AMLATOR . 10 mg. 10 mg. 30 tablets
AMLATOR . 10 mg. / 10 mg. 30 tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlator 10 mg/10 mg film-coated tablets:
Each tablet contains 10 mg atorvastatin (as atorvastatin L-lysine) and 10 mg of amlodipine (as amlodipine besylate).
Amlator is indicated as replacement therapy for those patients who are adequately controlled with amlodipine and atorvastatin given concurrently at the same dose level as in combination to treat hypertension (with or without chronic stable coronary artery disease) in adult patients with a corresponding to the following conditions: Primary hypercholesterolaemia (including familial hypercholesterolaemia (heterozygous variant in) or combined (mixed) hyperlipidaemia (corresponding to type IIa and IIb classification Fredrickson), Homozygous familial hypercholesterolemia.
DOSAGE AND ADMINISTRATION:
Amlator not recommended for initial therapy. Amlator dosage should be determined by titration of the individual components based dosing and administration of amlodipine and atorvastatin.
In accordance with the results of dose titration, the recommended dose is one tablet Amlator 10 mg/10 mg daily. The maximum dose is one tablet Amlator 20 mg/10 mg daily.
Amlator can be taken at any time of the day and does not depend on nutrition.
Use in elderly patients
Efficacy and safety in patients over the age of 70 who use the recommended doses are similar to those observed in the general population.
Use in children and adolescents
Amlator not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Patients with hepatic impairment
Atorvastatin should be used with caution in patients with hepatic impairment. Atorvastatin is contraindicated in patients with active liver disease.
Patients with renal impairment:
Changes in plasma concentrations of amlodipine are not related to the degree of renal impairment and renal disease has no influence on the plasma concentrations or lipid effects of atorvastatin. Therefore does not require dose adjustment.
Amlodipine is not amenable to dialysis.
Hypersensitivity to the active substances or to dihydropyridines, or statins, or any of the excipients
Shock (including cardiogenic shock)
Outflow of the left ventricle (eg high grade aortic stenosis)
Hemodynamically unstable heart failure after acute myocardial infarction
Active liver disease or obscure persistent elevations of serum transaminases more than three times the upper limit of normal
During pregnancy, during lactation, and in women of childbearing potential not using adequate contraception.
DRUG INTERACTIONS AND OTHER:
In a drug interaction study in healthy volunteers, coadministration of atorvastatin 80 mg and 10 mg of amlodipine resulted in a 18% increase in AUC of atorvastatin. Co-administration of multiple doses of 10 mg of amlodipine with 80 mg of atorvastatin resulted in no significant change in the steady state pharmacokinetic parameters of atorvastatin. No studies of interactions with the combination of amlodipine and atorvastatin and other drugs, but studies have been conducted with the individual components amlodipine and atorvastatin.
Pregnancy and lactation:
The safety of atorvastatin and amlodipine in pregnant women.
In reproduction studies in rats atorvastatin toxicity was observed but postponed the date of birth and prolonged duration of parturition at doses greater than 50 times the maximum recommended human dose.
Atorvastatin is contraindicated during pregnancy has established its safety in pregnant women. There are no controlled clinical trials of atorvastatin in pregnant women. Received rare reports of congenital anomalies following intrauterine exposure to inhibitors of HMG-CoA reductase. In animal studies, reproductive toxicity was observed.
It is not known whether amlodipine, atorvastatin and its metabolites are excreted in human breast milk. In rats, plasma concentrations of atorvastatin and its active metabolites were similar to those in milk. Because of the potential for serious adverse reactions, women taking Amlator should not breastfeed their children. Atorvastatin is contraindicated during lactation.
Possible adverse reactions observed with the use of atorvastatin and amlodipine are potential side effects of using Amlator.
The database of placebo-controlled trials of atorvastatin containing 16 066 patients (8755 receiving atorvastatin compared to 7,311 received placebo) treated for a median of 53 weeks, 5.2% of patients receiving atorvastatin who discontinued due adverse events compared with 4.0% of patients receiving placebo.