Caduet pills 5mg+10mg, 30pcs

Composition

1 table. contains

amlodipine 5 mg and atorvastatin 10 mg;

excipients:

calcium carbonate,

croscarmellose sodium,

microcrystalline cellulose,

pregelatinized starch,

polysorbate 80 (tween 80),

hyprolose,

colloidal silicon dioxide,

magnesium stearate,

Opadray II white film coating 85F28751 (polyvinyl alcohol, titanium dioxide, macrogol (PEG) 3000, talc).

Pharmacological action

A combination drug that combines two drugs: the dihydropyridine calcium antagonist amlodipine and the HMG-CoA reductase inhibitor atorvastatin. In this combination, amlodipine inhibits the transmembrane flow of calcium ions in the smooth muscle fibers of blood vessels and the heart; atorvastatin is a selective powerful inhibitor of HMG-CoA reductase, a key enzyme for converting HMG-CoA to mevalonate, a substance that is a precursor of styrenes, including cholesterol.

Mechanism of antihypertensive action: amlodipine affects the relaxation of vascular smooth muscle fibers. The mechanism of antianginal action of amlodipine is insufficiently studied, it is believed that the drug:

• dilates the peripheral arterioles and thereby reduces OPSS (afterload). Since the heart rate practically does not change, reducing the load on the heart leads to a decrease in energy consumption and the need for oxygen in the myocardium;
• it contributes to the expansion of large coronary arteries and coronary arterioles in both unchanged and ischemic areas of the myocardium. This dilation increases oxygen supply to the myocardium in patients with vasospastic angina (Prinzmetal angina or variant angina) and prevents the development of coronary vasoconstriction.

In patients with hypertension, a single dose of amlodipine provides a clinically significant reduction in blood pressure for 24 hours in both lying and standing positions. Due to its slow onset of action, amlodipine does not cause acute hypotension. In patients with angina, amlodipine increases exercise tolerance, reduces the frequency of angina attacks, and reduces the need for nitroglycerin tablets. Amlodipine does not cause metabolic disorders or changes in plasma lipids, so the drug can be prescribed to patients with asthma, diabetes mellitus or gout. The results of hemodynamic studies and controlled clinical trials in patients with functional class II–III heart failure (NYHA) showed that amlodipine does not cause deterioration of their condition according to such criteria as exercise tolerance, left ventricular ejection fraction, and clinical symptoms. Placebo-controlled studies have shown that the use of amlodipine does not increase the risk of mortality or the combined mortality rate in patients with class III–IV heart failure (NYHA) treated with digoxin, diuretics and ACE inhibitors. Atorvastatin is a selective, potent HMG-CoA reductase inhibitor that regulates the rate of conversion of HMG-CoA to mevalonate, a precursor of styrene (including cholesterol). In patients with homozygous and heterozygous hereditary and non-hereditary forms of hypercholesterolemia and mixed dyslipidemia, atorvastatin reduces the concentration of total cholesterol, LDL-C and apolipoprotein B, the concentration of VLDL-C and TG, and slightly increases the level of HDL-C. It also reduces the levels of cholesterol and lipoproteins in blood plasma by inhibiting HMG-CoA reductase and CHOLESTEROL synthesis in the liver and increasing the number of hepatic LDL receptors on the cell surface, which leads to an increase in LDL uptake and catabolism. Atorvastatin reduces LDL synthesis and reduces the number of LDL particles. It causes a pronounced and persistent increase in the activity of LDL receptors in combination with positive changes in the quality of circulating LDL particles. Atorvastatin reduces LDL levels in patients with homozygous hereditary hypercholesterolemia, in which therapy with conventional lipid-lowering agents is often ineffective. In humans, both atorvastatin and some of its metabolites exhibit pharmacological activity. The primary site of action of atorvastatin is the liver, which plays a major role in the synthesis of cholesterol and LDL clearance. A decrease in the level of LDL-C correlates well with the dose of the drug and its concentration in the body. Individual dosage of the drug is based on therapeutic effectiveness. During the study of the dose effect, atorvastatin (10-80 mg) reduced the level of total cholesterol (30-46%), LDL-C (41-61%), apolipoprotein B (34-50%) and TG (14-33%). This result is persistent in patients with heterozygous hereditary and non-hereditary forms of hypercholesterolemia and mixed forms of hyperlipidemia, including patients with insulin-dependent diabetes mellitus. In patients with isolated hypertriglyceridemia, atorvastatin reduces the level of total cholesterol, LDL-C, VLDL-C, apolipoprotein B, TG, LDL-C and increases HDL-C. In patients with dysbetalipoproteinemia, atorvastatin reduces the level of LDL-C. In patients with hyperlipoproteinemia of Fredrickson type IIa and IIb, the average percentage of HDL-C increase with 10-80 mg of atorvastatin was 5.1-8.7%, regardless of the dose. In addition, there was a significant dose-dependent decrease in the ratio of total cholesterol/HDL-C and LDL-C/HDL-C. The effect of atorvastatin at a dose of 80 mg per day for 16 weeks on the occurrence of ischemia and overall mortality in patients with unstable angina or non-Q-wave myocardial infarction was shown to significantly reduce the risk of myocardial ischemia and mortality, the risk of rehospitalization for angina and confirmed myocardial ischemia. Atorvastatin reduced the risk of ischemia and death inversely proportional to the concentration of LDL-C, the risk of ischemia and death in patients with non-Q-wave myocardial infarction and unstable angina to the same extent in patients under the age of 65 and older of both sexes. Atorvastatin significantly reduced the incidence of fatal cardiovascular diseases and non-fatal myocardial infarction, the overall incidence of cardiovascular diseases, the incidence of fatal and non-fatal stroke, and reduced the need for myocardial revascularization. With atorvastatin, overall mortality and mortality due to cardiovascular diseases were slightly reduced. The effect of therapy did not depend on gender, age, or the initial level of LDL-C. In boys and girls in the post-pubertal period (10-17 years) with heterozygous hereditary hypercholesterolemia or hypercholesterolemia, atorvastatin at a dose of 10-20 mg once a day significantly reduced the level of total cholesterol, LDL-C, TG and apolipoprotein B in blood plasma. However, there was no significant effect on growth and puberty in boys or on the duration of the menstrual cycle in girls. The safety and efficacy of a dose higher than 20 mg for the treatment of children have not been studied. The effect of long-term efficacy of atorvastatin therapy in childhood on reducing morbidity and mortality in adult patients has not been established. Absorption. When the amlodipine/atorvastatin combination is administered orally, two separate maximum plasma concentrations are observed. The first, within 1-2 hours after use, associated with atorvastatin; the second, within 6-12 hours after use, associated with amlodipine. The rate of absorption (bioavailability) of amlodipine and atorvastatin in the amlodipine/atorvastatin combination does not differ from the bioavailability of amlodipine and atorvastatin taken separately as tablets, as can be seen from the maximum plasma concentration (Cmax) of 101% (90% confidence interval (CI): 98; 104) and AUC of 100% (90% CI: 97; 103) for amlodipine in the amlodipine/atorvastatin combination. atorvastatin, and Cmax of 94% (90% CI: 85; 104) and AUC of 105% (90% CI: 99; 111) for atorvastatin in the amlodipine/atorvastatin combination. The bioavailability of amlodipine in the combination of amlodipine/atorvastatin did not worsen with the use of the drug after meals, which was confirmed by Cmax — 105% (90% CI: 99; 111) and AUC-101% (90% CI: 97; 105) compared with the values when taking the drug on an empty stomach. Although food intake reduced the rate and volume of absorption of atorvastatin when using the combined drug by almost 32 and 11%, respectively, which was confirmed by Cmax-68% (90% CI: 60; 79) and AUC-89% (90% CI: 83; 95) compared with the values when taking the drug on an empty stomach. A similar decrease in blood plasma concentrations with atorvastatin after use was also observed with atorvastatin monotherapy, but this was not accompanied by a decrease in the effect on LDL-C reduction. Studies conducted with the use of amlodipine. After oral use in therapeutic doses, amlodipine is well absorbed, reaching a maximum concentration in the blood after 6-12 hours. Absolute bioavailability reaches 64-80%. The volume of distribution is approximately 21 l / kg. In vitro studies have shown that approximately 97.5% of amlodipine binds to plasma proteins. Food intake does not affect the absorption of amlodipine. Studies conducted with the use of atorvastatin. Atorvastatin is rapidly absorbed after oral use; its concentration in blood plasma reaches a maximum within 1-2 hours. Absorption and plasma concentrations increase in proportion to the dose of the drug. Atorvastatin tablets have a bioavailability of 95-99% compared to the solution. The absolute bioavailability of atorvastatin is approximately 12%, and the systemic availability of inhibitory activity relative to HMG-CoA reductase is about 30%. Low systemic bioavailability is associated with presystemic clearance in the gastrointestinal mucosa and / or biotransformation during the first passage through the liver.Despite the fact that the proportion and degree of absorption of the drug decreases when taken with food by approximately 25 and 9%, respectively (in Cmax and AUC), the decrease in LDL-C levels did not depend on whether atorvastatin was taken with food or not. When atorvastatin is taken in the evening, its plasma concentration is lower (approximately 30% for Cmax and AUC) than when taken in the morning. However, the decrease in LDL-C level does not depend on the time of taking the drug. Distribution of atorvastatin. The average volume of distribution of atorvastatin is approximately 381 liters. More than 98% of the drug binds to plasma proteins. The red blood cell / plasma ratio is approximately 0.25, which indicates a weak penetration of the drug into red blood cells. Metabolism and excretion of amlodipine. The half-life from blood plasma is approximately 35-50 hours, which allows the drug to be prescribed once a day. Stable steady-state plasma concentrations are reached after 7-8 days of regular amlodipine use. Amlodipine is extensively transformed in the liver to form inactive metabolites. It is excreted in the urine: 10% of the administered dose is unchanged,60% is in the form of metabolites. Studies conducted with the use of atorvastatin. Atorvastatin is metabolized to ortho – and parahydroxylated derivatives and a variety of beta-oxidized products. In vitro inhibition of HMG-CoA reductase by ortho-and parahydroxylated metabolites is almost equal to the effect of atorvastatin. The inhibitory effect of the drug on HMG-CoA reductase is approximately 70% realized due to the activity of circulating metabolites. The results of in vitro studies showed the importance of hepatic cytochrome P450 – 4 for the metabolism of atorvastatin, which can affect the increase in the concentration of atorvastatin in human blood plasma due to the combined use with erythromycin, which is an inhibitor of this enzyme. In vitro studies also showed that atorvastatin is a weak inhibitor of cytochrome P450 — 4. Concomitant use of atorvastatin and terfenadine, a compound that is mainly metabolized by cytochrome P450 — 4, did not significantly increase the concentration of terfenadine in blood plasma. It is unlikely that atorvastatin will significantly alter the pharmacokinetics of other cytochrome P450-4 substrates. In animals, orthohydroxyl metabolites undergo further glucuronidation. Atorvastatin and its metabolites are mainly excreted in the bile due to hepatic and / or extrahepatic metabolism. However, the drug does not undergo significant intestinal-hepatic recycling. The average half-life of atorvastatin in humans is approximately 14 hours, but the average period of inhibitory activity relative to HMG-CoA reductase, due to circulating active metabolites, is 20-30 hours. Less than 2% of the dose of atorvastatin after oral use is excreted in the urine. Liver failure. The level of atorvastatin concentration in blood plasma significantly increases (Cmax approximately 16 times, and AUC-11 times) in patients with alcoholic cirrhosis of the liver (severity according to the Child-Pugh — B classification). Kidney failure. Studies conducted with the use of amlodipine. Changes in the plasma concentration of amlodipine did not correlate with the degree of renal failure. Amlodipine is not eliminated by hemodialysis. Studies conducted with the use of atorvastatin. Renal disease did not affect the plasma concentration of atorvastatin or its effect on lipids. Therefore, a change in the concentration of atorvastatin in patients with impaired renal function is not required. Gender: The level of atorvastatin concentration in blood plasma in women differs from the level of plasma concentration in men (approximately 20% higher for Cmax and 10% lower for AUC). However, there was no clinically significant difference between the effect on lipids in men and women. Elderly and senile patients. Studies conducted with the use of amlodipine. The time to reach steady-state plasma concentrations of amlodipine is similar in both elderly patients and adults. Clearance of amlodipine. In senile patients and patients with congestive heart failure, there is a tendency to decrease the clearance of amlodipine, which leads to an increase in the AUC and half-life of the drug. The same doses of amlodipine were well tolerated by both young, elderly and senile patients. Studies conducted with the use of atorvastatin. The level of atorvastatin concentration in blood plasma in healthy elderly people (older than 65 years) is higher (approximately 40% for maximum concentration and 30% for AUC) than in young people. Children’s patients. When using amlodipine at an average daily dose of 0.17 mg / kg in children with a median body weight of 45 kg, the clearance of the drug was 23.7 l / h for boys and 17.6 l / h for girls. These indicators are similar to the indicators (24.8 l / h) in adults with a body weight of 70 kg. The mean volume of distribution in patients with a body weight of 45 kg was 1130 l (25.11 l / kg). The hypotensive effect fluctuated slightly during the day. When studying the pharmacokinetic parameters in adults, it was found that the use of amlodipine once a day is optimal.

Indications

Arterial hypertension with three or more risk factors for the development of cardiovascular events (fatal and non-fatal CHD, need for revascularization, fatal and non-fatal myocardial infarction, stroke, and transient ischemic attack), with normal or moderately elevated Cholesterol levels without clinically pronounced CHD.

The drug is used in cases where combination therapy with amlodipine and low doses of atorvastatin is recommended.

It is possible to combine Caduet with other antihypertensive and / or antianginal agents.

Caduet is used in cases where a hypolipidemic diet and other non-pharmacological methods of treating dyslipidemia are insufficient or ineffective.

Use during pregnancy and lactation

It is contraindicated in pregnant women and during lactation.

Contraindications

Known hypersensitivity to dihydropyridines, amlodipine, atorvastatin, or any component of the drug;

active liver disease or increased serum transaminase levels

that are three times higher than normal;

pregnancy and lactation or childbearing age in the absence of adequate contraceptives.

Side effects

In clinical trials, the safety of amlodipine and atorvastatin was studied in patients with a combination of arterial hypertension and dyslipidemia, while no unexpected undesirable effects were recorded with the combination therapy.

The adverse effects were consistent with those previously identified with amlodipine and / or atorvastatin. Overall, the tolerability of the combination therapy was good. Most of the adverse effects were mild to moderate. In controlled clinical trials, treatment with amlodipine and atorvastatin was discontinued in 5.1% of patients due to undesirable effects or laboratory abnormalities, while placebo was discontinued in 4.0% of patients.

Amlodipine

Further, the frequency of adverse reactions is understood as: frequent (> 1%), infrequent (>< 1%), rare (< 0.1%), very rare (

From the cardiovascular system: often-peripheral edema (ankles and feet), palpitations; infrequently-excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely-development or aggravation of heart failure; very rarely – cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, chest pain, migraine.

Musculoskeletal disorders: infrequently-arthralgia, muscle cramps, myalgia, back pain, osteoarthritis; rarely-myasthenia gravis.

From the central nervous system and peripheral nervous system: a feeling of heat and flushes of blood to the skin of the face, increased fatigue, dizziness, headache, drowsiness; infrequently – malaise, fainting, increased sweating, asthenia, hypesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, lability of mood, unusual dreams, nervousness, depression, anxiety; rarely – convulsions, apathy, agitation; very often rarely – ataxia, amnesia.

From the digestive system: often-abdominal pain, nausea; infrequently-vomiting, changes in bowel movements (including constipation, flatulence), dyspepsia, diarrhea, anorexia, dry mouth, thirst; rarely – gum hyperplasia, increased appetite; very rarely – gastritis, pancreatitis, hyperbilirubinemia, jaundice (usually cholestatic), increased activity of liver transaminases, hepatitis.

From the hematopoietic system: very rarely – thrombocytopenic purpura, leukopenia, thrombocytopenia.

Metabolic disorders: very rarely – hyperglycemia.

From the respiratory system: infrequently – shortness of breath, rhinitis; very rarely-cough.

From the urinary system: infrequently-frequent urination, painful urination, nocturia, impotence; very rarely-dysuria, polyuria.

From the side of the visual organ: infrequently-visual disturbances, diplopia, accommodation disorders, xerophthalmia, conjunctivitis, eye pain.

From the skin: infrequently-alopecia; rarely-dermatitis; very rarely-xeroderma, skin pigmentation disorder.

Allergic reactions: infrequently-pruritus of the skin, rash; very rarely-angioedema, erythema multiforme, urticaria.

Others: infrequently-tinnitus, gynecomastia, weight gain/loss, taste distortion, chills, nosebleeds; very rarely-parosmia, “cold” sweat.

Atorvastatin

It is usually well tolerated. Adverse reactions are usually mild and transient.

Most common adverse reactions (≥1%):

From the central nervous system: insomnia, headache, asthenic syndrome.

From the digestive system: nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence.

Musculoskeletal disorders: myalgia.

Less frequent adverse reactions:

From the central nervous system and peripheral nervous system: malaise, dizziness, amnesia, paresthesia, peripheral neuropathy, hypesthesia.

From the digestive system: vomiting, anorexia, hepatitis, pancreatitis, cholestatic jaundice.

Musculoskeletal disorders: back pain, muscle cramps, myositis, myopathy, arthralgia, rhabdomyolysis.

Allergic reactions: urticaria, pruritus, skin rash, anaphylaxis, bullous rash, erythema multiforme, toxic epidermal necrolysis (Lyell’s syndrome), malignant exudative erythema (Stevens-Johnson syndrome).

Metabolic disorders: hypoglycemia, hyperglycemia, increased serum creatinine clearance, weight gain.

From the hematopoietic system: thrombocytopenia.

Others: impotence, peripheral edema, chest pain, secondary renal failure, alopecia, tinnitus, fatigue.

Interaction

Data on the drug interaction between amlodipine and atorvastatin in healthy individuals indicate that the pharmacokinetics of amlodipine with the combined use of these drugs do not change. Amlodipine did not affect the Cmax for atorvastatin: 91% (90% confidence interval: 80-103%), but increased the AUC of atorvastatin by 18% (90% CI: 109-127%).

The drug interaction between the concentration of amlodipine/atorvastatin and other drugs has not been studied, but there are studies on the effects of amlodipine and atorvastatin separately. These obtained data are shown below.

Amlodipine can be safely used together with thiazide diuretics, beta – and alpha-adrenergic blockers, ACE inhibitors, long-acting nitrates, sublingual forms of nitroglycerin, NSAIDs, antibiotics, and oral hypoglycemic agents. In vitro data obtained from human plasma studies indicate that amlodipine does not affect protein binding to digoxin, phenytoin, warfarin, or Indometacin. Cimetidine-concomitant use of amlodipine and cimetidine does not alter the pharmacokinetics of amlodipine.

Grapefruit juice-Co-use of 240 ml of grapefruit juice and a single dose of 10 mg of amlodipine orally in 20 healthy volunteers did not affect the pharmacokinetics of amlodipine.

Aluminum / magnesium (antacid) – the combined use of aluminum/magnesium (antacid) and a single dose of amlodipine does not affect the pharmacokinetics of amlodipine.

Sildenafil-a single dose of 100 mg sildenafil in patients with essential hypertension did not affect the pharmacokinetic parameters of amlodipine. With the combined use of amlodipine and sildenafil, each of the drugs independently shows its hypotensive effect.

Digoxin-the combined use of amlodipine and digoxin does not change the serum concentration and renal clearance of digoxin in healthy volunteers.

Ethyl alcohol (alcohol) — single and multiple doses of 10 mg of amlodipine do not affect the pharmacokinetics of ethyl alcohol.

Warfarin-the combined use of amlodipine and warfarin does not change the warfarin-dependent prothrombin time. Cyclosporine – Pharmacokinetic studies of cyclosporine indicate that amlodipine does not alter the pharmacokinetics of cyclosporine.

The effect on the performance of laboratory tests is not known.

The risk of developing myopathy during treatment with HMG-CoA reductase inhibitors (including atorvastatin) increases with concomitant use of cyclosporine, fibric acid derivatives, erythromycin, azole antifungal agents or nicotinic acid.

Antacids-the combined use of atorvastatin and oral antacid suspensions containing magnesium and aluminum hydroxides reduces the concentration of atorvastatin in blood plasma by approximately 35%; however, the magnitude of the decrease in LDL-C levels does not change.

Phenazone (antipyrine — – since atorvastatin does not affect the pharmacokinetics of phenazone, interaction with other agents that are metabolized by the same cytochrome isoenzymes is unlikely. Colestipol-with the combined use of colestipol and atorvastatin, the concentration in blood plasma decreases by almost 25%. However, the effect on lipids is more pronounced with combined than with separate use of these agents.

Digoxin-with combined repeated use of digoxin and 10 mg of atorvastatin, the steady-state concentration of digoxin in blood plasma does not change. However, with the combined use of digoxin and 80 mg of atorvastatin per day, the concentration of digoxin increases by almost 20%. Patients taking digoxin require appropriate monitoring.

Erythromycin / clarithromycin-combined use of atorvastatin and erythromycin (500 mg 4 times a day) or clarithromycin (500 mg 2 times a day) — known cytochrome P450 — 4 inhibitors-increases the plasma concentration of atorvastatin.

Azithromycin-the combined use of atorvastatin (10 mg once a day) and azithromycin (500 mg once a day) does not change the concentration of atorvastatin in blood plasma.

Terfenadine-concomitant use of atorvastatin and terfenadine does not cause clinically significant changes in the pharmacokinetics of terfenadine.

Oral contraceptives-combined use with oral contraceptives containing norethindrone and ethinylestradiol increases the equal AUC for norethindrone and ethinylestradiol by approximately 30 and 20%. This increase should be considered when choosing an oral contraceptive for women taking atorvastatin. Warfarin-when studying the interaction of atorvastatin and warfarin with combined use, no clinically significant interaction was found.

Cimetidine-when studying the interaction of atorvastatin and cimetidine with combined use, no clinically significant interaction was found.

Protease inhibitors-the combined use of atorvastatin and protease inhibitors — known cytochrome P450 — 4 inhibitors-leads to a decrease in the concentration of atorvastatin in blood plasma.

Other drugs-in clinical trials, atorvastatin was used together with antihypertensive drugs and estrogen replacement therapy. No clinically significant adverse interaction was identified. Interaction studies with specific agents were not performed.

How to take, course of use and dosage

Caduet is taken orally 1 tablet 1 time/day. at any time, regardless of the meal.

Initial and maintenance doses are selected individually, taking into account the effectiveness and tolerability of both components in the treatment of hypertension/angina and dyslipidemia. Caduet can be prescribed to patients who are already taking one of the components of the drug in monotherapy.

Caduet is used in combination with non-drug treatments, including diet, exercise, weight loss in obese patients, and smoking cessation.

Start treatment with 5/10 mg tablets (amlodipine/atorvastatin, respectively). In patients with arterial hypertension, blood pressure should be monitored every 2-4 weeks and, if necessary, it is possible to switch to taking 10/10 mg tablets (amlodipine/atorvastatin, respectively).

In CHD, the recommended dose of amlodipine is 5-10 mg once a day.

Overdose

There is no information about an overdose of the drug.

Both amlodipine and atorvastatin actively bind to plasma proteins, so a significant increase in the clearance of the combined drug during hemodialysis is unlikely.

Symptoms of amlodipine overdose: excessive peripheral vasodilation, leading to reflex tachycardia, and a pronounced and persistent decrease in blood pressure, including with the development of shock and death.

Symptoms of atorvastatin overdose are not described.

Treatment of amlodipine overdose: taking activated charcoal immediately or within 2 hours after taking amlodipine at a dose of 10 mg leads to a significant delay in the absorption of the drug. In some cases, gastric lavage may be effective. Clinically significant arterial hypotension caused by an overdose of amlodipine requires active measures aimed at maintaining the function of the cardiovascular system, including monitoring of heart and lung function, elevated limb position, and control of BCC and diuresis. To restore vascular tone and blood pressure, it may be useful to use a vasoconstrictor drug, if there are no contraindications to its appointment, and to eliminate the consequences of calcium channel blockade – intravenous use of calcium gluconate.

There are no specific treatments for atorvastatin overdose. In case of overdose, symptomatic and supportive treatment should be provided as needed.

Special instructions

Myalgia was observed in patients treated with atorvastatin. The diagnosis of myopathy (muscle pain or weakness combined with an increase in CK activity more than 10 times compared to ULN) should be assumed in patients with advanced myalgia, muscle soreness or weakness, and/or a pronounced increase in CK activity. Patients should immediately consult a doctor if they experience unexplained muscle pain or weakness, especially if they are accompanied by malaise or fever. Drug therapy Caduet should be discontinued if there is a marked increase in CKD activity or if there is a confirmed or suspected myopathy.

The risk of myopathy associated with other drugs in this class increases with concomitant use of cyclosporine, fibroic acid derivatives, erythromycin, nicotinic acid, or azole antifungal medications.Many of these drugs inhibit CYP3A4-mediated metabolism and / or drug transport. It is known that CYP3A4 is the main liver isoenzyme involved in the biotransformation of atorvastatin. When prescribing atorvastatin in hypolipidemic doses in combination with fibroic acid derivatives, erythromycin, immunosuppressants, azole antifungal drugs or nicotinic acid, the expected benefit and risk of treatment should be carefully weighed and patients should be regularly monitored for muscle pain or weakness, especially during the first months of treatment and during the period of increasing the dose of any drug. In such situations, periodic monitoring of CPK activity can be recommended, although such monitoring does not prevent the development of severe myopathy.

Reception Cadueta may cause an increase in CKD activity. Rare cases of rhabdomyolysis with acute renal failure due to myoglobinuria have been reported with the use of atorvastatin, as well as other drugs of this class. Drug therapy Caduet should be temporarily discontinued or completely discontinued if there are signs of possible myopathy or a risk factor for developing renal failure due to rhabdomyolysis (for example, severe acute infection, hypotension, surgery, trauma, metabolic, endocrine and electrolyte disorders and uncontrolled seizures). Treatment with amlodipine at an adequate dose to control hypertension may be continued.

Influence on the ability to drive motor vehicles and manage mechanisms

Although the available data on amlodipine and atorvastatin suggest that the combined drug should not impair the ability to drive and use machinery, caution should be exercised when driving vehicles and operating mechanisms (taking into account the possible development of excessive blood pressure reduction, dizziness, fainting).

Form of production

Film-coated tablets.

Storage conditions

At a temperature of 15-30 °C

Shelf life

2 years

Active ingredient

Amlodipine, Atorvastatin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets