a consequence, to dehydration. Measures should be taken to restore the water-electrolyte balance.

    Interaction:

    The drug Pikoprep® can affect the absorption of oral drugs of constant use (antiepileptic, hypoglycemic drugs, oral contraceptives, antibiotics).For example, there are cases of epileptic seizures in connection with taking Pikoprep® against a background of previously compensated epilepsy with epilepsy. In such patients, Pikoprep® should be used with caution.

    Simultaneous administration of Pikoprep with diuretics, corticosteroids or cardiac glycosides increases the risk of hypokalemia.

    Simultaneous administration of Pikoprep with non-steroidal anti-inflammatory drugs (NSAIDs), as well as with drugs that can cause the syndrome of inappropriate secretion of the antidiuretic hormone or salt-losing syndrome (eg, tricyclic antidepressants, selective serotonin reuptake inhibitors, antipsychotics and carbamazepine) increases the risk of disturbance of the water-electrolyte balance.

    Special instructions:

    The drug is not intended to be used as a regular laxative.

    In patients with signs of hyponatremia, urgent measures should be taken to restore the water-electrolyte balance.

    The drug contains potassium hydrogen carbonate, which should be taken into account in patients with a low-potassium diet.

    The composition of the flavor of the orange preparation Pikoprep® includes lactose. Therefore, patients with lactose intolerance, Lappease lactase deficiency, or glucose-galactose malabsorption, this drug is not recommended.

    In patients with a significant decrease in renal function, the magnesium content of the plasma may increase. In this case, another drug should be used.

    Insufficient intake of water and electrolytes can cause a clinically significant deficiency of these components, especially in weakened patients.

    The period of preparation for bowel cleansing should not exceed 24 hours, a longer period increases the risk of disturbance of the water-electrolyte balance.

    Against the background of taking other powdered laxatives, the effectiveness of Pikoprep® is reduced.

    Effect on the ability to drive transp. cf. and fur:

    In connection with the possibility of developing side effects from the nervous system, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Powder effervescent for solution for oral administration.
    Packaging:

    By 16.1 g of powder in a four-layer (paper / polyethylene / aluminum foil / surlin) sachet.

    2 packs together with instructions for use in a cardboard pack.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Use immediately after opening the sachet. Unsealed, but unused package is subject to destruction.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002537
    Date of registration:16.07.2014 / 27.04.2015
    Date of cancellation:2019-07-16
    The owner of the registration certificate:Ferring Artsynmittel GmbHFerring Artsynmittel GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspFERRING PHARMACEUTICALS LLCFERRING PHARMACEUTICALS LLCRussia
    Information update date: & nbsp30.01.2016
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