"Caduet 5/10" tablets are used for the prevention of cardiovascular events in patients with arterial hypertension, with three concomitant cardiovascular risk factors, with normal to moderately elevated cholesterol levels, without clinical manifestations of coronary heart disease, and also when, in accordance with current treatment recommendations, the combined use of amlodipine and low dose atorvastatin is considered appropriate. In case of insufficient effectiveness of a hypolipidemic diet and other non-pharmacological measures.
Composition
One tablet contains (active ingredients) amlodipine besylate 6.94 mg, equivalent to amlodipine 5 mg; atorvastatin calcium trihydrate 10.85 mg, equivalent to atorvastatin 10 mg.
Excipients: calcium carbonate, croscarmellose sodium, microcrystalline cellulose, pregelatinized starch, polysorbate 80, hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate, Opadry II White 85F28751: partially hydrolyzed polyvinyl alcohol, polyethylene glycol 3000, titanium dioxide (E 171), talc.
Contraindication
Hypersensitivity to the dihydropyridines of the active substances amlodipine and atorvastatin or to any of the excipients listed in the "Composition" section; active liver disease or persistent elevation of serum transaminases of unknown etiology exceeding 3 times the upper limit of normal; pregnant women; breastfeeding women or women of reproductive age not using adequate contraception; severe arterial hypotension; shock (including cardiogenic shock); obstruction of the left ventricular outflow tract (e.g. severe aortic stenosis); hemodynamically unstable heart failure after acute myocardial infarction; concomitant use with antiviral drugs for the treatment of hepatitis C glecaprevir / pibrentasvir.
Method of application
"Caduet 5/10" is intended for oral use.
The initial dose is 5 mg/10 mg once daily.
If the patient requires more effective blood pressure control, 10 mg/10 mg once daily may be taken.
This medicine can be taken at any time of the day with or without food.
"Caduet 5/10" can be used alone or in combination with antihypertensive agents, but it cannot be used with other calcium channel blockers or with other statins.
Application features
Children
The safety and effectiveness of the drug "Caduet 5/10" for children have not been established, therefore its use in this category of patients is not recommended.
Drivers
No studies have been conducted to determine the effect of the drug "Caduet 5/10" on the ability to drive vehicles and operate machinery. Atorvastatin, which is part of the drug "Caduet 5/10", has a minor effect on the ability to drive vehicles and operate machinery. However, based on the pharmacodynamic properties of amlodipine, which is part of the drug "Caduet 5/10", when driving a car and operating machinery, the possibility of dizziness, headache, increased fatigue or nausea should be taken into account.
Overdose
There is no information on overdose with the drug "Caduet 5/10" in humans.
Side effects
The safety of Kaduet 5/10 was evaluated in double-blind, placebo-controlled studies in 1092 patients treated for concomitant hypertension and dyslipidemia. During clinical studies with Kaduet 5/10, no adverse reactions characteristic of this combination were observed. Adverse reactions were limited to those previously reported with amlodipine and/or atorvastatin.
Storage conditions
Store at a temperature not exceeding 30 °C, out of the reach of children.
Shelf life - 3 years.
