Fortrans powder for mortar pack N4
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Active ingredients
Macrogol
Release form
Powder
Composition
Active substances: Macrogol 4000 64.0 Auxiliary substances: Sodium chloride 1.46Calia chloride 0.75Sodium bicarbonate 1.68Sodium sulfate anhydrous 5.70Sodium saccharinate 0.10
Pharmacological effect
Fortrans is an osmotic laxative that contains Macrogol 4000 (polyethylene glycol) and electrolytes (sodium, potassium, bicarbonate and chlorides). Macrogol 4000 is a high molecular compound that is a long linear polymer that can hold water molecules with hydrogen bonds. After ingestion, the drug increases the volume of fluid in the intestines. The amount of unabsorbed fluid contained in the intestine provides a laxative effect of the drug solution. The electrolytes contained in the preparation maintain the composition of the blood plasma. The concentration of electrolytes in the solution of Fortrans is such that the electrolyte metabolism between the contents of the intestine and the blood plasma is practically reduced to zero. Thus, the presence of electrolytes in the preparation Fortran prevents their loss from the body during the passage of large amounts of fluid 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 and isosmotic with the contents of the colon by the composition of electrolytes. Results of pharmacokinetic studies confirm the absence of absorption and Macrogol's biotransformation 4000 after ingestion.
Indications
Colon cleansing in preparing the patient for: - endoscopic or radiological examination of the colon, - surgical interventions that require the lack of contents in the colon.
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; - Gastric ulcer; - A common malignant tumor or other colon disease, accompanied by extensive damage to the intestinal mucosa; - Gastrointestinal obstruction; obstruction of the gastrointestinal tract; perforation or risk of perforation of the gastrointestinal tract; violations of gastric emptying (including gastric roparesis); - toxic colitis or toxic megacolon; - children under 18 years of age (efficacy and safety have not been established in this population).
Precautionary measures
With caution in 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 patients with impaired motor functions, in patients with aspiration, and / or in a sex / unconscious state (see section "Special instructions").
Use during pregnancy and lactation
Pregnancy The experience with the drug Fortrans in pregnant women is limited. Data preclinical studies of reproductive toxicity are insufficient. The drug can be used during pregnancy only after a thorough assessment of the risk ratio for the fetus and benefits for the mother. Breastfeeding Period Experience with Fortrans during breastfeeding is limited. It is not known whether Macrogol 4000 is excreted into breast milk. The risk for a newborn / infant cannot be ruled out. The drug can be used during breastfeeding only if the benefit to the mother exceeds the possible risk for the infant. Fertility There are no data on the effect of Fortrans on fertility.
Dosage and administration
The drug can be used only in adult patients. The drug is intended for oral administration. Preparation of a solution of the drug: pour the contents of one sachet into 1 liter of water and mix well until completely dissolved. The resulting solution should be clear and colorless. Similarly, prepare the required amount of solution (3-4 liters), using only whole (unbroken) sachets. To obtain a 4 l solution of the drug Fortrans, you must dissolve the contents of 4 sachets in 4 l of water. To improve the taste of the solution is better to take chilled. The recommended dose is 1 sachet / 1 liter of solution per 15-20 kg of the patient’s body weight or, on average, from 3 to 4 liters of the resulting solution. It is recommended to drink one full glass (250 ml) of the resulting solution every 15 minutes until the prepared volume of the solution is consumed completely. Usually taking the drug takes 4-6 hours. The full dose can be divided into two doses (2 liters in the evening and 1 to 2 liters the next morning).It is usually recommended to complete the last dose of the drug no later than 3 hours before the examination or surgical intervention. With a single dose of a full dose, 3-4 liters of solution are taken on the evening before the prescribed procedure. When a drug is administered through a gastric tube, the introduction rate should be 15-20 ml per minute. Fortrans is designed to cleanse the gastrointestinal tract and facilitates the evacuation of intestinal contents as in diarrhea. The first loose stools should appear within 1-2 hours after the start of the procedure.
Side effects
Nausea and vomiting may develop at the beginning of the drug. These side effects usually stop when you continue to take the drug. The table below summarizes the most frequent undesirable drug reactions (NLR), registered during clinical studies and post-registration observation. The NLR frequency 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 isolated cases), the frequency is not set (it is impossible to estimate according to the available data). System organ class Frequency Description NLR Disorders of the gastrointestinal tract: Very often Nausea, Abdominal Pain, Abdominal Distention. Often Vomiting Immune system disorders: Frequency not established (post-registration data) Reactions of hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, itching)
Overdose
Experience in treating overdose with drug Fortrans is limited. Overdose may experience nausea, vomiting, diarrhea, and electrolyte imbalance. Symptomatic therapy is recommended for the treatment of symptoms of overdose, including ingestion of fluids. In rare cases of overdose, accompanied by severe metabolic disorders, intravenous rehydration is recommended.
Interaction with other drugs
Diarrhea caused by taking Fortrans is likely to impair the absorption of other concomitant drugs. The effectiveness of drugs that have a narrow therapeutic index or a short half-life can be reduced. In this regard, the physician prescribing Fortrans should be informed of all the drugs simultaneously taken by the patient.
special instructions
Elderly people with poor health are advised to use the drug only under the supervision of medical personnel. It is necessary to avoid taking solid food for at least two hours before using Fortrans and until the end of the examination. Drinks such as tea, coffee (without milk) and other soft drinks are allowed. The patient must maintain an interval of at least 1 hour between taking Fortrans and other drugs. The drug contains Macrogol 4000 (polyethylene glycol). Allergic reactions (anaphylactic shock, angioedema, urticaria, rash on the skin) have been reported after administration of drugs containing polyethylene glycol. Care must be taken when administering 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 functions due to the risk of developing aspiration pneumonia. In such patients, the drug is administered in a "sitting" and through a nasogastric tube. Patients who are sexually / unconscious need to be carefully monitored while using the drug. If you experience symptoms of pain or abdominal distention, you should reduce the rate of administration of the drug or suspend the use 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 water-electrolyte balance disorder. Patients with impaired water and electrolyte balance should be given appropriate therapy to eliminate them before carrying out the bowel cleansing procedure. The drug should be used with caution in patients prone to the development of water and electrolyte disbalance, including hyponatremia and hypokalemia, as well as in patients who have a higher risk of side effects (in patients with impaired renal function, heart failure or in patients with concomitant diuretic therapy ).The use of the drug in these patients should be carefully monitored. Particular caution should be observed in patients with cardiac and renal failure, because they have a risk of developing pulmonary edema due to fluid overload. The experience of medical use of the drug in patients with impaired renal function is limited. The efficacy and safety of Fortrans in children under the age of 18 years has not been established.