Primary Information
Composition and form of issue
Tablet controlled release, film-coated, round, convexoconvex, pinkish, with napechatkoy black ink "ADALAT 30" on the one hand.
1 tab.
nifedipine 30 mg
Other ingredients: hypromellose, magnesium stearate, polyethylene oxide, sodium chloride, cellulose acetate, polyethylene glycol 4000, Opadry OY-S-24 914 (red iron oxide + titanium dioxide).
14 pcs. - Blisters (2) - packs cardboard.
Tablet controlled release, film-coated, round, convexoconvex, pinkish, with napechatkoy black ink "ADALAT 60" on the one hand.
1 tab.
nifedipine 60 mg
Other ingredients: hypromellose, magnesium stearate, polyethylene oxide, sodium chloride, cellulose acetate, polyethylene glycol 4000, Opadry OY-S-24 914 (red iron oxide + titanium dioxide).
14 pcs. - Blisters (2) - packs cardboard.
Registration number:
tab., cover. shell, with controlled release of 30 mg, 60 mg: 28 pcs. - P # 014946/01 24.06.05
Pharmacological action
Selective blocker of slow calcium channel class II, a derivative of 1,4-dihydropyridine. Reduces the flow of extracellular calcium inside of cardiomyocytes, smooth muscle cells of the coronary and peripheral arteries. Reduces the number of functioning of channels without having an impact on the time of their activation, inactivation and recovery.
Nifedipine provides vazodilatirtee effect, especially in the large coronary arteries that affects the intact segments of the wall of a partially stenosed vessels. Lowers tone smooth muscles coronary arteries and prevents the development of angiospasm, that causes the strengthening of poststenotic blood flow and improving the procurement of myocardial oxygen. In addition, nifedipine reduces the need heart of oxygen, reducing the CSO (postnagruzku).
Nifedipine exerts antihypertensive effect associated with a decrease the tone of smooth muscles of arterioles and the reduction of elevated systemic vascular resistance.
In the beginning of the treatment of Osmo-Adalat may be a temporary minor reflex increase heart RATE and cardiac output. Nifedipine as a short-term, and in long-term use increases the excretion of sodium and water from the body. The hypotensive effect of nifedipine is especially pronounced in patients with initially high AD.
In the international, randomized, double-blind, prospective study with the period of observation from 3 up to 4.8 years, which included 6321 of the patient with hypertension and at least one risk factor, it was shown that Osmo-Adalat reduces the frequency of cardiovascular and cerebrovascular episodes in the same degree, as a combination of diuretics.
Indications
- Ischemic heart DISEASE: stable stenocardia (angina);
- Arterial hypertension.
The dosage
The recommended initial dose is 30 mg / day. Depending on the severity of the disease and the individual response of the patient dose of Osmo-Adalat can be gradually increased to 120 mg / day. The duration of treatment set individually.
Elderly patients receiving combination (antianginalnuu or antihypertensive therapy should designate smaller doses.
If any of the liver, in patients with severe violations of cerebral circulation dose of the drug should be reduced.
Pills Osmo-Adalat should be swallowed whole, squeezed small amounts of liquid, regardless of meals. Tablets should not be chewed, or crush.
Side effect
From the cardiovascular system:> = 1 - <10% - feeling tide blood to a person, palpitations, peripheral edema;> = 0.1-<1% - arterial gipotenzia (incl. ortostatical), syncope, tachycardia, pain in the chest area .
From the digestive system:> = 1 - <10% - constipation;> = 0.1-<1% diarrhoea, dyspepsia, abdominal distension, nausea;> = 0.01-<0.1% - a violation of appetite, eructation, gingivitis, gingival hyperplasia , increased activity of hepatic transaminases, intra-hepatic cholestasis; <0.01% - dysphagia, esophagitis, intestinal occlusion, ulceration wall of the bowel, or jaundice.
From the side of the central nervous system and peripheral nervous system:> = 1 - <10% dizziness, headache;> = 0.1-<1% - sleep disorder, nervousness, paresthesia, vertigo, drowsiness;> = 0.01-<0.1% - giposteziya, tremor (at high doses), vision disorders; <0.01% - diplopia.
Endocrine system: <0.01% - hyperglycemia, decreased body mass, gynecomastia.
From the respiratory system:> = 0.1-<1% - dyspnoea;> = 0.01-<0.1% - nosebleeds.
On the part of the urinary system:> = 0.1-<1% - increase in daily diuresis;> = 0.01-<0.1%: dysuria, frequency of urination, the deterioration of renal function (in patients with renal insufficiency).
From the musculoskeletal system:> = 0.1-<1% - cramps in the calf muscles, mialgia;> = 0.01-<0.1% - arthralgia.
Dermatological reactions:> = 0.1-<1%, itching, rash (exantema, erythema, urticaria); <0.01% - photodermatitis, exfoliativei dermatitis.
Haemopoiesis: <0.01% - lakopenia, thrombocytopenic purpura.
Other:> = 1 - <10% - fatigue, weakness;> = 0.1-<1% pain in the extremities;> = 0.01-<0.1% - allergic reactions, chills, fever; <0.01% - anaphylacticskie reaction.
Contraindications
- Cardiogenny shock;
- Expressed arterial hypotension (systolic blood pressure <90 mm hg.);
- The acute phase of myocardial infarction (first 8 days);
- Pronounced aortic or mitral stenosis;
- Idiopathic hypertrophic subaortalny stenosis;
- Tachycardia;
- Ileostoma, installed after the proktokolektomii;
- The simultaneous use of rifampicin;
- Pregnancy;
- Lactation (breast-feeding);
- Child and adolescence to 18 years;
- Increased sensitivity to components of the preparation and of other derivative dihydropyridine.
Be wary appoint an Osmo-Adalat in patients with hepatic or renal insufficiency, severe stenosis of the digestive TRACT, severe violations of cerebral circulation, at a malignant arterial hypertension, in severe heart failure, and patients on hemodialysis (because of the risk of development of arterial hypotension) or with decompensated diabetes mellitus.
Pregnancy and lactation
Osmo-Adalat is contraindicated during pregnancy because it is possible embriotoksicescoe, fetotoksicheskoe and teratogenic effects of the drug.
When necessary, the use of Osmo-Adalat lactating breast-feeding should be discontinued, since the effect of nifedipine on the body of an infant is not known.
Special instructions
In patients with malignant hypertension and hypovolaemia, in gemodialise, on a background of reception Osmo-Adalat may experience an excessive reduction of blood.
In patients with severe stenosis of the digestive TRACT application of tablets an Osmo-Adalat with inelastic shell, may cause gastro-intestinal blockage.
Treatment of Osmo-Adalat patients with impaired hepatic function should be carried out in a careful medical supervision. In severe cases it may be necessary to reduce the dose of the drug.
In the radiological studies TRACT with the use of barium as a radio-opaque means pills Osmo-Adalat may be the cause false-positive results for the presence of polyps.
In the application of Osmo-Adalat perhaps false improvement of the results of spectrophotometric determination of concentration of vanilla-almond acid in the urine; however, when using the method HPLC this is not observed.
Effects on ability to drive and use machines
Individual reaction of organism to the reception of Osmo-Adalat can become the reason of decrease of the speed of psychomotor reactions, reduced ability to concentrate, which has a negative impact on the ability to drive and work with complex mechanisms. This is particularly important at the beginning of treatment, with the change of the preparation and of the simultaneous use of alcohol.
Overdose
Symptoms: expressed in intoxication possible violations of consciousness up to coma, collapse, cardiac rhythm disturbances on the type of taha-or bradycardia, hyperglycemia, metabolic acidosis, hypoxia, cardiogenny shock with pulmonary edema.
Treatment: gastric lavage is recommended, if necessary in conjunction with the washing of the small intestine; a simptomaticescuu therapy: if bradikardii - introduction of beta-sympathomimetics (with life-threatening bradycardia it is possible to recommend the establishment of artificial driver rhythm; when the arterial hypotension, caused as a result of cardiogennogo shock and vasodilation demonstrates the use of drugs calcium (in / in slow infusion of 10-20 ml of 10% solution of calcium glukonata; if necessary, repeat infusion). If a sufficient increase the HELL does not occur, it is recommended that additional simpatomimetikov - dopamine or norepinephrine; doses of these drugs picked individually depending on the clinical effect.
In the development of heart failure in / in the introduction strophanthin.
Because of the danger of increasing the load on the heart of the additional introduction of the liquid should be made with caution. Catecholamines should be used only in life-threatening violations of the circulatory system (in connection with their low efficiency requires a high dose, because this increases the risk of arrhythmia caused by intoxication). It is recommended that the control of glucose and electrolytes (K +, Ca2 +) in the blood.
A kidney dialysis is not effective, since nifedipine is not subject to dialysis; at the same time, plasmapheresis may be effective (high relationship with blood plasma proteins and, as a consequence, low Vd).
Drug interaction
Antihypertensive effect of Osmo-Adalat may be amplified by concomitant use of other antihypertensive drugs, diuretics, and ranitidine.
While the use of Osmo-Adalat with beta-adrenergic blockers may develop expressed arterial hypotension; in some cases, aggravation of cardiac insufficiency (requires careful medical supervision).
While the use of Osmo-Adalat with nitrates increases tachycardia and hypotension.
Tablet controlled release, film-coated, round, convexoconvex, pinkish, with napechatkoy black ink "ADALAT 30" on the one hand.
1 tab.
nifedipine 30 mg
Other ingredients: hypromellose, magnesium stearate, polyethylene oxide, sodium chloride, cellulose acetate, polyethylene glycol 4000, Opadry OY-S-24 914 (red iron oxide + titanium dioxide).
14 pcs. - Blisters (2) - packs cardboard.
Tablet controlled release, film-coated, round, convexoconvex, pinkish, with napechatkoy black ink "ADALAT 60" on the one hand.
1 tab.
nifedipine 60 mg
Other ingredients: hypromellose, magnesium stearate, polyethylene oxide, sodium chloride, cellulose acetate, polyethylene glycol 4000, Opadry OY-S-24 914 (red iron oxide + titanium dioxide).
14 pcs. - Blisters (2) - packs cardboard.
Registration number:
tab., cover. shell, with controlled release of 30 mg, 60 mg: 28 pcs. - P # 014946/01 24.06.05
Pharmacological action
Selective blocker of slow calcium channel class II, a derivative of 1,4-dihydropyridine. Reduces the flow of extracellular calcium inside of cardiomyocytes, smooth muscle cells of the coronary and peripheral arteries. Reduces the number of functioning of channels without having an impact on the time of their activation, inactivation and recovery.
Nifedipine provides vazodilatirtee effect, especially in the large coronary arteries that affects the intact segments of the wall of a partially stenosed vessels. Lowers tone smooth muscles coronary arteries and prevents the development of angiospasm, that causes the strengthening of poststenotic blood flow and improving the procurement of myocardial oxygen. In addition, nifedipine reduces the need heart of oxygen, reducing the CSO (postnagruzku).
Nifedipine exerts antihypertensive effect associated with a decrease the tone of smooth muscles of arterioles and the reduction of elevated systemic vascular resistance.
In the beginning of the treatment of Osmo-Adalat may be a temporary minor reflex increase heart RATE and cardiac output. Nifedipine as a short-term, and in long-term use increases the excretion of sodium and water from the body. The hypotensive effect of nifedipine is especially pronounced in patients with initially high AD.
In the international, randomized, double-blind, prospective study with the period of observation from 3 up to 4.8 years, which included 6321 of the patient with hypertension and at least one risk factor, it was shown that Osmo-Adalat reduces the frequency of cardiovascular and cerebrovascular episodes in the same degree, as a combination of diuretics.
Indications
- Ischemic heart DISEASE: stable stenocardia (angina);
- Arterial hypertension.
The dosage
The recommended initial dose is 30 mg / day. Depending on the severity of the disease and the individual response of the patient dose of Osmo-Adalat can be gradually increased to 120 mg / day. The duration of treatment set individually.
Elderly patients receiving combination (antianginalnuu or antihypertensive therapy should designate smaller doses.
If any of the liver, in patients with severe violations of cerebral circulation dose of the drug should be reduced.
Pills Osmo-Adalat should be swallowed whole, squeezed small amounts of liquid, regardless of meals. Tablets should not be chewed, or crush.
Side effect
From the cardiovascular system:> = 1 - <10% - feeling tide blood to a person, palpitations, peripheral edema;> = 0.1-<1% - arterial gipotenzia (incl. ortostatical), syncope, tachycardia, pain in the chest area .
From the digestive system:> = 1 - <10% - constipation;> = 0.1-<1% diarrhoea, dyspepsia, abdominal distension, nausea;> = 0.01-<0.1% - a violation of appetite, eructation, gingivitis, gingival hyperplasia , increased activity of hepatic transaminases, intra-hepatic cholestasis; <0.01% - dysphagia, esophagitis, intestinal occlusion, ulceration wall of the bowel, or jaundice.
From the side of the central nervous system and peripheral nervous system:> = 1 - <10% dizziness, headache;> = 0.1-<1% - sleep disorder, nervousness, paresthesia, vertigo, drowsiness;> = 0.01-<0.1% - giposteziya, tremor (at high doses), vision disorders; <0.01% - diplopia.
Endocrine system: <0.01% - hyperglycemia, decreased body mass, gynecomastia.
From the respiratory system:> = 0.1-<1% - dyspnoea;> = 0.01-<0.1% - nosebleeds.
On the part of the urinary system:> = 0.1-<1% - increase in daily diuresis;> = 0.01-<0.1%: dysuria, frequency of urination, the deterioration of renal function (in patients with renal insufficiency).
From the musculoskeletal system:> = 0.1-<1% - cramps in the calf muscles, mialgia;> = 0.01-<0.1% - arthralgia.
Dermatological reactions:> = 0.1-<1%, itching, rash (exantema, erythema, urticaria); <0.01% - photodermatitis, exfoliativei dermatitis.
Haemopoiesis: <0.01% - lakopenia, thrombocytopenic purpura.
Other:> = 1 - <10% - fatigue, weakness;> = 0.1-<1% pain in the extremities;> = 0.01-<0.1% - allergic reactions, chills, fever; <0.01% - anaphylacticskie reaction.
Contraindications
- Cardiogenny shock;
- Expressed arterial hypotension (systolic blood pressure <90 mm hg.);
- The acute phase of myocardial infarction (first 8 days);
- Pronounced aortic or mitral stenosis;
- Idiopathic hypertrophic subaortalny stenosis;
- Tachycardia;
- Ileostoma, installed after the proktokolektomii;
- The simultaneous use of rifampicin;
- Pregnancy;
- Lactation (breast-feeding);
- Child and adolescence to 18 years;
- Increased sensitivity to components of the preparation and of other derivative dihydropyridine.
Be wary appoint an Osmo-Adalat in patients with hepatic or renal insufficiency, severe stenosis of the digestive TRACT, severe violations of cerebral circulation, at a malignant arterial hypertension, in severe heart failure, and patients on hemodialysis (because of the risk of development of arterial hypotension) or with decompensated diabetes mellitus.
Pregnancy and lactation
Osmo-Adalat is contraindicated during pregnancy because it is possible embriotoksicescoe, fetotoksicheskoe and teratogenic effects of the drug.
When necessary, the use of Osmo-Adalat lactating breast-feeding should be discontinued, since the effect of nifedipine on the body of an infant is not known.
Special instructions
In patients with malignant hypertension and hypovolaemia, in gemodialise, on a background of reception Osmo-Adalat may experience an excessive reduction of blood.
In patients with severe stenosis of the digestive TRACT application of tablets an Osmo-Adalat with inelastic shell, may cause gastro-intestinal blockage.
Treatment of Osmo-Adalat patients with impaired hepatic function should be carried out in a careful medical supervision. In severe cases it may be necessary to reduce the dose of the drug.
In the radiological studies TRACT with the use of barium as a radio-opaque means pills Osmo-Adalat may be the cause false-positive results for the presence of polyps.
In the application of Osmo-Adalat perhaps false improvement of the results of spectrophotometric determination of concentration of vanilla-almond acid in the urine; however, when using the method HPLC this is not observed.
Effects on ability to drive and use machines
Individual reaction of organism to the reception of Osmo-Adalat can become the reason of decrease of the speed of psychomotor reactions, reduced ability to concentrate, which has a negative impact on the ability to drive and work with complex mechanisms. This is particularly important at the beginning of treatment, with the change of the preparation and of the simultaneous use of alcohol.
Overdose
Symptoms: expressed in intoxication possible violations of consciousness up to coma, collapse, cardiac rhythm disturbances on the type of taha-or bradycardia, hyperglycemia, metabolic acidosis, hypoxia, cardiogenny shock with pulmonary edema.
Treatment: gastric lavage is recommended, if necessary in conjunction with the washing of the small intestine; a simptomaticescuu therapy: if bradikardii - introduction of beta-sympathomimetics (with life-threatening bradycardia it is possible to recommend the establishment of artificial driver rhythm; when the arterial hypotension, caused as a result of cardiogennogo shock and vasodilation demonstrates the use of drugs calcium (in / in slow infusion of 10-20 ml of 10% solution of calcium glukonata; if necessary, repeat infusion). If a sufficient increase the HELL does not occur, it is recommended that additional simpatomimetikov - dopamine or norepinephrine; doses of these drugs picked individually depending on the clinical effect.
In the development of heart failure in / in the introduction strophanthin.
Because of the danger of increasing the load on the heart of the additional introduction of the liquid should be made with caution. Catecholamines should be used only in life-threatening violations of the circulatory system (in connection with their low efficiency requires a high dose, because this increases the risk of arrhythmia caused by intoxication). It is recommended that the control of glucose and electrolytes (K +, Ca2 +) in the blood.
A kidney dialysis is not effective, since nifedipine is not subject to dialysis; at the same time, plasmapheresis may be effective (high relationship with blood plasma proteins and, as a consequence, low Vd).
Drug interaction
Antihypertensive effect of Osmo-Adalat may be amplified by concomitant use of other antihypertensive drugs, diuretics, and ranitidine.
While the use of Osmo-Adalat with beta-adrenergic blockers may develop expressed arterial hypotension; in some cases, aggravation of cardiac insufficiency (requires careful medical supervision).
While the use of Osmo-Adalat with nitrates increases tachycardia and hypotension.
