Fortrans - instructions for use, doses, side effects, contraindications

Active substanceMacrogolMacrogol

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Fortrans®

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Dosage form: & nbspPowder for solution for oral administration

Composition:

COMPOSITION (g / sachet):

Active substances:

Macrogol 4000 64.0

Excipients:

Sodium chloride 1.46

Potassium chloride 0.75

Sodium hydrogen carbonate 1.68

Sodium sulfate anhydrous 5.70

Sodium saccharinate 0.10

Description:White powder, easily soluble in water.

Pharmacotherapeutic group:Osmotic laxative

ATX: & nbsp

A.06.A.D.15 Macrogol

Pharmacodynamics:

Fortrans® is an osmotic laxative that includes Macrogol 4000 (polyethylene glycol) and electrolytes (sodium, potassium, bicarbonate and chlorides).

High-molecular compound Macrogol 4000 is a long linear polymer that can hold water molecules with hydrogen bonds. After ingestion, the drug increases the volume of fluid in the intestine.The volume of unabsorbed liquid in the intestine provides a laxative effect of the drug solution.

The electrolytes included in the preparation ensure the maintenance of the blood plasma composition. The concentration of electrolytes in the solution of Fortrans® is such that the electrolyte exchange between the contents of the intestine and the blood plasma practically reduces to zero. Thus, the presence of electrolytes in the preparation Fortrans® prevents their loss from the body when passing a large amount of fluid through the gastrointestinal tract against the background of the drug.

Pharmacokinetics:

The solution, prepared by dissolving 1 sachet of the preparation in 1 liter of water, is isotonic and iso-isosmotic in the composition of the electrolytes in the contents of the large intestine. The results of pharmacokinetic studies confirm the absence of absorption and biotransformation of Macrogol 4000 after ingestion.

Indications:

Cleansing the colon in preparation for:

- endoscopic or radiographic examination of the colon,

- operative interventions requiring lack of contents in the large intestine.

Contraindications:

- hypersensitivity to active substances or any other component of the drug;

- severe general condition of the patient, eg dehydration or severe heart failure;

- stomach ulcer;

- a common malignant tumor or other colon disease, accompanied by extensive damage to the mucosa

- gastrointestinal obstruction;

- obstruction of the gastrointestinal tract;

- Perforation or perforation risk of the gastrointestinal tract;

- disorders of gastric emptying (including gastroparesis);

- toxic colitis or toxic megacolon;

- children under 18 years of age (efficacy and safety not established in this population).

Carefully:

In case of impaired renal function, heart failure, in patients with concomitant diuretic therapy; in patients prone to the development of water-electrolyte imbalance, including hyponatremia and hypokalemia; in patients with neurological disorders, in bedridden patients and / or in patients with impaired motor functions, in patients with a tendency to aspiration, and / or in a semi-unconscious state (see section "Special instructions").

Pregnancy and lactation:

Pregnancy

The experience with Fortrans® in pregnant women is limited. Data from preclinical studies of reproductive toxicity are inadequate. The drug can be used during pregnancy only after a careful assessment of the risk ratio for the fetus and benefit to the mother.

Breastfeeding period

The experience with Fortrans® during the period of breastfeeding is limited. It is not known whether Macrogol 4000 in breast milk. You can not exclude the risk for a newborn / infant.

The drug can be used during breastfeeding only if the benefit to the mother exceeds the possible risk for the baby.

Fertility

There is no information on the effect of Fortrans® on fertility.

Dosing and Administration:

The drug can be used only in adult patients.

The drug is intended for oral administration.

Preparation of the drug solution: pour the contents of one sachet into 1 liter of water and mix well until complete dissolution. The resulting solution should be clear and colorless. Similarly, prepare the required amount of solution (3-4 liters), using only whole (unbuttoned) sachets.To obtain 4 liters of Fortran® solution, it is necessary to dissolve the contents of 4 sachets in 4 liters of water.

To improve the taste, it is better to take the solution chilled.

Recommended dose is 1 sachet / 1 liter of solution per 15-20 kg of patient's body weight or, on average, 3 to 4 liters of the solution obtained.

It is recommended to drink one full glass (250 ml) of the obtained solution of the drug every 15 minutes until the prepared volume of the solution is completely consumed. Usually the drug takes 4-6 hours. The full dose can be divided into two doses (2 liters in the evening and from 1 to 2 liters the next morning). It is usually recommended that the last dose of the drug be completed no later than 3 hours before the examination or surgery. When a single dose of a full dose of 3-4 liters of solution is taken in the evening before the appointed procedure.

When administering the drug through the gastric tube, the rate of administration should be 15-20 ml per min.

Fortrans® is designed to purify the gastrointestinal tract and helps evacuate the contents of the intestine as with diarrhea. The first liquid stool should appear within 1-2 hours after the start of the procedure.

Peculiarities of application in separate groups of patients

Patients with impaired renal function

Precautions should be taken when taking this medication in patients with altered renal function.

Elderly patients

A dose change is not required.

Side effects:

At the beginning of the drug may develop nausea and vomiting. These side effects usually stop when the drug is continued.

The table below summarizes the most frequent adverse drug reactions (NLR) recorded during clinical trials and post-registration follow-up.

The frequency of NLR was determined according to the following gradation: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000, <1/1000), very rarely (<1/10000, including single cases), the frequency is not established (it is impossible to estimate from available data).

System-Organic grade	Frequency	Description of NLR
Disorders from the gastrointestinal tract	Often	Nausea Abdominal pain Bloating
Disorders from the gastrointestinal tract	Often	Vomiting
Immune system disorders	The frequency is not set (post-registration data)	Reactions of hypersensitivity (anaphylactic shock, angioedema, hives, rashes, itching)

Overdose:

The experience of overdose treatment with Fortrans® is limited. In case of an overdose, nausea, vomiting, diarrhea and electrolyte imbalance may occur. To treat symptoms of overdose, symptomatic therapy is recommended, including taking the liquid inside. In rare cases of overdose accompanied by severe metabolic disorders, it is recommended that intravenous rehydration be performed.

Interaction:

Diarrhea caused by taking Fortrans® is likely to result in impaired absorption of other concomitant medications. The effectiveness of drugs that have a narrow therapeutic index or a short half-life can be reduced. In this connection, the doctor, appointing Fortrans®, should be informed of all concomitant medications taken by the patient.

Special instructions:

The elderly, who have a weak state of health, are recommended to use the drug only under the supervision of medical personnel.

Do not take solid food at least two hours before using Fortrans® and before the end of the examination.Acceptance of such drinks as tea, coffee (without milk) and other non-alcoholic beverages is allowed.

The patient should maintain an interval of at least 1 hour between taking Fortrans® and other medications.

The preparation contains Macrogol 4000 (polyethylene glycol). Allergic reactions (anaphylactic shock, angioedema, hives, rashes on the skin) were recorded after the administration of preparations containing polyethylene glycol.

Care must be taken when prescribing Fortrans® to patients with inflammation of the intestinal mucosa, including the rectum.

The drug should be used with caution and only under the supervision of medical personnel in patients with aspiration tendency, in bedridden patients, in patients with neurologic disorders and / or in patients with impaired motor functions due to the risk of developing aspiration pneumonia. In such patients, the drug is administered in a "sitting" state and through a nasogastric tube.

Patients who are in a semi / unconscious state should be carefully monitored during the application of the drug.When symptoms of pain or bloating appear, reduce the speed of the drug or suspend the use until the symptoms disappear.

Due to the isotonic composition of the Fortrans® preparation, patients are not expected to develop an electrolyte imbalance after administration, except for patients at risk of a water-electrolyte balance disorder. Patients with violations of water-electrolyte balance should be given appropriate therapy to eliminate them before carrying out the procedure of bowel cleansing. The drug should be used with caution in patients prone to developing water-electrolyte imbalances, including hyponatremia and hypokalemia, as well as in patients who have a higher risk of developing side effects (in patients with impaired renal function, with heart failure or in patients with concomitant diuretic therapy). The use of the drug in such patients should be carefully monitored.

Particular care should be taken in patients with cardiac and renal insufficiency, since they have a risk of developing acute pulmonary edema due to fluid overload.The experience of medical use of the drug in patients with impaired renal function is limited. The effectiveness and safety of Fortrans® in children under the age of 18 years is not established.

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

Not installed.

However, given the pharmacological effect of the drug and the possibility of manifestations of undesirable reactions, care should be taken when driving and working with machinery.

Form release / dosage:

Powder for solution for oral administration, 64 g.

Packaging:

By 73.69 g of the drug is placed in sachets of paper, laminated aluminum foil and polyethylene. 4 bags together with the instruction is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N014306 / 01

Date of registration:17.08.2007 / 27.03.2012

The owner of the registration certificate:IPSEN PHARMA IPSEN PHARMA France

Manufacturer: & nbsp

BEAUFOUR IPSEN INDUSTRIE France

Representation: & nbspIPSEN PHARMA IPSEN PHARMA France

Information update date: & nbsp29.02.2016

Illustrated instructions

Instructions

Fortrans® (Fortrans®)