Active substanceMacrogolMacrogol
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  • Dosage form: & nbspPowder for solution for oral administration
    Composition:
    Each packet (73.69 g) contains:
    Active substance:
    Macrogol 4000 64 g.
    Excipients:
    Sodium chloride 1.46 g
    Potassium chloride 0.75 g
    Sodium bicarbonate 1.68 g
    Sodium sulfate anhydrous 5.7 g
    Sodium saccharinate 0.1 g
    Description:Waxy granular powder from white to slightly yellowish color.
    Pharmacotherapeutic group:Laxative
    ATX: & nbsp

    A.06.A.D.15   Macrogol

    Pharmacodynamics:
    pharmachologic effect
    Osmotic laxative. A high-molecular substance, which is a long linear polymer, which by means of hydrogen bonds is capable of retaining water molecules. Increases the osmotic pressure and volume of fluid in the intestine, enhancing peristalsis.Increases the volume of chyme, prevents the loss of electrolytes with fecal masses. It restores the reflex of evacuation, does not change the pH of the chyme. The laxative effect occurs 24-48 hours after oral ingestion. Prevents the violation of water-electrolyte balance.
    Pharmacodynamics
    Laxative drug. The effect of the drug is based on the combination of a high molecular weight polymer with an isotonic solution of electrolytes. Macrogol prevents the absorption of water from the stomach and intestines and facilitates the accelerated evacuation of intestinal contents (by frequent defecation).
    Electrolytes, which are part of the drug, interfere with the water-electrolyte balance of the body.
    Pharmacokinetics:Pharmacokinetic data confirm the absence of intestinal absorption and macrogol metabolism when administered orally.
    Indications:Preparation for diagnostic studies (endoscopic, roentgenologic) and surgical interventions on the large intestine.
    Contraindications:Hypersensitivity, dehydration, chronic heart failure, erosive-ulcerative lesions of the mucous membrane of the large intestine (incl.ulcerative rectocolitis, Crohn's disease); severe inflammatory bowel disease or toxic megacolon in combination with symptomatic stenosis, perforation or the risk of perforation of the hollow organ, ileus (including spastic, obstructive); abdominal pain of unknown etiology, renal dysfunction, children up to 15 years (due to the lack of clinical application data).
    Carefully:
    Ulcerative colitis, patients with impaired swallowing reflex, reflux esophagitis, depression of consciousness, pregnancy, children, elderly.
    It is recommended to use the drug with caution in patients with ulcerative colitis in view of the high risk of perforation. Given the serious consequences of aspiration, it is recommended to use the drug with caution in patients with impaired swallowing reflex, reflux oesophagitis or suppression of consciousness.
    The introduction of the solution through the nasogastric tube is accompanied by a risk of aspiration, especially significant in children and elderly patients.
    Pregnancy and lactation:
    The study of reproduction on animals showed no adverse effect on the fetus, and adequate and strictly controlled studies in pregnant women were not conducted.
    When pregnancy is used only if the intended benefit for the mother exceeds the risk for the child.
    The drug may be given during breastfeeding.
    Dosing and Administration:
    Macrogol solution with electrolytes is usually taken orally, but can also be administered via a nasogastric tube. The interval from the reception of food before the start of the solution should be at least 2-3 hours.
    Doses for colon preparation for colonoscopy, X-ray examination and surgical interventions in adults and adolescents over 15 years of age:
    Dissolve the contents of 1 packet in 1 liter of water immediately before use. Take 200 ml every 20 minutes in the evening on the eve of examination or surgery until the released fluid becomes clear or until the total amount of the solution taken is 3-4 liters.
    Doses when administered through the gastric tube: Dissolve the contents of 1 packet in 1 liter of water immediately before use. Enter with a speed of 20-30 ml / min. Evacuation of intestinal contents usually begins 1 hour after the start of the injection and ends after about 4 hours.
    Side effects:
    From the digestive system: sensation of anterior abdominal wall stretching, abdominal pain, nausea, diarrhea; vomiting, strong urge to defecate, fecal incontinence, irritation of the perianal area, flatulence.
    Allergic reactions: urticaria, skin itch, skin rash, swelling of the face, Quincke's edema, anaphylactic shock, fulminant and acute edema of the lungs (after administration of a balanced macrogol solution with electrolytes through the nasogastric tube).
    Overdose:Exceeding the dose can lead to disruption of the water-electrolyte balance, to the development of diarrhea, which, as a rule, stops on its own 1-2 days after the drug is discontinued.
    Interaction:
    Diarrhea caused by the use of Osmomol® can lead to impaired absorption of other concomitant medications. In the case of simultaneous reception of Osmoglо with other drugs, it is recommended to prescribe it 2 h after their administration.
    Simultaneous reception of macrogol and digoxin leads to a decrease in the degree of absorption of the latter in the intestine.
    The simultaneous administration of amoxicillin and macrogol for 4 days is accompanied by an increase in duration and a decrease in the rate of absorption of amoxicillin.
    Special instructions:
    For elderly patients with various concomitant diseases, the drug is recommended for use under medical supervision.
    The patient should be warned about the need to inform the doctor about all concomitant medications.
    In the case of diarrhea, special control and monitoring of electrolyte blood composition is necessary in patients prone to the development of electrolyte disorders.
    Freshly prepared solution of the drug should be stored in the refrigerator and used within 6 hours after preparation. Longer storage of the solution is not allowed.
    It is recommended to use the drug with caution in patients with ulcerative colitis due to the high risk of perforation.
    Given the severe consequences of aspiration, it is recommended to use the drug with caution in patients with a violation of the swallowing reflex, reflux esophagitis or depression of consciousness.
    The introduction of the solution through the nasogastric tube is accompanied by a risk of aspiration, especially significant in children and elderly patients.
    Form release / dosage:
    Powder for solution for oral administration, 64 g.
    Packaging:
    At 73.69 grams in a single-dose package.For 4 single-dose packages in a pack of cardboard along with the instructions for use.
    Storage conditions:At a temperature of no higher than 25 ° C in a dry, dark place. Keep out of the reach of children.
    Shelf life:
    5 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-005777/10
    Date of registration:23.06.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Promed Exports Pvt. Ltd.Promed Exports Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspPROMED EXPORTS Pvt. Ltd. PROMED EXPORTS Pvt. Ltd. India
    Information update date: & nbsp14.06.2017
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