Composition
1 table. contains
amlodipine 10 mg (in the form of amlodipine besylate 13.89 mg, respectively);
excipients:
MCC;
sodium starch glycolate;
magnesium stearate;
colloidal anhydrous silicon dioxide.
Pharmacological action
Cardilopin has a hypotensive, antianginal effect.
Indications
-Arterial hypertension (in the form of monotherapy or, if necessary, in combination therapy with other antihypertensive agents). – Stable angina pectoris (in the form of monotherapy or in combination therapy with other antianginal agents).
– Angiospastic angina pectoris (Prinzmetal angina pectoris) (in the form of monotherapy or as part of combination therapy with other antianginal agents).
Use during pregnancy and lactation
Given the lack of clinical experience with the use of amlodipine during pregnancy and lactation, the drug should not be prescribed to pregnant women, as well as women of reproductive age who do not use effective methods of contraception, except in cases where the therapeutic benefit of the drug justifies the possible risk.
If it is necessary to use the drug during lactation, stop breastfeeding.
Contraindications
-Unstable angina pectoris. – Clinically significant aortic stenosis. – Severe arterial hypotension. – Children and adolescents under 18 years of age (due to lack of clinical experience). – Pregnancy. – The period of lactation (breastfeeding). – Hypersensitivity to amlodipine and other components of the drug.
Caution should be exercised when prescribing the drug. :
– Impaired liver function. – SSS (pronounced bradycardia, tachycardia). – Chronic heart failure in the stage of decompensation. – Mild or moderate arterial hypotension. – Aortic stenosis. – Mitral stenosis. – Hypertrophic obstructive cardiomyopathy. – Acute myocardial infarction (and within 1 month after). – Diabetes mellitus. – Elderly patients.
Side effects
Common side effects (>1%) depending on the dose (in%): peripheral edema (frequency of occurrence for doses of 5 mg and 3.0% for 10 mg and 10.8%); dizziness (frequency of occurrence for doses of 5 mg and 10 mg and 3.4%); tides (5 mg and 1.4% for 10 mg and 2.6%); heartbeat (5 mg and 1.4% for 10 mg and 4.5%).
Frequent side effects (>1%), independent of dose (in%): headache (7.3%); abdominal pain (1.6%); fatigue (4.5%); drowsiness (1.4%); nausea (2.9%).
Other rare side effects: skin rash, gum hyperplasia, dyspepsia, asthenia, arthralgia, myalgia, muscle spasms, sexual disorders (both in men and women), dyspnoea, pruritus, pollakiuria.
Very rare side effects: liver dysfunction, jaundice, erythema multiforme, gynecomastia.
Other side effects: As with other BCCs, patients with severe occlusive coronary disease may experience progressive symptoms of angina, myocardial infarction, and arrhythmias (atrial fibrillation and ventricular tachycardia-which, however, cannot be differentiated from the underlying disease).
Interaction
Concomitant use of amlodipine with thiazide diuretics, beta-blockers, long-acting nitrates, sublingual nitroglycerin preparations, NSAIDs, antibiotics and oral hypoglycemic agents is possible.
Thiazide and loop diuretics, beta-blockers, verapamil, ACE inhibitors, and nitrates enhance the antianginal and antihypertensive effects of amlodipine.
Amiodarone, quinidine, alpha-1 blockers, antipsychotic drugs (neuroleptics), and slow calcium channel blockers may enhance the antihypertensive effect of ammlodipine.
Calcium supplements may reduce the effect of slow calcium channel blockers (including amlodipine).
Microsomal oxidation inhibitors increase the plasma concentration of amlodipine and increase the risk of side effects, while inducers of microsomal liver enzymes decrease the risk.
The antihypertensive effect of amlodipine is weakened by NSAIDs, especially Indometacin (due to sodium retention and blockade of prostaglandin synthesis by the kidneys), alpha-adrenomimetics, estrogens (due to sodium retention), sympathomimetics.
Procainamide, quinidine, and other drugs that cause prolongation of the QT interval increase the negative inotropic effect of amlodipine and may increase the risk of significant prolongation of the QT interval.
Cimetidine does not affect the pharmacokinetics of amlodipine.
Amlodipine does not affect the pharmacokinetic parameters of digoxin and warfarin.
Grapefruit juice may slightly increase the level of amlodipine in the blood serum, but this does not lead to significant changes in blood pressure.
How to take, course of use and dosage
For the treatment of hypertension or angina, the usual starting dose is 5 mg 1 time / day (preferably at the same time). Taking into account the patient’s reaction, the initial dose can be increased to 10 mg 1 time / day.
The dose of Cardilopin is not changed if it is used simultaneously with diuretics from the thiazide group, beta-blockers or ACE inhibitors.
Overdose
Symptoms: marked decrease in blood pressure, tachycardia, excessive peripheral vasodilation.
Treatment: the patient should be given a horizontal position with raised legs. Gastric lavage, use of activated charcoal, maintenance of the cardiovascular system, monitoring of heart and lung function indicators, monitoring of BCC and diuresis are performed. Conduct intensive symptomatic therapy. Vasoconstrictor drugs are indicated to restore vascular tone (in the absence of contraindications to their use); to eliminate the consequences of calcium channel blockade, intravenous use of calcium gluconate is indicated. Hemodialysis is not effective.
Special instructions
Studies in patients with NYHA stage II and III heart failure when taking amlodipine did not show a decrease in exercise tolerance, left ventricular ejection function, or worsening of clinical symptoms. Results of clinical trials involving patients with NYHA stage III-IV heart failure have shown that amlodipine does not increase the incidence of cardiovascular disorders or mortality when co-administered with ACE inhibitors, diuretics or digoxin.
During the treatment period, it is necessary to maintain dental hygiene and visit the dentist (to prevent soreness, bleeding and gum hyperplasia).
The dosage regimen for the elderly is the same as for patients of other age groups. When increasing the dose, careful monitoring of elderly patients is necessary. The vasodilating effect of amlodipine develops gradually. Therefore, acute arterial hypotension after its use is very rare, however, a gradual reduction in doses is recommended before stopping treatment.
Amlodipine does not affect plasma concentrations of potassium, glucose, triglycerides, total cholesterol, LDL, uric acid, creatinine and uric acid nitrogen.
Form of production
Pills.
Storage conditions
In a dark place, at a temperature of 15-25 °C
Shelf life
5 years
Active ingredient
Amlodipine
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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Side effects of Cardilopin, pills 10mg, 30pcs.
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