Composition, structure and packing
Tablets are white, round, flat, beveled edges, with the risk on one side.
1 tab. amlodipine (in the form bezilata) 5 mg.
Excipients: corn starch, calcium phosphate dibasic, purified talc, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate.
Clinico-pharmacological group: Calcium channel blockers.
Pharmacological action
Calcium channel blockers dihydropyridine derivatives of the group. Antihypertensive and antianginal effects. Amlodipine inhibits the transmembrane entry of calcium ions into smooth muscle cells of blood vessels and myocardium.
Mechanism of antihypertensive action is due to the direct relaxing effect on smooth muscles of blood vessels. Antianginal effect of the drug is due, firstly, its ability to expand the peripheral arterioles, which leads to a decrease TPVR. Reducing the load on the heart reduces myocardial oxygen demand. Secondly, the drug dilates coronary arteries and arterioles, which increases oxygen supply to the myocardium (especially important when angiospastic angina).
Amlodipine has no adverse effect on metabolism and lipid content of blood plasma, has antiateroskleroticheskoy, antithrombotic activity, increases the glomerular filtration rate, has a weak natriuretic effect. In diabetic nephropathy does not increase the severity of microalbuminuria.
Statement
hypertension (as monotherapy and as part of combination therapy);
Stable angina;
angiospastic angina (Prinzmetal angina).
Dosage regimen
When hypertension prescribe oral initial dose of 2.5 mg. For prevention of angina attacks - 5 mg. The recommended maintenance dose in arterial hypertension and angina - 5 mg / day.
If necessary, the daily dose may be increased to 10 mg. Do not exceed the recommended initial daily dose in patients with hepatic impairment, elderly patients and patients with reduced body weight. The maximum daily dose - 10 mg. With simultaneous application tiazidopodobnyh diuretics, beta-blockers or ACE inhibitors correct dosing regimen Akridipina not required.
Side effect
Since the cardiovascular system: heart rate, shortness of breath, excessive lowering of blood pressure, syncope, vasculitis, edema ankles and feet, hot flushes, rarely, cardiac arrhythmias - (bradycardia, ventricular tachycardia, atrial flutter), chest pain, orthostatic hypotension.
From the central nervous system and peripheral nervous system: dizziness, headache, drowsiness, fatigue, rarely - asthenia, mood changes, cramps, myalgia, visual disturbances, paresthesia.
On the part of the digestive system: the phenomenon of dyspepsia, abdominal pain, rarely - increased activity of hepatic transaminases, jaundice (due to intrahepatic cholestasis), gingival hyperplasia, pancreatitis, taste perversion, dry mouth.
On the part of the hemopoietic system: rarely - thrombocytopenia, leukopenia.
Dermatological reactions: skin rash, itching, rarely - erythema multiforme, discoloration of the skin.
Other: rarely - gynecomastia, impotence, frequent urination, increase / decrease in body weight.
Contraindications
hypotension;
heart failure, III and IV functional class;
aortic stenosis;
idiopathic hypertrophic subaortalny stenosis;
collapse;
cardiogenic shock;
myocardial infarction (during the first week);
tachycardia
Hypersensitivity to amlodipine and other derivatives of dihydropyridine.
Pregnancy and lactation
Application Akridipina during pregnancy is possible only when the intended benefits to the mother outweighs the potential risk to the fetus or baby (due to lack of reliable clinical data supporting the safety of the drug in these periods).
If necessary, use Akridipina during lactation should decide the issue of termination of breastfeeding.
Application for violations of liver function
Precautions appoint Akridipin patients with impaired liver function.
Application for violations of renal function
Precautions appoint Akridipin patients with impaired renal function.
Cautions
Precautions appoint Akridipin patients with impaired liver function and kidney. During treatment requires monitoring of body weight, diet (especially restricted sodium intake), the maintenance of oral hygiene and regular dental visits (to prevent soreness, bleeding and gingival hyperplasia).
Be used together with Akridipina tiazidopodobnymi diuretics, alpha-and beta-blockers, ACE inhibitors, nitrates (including prolonged), NSAIDs, antibiotics, oral hypoglycemic drugs.
Use in Pediatrics
Experience with Akridipina children missing.
Overdose
Symptoms: marked reduction of blood pressure, tachycardia, excessive peripheral vasodilatation.
Treatment: perform control BCC, diuresis, cardiovascular system, monitoring of vital body functions and common activities aimed at maintaining them. The patient should be given to a horizontal position with legs elevated. To restore the tone of the vessels used vasoconstrictive drugs (in the absence of contraindications to their use) to eliminate the effects of the blockade of calcium channels - in / injected calcium gluconate. Hemodialysis is not effective.
Drug Interactions
The simultaneous use of Akridipina and digoxin does not alter the level of digoxin concentration in serum and renal clearance of digoxin.
Joint application Akridipina and cimetidine does not alter the pharmacokinetics of amlodipine. The simultaneous appointment Akridipina not significantly modify the effect of warfarin on prothrombin time in healthy male volunteers.
Antihypertensive effect Akridipina weaken NSAIDs, especially indomethacin (there is a delay of sodium and blocking the synthesis of prostaglandins by the kidneys), sympathomimetic and estrogens (cause sodium retention).
When the joint application of funds for inhalation anesthesia (derivatives of hydrocarbons), amiodarone, quinidine, calcium channel blockers may increase the hypotensive effect Akridipina.
When combined with the use of lithium therapy may be a manifestation of neurotoxicity.
Terms and Conditions of storage
List B. The drug should be stored in dry, dark place at temperatures not above 25 ° C. Shelf life - 3 years.
Tablets are white, round, flat, beveled edges, with the risk on one side.
1 tab. amlodipine (in the form bezilata) 5 mg.
Excipients: corn starch, calcium phosphate dibasic, purified talc, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate.
Clinico-pharmacological group: Calcium channel blockers.
Pharmacological action
Calcium channel blockers dihydropyridine derivatives of the group. Antihypertensive and antianginal effects. Amlodipine inhibits the transmembrane entry of calcium ions into smooth muscle cells of blood vessels and myocardium.
Mechanism of antihypertensive action is due to the direct relaxing effect on smooth muscles of blood vessels. Antianginal effect of the drug is due, firstly, its ability to expand the peripheral arterioles, which leads to a decrease TPVR. Reducing the load on the heart reduces myocardial oxygen demand. Secondly, the drug dilates coronary arteries and arterioles, which increases oxygen supply to the myocardium (especially important when angiospastic angina).
Amlodipine has no adverse effect on metabolism and lipid content of blood plasma, has antiateroskleroticheskoy, antithrombotic activity, increases the glomerular filtration rate, has a weak natriuretic effect. In diabetic nephropathy does not increase the severity of microalbuminuria.
Statement
hypertension (as monotherapy and as part of combination therapy);
Stable angina;
angiospastic angina (Prinzmetal angina).
Dosage regimen
When hypertension prescribe oral initial dose of 2.5 mg. For prevention of angina attacks - 5 mg. The recommended maintenance dose in arterial hypertension and angina - 5 mg / day.
If necessary, the daily dose may be increased to 10 mg. Do not exceed the recommended initial daily dose in patients with hepatic impairment, elderly patients and patients with reduced body weight. The maximum daily dose - 10 mg. With simultaneous application tiazidopodobnyh diuretics, beta-blockers or ACE inhibitors correct dosing regimen Akridipina not required.
Side effect
Since the cardiovascular system: heart rate, shortness of breath, excessive lowering of blood pressure, syncope, vasculitis, edema ankles and feet, hot flushes, rarely, cardiac arrhythmias - (bradycardia, ventricular tachycardia, atrial flutter), chest pain, orthostatic hypotension.
From the central nervous system and peripheral nervous system: dizziness, headache, drowsiness, fatigue, rarely - asthenia, mood changes, cramps, myalgia, visual disturbances, paresthesia.
On the part of the digestive system: the phenomenon of dyspepsia, abdominal pain, rarely - increased activity of hepatic transaminases, jaundice (due to intrahepatic cholestasis), gingival hyperplasia, pancreatitis, taste perversion, dry mouth.
On the part of the hemopoietic system: rarely - thrombocytopenia, leukopenia.
Dermatological reactions: skin rash, itching, rarely - erythema multiforme, discoloration of the skin.
Other: rarely - gynecomastia, impotence, frequent urination, increase / decrease in body weight.
Contraindications
hypotension;
heart failure, III and IV functional class;
aortic stenosis;
idiopathic hypertrophic subaortalny stenosis;
collapse;
cardiogenic shock;
myocardial infarction (during the first week);
tachycardia
Hypersensitivity to amlodipine and other derivatives of dihydropyridine.
Pregnancy and lactation
Application Akridipina during pregnancy is possible only when the intended benefits to the mother outweighs the potential risk to the fetus or baby (due to lack of reliable clinical data supporting the safety of the drug in these periods).
If necessary, use Akridipina during lactation should decide the issue of termination of breastfeeding.
Application for violations of liver function
Precautions appoint Akridipin patients with impaired liver function.
Application for violations of renal function
Precautions appoint Akridipin patients with impaired renal function.
Cautions
Precautions appoint Akridipin patients with impaired liver function and kidney. During treatment requires monitoring of body weight, diet (especially restricted sodium intake), the maintenance of oral hygiene and regular dental visits (to prevent soreness, bleeding and gingival hyperplasia).
Be used together with Akridipina tiazidopodobnymi diuretics, alpha-and beta-blockers, ACE inhibitors, nitrates (including prolonged), NSAIDs, antibiotics, oral hypoglycemic drugs.
Use in Pediatrics
Experience with Akridipina children missing.
Overdose
Symptoms: marked reduction of blood pressure, tachycardia, excessive peripheral vasodilatation.
Treatment: perform control BCC, diuresis, cardiovascular system, monitoring of vital body functions and common activities aimed at maintaining them. The patient should be given to a horizontal position with legs elevated. To restore the tone of the vessels used vasoconstrictive drugs (in the absence of contraindications to their use) to eliminate the effects of the blockade of calcium channels - in / injected calcium gluconate. Hemodialysis is not effective.
Drug Interactions
The simultaneous use of Akridipina and digoxin does not alter the level of digoxin concentration in serum and renal clearance of digoxin.
Joint application Akridipina and cimetidine does not alter the pharmacokinetics of amlodipine. The simultaneous appointment Akridipina not significantly modify the effect of warfarin on prothrombin time in healthy male volunteers.
Antihypertensive effect Akridipina weaken NSAIDs, especially indomethacin (there is a delay of sodium and blocking the synthesis of prostaglandins by the kidneys), sympathomimetic and estrogens (cause sodium retention).
When the joint application of funds for inhalation anesthesia (derivatives of hydrocarbons), amiodarone, quinidine, calcium channel blockers may increase the hypotensive effect Akridipina.
When combined with the use of lithium therapy may be a manifestation of neurotoxicity.
Terms and Conditions of storage
List B. The drug should be stored in dry, dark place at temperatures not above 25 ° C. Shelf life - 3 years.
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