Trimedat forte 300 mg, 20 extended-release film-coated tablets


Pain in the abdominal cavity is often associated with disorders of intestinal motility. Spasms of the muscles of both the small and large intestines lead to difficulty passing stool and abdominal pain. Trimedat successfully relieves unpleasant symptoms by normalizing intestinal muscle tone.

How to take Trimedat

For chronic abdominal pain, Trimedat is taken orally, 1 tablet.

The frequency of administration for adults and children over 12 years of age is three times a day.

Children from three to five years old can take the drug in a dose equal to a quarter of a tablet containing 100 mg of trimebutine, that is, 1 dose = 25 mg.

Children from 5 to 12 years old are given half a tablet containing 100 mg of trimebutine.

For both age groups, it is recommended to take it three times a day.

Trimedat forte 300 mg, 20 extended-release film-coated tablets

Registration Certificate Holder

VALENTA PHARM (Russia)

Dosage form

Medicine - Trimedat® forte (Trimedat forte)

Description

Extended-release film-coated tablets

white, round, biconvex, with an embossed symbol in the form of two drop-shaped elements on one side; On a cross section, the core is white or almost white.

1 tab.

trimebutine maleate 300 mg

Excipients

: microcrystalline cellulose, povidone (K25), hypromellose, magnesium stearate.

Shell composition:

Opadry II 85F18422 (partially hydrolyzed polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc).

10 pieces. — cellular contour packages (1) — cardboard packs. 10 pieces. — contour cell packaging (2) — cardboard packs. 10 pieces. — contour cell packaging (6) — cardboard packs.

Indications

For oral and rectal administration: symptomatic treatment of pain associated with functional disorders of the gastrointestinal tract and biliary tract.

For parenteral use: symptomatic treatment of severe pain in functional disorders of the gastrointestinal tract; treatment of postoperative paralytic ileus and in preparation for X-ray and endoscopic examinations.

Contraindications for use

Hypersensitivity to trimebutine.

pharmachologic effect

A drug that regulates gastrointestinal motility. It is believed that the effect of trimebutine is due to its effect on opioid receptors in the gastrointestinal tract.

Dosage regimen

Individual. The daily dose for oral administration is up to 300 mg, rectally - 100-200 mg. IM or IV single dose - 50 mg, frequency and duration of use depend on the clinical situation.

In children, the dose is determined depending on age.

Side effect

Maybe:

skin allergic reactions; with intravenous administration - short-term fainting.

special instructions

The compliance of the dosage form used with the indications for use should be strictly observed.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.

Use during pregnancy and lactation (breastfeeding) is not recommended.

Use in children

Restrictions for children - With caution.

In children, the dose is determined depending on age.

How long to take Trimedat

The course of therapy depends on the symptoms and diagnosis. For episodic, sudden and short-term pain, it is enough to take the drug for 24 hours to get rid of the symptoms. This situation is typical for non-toxic food poisoning, when the unpleasant symptoms cease with the cleansing of the intestines. In this case, Trimedat will relieve spasms and normalize sudden contractions of the intestines, leading to pain.

If irritable bowel syndrome is diagnosed, two-week therapy is prescribed. After the disappearance of unpleasant symptoms, therapy is not stopped. To maintain the positive effect, in order to exclude relapse, Trimedat continues to be taken for another 3 months.

Instructions for use ETODIN FORT

Cardiovascular diseases

When using selective COX-2 inhibitors and non-selective NSAIDs, the risk of cardiovascular thrombotic complications (myocardial infarction and stroke), which can be fatal, increases. All NSAIDs, both selective and non-selective, have this risk. To reduce adverse reactions from the cardiovascular system, use the minimum effective dose of NSAIDs whenever possible for the shortest period of time. Cardiac disorders can occur even without preliminary symptoms. There is no evidence of a reduction in cardiovascular symptoms with simultaneous use of acetylsalicylic acid. Concomitant use of acetylsalicylic acid increases the risk of developing severe adverse reactions from the digestive tract.

The use of selective COX-2 inhibitors for the treatment of pain in the first 10-14 days of coronary artery bypass grafting increases the risk of myocardial infarction.

Arterial hypertension

Taking NSAIDs, including etodolac, may lead to increased blood pressure or worsening of pre-existing hypertension, which may contribute to adverse reactions from the cardiovascular system. Patients who take thiazide and loop diuretics concomitantly with etodolac may experience a decrease in the effect of the latter. Blood pressure should be monitored while taking NSAIDs.

Chronic heart failure and edema

Patients taking NSAIDs experience fluid retention and swelling. Etodolac should be used with caution in patients with fluid retention or heart failure.

Effect on the digestive tract

Taking NSAIDs, including etodolac, can cause severe adverse reactions from the digestive tract, including inflammation, bleeding, ulcers or perforation of the stomach or intestines, which can be fatal. NSAIDs should be used with caution in patients with a history of peptic ulcers or gastrointestinal bleeding. Other risk factors that increase the risk of gastrointestinal bleeding include concomitant use of oral corticosteroids, anticoagulants, long-term use of NSAIDs, smoking, alcohol intake, advanced age, and severe general condition. Most spontaneous reports were recorded in elderly and debilitated patients. To reduce the potential risk of adverse reactions from the digestive tract, use the lowest effective doses possible for the shortest period of time. Physicians and patients should be aware of the symptoms of gastrointestinal bleeding and ulcers when treating NSAIDs, and if adverse reactions are suspected, the patient should be assessed, the drug discontinued, and appropriate measures taken.

Effect on the kidneys

Long-term use of NSAIDs can lead to the development of papillary necrosis and other kidney damage. Renal prostaglandins play a compensatory role in maintaining renal perfusion. Patients using NSAIDs may experience a dose-dependent decrease in prostaglandin formation, which contributes to the development of renal failure. Risk factors for the development of these reactions include impaired renal and/or liver function, heart failure, use of diuretics and ACE inhibitors, and old age. Stopping NSAIDs usually results in a return to the previous condition.

There is no information on the use of etodolac in patients with progressive renal failure, therefore it is not recommended to use etodolac in patients in this category. Renal function should be examined before starting treatment with etodolac.

Anaphylactoid reactions

As with other NSAIDs, patients taking etodolac may experience anaphylactoid reactions without a history of them. Etodolac should not be prescribed to patients with the aspirin triad (polypous rhinosinusitis, bronchospasm attacks and intolerance to NSAIDs). Deaths have occurred in such patients.

Skin reactions

NSAIDs, including etodolac, can cause severe skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, sometimes fatal. These severe reactions may occur without warning. Patients should be informed of the symptoms of severe skin manifestations. If skin rashes or any other manifestation of hypersensitivity reactions occur, use of the drug should be discontinued.

Effect on the liver

When taking etodolac, there is an increase in the activity of liver enzymes. Laboratory changes may progress, remain unchanged, or decrease after discontinuation of therapy. A significant increase in ALT and AST (about 3 or more times) was observed in 15% of patients during clinical studies of NSAIDs. Rare cases of severe liver reactions have been reported, including jaundice and fulminant hepatitis with a fatal outcome, liver necrosis, liver failure, sometimes with a fatal outcome. If clinical symptoms of renal dysfunction develop, systemic manifestations (eosinophilia, skin rashes) are possible, in which case the use of etodolac should be discontinued.

Effect on blood

Anemia sometimes occurs with the use of NSAIDs, including etodolac. This can be observed due to fluid retention, as a result of gastrointestinal bleeding, and impaired erythropoiesis. In patients with long-term use of NSAIDs, including etodolac, hemoglobin and hematocrit levels should be monitored. NSAIDs inhibit platelet aggregation and prolong bleeding time in some patients. Compared to acetylsalicylic acid, the effect on platelets is significantly smaller or less durable. Platelet levels should be monitored in patients taking etodolac as coagulation disorders may occur, especially in patients taking anticoagulants.

Bronchial asthma

Patients with bronchial asthma may develop bronchospasm. The use of acetylsalicylic acid for aspirin-induced asthma causes severe bronchospasm. Due to the possibility of a cross-reaction, the drug should not be used in patients who have a history of asthma, rhinitis, or urticaria during treatment with other NSAIDs.

Other Cautions

Etodolac is not a substitute for corticosteroids for adrenal insufficiency. In patients with long-term use of corticosteroids, the latter should be withdrawn gradually.

The drug contains lactose, so it should not be used in cases of hereditary galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption disorder.

Like other NSAIDs, etodolac may inhibit platelet function, especially in patients taking anticoagulants. In this case, patients should be under medical supervision. In case of bleeding, treatment is stopped.

In patients with heart failure, chronic hepatic or renal failure, liver cirrhosis, as well as in elderly patients, renal and liver function should be monitored (at least once a month).

Patients with SLE and systemic connective tissue diseases have an increased risk of non-infectious meningitis.

Etodolac can weaken a woman's reproductive function. Patients undergoing research for infertility should discontinue the drug.

Impact on the ability to drive vehicles and operate machinery

The patient should be warned that taking the drug may cause dizziness, general weakness, and visual impairment. While taking the drug, you must be careful when driving vehicles or other machinery. If these reactions develop, it is necessary to refrain from driving vehicles and working with moving mechanisms.

How to take Trimedat for constipation

The causes of constipation and its nature determine the duration of medication use. In case of one-time stool retention due to poor nutrition and low mobility, it is enough to take the drug three times a day in a standard dosage until the intestines can empty. Most often this takes a day, less often – up to 5 days. In this case, the absence of relapse can be guaranteed by the patient himself by changing eating habits and adjusting daily physical activity.

In case of constipation that occurs due to intestinal obstruction caused by circulatory disorders in the inferior vena cava, Trimedat is taken over a long course, starting from 4 weeks. To avoid relapse and worsen the situation, the patient is prescribed a diet high in fiber-rich plant products. This approach to nutrition will ensure softness of the stool, which will significantly facilitate its passage through the intestines, and will eliminate cases of injury to the walls by hard lumps of feces.

How to take Trimedat: before or after meals

The drug begins to work an hour after it enters the gastrointestinal tract. To prevent food intake from causing pain, belching, bloating and other unpleasant symptoms, Trimedat should be taken 20-30 minutes before the intended meal. When the food is processed by gastric juice and enters the duodenum, the drug will already begin to act and will not allow the food to stagnate, which will reduce the risk of developing rotting processes, which cause flatulence, nausea and belching.

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