Dalneva tabs 5mg + 4mg #30

Dalneva user manual

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Dalneva is a combined drug with antihypertensive and antianginal effects.

Release form and composition

Dalneva is available in the form of tablets of almost white or white color: 5 mg + 4 mg - a little round biconvex, with a chamfer; 10 mg + 4 mg - biconvex capsule form, on one side - dividing risk; 5 mg + 8 mg - round biconvex, chamfered; 10 mg + 8 mg - round biconvex, with a chamfer and a dividing line on one side (10 pcs. In a blister strip, in a cardboard box 3 or 9 packs).
1 tablet contains:
    active ingredients: amlodipine besylate + perindopril erbumin A (in the form of granules) - 6.935 mg + 21 mg, 13.87 mg + 21 mg, 6.935 mg + 42 mg or 13.87 mg + 42 mg, which is equivalent to 5 mg + 4 mg, 10 mg + 4 mg, 5 mg + 8 mg or 10 mg amlodipine + 8 mg perindopril erbumin;
    auxiliary components: microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch, sodium bicarbonate, colloidal silicon dioxide, magnesium stearate.

Indications for use

Dalneva's use is indicated for the treatment of arterial hypertension and / or ischemic heart disease in patients with stable exertional angina.

Contraindications

    an indication of a history of angioedema, including after the use of other angiotensin-converting enzyme (ACE) inhibitors;
    hereditary or idiopathic angioedema;
    severe arterial hypotension [systolic blood pressure (BP) less than 90 mm Hg], shock (including cardiogenic);
    unstable angina (except for Prinzmetal's angina);
    severe aortic stenosis, obstruction of the outflow tract of the left ventricle;
    hemodynamically unstable heart failure after acute myocardial infarction;
    renal failure with creatinine clearance (CC) less than 60 ml / min;
    age up to 18 years;
    period of pregnancy;
    breast-feeding;
    hypersensitivity to dihydropyridine derivatives and ACE inhibitors, including amlodipine and perindopril, as well as to the auxiliary components of Dalneva.
Caution should be exercised when taking Dalneva with chronic heart failure, hypertrophic obstructive cardiomyopathy (GOKMP), aortic and / or mitral stenosis, liver failure, bilateral renal artery stenosis, artery stenosis of the only functioning kidney, systemic connective tissue diseases (including systemic lupus erythematosus, ), diabetes mellitus, cerebrovascular diseases, atherosclerosis, renovascular hypertension, reduced blood volume (against the background of vomiting, diarrhea, taking diuretics, adherence to a diet with limited salt), hyperkalemia, taking potassium-containing substitutes for table salt, treating elderly patients or negroid race, surgery and general anesthesia, condition after kidney transplantation, hemodialysis using high-flow polyacrylonitrile membranes.
In addition, Dalneva is used with caution before the apheresis procedure for low-density lipoproteins using dextran sulfate, with concomitant therapy with allopurinol, immunosuppressants, procainamide, estramustine, dantrolene, potassium and lithium preparations, potassium-sparing diuretics, hymenoptera venom or other allergies.

Method of administration and dosage

Tablets are taken orally, preferably before breakfast, 1 pc. in a day.
The daily dose is set based on the results of preliminary titration of doses of each of Dalneva components by the method of individual selection, taking into account clinical indications.
The maximum dose is 10 mg + 8 mg per day.
In case of kidney disease (CC more than 60 ml / min), the dose is set depending on the degree of impairment of its function. A change in the level of amlodipine in blood plasma does not affect the severity of renal failure.
Elderly patients do not need dose adjustment.

Side effects

    from the circulatory and lymphatic systems: very rarely - agranulocytosis, leukopenia or neutropenia, thrombocytopenia, pancytopenia, with congenital deficiency of glucose-6-phosphate dehydrogenase - hemolytic anemia, a decrease in the concentration of hematocrit and hemoglobin;
    on the part of the cardiovascular system: often - a pronounced decrease in blood pressure, rush of blood to the skin of the face, a feeling of palpitations; infrequently - fainting; rarely - chest pain; very rarely - angina pectoris, myocardial infarction, arrhythmias (including bradycardia, atrial fibrillation, ventricular tachycardia), stroke, vasculitis;
    from the immune system: infrequently - urticaria;
    from the nervous system: often - headache, dizziness, drowsiness, vertigo, paresthesia; infrequently - sleep disturbance, insomnia, tremors, mood lability, hypesthesia; very rarely - confusion, peripheral neuropathy;
    metabolic disorders: infrequently - an increase or decrease in body weight; very rarely - hyperglycemia; frequency unknown - hypoglycemia;
    from the senses: often - tinnitus, visual impairment;
    from the digestive system: often - dyspepsia, nausea, vomiting, abdominal pain, constipation, diarrhea; infrequently - dryness of the oral mucosa, impaired taste sensation, disturbance of the rhythm of defecation; very rarely - gastritis, gingival hyperplasia, pancreatitis, cholestatic jaundice, hepatitis, cholestatic or cytolytic hepatitis;
    from the respiratory system: often - cough, shortness of breath; infrequently - bronchospasm, rhinitis; very rarely - eosinophilic pneumonia;
    on the part of the musculoskeletal system: often - muscle spasms; infrequently - back pain, arthralgia, myalgia;
    on the part of the skin: often - itching, rash; infrequently - angioedema of the vocal folds and / or larynx, tongue, lips, mucous membranes, face or extremities, photosensitivity, hemorrhagic rash, excessive sweating, alopecia; very rarely - erythema multiforme, Quincke's edema, Stevens-Johnson syndrome;
    from the reproductive system: infrequently - gynecomastia, impotence;
    on the part of the urinary system: infrequently - nocturia, urinary disorders, renal failure, frequent urination; very rarely - acute renal failure;
    laboratory indicators: rarely - an increase in the level of bilirubin; very rarely - an increase in the activity of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), more often in combination with cholestasis; frequency unknown - increased serum creatinine and urea levels;
    others: often - asthenia, peripheral edema, increased fatigue; infrequently - malaise, chest pain.

Special instructions

If symptoms of the development of angioedema of the larynx and / or vocal folds, lips, tongue, face appear, the use of Dalneva should be stopped immediately and the patient's condition should be monitored until the signs of edema disappear completely. If necessary (swelling of the tongue or larynx), antihistamine therapy is required, since there is a high risk of airway obstruction and death.
Since against the background of the use of ACE inhibitors, the development of intestinal angioedema is possible, this should be taken into account when carrying out a differential diagnosis in patients with abdominal pain and used in the diagnosis of computed tomography of the abdominal cavity or ultrasound examination. After discontinuation of the drug, the symptoms disappear.
In order to prevent the development of anaphylactoid reactions during a desensitizing procedure with the poison of hymenoptera insects or apheresis of low density lipoproteins using dextran sulfate, the patient must stop taking the tablets 24 hours before the start of each of the procedures.
When using high-flow membranes for hemodialysis, the risk of developing anaphylactoid reactions increases; therefore, it is recommended to use a different type of membrane.
Taking the tablets is recommended to be accompanied by regular monitoring of the level of leukocytes in the blood plasma.
If a high body temperature, sore throat or other symptoms of an infectious disease appear, the patient should consult a doctor.
In patients with impaired liver function, the activity of hepatic enzymes should be regularly monitored; in case of its increase or the development of jaundice, immediate discontinuation of Dalneva is required.
The presence of perindopril in the composition causes a blockade of the renin-aldosterone-angiotensin system, therefore, the use of the drug can contribute to a sharp decrease in blood pressure and / or an increase in the concentration of creatinine in the blood plasma. This usually occurs when the first dose is taken or within two weeks of starting therapy.
It is recommended to avoid the simultaneous administration of perindopril and potassium-sparing diuretics, potassium preparations and potassium-containing substitutes for table salt. If necessary, concomitant therapy with potassium-sparing diuretics or potassium preparations in patients with confirmed hypokalemia should regularly monitor the parameters of electrocardiography and the level of potassium in the blood plasma.
Perhaps the appearance of a dry, unproductive cough associated with the presence of an ACE inhibitor and passing after Dalneva is discontinued.
A prerequisite for the treatment of patients with impaired renal function is regular monitoring of the concentration of creatinine and potassium in the blood plasma.
In patients with chronic heart failure of III and IV functional classes according to the NYHA (New York Heart Association) classification, pulmonary edema may develop against the background of Dalneva's use.
With extensive surgical intervention or the use of general anesthesia with a hypotensive effect in patients taking Dalneva, a pronounced decrease in blood pressure may occur. Therefore, during a planned operation, it is recommended to stop using the drug 24 hours before the start of general anesthesia.
Care must be taken when driving vehicles and mechanisms, since dizziness and other side effects may occur that affect the speed of psychomotor reactions and concentration.

Drug interactions

With concomitant therapy with other drugs, it is necessary to take into account the interaction with them of each of the active components of Dalneva.
With the simultaneous use of Dalneva:
    spironolactone, triamterene, amiloride and other potassium-sparing diuretics, potassium preparations containing potassium, salt substitutes can cause a significant increase in the level of potassium in the blood plasma;
    lithium preparations increase the concentration of lithium in the blood serum and the development of toxic effects;
    estramustine increases the risk of developing angioedema;
    non-steroidal and non-selective anti-inflammatory drugs, high doses (more than 3 g per day) of acetylsalicylic acid can lead to a decrease in the hypotensive, diuretic, natriuretic action of perindopril, deterioration of renal function up to the development of acute renal failure, an increase in serum potassium;
    oral hypoglycemic agents, insulin enhance their effect;
    thiazide and loop diuretics can significantly lower blood pressure;
    sympathomimetics can reduce the antihypertensive effect of the drug;
    gold preparations for injection sometimes cause nausea, vomiting, flushing of the face, lowering blood pressure;
    glucocorticosteroids (GCS) for systemic use, cytostatic and immunosuppressive agents, allopurinol, procainamide increase the risk of leukopenia;
    agents for general anesthesia, tricyclic antidepressants, antipsychotics enhance the hypotensive effect of Dalneva, increasing the risk of orthostatic hypotension;
    intravenous dantrolene increases the risk of hyperkalemia;
    rifampicin, St. John's wort, anticonvulsants (carbamazepine, phenobarbital, phosphenytoin, primidone, phenytoin) can cause an increase in the metabolism of amlodipine and a decrease in its plasma concentration;
    protease inhibitors, azole antifungals (itraconazole, ketoconazole), macrolides (including erythromycin, clarithromycin, diltiazem, verapamil) may increase the plasma content of amlodipine and increase the risk of undesirable effects;
    beta-blockers (bisoprolol, metoprolol), carvedilol increase the risk of arterial hypotension and enhance the negative inotropic effect of the drug;
    baclofen, vasodilators can potentiate the hypotensive effect of Dalneva;
    mineralocorticosteroids and corticosteroids, tetracosactide reduce the hypotensive effect of the drug;
    prazosin, alfuzosin, tamsulosin, doxazosin, terazosin (alpha-blockers) increase the hypotensive effect and increase the risk of orthostatic hypotension;
    amifostine may increase the hypotensive effect of amlodipine;
    cimetidine, sildenafil, grapefruit juice (240 ml) do not affect the pharmacokinetics of amlodipine;
    cyclosporin, atorvastatin, digoxin, warfarin do not change their pharmacokinetic parameters.

Terms and conditions of storage

Keep out of the reach of children.
Store at temperatures up to 25 ° C.
The shelf life is 3 years.

Terms of sell

You don't need a prescription to buy Dalneva.