Fortrans, 64 g 4 pcs

Pharmacodynamics

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

Macrogol 4000 high molecular weight compound is a long linear polymers capable of holding water molecules with the help of hydrogen bonds. After oral administration the compound increases the volume of liquid in the intestine. The volume of liquid unabsorbed in intestine ensures the laxative effect of the drug solution.

The electrolytes contained in the drug ensure maintenance of the blood plasma composition. The concentration of electrolytes in Fortranz® solution is such that electrolyte exchange between intestinal contents and blood plasma is practically reduced to zero. Thus the presence of electrolytes in Fortranz® preparation prevents their loss from the body during large amount of fluid passing through the gastrointestinal tract during drug administration.

Pharmacokinetics

The solution prepared by dissolving 1 sachet of the preparation in 1 liter of water is isotonic and isoosmotic to the large intestine.

The results of pharmacokinetic studies confirm the absence of absorption and biotransformation of Macrogol 4000 after oral administration.

Indications

Cleansing the colon in preparation of the patient for the following procedures: endoscopic or x-ray examination of the colon; surgical interventions requiring the absence of contents in the colon.

Pharmacological effect

Pharmacodynamics

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

The high-molecular compound Macrogol 4000 is a long linear polymer that, using hydrogen bonds, can hold water molecules. After oral administration, the drug increases the volume of fluid in the intestines. The volume of unabsorbed fluid contained in the intestine provides the laxative effect of the drug solution.

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

Pharmacokinetics

The solution prepared by dissolving 1 sachet of the drug in 1 liter of water is isotonic in composition of electrolytes and isosmotic to the contents of the colon.

The results of pharmacokinetic studies confirm the lack of absorption and biotransformation of Macrogol 4000 after oral administration.

Special instructions

Elderly people with poor health are recommended to use the drug only under the supervision of medical personnel.

You should avoid eating solid food at least two hours before using Fortrans® and until the end of the examination. Drinks such as tea, coffee (without milk) and other non-alcoholic drinks are allowed.

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

The drug contains Macrogol 4000 (polyethylene glycol). Allergic reactions (anaphylactic shock, angioedema, urticaria, skin rashes) have been reported after the administration of drugs containing polyethylene glycol.

Caution must be exercised 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 a tendency to aspiration, in bedridden patients, in patients with neurological disorders and/or in patients with impaired motor function due to the risk of developing aspiration pneumonia. For such patients, the drug is administered in a “sitting” state and through a nasogastric tube.

Semi/unconscious patients should be carefully monitored while using the drug. If symptoms of pain or bloating appear, the rate of administration of the drug should be reduced or the use should be suspended until these symptoms disappear.

Due to the isotonic composition of the drug Fortrans®, patients are not expected to develop electrolyte imbalance after taking it, with the exception of patients at risk of fluid and electrolyte balance disorders. Patients with fluid and electrolyte imbalances must undergo appropriate therapy to eliminate them before undergoing a bowel cleansing procedure.

The drug should be used with caution in patients prone to developing fluid and electrolyte imbalances, including hyponatremia and hypokalemia, as well as in patients at higher risk of side effects (patients with impaired renal function, heart failure, or patients on concomitant diuretic therapy). The use of the drug in such patients should be carefully monitored.

Particular caution must be observed in patients with cardiac and renal failure, as due to fluid overload they are at risk of developing acute pulmonary edema. Experience in medical use of the drug in patients with impaired renal function is limited.
The effectiveness and safety of Fortrans® in children under 18 years of age have not been established.

Impact on the ability to drive a car and operate machinery

Not installed.
However, given the pharmacological effect of the drug and the possibility of adverse reactions, caution should be exercised when driving a car and operating machinery.

Active ingredient

Macrogol

Composition

Active substances:

Pregnancy

Pregnancy

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

Breastfeeding period

Experience with the use of Fortrans® during breastfeeding is limited. It is not known whether Macrogol 4000 is excreted in breast milk. A risk to the newborn/infant cannot be excluded.
The drug can be used during breastfeeding only if the benefit obtained for the mother outweighs the possible risk for the baby.

Fertility

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

Contraindications

Hypersensitivity to the active substances or any other component of the drug;
severe general condition of the patient, such as dehydration or severe heart failure;
stomach ulcer;
widespread malignant tumor or other disease of the colon, accompanied by extensive damage to the intestinal mucosa;
gastrointestinal obstruction;
obstruction of the gastrointestinal tract;
perforation or risk of perforation of the gastrointestinal tract;
gastric emptying disorders (including gastroparesis);
toxic colitis or toxic megacolon;
children under 18 years of age (efficacy and safety have not been established in this population).
With caution

In case of impaired renal function, heart failure, in patients with concomitant diuretic therapy; in patients prone to the development of water and 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”).

Side Effects

From the digestive system: possible – nausea and vomiting at the beginning of treatment, which stopped with continued use, bloating.

Interaction

Diarrhea caused by taking Fortrans® is likely to impair the absorption of other drugs taken at the same time.

Overdose

Experience in the treatment of overdose with Fortrans® is limited. In case of overdose, nausea, vomiting, diarrhea and electrolyte imbalance may occur.

To treat symptoms of overdose, symptomatic therapy is recommended, including oral fluid intake. In rare cases of overdose accompanied by severe metabolic disorders, intravenous rehydration is recommended.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

5 years

Manufacturer

Ipsen Pharma, France