AMLATOR. 10 mg. 5 mg. 30 tablets

AMLATOR. 10 mg.  5 mg. 30 tablets
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Amlator 10 mg/10 mg film-coated tablets:
Each tablet contains 10 mg of atorvastatin (atorvastatin L-lysine) and 5 mg of amlodipine (amlodipine besylate).

AMLATOR. 10 mg. / 5 mg. 30 tablets

 
 
QUALITATIVE AND QUANTITATIVE COMPOSITION

Amlator 10 mg/10 mg film-coated tablets:
Each tablet contains 10 mg of atorvastatin (atorvastatin L-lysine) and 5 mg of amlodipine (amlodipine besylate).

3. Indications

Amlator is indicated as substitution therapy for those patients who are adequately controlled with amlodipine and atorvastatin administered concomitantly 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 of Fredrickson),
- Homozygous familial hypercholesterolemia.

4. DOSAGE AND ADMINISTRATION:

Amlator not recommended for initial therapy. The dosage of Amlator must be determined by titration of the individual components based on dosage and method of administration of amlodipine and atorvastatin.
In accordance with the results of dose titration, the recommended dose is one tablet Amlator 10 mg / 5 mg. The maximum daily 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
The efficacy and safety in patients over the age of 70, using the recommended dosages 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 amlodipine plasma concentrations are not associated with the degree of renal impairment and renal disease does not affect the plasma concentrations or lipid effects of atorvastatin. Therefore does not require dose adjustment.
Amlodipine is not amenable to dialysis.

 

5. CONTRAINDICATIONS

Hypersensitivity to the active substances or to dihydropyridines, or statins, or any of the excipients
Severe hypotension,
Shock (including cardiogenic shock)
Outlet obstruction of the left ventricle (eg high grade aortic stenosis)
Hemodynamically unstable heart failure after acute myocardial infarction
Active liver disease or vague persistent increases of serum transaminases more than 3 times the upper limit of normal,
During pregnancy, during lactation and in women of childbearing potential not using adequate contraception.

 

6. Interactions:

In a drug interaction study in healthy volunteers, concomitant administration of atorvastatin 80 mg and 10 mg amlodipine resulted in 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:
There was no safety of amlodipine and atorvastatin in pregnant women.
In reproduction studies with atorvastatin in rats was observed toxicity but postponed 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 inhibitors. 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, the plasma concentrations of atorvastatin and its active metabolites are 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.
Undesirable effects:
Possible adverse reactions observed with the use of atorvastatin or amlodipine be potential adverse reactions with the use of Amlator.
The database of placebo-controlled clinical trials of atorvastatin comprising 16 066 patients (8755 receiving atorvastatin versus 7311 placebo) treated for a median of 53 weeks, 5.2% of patients receiving atorvastatin stopped taking due adverse reactions compared with 4.0% of patients receiving placebo.


 
 
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