Фортранс

By order of the Chairman

Pharmacy Committee

Ministry of Health of the Republic of Kazakhstan

Instructions for medical use of the drug

Fortrans®

Tradename

Fortrans®

International nonproprietary name

No

Dosage form

Powder for solution for oral administration

Compound

One single dose package contains

active ingredients: macrogol 4000 - 64.0 g, potassium chloride - 0.75 g, sodium chloride - 1.46 g, sodium sulfate anhydrous - 5.70 g, sodium bicarbonate - 1.68 g,

excipients: sodium saccharin – 0.1 g

Description

White powder, easily soluble in water, bitter-salty taste

Pharmacotherapeutic group

Laxatives. Osmotic laxatives. Macrogol

ATX code A06AD15

Pharmacological properties

Pharmacokinetics

Macrogol 4000 is not absorbed from the gastrointestinal tract and is not metabolized.

Pharmacodynamics

The action of Fortrans is based on the combination of a high molecular weight polymer with an isotonic solution of electrolytes. Macrogol 4000 prevents the absorption of water from the stomach and intestines and promotes accelerated evacuation of intestinal contents through frequent bowel movements. The electrolytes contained in Fortrans prevent disruption of the body's water and electrolyte balance.

Indications for use

- preparation for endoscopic or x-ray examinations of the large intestine

- preparation for surgical interventions on the large intestine

Directions for use and doses

Take orally.

The drug is intended for adults only.

Each sachet is diluted in 1 liter of water. Stir until the powder is completely dissolved in water. The approximate dose is 1 liter of solution per 15 - 20 kg of body weight, which corresponds to, on average, 3 - 4 liters of solution.

Mode of application. It is possible to take the drug both in a single dose and in separate dosages, provided that the full dose of the reconstituted solution is taken (on average, from 3 to 4 liters of solution, depending on the patient’s body weight).

- For separate dosages: take 2 liters of solution the evening before the procedure and 1 or 2 liters in the morning on the day of the procedure. The last dose of Fortrans should be 3-4 hours before the procedure. Or take 3 liters of solution the evening before the procedure and 1 liter in the morning on the day of the procedure. The last dose of Fortrans should be 3-4 hours before the procedure.

- For a single dosage: take 3-4 liters of solution the evening before the procedure. A break of 1 hour is possible after taking the first two liters.

The recommended intake rate is 1-1.5 liters per 1 hour (i.e. approximately 250 ml every 10-15 minutes).

The physician may adjust the recommended dosage rate based on the patient's clinical condition and potential comorbidities.

Side effects

Diarrhea is an expected effect of using Fortrans. Nausea and vomiting have been reported at the beginning of the drug, which usually resolve with continued use.

The table below lists adverse reactions observed during clinical trials as well as adverse events reported from post-marketing sources. Frequency is determined according to the following scale: very often (≥ 1/10); often (from ≥1/100 to <1/10); not often (from ≥ 1/1000 to < 1/100); rare (from ≥ 1/10000 to < 1/1000); very rare (< 1/10000), unknown (cannot be estimated based on available data).

Organ systems and classes

Frequency

Adverse Reactions

Gastrointestinal disorders

Often

Nausea

Abdominal pain

Bloating

Often

Vomit

Immune system disorders

Not known

Hypersensitivity (anaphylactic shock, angioedema (Quincke's edema), urticaria, rash, itching)

Contraindications

- hypersensitivity to the active substance or to any of the excipients

- severe general health problems such as dehydration or severe heart failure

- advanced form of cancer or other diseases of the colon, leading to excessive weakness of the mucous membranes

- tendency to develop intestinal obstruction or gastrointestinal obstruction

- perforation of the digestive tract or risk of perforation

- gastric emptying disorders (eg gastroparesis)

- toxic colitis or toxic megacolon

Drug interactions

The doctor should be informed about any other medications taken orally by the patient. Due to gastric emptying as a result of Fortrans, other oral medications cannot be absorbed. They should be taken more than 2 hours before Fortrans is administered. Avoid taking oral medications before and after taking a laxative until a medical evaluation has been completed. This is especially important for drugs with a narrow therapeutic index or with a short half-life.

special instructions

Elderly people with a weakened general condition should use this drug only under the supervision of a doctor.

Diarrhea caused by the use of Fortrans can lead to significant impairment