Nolaksen 20s 25 mg coated tablets
- $22.50
Sku:
d7093fd8e706
The instruction for medical use
of Nolaksen Torgovoye medicine a name
Nolaksen
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
of the Tablet, coated, 25mg/25 mg
Structure
One tablet contains
active agents: Hydrochlorthiazidum of 25 mg
Spironolactonum of 25 mg,
excipients: corn starch, lactose, povidone (K30), cellulose microcrystalline, sodium krakhmalglikolit, magnesium stearate.
structure of a cover: a gipromelloz (E15), the titan dioxide, sanst yellow varnish, talc, propylene glycol.
The description
Round biconvex tablets, coated orange color with an engraving of NOLX on one party and smooth on another.
Pharmacotherapeutic group
Drugs for treatment of diseases of warmly vascular system.
A combination of diuretics with kaliysberegayushchy drugs.
The code of automatic telephone exchange C03EA01
the Pharmacological
Pharmacokinetics Absorption At properties intake Spironolactonum is quickly and completely soaked up from zheludochno – an intestinal path and turns into active metabolites: the metabolite containing sulfur (80%) and partially kanrenon (20%). The maximum concentration (Cmax) of a kanrenon in blood plasma is reached in 2-4 hours. Communication with proteins of blood plasma of 90%.
Absorption of a hydrochlorothiazide – 80%, fast. Communication with proteins of blood plasma – 60-80%. Bioavailability – 70%.
Metabolism
Spironolactonum badly nestles close in bodies and fabrics, at the same time itself and its metabolites get through a placental barrier, and kanrenon – into breast milk. Distribution volume – 0.05 l/kg.
The hydrochlorothiazide nestles close through a gemato-plantsentarny barrier and in breast milk. It is not metabolized in a liver.
Removal
Elimination half-life (T1/2) of Spironolactonum 13-24 hours, active metabolites – till 15 o'clock. To be removed by kidneys: 50% - in the form of metabolites, 10% - in not changed look and partially – stool. Removal of a kanrenon (kidneys) – two-phase, T1/2 in the first phase-2-3 hours, in the second – 12-96 hours.
Hydrochlorothiazide TCmax – 2-5 hours. T1/2 – 6-15 hours. To be removed a hydrochlorothiazide by kidneys: 95% in not changed look and about 4% in the form of a hydrolyzate - 2-amino-4-chloro-m-benzenedisulfonamida (decreases at alkalinuria) – by glomerular filtration and active canalicular secretion in proximal department of nephron.
A pharmacodynamics
Nolaksen – the combined drug which diuretic and hypotensive effect is caused by a combination of properties of Spironolactonum and a hydrochlorothiazide. Spironolactonum is kaliysberegayushchy diuretic, the specific antagonist of Aldosteronum of the prolonged action (mineralokortikosteroidny adrenal hormone). Contacting Aldosteronum receptors, increases excretion of water, ions of sodium and chlorine with urine, reduces removal of potassium and urea, reduces acidity of urine.
A hydrochlorothiazide – thiazide diuretic. Reduces a reabsorption of ions of sodium, strengthens discharge with urine of potassium, a hydrocarbonate and phosphates. Lowers arterial blood pressure due to reduction of the volume of the circulating blood (VCB), change of reactivity of a vascular wall, decrease in pressor influence of vasoconstrictive substances and strengthening of depressor influence on a ganglion.
Indications
- an edematous syndrome of various genesis (chronic heart failure,
diseases of a liver and kidneys)
- arterial hypertension as a part of complex therapy
the Route of administration and doses
the Drug Nolaksen is taken inside at meal time, washing down with enough liquid.
At an edematous syndrome appoint 2 tablets once or in two steps. The dose is selected individually depending on a condition of the patient and can vary within 1 - 4 tablet a day.
In arterial hypertension 1 – 2 tablets once or in two steps are appointed.
The course of treatment makes 14 – 21 day. Repetition of a course is possible each 10 – 14 days.
Duration of a course of treatment is determined by the attending physician.
Side effects
- nausea, vomiting, an abdominal pain, intestinal colic, diarrhea, a constipation, gastritis,
ulcerations and bleedings from zheludochno – an intestinal path
- an abnormal liver function
- an ataxy, block, dizziness, a headache, a lethargy,
confusion of consciousness, a muscular spasm
- a leukopenia (including an agranulocytosis), thrombocytopenia
- a giperkreatininemiya, the increased concentration of urea, disturbance of water
salt metabolism (hyperpotassemia, a hyponatremia) and acid-base
balance (metabolic giperkhloremichesky acidosis or an alkalosis),
a hyperuricemia
- a gynecomastia (the likelihood of development depends on a dose, duration of treatment and
, usually, has reversible character) - at men, coarsening are voices, disturbance
of a menstrual cycle, a dysmenorrhea, an amenorrhea, a metrorrhagia in
a climacteric, the hirsutism, pains in mammary glands - at women
is urticaria, seldom makulopapulezny and erythematic rash, medicinal
fever, an itching
- an alopecia, a hypertrichosis
- an acute renal failure
- spasms of gastrocnemius muscles
of the Contraindication
- hypersensitivity to drug components
- an acute renal failure, an anury
- the profound abnormal liver functions (a prekoma and a hepatic coma)
- not giving in corrections of disturbance of exchange of electrolytes: a hypopotassemia,
a hyperpotassemia, a hypercalcemia, a hyponatremia
- hypersensitivity to sulfonamides (because of danger
of cross allergic reactions)
- pregnancy, the lactation period
Medicinal interactions
It is necessary to avoid simultaneous use of Nolaksen with lithium salts as removal of salts of lithium decreases, raises kardio – and neurotoxicity. At joint reception of Nolaksen and high doses of salicylates the toxic effect of salicylates on the central nervous system can amplify. Non-steroidal anti-inflammatory drugs (indometacin and acetylsalicylic acid) reduce diuretic, natriuretic and antihypertensive activity of Nolaksen and increase risk of developing a renal failure. Administration of drug with cardiac glycosides, in case of a hypopotassemia and a hypomagnesiemia, can increase toxicity of drugs of a foxglove. Joint reception of Nolaksen can enhance effect and duration of action of not depolarizing muscle relaxants. Hypotensive action of Nolaksen is exponentiated by antihypertensive drugs (dose adjustment can be required), barbiturates, antidepressants, thiazide diuretics, vasodilators and alcohol intake. Joint reception of Nolaksen can weaken action of anti-diabetic means, adrenaline, noradrenaline, the drugs splitting uric acid slows down antiulcerous action of a karbenoksolon (accelerates biotransformation and removal). At a concomitant use of Nolaksen with potassium salts, kaliysberegayushchy diuretics, inhibitors of angiotensin-converting enzyme (APF), indometacin, cyclosporine the hyperpotassemia can develop. Joint reception of Nolaksen with Amiodaronum (its simultaneous use with thiazide diuretics can lead to increase in risk of arrhythmia, connected with a hypopotassemia). At combined use of APF inhibitor, furosemide and Nolaksen there can be an acute renal failure. Joint reception with Neomycinum, holestiraminy can reduce Nolaksen's digestibility. Development of a hyperpotassemia at joint administration of drugs of calcium with Nolaksen is possible.
Special instructions
With care to appoint Nolaksen sick with gout, diabetes, in an abnormal liver function and/or kidneys, to patients with the increased risk of a respiratory and metabolic acidosis.
At prolonged use of Nolaksen it is necessary to control periodically the content of electrolytes in serum and also urea, creatinine, glucose and uric acid.
During Nolaksen's reception it is forbidden to take alcohol.
Use in pediatrics
Safety and Nolaksen's efficiency at children was not studied.
Pregnancy and the period of a lactation
Use of the drug Nolaksen at pregnancy and the period of a lactation is contraindicated. In case of pregnancy against the background of administration of drug it should be cancelled.
Administration of drugs, directly acting on a system renin-angiotensin, during II and III trimesters of pregnancy can lead to death of a fruit.
Use of diuretics at healthy pregnant women is not recommended in connection with risk of developing of jaundice of a fruit and the newborn, thrombocytopenia at mother. Therapy by diuretics does not prevent development of toxicosis of pregnancy.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mekhanizmamiv an initial stage of use of drug is forbidden to run motor transport and to perform other works demanding speed of physical and mental reactions. Further the possibility of their implementation is defined individually.
Overdose
Symptoms: a long diuresis and a hyperpotassemia with disturbance of a warm rhythm, falling of arterial blood pressure, confusion of consciousness, nausea, vomiting, dryness in a mouth, thirst.
Treatment: the termination of administration of drug, induction of vomiting, gastric lavage, symptomatic therapy of dehydration and disturbances vodno – electrolytic balance, arterial hypotension, maintenance of the vital functions.
In case of a hyperpotassemia: fast intravenous administration of 20-50% of solution of glucose and insulin: 0.25-0.5 PIECES/g of glucose. Carrying out a hemodialysis is possible. There is no specific antidote.
Form of release and packing
of the Tablet, coated. 10 tablets in blister strip packaging.
2 packs in a cardboard box together with the instruction for medical use.
To Store storage conditions in the dry place, at a temperature not higher than + 250C.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
Bailey's Laboratory — Kreat Producer, France
(Shmen de Nouizmen of Z.I. 150 Arpen, 28500 Vernuye – Frans)
according to the license Medrayk, Great Britain for UORLD MEDITSIN, Great Britain
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from the consumer on quality of products (goods) of RK, Almaty, Suyunbaya 222 BTel St. / fax: 8 (7272) 529090www.worldmedicine.kz
to Develop
of Nolaksen Torgovoye medicine a name
Nolaksen
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
of the Tablet, coated, 25mg/25 mg
Structure
One tablet contains
active agents: Hydrochlorthiazidum of 25 mg
Spironolactonum of 25 mg,
excipients: corn starch, lactose, povidone (K30), cellulose microcrystalline, sodium krakhmalglikolit, magnesium stearate.
structure of a cover: a gipromelloz (E15), the titan dioxide, sanst yellow varnish, talc, propylene glycol.
The description
Round biconvex tablets, coated orange color with an engraving of NOLX on one party and smooth on another.
Pharmacotherapeutic group
Drugs for treatment of diseases of warmly vascular system.
A combination of diuretics with kaliysberegayushchy drugs.
The code of automatic telephone exchange C03EA01
the Pharmacological
Pharmacokinetics Absorption At properties intake Spironolactonum is quickly and completely soaked up from zheludochno – an intestinal path and turns into active metabolites: the metabolite containing sulfur (80%) and partially kanrenon (20%). The maximum concentration (Cmax) of a kanrenon in blood plasma is reached in 2-4 hours. Communication with proteins of blood plasma of 90%.
Absorption of a hydrochlorothiazide – 80%, fast. Communication with proteins of blood plasma – 60-80%. Bioavailability – 70%.
Metabolism
Spironolactonum badly nestles close in bodies and fabrics, at the same time itself and its metabolites get through a placental barrier, and kanrenon – into breast milk. Distribution volume – 0.05 l/kg.
The hydrochlorothiazide nestles close through a gemato-plantsentarny barrier and in breast milk. It is not metabolized in a liver.
Removal
Elimination half-life (T1/2) of Spironolactonum 13-24 hours, active metabolites – till 15 o'clock. To be removed by kidneys: 50% - in the form of metabolites, 10% - in not changed look and partially – stool. Removal of a kanrenon (kidneys) – two-phase, T1/2 in the first phase-2-3 hours, in the second – 12-96 hours.
Hydrochlorothiazide TCmax – 2-5 hours. T1/2 – 6-15 hours. To be removed a hydrochlorothiazide by kidneys: 95% in not changed look and about 4% in the form of a hydrolyzate - 2-amino-4-chloro-m-benzenedisulfonamida (decreases at alkalinuria) – by glomerular filtration and active canalicular secretion in proximal department of nephron.
A pharmacodynamics
Nolaksen – the combined drug which diuretic and hypotensive effect is caused by a combination of properties of Spironolactonum and a hydrochlorothiazide. Spironolactonum is kaliysberegayushchy diuretic, the specific antagonist of Aldosteronum of the prolonged action (mineralokortikosteroidny adrenal hormone). Contacting Aldosteronum receptors, increases excretion of water, ions of sodium and chlorine with urine, reduces removal of potassium and urea, reduces acidity of urine.
A hydrochlorothiazide – thiazide diuretic. Reduces a reabsorption of ions of sodium, strengthens discharge with urine of potassium, a hydrocarbonate and phosphates. Lowers arterial blood pressure due to reduction of the volume of the circulating blood (VCB), change of reactivity of a vascular wall, decrease in pressor influence of vasoconstrictive substances and strengthening of depressor influence on a ganglion.
Indications
- an edematous syndrome of various genesis (chronic heart failure,
diseases of a liver and kidneys)
- arterial hypertension as a part of complex therapy
the Route of administration and doses
the Drug Nolaksen is taken inside at meal time, washing down with enough liquid.
At an edematous syndrome appoint 2 tablets once or in two steps. The dose is selected individually depending on a condition of the patient and can vary within 1 - 4 tablet a day.
In arterial hypertension 1 – 2 tablets once or in two steps are appointed.
The course of treatment makes 14 – 21 day. Repetition of a course is possible each 10 – 14 days.
Duration of a course of treatment is determined by the attending physician.
Side effects
- nausea, vomiting, an abdominal pain, intestinal colic, diarrhea, a constipation, gastritis,
ulcerations and bleedings from zheludochno – an intestinal path
- an abnormal liver function
- an ataxy, block, dizziness, a headache, a lethargy,
confusion of consciousness, a muscular spasm
- a leukopenia (including an agranulocytosis), thrombocytopenia
- a giperkreatininemiya, the increased concentration of urea, disturbance of water
salt metabolism (hyperpotassemia, a hyponatremia) and acid-base
balance (metabolic giperkhloremichesky acidosis or an alkalosis),
a hyperuricemia
- a gynecomastia (the likelihood of development depends on a dose, duration of treatment and
, usually, has reversible character) - at men, coarsening are voices, disturbance
of a menstrual cycle, a dysmenorrhea, an amenorrhea, a metrorrhagia in
a climacteric, the hirsutism, pains in mammary glands - at women
is urticaria, seldom makulopapulezny and erythematic rash, medicinal
fever, an itching
- an alopecia, a hypertrichosis
- an acute renal failure
- spasms of gastrocnemius muscles
of the Contraindication
- hypersensitivity to drug components
- an acute renal failure, an anury
- the profound abnormal liver functions (a prekoma and a hepatic coma)
- not giving in corrections of disturbance of exchange of electrolytes: a hypopotassemia,
a hyperpotassemia, a hypercalcemia, a hyponatremia
- hypersensitivity to sulfonamides (because of danger
of cross allergic reactions)
- pregnancy, the lactation period
Medicinal interactions
It is necessary to avoid simultaneous use of Nolaksen with lithium salts as removal of salts of lithium decreases, raises kardio – and neurotoxicity. At joint reception of Nolaksen and high doses of salicylates the toxic effect of salicylates on the central nervous system can amplify. Non-steroidal anti-inflammatory drugs (indometacin and acetylsalicylic acid) reduce diuretic, natriuretic and antihypertensive activity of Nolaksen and increase risk of developing a renal failure. Administration of drug with cardiac glycosides, in case of a hypopotassemia and a hypomagnesiemia, can increase toxicity of drugs of a foxglove. Joint reception of Nolaksen can enhance effect and duration of action of not depolarizing muscle relaxants. Hypotensive action of Nolaksen is exponentiated by antihypertensive drugs (dose adjustment can be required), barbiturates, antidepressants, thiazide diuretics, vasodilators and alcohol intake. Joint reception of Nolaksen can weaken action of anti-diabetic means, adrenaline, noradrenaline, the drugs splitting uric acid slows down antiulcerous action of a karbenoksolon (accelerates biotransformation and removal). At a concomitant use of Nolaksen with potassium salts, kaliysberegayushchy diuretics, inhibitors of angiotensin-converting enzyme (APF), indometacin, cyclosporine the hyperpotassemia can develop. Joint reception of Nolaksen with Amiodaronum (its simultaneous use with thiazide diuretics can lead to increase in risk of arrhythmia, connected with a hypopotassemia). At combined use of APF inhibitor, furosemide and Nolaksen there can be an acute renal failure. Joint reception with Neomycinum, holestiraminy can reduce Nolaksen's digestibility. Development of a hyperpotassemia at joint administration of drugs of calcium with Nolaksen is possible.
Special instructions
With care to appoint Nolaksen sick with gout, diabetes, in an abnormal liver function and/or kidneys, to patients with the increased risk of a respiratory and metabolic acidosis.
At prolonged use of Nolaksen it is necessary to control periodically the content of electrolytes in serum and also urea, creatinine, glucose and uric acid.
During Nolaksen's reception it is forbidden to take alcohol.
Use in pediatrics
Safety and Nolaksen's efficiency at children was not studied.
Pregnancy and the period of a lactation
Use of the drug Nolaksen at pregnancy and the period of a lactation is contraindicated. In case of pregnancy against the background of administration of drug it should be cancelled.
Administration of drugs, directly acting on a system renin-angiotensin, during II and III trimesters of pregnancy can lead to death of a fruit.
Use of diuretics at healthy pregnant women is not recommended in connection with risk of developing of jaundice of a fruit and the newborn, thrombocytopenia at mother. Therapy by diuretics does not prevent development of toxicosis of pregnancy.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mekhanizmamiv an initial stage of use of drug is forbidden to run motor transport and to perform other works demanding speed of physical and mental reactions. Further the possibility of their implementation is defined individually.
Overdose
Symptoms: a long diuresis and a hyperpotassemia with disturbance of a warm rhythm, falling of arterial blood pressure, confusion of consciousness, nausea, vomiting, dryness in a mouth, thirst.
Treatment: the termination of administration of drug, induction of vomiting, gastric lavage, symptomatic therapy of dehydration and disturbances vodno – electrolytic balance, arterial hypotension, maintenance of the vital functions.
In case of a hyperpotassemia: fast intravenous administration of 20-50% of solution of glucose and insulin: 0.25-0.5 PIECES/g of glucose. Carrying out a hemodialysis is possible. There is no specific antidote.
Form of release and packing
of the Tablet, coated. 10 tablets in blister strip packaging.
2 packs in a cardboard box together with the instruction for medical use.
To Store storage conditions in the dry place, at a temperature not higher than + 250C.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
Bailey's Laboratory — Kreat Producer, France
(Shmen de Nouizmen of Z.I. 150 Arpen, 28500 Vernuye – Frans)
according to the license Medrayk, Great Britain for UORLD MEDITSIN, Great Britain
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from the consumer on quality of products (goods) of RK, Almaty, Suyunbaya 222 BTel St. / fax: 8 (7272) 529090www.worldmedicine.kz
to Develop
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