Cardilopin, tablets 10 mg 30 pcs

– Arterial hypertension (as monotherapy or, if necessary, as part of combination therapy with other antihypertensive agents).

– Stable angina pectoris (as monotherapy or as part of combination therapy with other antianginal agents).

– Angiospastic angina pectoris (Prinzmetal angina pectoris) (as monotherapy or in combination therapy with other antianginal agents).

Active ingredient

Composition

1 tablet contains

amlodipine 10 mg (as amlodipine besilate 13.89 mg, respectively);

accompanies:

MCC;

sodium starch glycolate;

magnesium stearate;

colloidal anhydrous silicon dioxide.

How to take, the dosage

For treatment of arterial hypertension or angina pectoris, the usual starting dose is 5 mg once daily (preferably at the same time). Taking into account the reaction of the patient, the initial dose may be increased to 10 mg once daily.

The dose of Cardilopin is not changed if used concomitantly with thiazide diuretics, beta-adrenoblockers or ACE inhibitors.

Interaction

Possible concomitant use of amlodipine with thiazide diuretics, beta-adrenoblockers, long-acting nitrates, nitroglycerin sublinguals, NSAIDs, antibiotics and oral hypoglycemic agents.

Thiazide and “loop” diuretics, beta-adrenoblockers, verapamil, ACE inhibitors and nitrates enhance the antianginal and hypotensive effects of amlodipine.

Amiodarone, quinidine, alpha 1-adrenoblockers, antipsychotic drugs (neuroleptics) and slow calcium channel blockers may increase the hypotensive effects of amlodipine.

Calcium preparations may decrease the effect of slow calcium channel blockers (including amlodipine).

Microsomal oxidation inhibitors, by increasing the plasma concentration of amlodipine, increase the risk of side effects, and inducers of microsomal liver enzymes decrease it.

The hypotensive effect of amlodipine is weakened by NSAIDs, especially indomethacin (due to sodium retention and blockade of prostaglandin synthesis by kidneys), alpha-adrenomimetics, estrogens (due to sodium retention), sympathomimetics.

Procainamide, quinidine and other drugs that cause QT interval prolongation increase the negative inotropic effect of amlodipine and may increase the risk of significant QT interval prolongation.

Cimetidine does not affect the pharmacokinetics of amlodipine.

Amlodipine has no effect on the pharmacokinetic parameters of digoxin and warfarin.

Grapefruit juice may slightly increase serum amlodipine levels, but this does not result in significant changes in BP.

Special Instructions

Studies in patients with NYHA stage II and III heart failure when taking amlodipine have shown no decrease in exercise tolerance, left ventricular ejection function or worsening of clinical symptoms. Results of clinical studies with patients with NYHA stage III-IV heart failure have shown that amlodipine does not increase incidence of cardiovascular events or mortality when combined with ACE inhibitors, diuretics or digoxin.

Tooth hygiene and dental visits are necessary during treatment (to prevent soreness, bleeding, and gum hyperplasia).

The dosing regimen for the elderly is the same as for patients in other age groups. Careful monitoring of elderly patients is necessary when increasing the dose. The vasodilator effect of amlodipine develops gradually. Therefore, acute arterial hypotension after its use is very rare, but a gradual reduction in doses is recommended before discontinuing treatment.

Amlodipine does not affect plasma concentrations of potassium, glucose, triglycerides, total cholesterol, LDL, uric acid, creatinine and uric acid nitrogen.

Contraindications

– Unstable angina.
– Clinically significant aortic stenosis.
– Severe arterial hypotension.
– Child and adolescent age under 18 years (due to lack of clinical experience).
– Pregnancy.
– Lactation period (breastfeeding).
– Hypersensitivity to amlodipine and other components of the drug.

The drug should be prescribed with caution when:

– Impaired liver function.
– CCSU (marked bradycardia, tachycardia).
– Chronic heart failure in decompensation.
– Mild or moderate degree of arterial hypotension.
– Aortic stenosis.
– Mitral stenosis.
– Hypertrophic obstructive cardiomyopathy.
– Acute myocardial infarction (and within 1 month after).
– Diabetes mellitus.
– Patients of elderly age.

Side effects

Frequent side effects (>1%), dose-dependent (in %): peripheral edema (incidence for 5 mg dose 3.0% and 10 mg 10.8%); dizziness (incidence for 5 mg and 10 mg dose 3.4%); hot flashes (for 5 mg 1.4% and for 10 mg 2.6%); palpitation (for 5 mg 1.4% and for 10 mg 4.5%).

Frequent side effects (>1%), independent of dose (in %): headache (7.3%); abdominal pain (1.6%); increased fatigue (4.5%); drowsiness (1.4%); nausea (2.9%).

Other rare side effects: skin rash, gum hyperplasia, dyspepsia, asthenia, arthralgia, myalgia, muscle cramps, sexual disorders (in both men and women), dyspnea, itching, polylakiuria.

Very rare side effects: liver dysfunction, jaundice, erythema multiforme, gynecomastia.

Other side effects: as with other BCIs, patients with severe occlusive coronary disease may experience progression of angina symptoms, myocardial infarction, and arrhythmias (atrial fibrillation and ventricular tachycardia – which, however, cannot be differentiated from underlying disease).

Overdose

Symptoms: marked BP decrease, tachycardia, excessive peripheral vasodilation.

Treatment: the patient should be put in horizontal position with elevated legs. Gastric lavage, administration of activated charcoal, maintenance of cardiovascular system function, control of cardiac and pulmonary function parameters, control of blood circulation and urine output. Intensive symptomatic therapy is carried out. To restore vascular tone vasoconstrictors are indicated (if there are no contraindications for their use); to eliminate the effects of calcium channel blockade – intravenous injection of calcium gluconate. Hemodialysis is not effective.

Pregnancy use

With due to insufficient clinical experience of amlodipine use in pregnancy and lactation, the drug should not be administered to pregnant women and women of reproductive age who do not use effective contraceptive methods, unless the therapeutic benefit of the drug justifies the possible risk.

Breast-feeding should be stopped if the drug has to be used during lactation.

Similarities