The instruction for medical use
of TRIGRIM medicine
the Trade name
Trigrim
the International unlicensed
name Torasemid Lekarstvennaya a form
of the Tablet of 2.5 mg, 5 mg, 10 mg
Structure
One tablet contains
active agent - torasemid 2.5 mg, 5 mg or 10 mg,
excipients: lactoses monohydrate, starch corn, silicon dioxide colloidal, magnesium stearate.
The description
of the Tablet of white color, round, biconvex, with a diameter of 4.9 - 5.3 mm (for a dosage of 2.5 mg).
Tablets of white color, round, flat with risky, with a diameter of 6.9 - 7.3 mm (for a dosage of 5 mg).
Tablets of white color, round, flat with risky, with a diameter of 8.9 - 9.3 mm (for a dosage of 10 mg).
Pharmacotherapeutic group
Diuretics. Loopback diuretics. Sulfanamide diuretics. Torasemid.
The ATX C03C A04 code
the Pharmacological
Pharmacokinetics Later properties of intake torasemid is quickly and almost completely soaked up. The maximum concentration in plasma is reached 1‑2 hours later, after reception. More than 99% of a torasemid contact proteins of plasma. The volume of distribution is 16 liters. Torasemid biotransformirutsya by step oxidation, hydroxylation and hydroxylation of a ring with formation of three metabolites: M1, M3 and M5. Elimination half-life of a torasemid and its metabolites at healthy faces makes 3-4 hours. The general clearance of a torasemid is 40 ml/min., and the renal clearance equals about 10 ml/min. About 80% of the entered dose are removed through renal tubules in not changed look: torasemid 24%, in the form of M1 metabolites - 12%, M3 - 3%, M5 - 41%. In a renal failure the elimination half-life of a torasemid does not change.
The pharmacodynamics
Torasemid is loopback diuretic. However at low doses its pharmakodinamichesky profile reminds thiazide diuretics in terms of level and duration of a diuresis. At high doses torasemid strengthens a diuresis depending on a dose.
The main mechanism of diuretic action is caused by reversible linking with a kotransporter of Na+/2Cl-/K + in an apical membrane of a thick segment of the ascending part of a Henle's loop owing to what decreases or the renal reabsorption of ions of sodium and chlorine in the ascending part of a Henle's loop is completely oppressed, the osmotic pressure of intracellular liquid and a reabsorption of water decreases. In the range of doses of 5-100 mg the increase in a diuresis is proportional to a dose logarithm. Increase in a diuresis arises and when other diuretic drugs (for example, tiazida) do not render sufficient effect, for example, at bounded function of kidneys any more. Eliminates hypostases, has antihypertensive effect which is caused by reduction of peripheric resistance of vessels due to reduction of content of free calcium in cells of a muscular layer of arteries and normalization of the broken electrolytic balance. Thereof the contractilnost and reaction of vessels to own pressor substances of an organism, in particular catecholamines decreases. Improves operating conditions of heart due to reduction before - and afterloads. After oral administration the maximum diuretic action continues 1-3 h, and the diuretic effect remains for nearly 12 h. Hypotensive effect of drug develops gradually within the first week and reaches a maximum no later than 12 weeks.
Indications
- the Edematous syndrome in stagnant heart failure, hypostases of hepatic, pulmonary or renal genesis.
- Primary arterial hypertension (medicine is used in monotherapy or in a combination with other antihypertensive drugs).
The route of administration and doses
use Medicine inside.
Adults:
Primary arterial hypertension:
The recommended dose of a torasemid makes 2.5 mg inside once a day. If necessary it is possible to increase a dose to 5 mg before achievement of effect once a day. The doses exceeding 5 mg a day do not lead to a further lowering of arterial pressure. The maximum effect is reached approximately in twelve weeks of continuous treatment.
Hypostases:
Usually apply 5 mg once a day, at inefficiency of a dose of 5 mg it is necessary to use drug in a dose 10 mg once a day, if necessary it is possible to increase a dose to 20 mg before achievement of adequate diuretic effect once a day. In individual cases appoint doses to 40 mg a day.
Patients of old age do not need special selection dosed
Children
there Are no available data regarding use of a torasemid for children.
Side effects
- disturbances of water and electrolytic balance (a hypovolemia, a hypopotassemia, a hyponatremia
- a hypopotassemia (especially in case of a diet with the low content of potassium or in vomiting, diarrhea or abuse of laxative medicines and also a liver failure)
- a headache, dizziness, weakness, drowsiness, confusion of consciousness
- arterial hypotension
- spasms
- increase in level of uric acid, glucose and lipids in plasma
- a metabolic alkalosis
- increase in activity of some enzymes of a liver
- a delay of outflow of urine at patients with narrowing of urinary tract
- increase in level of urea and creatinine in plasma
is rare also lt, 1/10,000
- paresthesia of extremities
- dryness in a mouth, loss of appetite
- the tromboembolic episodes and disturbances of blood circulation connected with increase in viscosity of blood
- a polyuria, a nocturia, increase in frequency of urination
- premature ventricular contraction, tachycardia, hypotonia
- face reddening
In isolated cases
- allergic reactions: a skin itching, rash and a photosensitization
- a disorder of vision, sonitus and decrease in hearing
- an erythropenia, a leukopenia and thrombocytopenia
- pancreatitis
- a polydipsia, nausea, vomiting, a meteorism,
the Contraindication abdominal pain
- hypersensitivity to a torasemid or auxiliary components of drug and other derivatives of sulphonylurea
- a renal failure with an anury
- a hepatic coma, precoma
- arterial hypotension
- arrhythmias (sinuatrial or atrioventricular block ІІ or ІІІ degrees
- pregnancy and the period of a lactation
- a hypovolemia, a hyponatremia, a hypopotassemia
- the significant disturbances of urination, for example, as a result of a prostatauxe
- children's age up to 18 years
- a concomitant use of aminoglikozidny antibiotics or cephalosporins or a renal failure after use of other medicines causing injury of kidneys.
Medicinal interactions
At simultaneous use with cardiac glycosides, the deficiency of potassium and/or magnesium can increase sensitivity of a myocardium to these medicines. There can be a potentiation of potassiumuretic action mineralo- and glucocorticosteroids and also depletive.
Trigrim, especially in high doses, can strengthen toxic effect of aminoglycosides, platinum drugs, nephrotoxic effect of cephalosporins and also kardio- and neurotoxic effect of lithium, kurarepodobny muscle relaxants and theophylline. At the patients accepting high doses of salicylates, Trigrim can increase their toxicity. Trigrim can reduce effect of hypoglycemic drugs.
Trigrim strengthens effect of other antihypertensive medicines, in particular APF inhibitors that can cause an excessive lowering of arterial pressure. This effect can be minimized, reducing an initial dose of APF inhibitor and/or reducing a dose or temporarily canceling Trigrim. Trigrim can reduce sensitivity of arteries to pressor factors, for example, to adrenaline and noradrenaline.
Non-steroidal anti-inflammatory drugs (for example, indometacin) and probenetsid can weaken diuretic and hypotensive action of Trigrim.
It is supposed that at the combined use with holestiraminy there is a decrease in the absorption entered inside, a torasemida.
Special instructions
Prior to treatment should be compensated a hypopotassemia, a hyponatremia and disturbances of urination.
At long treatment by Trigrim the regular monitoring of level of electrolytes, glucose, uric acid, creatinine and lipids in blood is recommended.
Careful monitoring of patients with a tendency to a hyperuricemia and urate diathesis is recommended. Also it is necessary to control metabolism of carbohydrates at the latent or manifest form of diabetes.
Drug should be used with care at patients with cardiac arrhythmias, the patient of advanced age with the profound atherosclerosis, against the background of long therapy by cardiac glycosides.
Patients with a prostatauxe and disturbances of urination need to appoint drug with care as intensive urination can lead to a delay of urination and a cystectasia.
Trigrim medicine contains lactose. To patients with rare hereditary diseases of intolerance of a galactose, deficiency of lactase (Lapp) or a sprue of glucose and a galactose, it is not necessary to take this medicine.
Use in pediatrics
Drug is not appointed to children due to the lack of data on safety.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
should not use drug during driving or other potentially dangerous mechanisms, the psychomotor reactions demanding speed and the increased concentration of attention.
Overdose
Symptoms: a polyuria, a hypovolemia and decrease in level of electrolytes that can result in drowsiness and confusion of consciousness, hypotension and cardiovascular collapse. Disturbances from digestive tract are possible.
Treatment: There is no specific antidote. Symptoms of overdose demand a dose decline or cancellation of a torasemid with simultaneous completion of losses of liquid and electrolytes.
A form of release and packing
On 10 tablets in blister strip packaging, from a film of polyvinylchloride and aluminum foil.
On 3 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place, at a temperature not above 25 °C.
To store out of children's reach.
A period of storage
of 5 years
not to use drug after an expiration date
Prescription status
According to the prescription
the Producer
the Pharmaceutical plant JSC Polfarm, Poland
of st. of Pelplinsk 19, 83-200 Starogard Gdanski
the Owner of the registration certificate
of JSC Khimfarm, the Republic of Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Khimfarm, Republic of Kazakhstan, Shymkent, Rashidov St., 81 Phone number 7252 (561342) Fax number 7252 (561342)
to Develop the E-mail address of infomed@santo.kz
of TRIGRIM medicine
the Trade name
Trigrim
the International unlicensed
name Torasemid Lekarstvennaya a form
of the Tablet of 2.5 mg, 5 mg, 10 mg
Structure
One tablet contains
active agent - torasemid 2.5 mg, 5 mg or 10 mg,
excipients: lactoses monohydrate, starch corn, silicon dioxide colloidal, magnesium stearate.
The description
of the Tablet of white color, round, biconvex, with a diameter of 4.9 - 5.3 mm (for a dosage of 2.5 mg).
Tablets of white color, round, flat with risky, with a diameter of 6.9 - 7.3 mm (for a dosage of 5 mg).
Tablets of white color, round, flat with risky, with a diameter of 8.9 - 9.3 mm (for a dosage of 10 mg).
Pharmacotherapeutic group
Diuretics. Loopback diuretics. Sulfanamide diuretics. Torasemid.
The ATX C03C A04 code
the Pharmacological
Pharmacokinetics Later properties of intake torasemid is quickly and almost completely soaked up. The maximum concentration in plasma is reached 1‑2 hours later, after reception. More than 99% of a torasemid contact proteins of plasma. The volume of distribution is 16 liters. Torasemid biotransformirutsya by step oxidation, hydroxylation and hydroxylation of a ring with formation of three metabolites: M1, M3 and M5. Elimination half-life of a torasemid and its metabolites at healthy faces makes 3-4 hours. The general clearance of a torasemid is 40 ml/min., and the renal clearance equals about 10 ml/min. About 80% of the entered dose are removed through renal tubules in not changed look: torasemid 24%, in the form of M1 metabolites - 12%, M3 - 3%, M5 - 41%. In a renal failure the elimination half-life of a torasemid does not change.
The pharmacodynamics
Torasemid is loopback diuretic. However at low doses its pharmakodinamichesky profile reminds thiazide diuretics in terms of level and duration of a diuresis. At high doses torasemid strengthens a diuresis depending on a dose.
The main mechanism of diuretic action is caused by reversible linking with a kotransporter of Na+/2Cl-/K + in an apical membrane of a thick segment of the ascending part of a Henle's loop owing to what decreases or the renal reabsorption of ions of sodium and chlorine in the ascending part of a Henle's loop is completely oppressed, the osmotic pressure of intracellular liquid and a reabsorption of water decreases. In the range of doses of 5-100 mg the increase in a diuresis is proportional to a dose logarithm. Increase in a diuresis arises and when other diuretic drugs (for example, tiazida) do not render sufficient effect, for example, at bounded function of kidneys any more. Eliminates hypostases, has antihypertensive effect which is caused by reduction of peripheric resistance of vessels due to reduction of content of free calcium in cells of a muscular layer of arteries and normalization of the broken electrolytic balance. Thereof the contractilnost and reaction of vessels to own pressor substances of an organism, in particular catecholamines decreases. Improves operating conditions of heart due to reduction before - and afterloads. After oral administration the maximum diuretic action continues 1-3 h, and the diuretic effect remains for nearly 12 h. Hypotensive effect of drug develops gradually within the first week and reaches a maximum no later than 12 weeks.
Indications
- the Edematous syndrome in stagnant heart failure, hypostases of hepatic, pulmonary or renal genesis.
- Primary arterial hypertension (medicine is used in monotherapy or in a combination with other antihypertensive drugs).
The route of administration and doses
use Medicine inside.
Adults:
Primary arterial hypertension:
The recommended dose of a torasemid makes 2.5 mg inside once a day. If necessary it is possible to increase a dose to 5 mg before achievement of effect once a day. The doses exceeding 5 mg a day do not lead to a further lowering of arterial pressure. The maximum effect is reached approximately in twelve weeks of continuous treatment.
Hypostases:
Usually apply 5 mg once a day, at inefficiency of a dose of 5 mg it is necessary to use drug in a dose 10 mg once a day, if necessary it is possible to increase a dose to 20 mg before achievement of adequate diuretic effect once a day. In individual cases appoint doses to 40 mg a day.
Patients of old age do not need special selection dosed
Children
there Are no available data regarding use of a torasemid for children.
Side effects
- disturbances of water and electrolytic balance (a hypovolemia, a hypopotassemia, a hyponatremia
- a hypopotassemia (especially in case of a diet with the low content of potassium or in vomiting, diarrhea or abuse of laxative medicines and also a liver failure)
- a headache, dizziness, weakness, drowsiness, confusion of consciousness
- arterial hypotension
- spasms
- increase in level of uric acid, glucose and lipids in plasma
- a metabolic alkalosis
- increase in activity of some enzymes of a liver
- a delay of outflow of urine at patients with narrowing of urinary tract
- increase in level of urea and creatinine in plasma
is rare also lt, 1/10,000
- paresthesia of extremities
- dryness in a mouth, loss of appetite
- the tromboembolic episodes and disturbances of blood circulation connected with increase in viscosity of blood
- a polyuria, a nocturia, increase in frequency of urination
- premature ventricular contraction, tachycardia, hypotonia
- face reddening
In isolated cases
- allergic reactions: a skin itching, rash and a photosensitization
- a disorder of vision, sonitus and decrease in hearing
- an erythropenia, a leukopenia and thrombocytopenia
- pancreatitis
- a polydipsia, nausea, vomiting, a meteorism,
the Contraindication abdominal pain
- hypersensitivity to a torasemid or auxiliary components of drug and other derivatives of sulphonylurea
- a renal failure with an anury
- a hepatic coma, precoma
- arterial hypotension
- arrhythmias (sinuatrial or atrioventricular block ІІ or ІІІ degrees
- pregnancy and the period of a lactation
- a hypovolemia, a hyponatremia, a hypopotassemia
- the significant disturbances of urination, for example, as a result of a prostatauxe
- children's age up to 18 years
- a concomitant use of aminoglikozidny antibiotics or cephalosporins or a renal failure after use of other medicines causing injury of kidneys.
Medicinal interactions
At simultaneous use with cardiac glycosides, the deficiency of potassium and/or magnesium can increase sensitivity of a myocardium to these medicines. There can be a potentiation of potassiumuretic action mineralo- and glucocorticosteroids and also depletive.
Trigrim, especially in high doses, can strengthen toxic effect of aminoglycosides, platinum drugs, nephrotoxic effect of cephalosporins and also kardio- and neurotoxic effect of lithium, kurarepodobny muscle relaxants and theophylline. At the patients accepting high doses of salicylates, Trigrim can increase their toxicity. Trigrim can reduce effect of hypoglycemic drugs.
Trigrim strengthens effect of other antihypertensive medicines, in particular APF inhibitors that can cause an excessive lowering of arterial pressure. This effect can be minimized, reducing an initial dose of APF inhibitor and/or reducing a dose or temporarily canceling Trigrim. Trigrim can reduce sensitivity of arteries to pressor factors, for example, to adrenaline and noradrenaline.
Non-steroidal anti-inflammatory drugs (for example, indometacin) and probenetsid can weaken diuretic and hypotensive action of Trigrim.
It is supposed that at the combined use with holestiraminy there is a decrease in the absorption entered inside, a torasemida.
Special instructions
Prior to treatment should be compensated a hypopotassemia, a hyponatremia and disturbances of urination.
At long treatment by Trigrim the regular monitoring of level of electrolytes, glucose, uric acid, creatinine and lipids in blood is recommended.
Careful monitoring of patients with a tendency to a hyperuricemia and urate diathesis is recommended. Also it is necessary to control metabolism of carbohydrates at the latent or manifest form of diabetes.
Drug should be used with care at patients with cardiac arrhythmias, the patient of advanced age with the profound atherosclerosis, against the background of long therapy by cardiac glycosides.
Patients with a prostatauxe and disturbances of urination need to appoint drug with care as intensive urination can lead to a delay of urination and a cystectasia.
Trigrim medicine contains lactose. To patients with rare hereditary diseases of intolerance of a galactose, deficiency of lactase (Lapp) or a sprue of glucose and a galactose, it is not necessary to take this medicine.
Use in pediatrics
Drug is not appointed to children due to the lack of data on safety.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
should not use drug during driving or other potentially dangerous mechanisms, the psychomotor reactions demanding speed and the increased concentration of attention.
Overdose
Symptoms: a polyuria, a hypovolemia and decrease in level of electrolytes that can result in drowsiness and confusion of consciousness, hypotension and cardiovascular collapse. Disturbances from digestive tract are possible.
Treatment: There is no specific antidote. Symptoms of overdose demand a dose decline or cancellation of a torasemid with simultaneous completion of losses of liquid and electrolytes.
A form of release and packing
On 10 tablets in blister strip packaging, from a film of polyvinylchloride and aluminum foil.
On 3 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place, at a temperature not above 25 °C.
To store out of children's reach.
A period of storage
of 5 years
not to use drug after an expiration date
Prescription status
According to the prescription
the Producer
the Pharmaceutical plant JSC Polfarm, Poland
of st. of Pelplinsk 19, 83-200 Starogard Gdanski
the Owner of the registration certificate
of JSC Khimfarm, the Republic of Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Khimfarm, Republic of Kazakhstan, Shymkent, Rashidov St., 81 Phone number 7252 (561342) Fax number 7252 (561342)
to Develop the E-mail address of infomed@santo.kz
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