

Caduet has an antihypertensive, antianginal, lipid-lowering effect.
Arterial hypertension with three or more risk factors for cardiovascular events (fatal and non-fatal coronary artery disease, the need for revascularization, fatal and non-fatal myocardial infarction, stroke and transient ischemic attack), with a normal or moderately elevated level of Cc without a clinically expressed coronary artery disease.
The drug is used in cases where combination therapy with amlodipine and low doses of atorvastatin is recommended. Caduette may be combined with other antihypertensive and / or antianginal agents.
Kaduet is used in cases where the lipid-lowering diet and other non-pharmacological treatments for dyslipidemia are of little or no effect.
1 tab. contains amlodipine 5 mg and atorvastatin 10 mg;
Excipients: calcium carbonate, croscarmellose sodium, microcrystalline cellulose, pregelatinized starch, polysorbate 80 (twin 80), hyprolosis, colloidal silicon dioxide, magnesium stearate, film coating Opadry II white 85F28751 (polyvinyl alcohol, titanium dioxide, macrogol
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Caduet is taken orally on 1 tablet 1 time / day. at any time, regardless of the meal.
The initial and maintenance doses are selected individually, taking into account the effectiveness and tolerability of both components in the treatment of arterial hypertension / angina pectoris and dyslipidemia. Kaduet can be prescribed to patients who are already taking one of the components of the drug in monotherapy.
Kaduet is used in combination with non-drug methods of treatment, including diet, exercise, weight loss in patients with obesity, and smoking cessation.
Treatment should begin with taking pills 5/10 mg (amlodipine / atorvastatin, respectively). In patients with arterial hypertension, blood pressure should be monitored every 2–4 weeks, and, if necessary, a switch to receive pills of 10/10 mg (amlodipine / atorvastatin, respectively) is possible.
With CHD, the recommended dose of amlodipine is 5-10 mg 1 time / day.
In clinical studies, the safety of amlodipine and atorvastatin has been studied in patients with a combination of arterial hypertension and dyslipidemia, with no unexpected undesirable effects in the combination therapy being reported.
Unwanted effects consistent with previously identified treatment with amlodipine and / or atorvastatin. Overall, the tolerability of the combination therapy was good. Most unwanted effects were mild or moderate. In controlled clinical trials, because of undesirable effects or abnormal laboratory parameters, treatment with amlodipine and atorvastatin was discontinued in 5.1% of patients, and placebo in 4.0%.
Amlodipine
Further, the frequency of adverse reactions is understood: frequent (> 1%), infrequent (<1%), rare (<0.1%), very rare (<0.01%).
Since the cardiovascular system: often - peripheral edema (ankles and feet), palpitations; infrequently - excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely, development or worsening of heart failure; very rarely - cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, chest pain, migraine.
From the musculoskeletal system: infrequently - arthralgia, muscle cramps, myalgia, back pain, arthrosis; rarely - myasthenia.
CNS and peripheral nervous system: sensation of heat and hot flushes to the skin of the face, fatigue, dizziness, headache, drowsiness; infrequently - malaise, fainting, increased sweating, asthenia, hypesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, mood lability, unusual dreams, nervousness, depression, anxiety; rarely - convulsions, apathy, agitation; very rarely - ataxia, amnesia.
From the digestive system: often - abdominal pain, nausea; infrequently - vomiting, changes in the mode of bowel movement (including constipation, flatulence), dyspepsia, diarrhea, anorexia, dry mouth, thirst; rarely - gingival hyperplasia, increased appetite; very rarely - gastritis, pancreatitis, hyperbilirubinemia, jaundice (usually cholestatic), increased activity of hepatic transaminases, hepatitis.
From the hemopoietic system: very rarely - thrombocytopenic purpura, leukopenia, thrombocytopenia.
Metabolic disorders: very rarely - hyperglycemia.
From the respiratory system: infrequently - shortness of breath, rhinitis; very rarely - cough.
On the part of the urinary system: infrequent urination, painful urination, nocturia, impotence; very rarely - dysuria, polyuria.
On the part of the organ of vision: infrequently - visual impairment, diplopia, accommodation disturbance, xerophthalmia, conjunctivitis, eye pain.
On the part of the skin: infrequently - alopecia; rarely - dermatitis; very rarely - xerodermia, a violation of skin pigmentation.
Allergic reactions: rarely - pruritus, rash; very rarely - angioedema, erythema multiforme, urticaria.
Other: infrequently - ringing in the ears, gynecomastia, increase / decrease in body weight, taste perversion, chills, nosebleeds; very rarely - parosmia, "cold" sweat.
Atorvastatin
Usually well tolerated. Adverse reactions are usually mild and transient.
The most frequent adverse reactions (≥1%):
From the side of the central nervous system: insomnia, headache, asthenic syndrome.
From the digestive system: nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence.
From the musculoskeletal system: myalgia.
Less frequent adverse reactions:
CNS and peripheral nervous system: malaise, dizziness, amnesia, paresthesia, peripheral neuropathy, hypoesthesia.
From the digestive system: vomiting, anorexia, hepatitis, pancreatitis, cholestatic jaundice.
From the musculoskeletal system: back pain, muscle cramps, myositis, myopathy, arthralgia, rhabdomyolysis.
Allergic reactions: urticaria, pruritus, skin rash, anaphylaxis, bullous rash, erythema multiforme exudative, toxic epidermal necrolysis (Lyell's syndrome), erythema malignant exudative (Stevens-Johnson syndrome).
Metabolic disorders: hypoglycemia, hyperglycemia, increased serum CPK, weight gain.
From the hemopoietic system: thrombocytopenia.
Other: impotence, peripheral edema, chest pain, secondary renal failure, alopecia, tinnitus, fatigue.
- active liver disease or persistent increase in liver enzyme activity is more than 3 times higher than the norm of unknown etiology;
- severe arterial hypotension;
- pregnancy;
- lactation period (breastfeeding);
- use in women of reproductive age who do not use adequate methods of contraception;
- children's and teenage age till 18 years (efficiency and safety are not established);
- Hypersensitivity to amlodipine and other derivatives of dihydropyridine, atorvastatin or any component of Cadouet.
Patients treated with atorvastatin had myalgia. The diagnosis of myopathy (pain or weakness in the muscles in combination with an increase in the activity of CPK more than 10 times compared with VGN) should be assumed in patients with common myalgias, muscle soreness or weakness and / or a pronounced increase in the activity of CPK. Patients should immediately consult a doctor if they develop unexplained pain or weakness in the muscles, especially if they are accompanied by indisposition or fever. Drug therapyCaduet should be stopped in case of a pronounced increase in CPK activity or in the presence of confirmed or suspected myopathy.
The risk of myopathy in the treatment of other drugs of this class increases with the simultaneous use of cyclosporine, derivatives of fibric acid, erythromycin, nicotinic acid or azole antifungal drugs. Many of these drugs inhibit CYP3A4-mediated metabolism and / or drug transport. CYP3A4 is known to be the major liver isoenzyme involved in atorvastatin biotransformation. When prescribing atorvastatin in lipid-lowering doses in combination with fibric acid derivatives, erythromycin, immunosuppressants, azole antifungal drugs, or nicotinic acid, you should carefully weigh the expected benefits and risks of treatment and regularly monitor patients 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 determination of CPK activity can be recommended, although such monitoring does not prevent the development of severe myopathy.
ReceptionCadwet may cause an increase in CPK activity. When using atorvastatin, as well as other drugs of this class, rare cases of rhabdomyolysis with acute renal failure caused by myoglobinuria are described. Drug therapyCaduet should be temporarily stopped or completely canceled if there are signs of possible myopathy or the presence of a risk factor for the development of renal failure in the presence of rhabdomyolysis (for example, severe acute infection, hypotension, surgery, trauma, metabolic, endocrine and electrolyte disorders and uncontrolled seizures). Treatment with amlodipine in an adequate dose to control arterial hypertension can be continued.
Influence on ability to drive motor transport and control mechanisms
Although the available data on amlodipine and atorvastatin indicate that the combination drug should not impair the ability to drive and use equipment, caution should be exercised when driving vehicles and controlling mechanisms (given the possible development of an excessive reduction in blood pressure, dizziness, fainting).
There is no information about drug overdose.
Both amlodipine and atorvastatin are actively associated with plasma proteins, therefore a significant increase in the clearance of the combined drug during hemodialysis is unlikely.
Symptoms 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 Atorvastatin overdose is not described.
Treatment Amlodipine overdose: taking activated carbon immediately or within 2 hours after taking amlodipine in 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 hypotension caused by an overdose of amlodipine, requires active measures aimed at maintaining the function of the cardiovascular system, including monitoring the performance of the heart and lungs, the elevated position of the limbs and monitoring 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 use, and to eliminate the effects of calcium channel blockade, i.v. administration of calcium gluconate.
Specific means fortreatment Atorvastatin overdose is not. In case of overdose, symptomatic and supportive treatment should be carried out as needed.
Studies and clinical trials of Amlodipine, Atorvastatin (Click to expand)