Dalneva, 10 mg+8 mg tablets 30 pcs

hypotensive combination therapy (angiotensin-converting enzyme inhibitor [ACE] + slow calcium channel blocker [CCB])

Indications

Hypertension (high blood pressure), Angina

Arterial hypertension and/or coronary heart disease: stable angina pectoris in patients requiring perindopril and amlodipine therapy.

Active ingredient

Amlodipine, Perindopril

Composition

for 1 tablet 5 mg + 4 mg/10 mg + 4 mg/5 mg + 8 mg/10 mg + 8 mg

Active substances:

Amlodipine besylate (amlodipine besylate) 6.935 mg/13.870 mg/6.935 mg/13.870 mg, equivalent to amlodipine 5 mg/10 mg/5 mg/10 mg

Perindopril erbumin A substance – granules 21,000 mg/21,000 mg/42,000 mg/42,000 mg, contains perindopril erbumin 4 mg/4 mg/8 mg/8 mg

Auxiliaries:

Microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch, sodium hydrogen carbonate, colloidal silicon dioxide, magnesium stearate

How to take, the dosage

Orally, one tablet once a day, preferably in the morning before a meal.

The dose of the drug Dalneva^® is adjusted after previously adjusted doses of individual drug components: perindopril and amlodipine in patients with AH and stable angina pectoris.

If therapeutic necessity, the dose of the drug Dalneva^® can be changed based on individual selection of doses of individual components: amlodipine 5 mg + perindopril 4 mg or amlodipine 10 mg + perindopril 4 mg,or amlodipine 5 mg + perindopril 8 mg,or amlodipine 10 mg + perindopril 8 mg.

Maximum daily dose: amlodipine 10 mg + perindopril 8 mg.

Interaction

Amlodipine

Unrecommended drug combinations

Dantrolene (intravenous administration)

Fatal ventricular fibrillation and collapse have been reported in laboratory animals against verapamil and intravenous dantrolene administration accompanied by hyperkalemia. Due to the risk of hyperkalemia, concomitant use of PBMCs, including amlodipine, should be excluded in patients with malignant hyperthermia as well as during treatment of malignant hyperthermia.

Drug combinations, require special attention

Isoenzyme inducers CYP3A4: Concomitant use with CYP3A4 isoenzyme inducers may alter the plasma concentration of amlodipine. Therefore it is necessary to monitor BP and adjust the dose both during and after their concomitant use, especially in case of use with potent inducers of CYP3A4 isoenzyme (e.g. rifampicin, St. John’s Wort preparations).

Inhibitors of the isoenzyme CYP3A4: Simultaneous administration of amlodipine and potent to moderate CYP3A4 isoenzyme inhibitors (protease inhibitors, antifungal drugs of the azole group, macrolides such as erythromycin or clarithromycin, verapamil or diltiazem) may result in significant increases in plasma amlodipine concentration. Clinical manifestations of these pharmacokinetic abnormalities may be more pronounced in elderly patients. Due to this clinical condition monitoring and dose adjustment may be required.

Patients taking amlodipine concomitantly with clarithromycin are at increased risk of arterial hypotension. Patients taking perindopril concomitantly with clarithromycin should be monitored closely.

Drug combinations., require attention

Amlodipine increases the antihypertensive effects of hypertensive drugs.

Tacrolimus:Tacrolimus risk increases serum concentrations when used simultaneously with amlodipine. To avoid the development of toxic effects of tacrolimus concomitantly using these drugs it is necessary to monitor the serum concentration of tacrolimus and adjust the dose if necessary.

Cyclosporine: There have been no studies examining the interaction of cyclosporine with amlodipine in healthy volunteers or other populations, with the exception of kidney transplant patients, in whom there has been variability in increasing the lowest plasma concentrations of cyclosporine (average of 0% to 40%). The possibility of controlling serum concentration of cyclosporine in patients after kidney transplantation during concomitant use with amlodipine should be considered. If necessary, the dose of cyclosporine should be decreased.

Simvastatin: Concomitant administration of multiple doses of 10 mg amlodipine and 80 mg simvastatin resulted in a 77% increase in simvastatin exposure compared with isolated simvastatin administration. In patients taking Dalneva^® at a dose of 10 mg + 4 mg or 10 mg + 8 mg, simvastatin administration should be limited to 20 mg per day.

The simultaneous use of amlodipine and consumption of grapefruit or grapefruit juice is not recommended due to the possible increased bioavailability of amlodipine in some patients, which in turn may increase the effects of BP reduction.

Inhibitors tTOR(mammalianTargetofRapamycinmammalian target of rapamycin: MTOR inhibitors such as sirolimus, temsirolimus, and everolimus are substrates of the CYP3A isoenzyme. Amlodipine is a weak inhibitor of CYP3A isoenzyme. When used concomitantly with mTOR inhibitors, amlodipine may increase their exposure.

Clarithromycin: clarithromycin is a CYP3A4 isoenzyme inhibitor. There is an increased risk of arterial hypotension in patients concomitantly using clarithromycin with amlodipine. Close monitoring of patients is recommended when using amlodipine concomitantly with clarithromycin.

Simultaneous use of beta-adrenoblockers (bisoprolol, metoprolol) and the alpha- and beta-adrenoblocker carvedilol in CHF: increases the risk of arterial hypotension and worsening the course of CHF in patients with uncontrolled or latent CHF (increased inotropic effect). In addition, beta-adrenoblockers can reduce excessive reflex cardiac sympathetic activation against concomitant CHF.

Concurrent use of amlodipine may increase systemic plasma exposure to tasonermine. In such cases, regular monitoring of plasma concentrations of tasonermine is necessary and dose adjustment if necessary.

Other drug combinations

Calcium preparations can reduce the effect of BMCC.

When concomitant use of BMCC with lithium preparations (no data available for amlodipine), their neurotoxicity may be increased (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).

In clinical studies of drug interactions, amlodipine had no effect on the pharmacokinetics of atorvastatin, digoxin, warfarin.

A single administration of 100 mg sildenafil in patients with essential hypertension has no effect on amlodipine pharmacokinetic parameters.

Perindopril

The data from clinical studies show that dual blockade of the RAAS as a result of simultaneous use of ACE inhibitors, ARA II or aliskiren leads to an increased incidence of adverse events such as arterial hypotension, hyperkalemia, and renal dysfunction (including acute renal failure) compared to situations in which only one RAAS-acting drug is used (see See Sections “Pharmacological Properties. Pharmacodynamics”, “Contraindications”, “Special Indications”).

Drugs that cause hyperkalemia

Some drugs may increase the risk of hyperkalemia: aliskiren, potassium salts, potassium-saving diuretics, ACE inhibitors, ARA II, nonsteroidal anti-inflammatory drugs (NSAIDs), heparin, immunosuppressants.such as cyclosporin or tacrolimus, trimethoprim, including a fixed combination of trimethoprim and sulfamethoxazole (co-trimoxazole). The combination of these drugs increases the risk of hyperkalemia.

Cyclosporine: concomitant use of ACE inhibitors with cyclosporine may cause hyperkalemia. It is recommended to monitor serum potassium content.

Heparin: possible increase in serum potassium. Monitoring of serum potassium is recommended.

Simultaneous use is contraindicated

Aliskiren and drugs containing aliskiren

The concomitant use of ACE inhibitors with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or moderate to severe impaired renal function (FFR less than 60 mL/min/1.73 m² body surface area) and is not recommended in other patients. (see section “Contraindications”). There is an increased risk of hyperkalemia, impaired renal function, cardiovascular morbidity and mortality.

Extracorporeal Therapy

Extracorporeal treatments that bring blood into contact with negatively charged surfaces, such as dialysis or hemofiltration using certain high-flow membranes (e.g., polyacrylonitrile), or LDL apheresis using dextran sulfate, are contraindicated because of an increased risk of severe anaphylactoid reactions (see See Contraindications). If the patient requires extracorporeal therapy, another type of dialysis membrane or another class of hypotensive drugs should be considered.

Inhibitors of neutral endopeptidase

The simultaneous use of ACE inhibitors with drugs containing sacubitril (neprilysin inhibitor) increases the risk of angioedema, therefore simultaneous use of these drugs is contraindicated. ACE inhibitors should not be prescribed earlier than 36 hours after withdrawal of the drugs containing sacubitril. Administration of drugs containing sacubitril is contraindicated in patients receiving ACE inhibitors and also within 36 hours after cancellation of ACE inhibitors.

Unrecommended drug combinations

Aliskiren and drugs containing aliskiren

In patients without diabetes mellitus or renal dysfunction, there may be an increased risk of hyperkalemia, impaired renal function, and increased cardiovascular morbidity and mortality.

Simultaneous administration of ACE inhibitors and ARA II

The literature suggests that in patients with established diagnoses of atherosclerosis, heart failure, or diabetes mellitus with target organ damage, concurrent administration of ACE inhibitors and ARA II leads to increased rates of arterial hypotension, syncope, hyperkalemia, and impaired renal function (including acute renal failure) compared with situations in which only one RAAS-acting drug is used. The use of dual RAAS blockade (e.g. simultaneous use of ACE inhibitors and ARA II) should be limited to single cases with strict monitoring of renal function, plasma potassium and BP (see section “Cautionary Note”).

Estramustine

Simultaneous use of estramustine with ACE inhibitors is associated with an increased risk of angioedema.

Co-trimoxazole (trimethoprim + sulfamethoxazole)

The risk of hyperkalemia may increase when concomitantly used with co-trimoxazole (trimethoprim + sulfamethoxazole) (see “Cautionary Note”). Kalium-saving diuretics (e.g., triamterene, amiloride) and potassium salts

Normally, plasma potassium levels remain within normal limits, but some patients receiving ACE inhibitors may develop hyperkalemia. The use of potassium-saving diuretics (e.g., spironolactone, triamterene, eplerenone or amiloride), potassium-containing table salt substitutes, other drugs that contribute to increase plasma potassium content may lead to a significant increase in serum potassium. Caution should also be exercised when perindopril is concomitantly prescribed with other drugs that may increase serum potassium, such as trimethoprim and co-trimoxazole (trimethoprim + sulfamethoxazole), since it is known that trimethoprim acts as a potassium-saving diuretic, such as amiloride. Therefore, concomitant use of perindopril with the above drugs is not recommended. If, nevertheless, concomitant use is indicated, it should be used with caution and regular monitoring of serum potassium content.

Lithium preparations

Concomitant use of lithium and ACE inhibitors may result in reversible increases in plasma lithium and associated toxic effects (severe neurotoxic effects). Simultaneous use of perindopril and lithium preparations is not recommended. If such therapy is necessary, regular monitoring of lithium content in blood plasma is necessary (see section “Special indications”).

Drug combinations requiring special attention

Hypoglycemic agents (insulin, sulfonylurea derivatives)

According to data from epidemiological studies, ACE inhibitors may increase the hypoglycemic effect of insulin and sulfonylurea derivatives with a risk of developing hypoglycemia. This effect is most likely to be observed in the first weeks of concomitant use and in patients with impaired renal function.

Kaliesaving diuretics

In patients receiving diuretics, especially in patients with hypovolemia and/or reduced salt concentration, a marked decrease in BP may be observed at the beginning of perindopril therapy, the risk of which can be reduced by withdrawing the diuretic, replenishing fluid or salt loss before starting perindopril therapy, and by prescribing perindopril in a low dose with its further gradual increase.

In AH patients with hypovolemia or reduced saline on diuretic therapy, diuretics should either be discontinued before starting an ACE inhibitor (with the potassium-saving diuretic to be prescribed again later) or the ACE inhibitor should be given at a low dose with a subsequent gradual increase in dose.

When using diuretics in cases of CHF an ACE inhibitor should be prescribed at a very low dose, possibly after reducing the dose of a concurrent potassium-saving diuretic.

In all cases, renal function (plasma creatinine concentration) should be monitored during the first weeks of ACE inhibitor use.

Kaliesaving diuretics (use of eplerenone, spironolactone in doses of 12.5 mg to 50 mg per day and low doses of ACE inhibitors)

When treating NYHA functional class II-IV CHF with left ventricular ejection fraction < 40% in patients with early-onset heart failure

Special Instructions

Renal artery stenosis (including bilateral), a single functioning kidney, hepatic insufficiency, renal failure, systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma), therapy with immunosuppressants, allopurinol, procainamide (risk of neutropenia, agranulocytosis), reduced circulating blood volume (CBC) (taking diuretics, salt-free diet, vomiting, diarrhea), atherosclerosis, cerebrovascular diseases, CHD with severe obstructive coronary artery disease, acute myocardial infarction (and the period within 1 month after it), unstable angina, sinus node weakness syndrome (marked tachycardia, bradycardia), renovascular hypertension, diabetes mellitus, primary hyperaldosteronism, CHF, concomitant use of CYP3A4 isoenzyme inhibitors or inducers, dantrolene, estramustine, potassium-saving diuretics, potassium-containing salt substitutes, lithium drugs, clarithromycin, tacrolimus, cyclosporine, hyperkalemia, surgery/general anesthesia, elderly patient, suppression of medullary hematopoiesis, history of allergic reactions or angioedema, prior hemodialysis with high-flow membranes (e.g., AN69sup>®), desensitizing therapy, low-density lipoprotein (LDL) apheresis, aortic stenosis/mitral stenosis/hypertrophic obstructive cardiomyopathy (HCMP), use in non-Hispanic patients, nonischemic CHF of NYHA class III-IV.

The drug Dalneva^® should not be administered to children and adolescents under 18 years of age because there are no data on the efficacy and safety of perindopril and amlodipine in these patient groups both in monotherapy and as part of combination therapy.

Patients with impaired renal function

The drug Dalneva^® may be used in patients with a CK equal to or greater than 60 ml/min.

The drug Dalneva^® is contraindicated in patients with IQ less than 60 ml/min. Individual selection of perindopril and amlodipine doses is recommended for such patients. Changes in amlodipine plasma concentration do not correlate with the severity of renal failure.

Elderly patients and patients with impaired liver function

The initial dose of Dalneva^® should be reduced to contain the lowest dose of amlodipine (i.e. i.e., to 1 tablet of amlodipine 5 mg + perindopril 4 mg or amlodipine 5 mg + perindopril 8 mg).

The special indications related to perindopril and amlodipine also apply to the drug Dalneva^®.

Amlodipine

The efficacy and safety of amlodipine in hypertensive crisis have not been established.

Heart failure

Treatment of patients with heart failure should be given with caution.

when using amlodipine in patients with chronic heart failure class III and IV according to NYHA classification, pulmonary edema may develop. PBMCs including amlodipine should be used with caution in patients with CHF due to the possible increase of risk of cardiovascular adverse events and mortality.

hepatic failure

In patients with impaired liver function, T_½ and AUC of amlodipine are increased. There are no dosing recommendations for the drug. Amlodipine should be started at the lowest dose and precautions should be taken both at the beginning of treatment and when increasing the dose. In patients with severe hepatic impairment, the dose should be increased gradually, ensuring close monitoring of the clinical condition.

Elderly patients

In elderly patients, dose increases should be given with caution (see Sections “Administration and Doses” and “Pharmacological Properties. Pharmacokinetics”).

Renal failure

Patients with renal insufficiency can take amlodipine at standard doses. Changes in plasma concentrations of amlodipine do not correlate with the degree of renal failure. Amlodipine is not eliminated from the body by dialysis.

Mitral stenosis/aortic stenosis/GOCMP

Amlodipine is contraindicated in patients with left ventricular outflow tract obstruction.

Cancel syndrome

Despite the absence of withdrawal syndrome in BMCCs, discontinuation of treatment with Dalneva^® should preferably be done gradually, reducing the drug dose. Amlodipine does not prevent the development of withdrawal when beta-adrenoblockers are stopped abruptly.

Peripheral edema

Mild to moderate peripheral edema was the most common adverse event of amlodipine in clinical trials. The incidence of peripheral edema increased with increasing dose (with amlodipine 2.5 mg, 5 mg and 10 mg daily, edema occurred in 1.8%, 3% and 10% of patients, respectively). Peripheral edema associated with amlodipine use should be carefully differentiated from symptoms of progression of left ventricular heart failure.

Other

It is necessary to maintain dental hygiene and see a dentist (to prevent sore, bleeding and gum hyperplasia).

Perindopril

Elevated sensitivity/angioneurotic edema (Quincke’s edema)

When using ACE inhibitors, including perindopril, the development of angioedema of the face, lips, tongue, vocal folds, and/or larynx may occur in rare cases. This may occur at any time. If these symptoms occur, the use of Dalneva^® should be stopped immediately and the patient should be observed until the signs of oedema have completely disappeared.If angioedema only affects the face and lips, its manifestations usually disappear on their own or antihistamines may be used to treat their symptoms. Angioedema accompanied by swelling of the tongue or larynx may cause airway obstruction and may be fatal. If these symptoms develop, epinephrine (adrenaline) 1:1000 (0.3 or 0.5 ml) subcutaneously injected immediately and/or airway patency assured. The patient should be under medical supervision until the symptoms completely and permanently disappear.

In rare cases, intestinal angioedema (angioedema of the intestine) develops against the background of ACE inhibitor therapy. Patients present with abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases without preceding angioedema of the face and with a normal serum C1-esterase concentration. Diagnosis is made by abdominal computed tomography, ultrasound or at the time of surgery. Symptoms disappear after discontinuation of ACE inhibitors. Therefore, in patients with abdominal pain receiving ACE inhibitors, the possibility of intestinal angioedema should be considered when making a differential diagnosis (see section “Side effects”).

The concomitant use of ACE inhibitors with racecadotril, mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), or DPP-IV (gliptins, including vildagliptin) increases the risk of angioedema (e.g., upper airway or tongue edema, with or without respiratory impairment) (see section “Interaction with other medicinal products”).

Caution should be exercised when initiating therapy with racecadotril, mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), or gliptins, including vildagliptin, when used concurrently with ACE inhibitors.

Anaphylactoid reactions during desensitization procedures

There have been isolated reports of long-term, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with Hymenoptera venom. In the same patients, anaphylactoid reactions were avoided by temporary withdrawal of ACE inhibitors, but anaphylactoid reactions occurred again if the drug was accidentally taken.

Anaphylactoid reactions during LDL apheresis with dextran sulfate

In rare cases, patients receiving ACE inhibitors may develop life-threatening anaphylactoid reactions when performing LDL apheresis with dextran sulfate. To prevent anaphylactoid reactions, ACE inhibitor therapy should be temporarily stopped before each LDL apheresis procedure with dextran sulfate.

Neutropenia/agranulocytosis, thrombocytopenia and anemia

In patients taking ACE inhibitors, there may be cases of neutropenia/agranulocytosis, thrombocytopenia and anemia. In patients with normal renal function in the absence of other aggravating factors neutropenia is rare.

Perindopril should be used with special caution in patients with systemic connective tissue diseases, against the background of taking immunosuppressants, allopurinol or procainamide, especially in patients with impaired renal function.

Some patients had severe infections, in some cases resistant to intensive antibiotic therapy. When prescribing perindopril to such patients, it is recommended to periodically monitor the number of leukocytes in the blood. Patients should inform the physician about any signs of infectious diseases (e.g., sore throat, fever).

Renovascular Hypertension

Patients with bilateral renal artery stenosis or artery stenosis of the only functioning kidney are at increased risk for arterial hypotension and renal failure with ACE inhibitor therapy. Taking diuretics may be an additional risk factor. Deterioration of renal function may be observed even with a small change in serum creatinine concentration, even in patients with unilateral renal artery stenosis.

Double RAAS blockade

There is evidence that concomitant use of ACE inhibitors, ARA II or aliskiren increases the risk of arterial hypotension, hyperkalemia and renal function impairment (including acute renal failure). Concomitant use of ACE inhibitors with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or moderate or severe renal insufficiency (FFR less than 60 ml/min/1.73 m² body surface area) and is not recommended in other patients. If therapy with dual RAAS blockade is considered absolutely necessary, it should be performed only under strict medical supervision and with regular monitoring of renal function, plasma electrolyte content and BP. ACE inhibitors usage simultaneously with APA II is contraindicated in patients with diabetic nephropathy and is not recommended in other patients (see section “Contraindications”).

Primary hyperaldosteronism

Patients with primary hyperaldosteronism are usually not susceptible to hypotensive drugs whose action is based on inhibition of the RAAS. Therefore it is not recommended to use this medicine.

Arterial hypotension

ACE inhibitors can cause a sharp decrease in BP. Symptomatic arterial hypotension rarely develops in patients without comorbidities. The risk of significant BP decrease is increased in patients with decreased blood pressure, which may be observed against the background of diuretic therapy, with strict salt-free diet, hemodialysis, diarrhea and vomiting, as well as in patients with severe AH with high renin activity (see sections “Interaction with other medicinal products” and “Side effects”). In patients with increased risk of symptomatic arterial hypotension, BP, renal function and serum potassium content during therapy with the drug Dalneva^®.

A similar approach is used in patients with angina and cerebrovascular disease in whom severe arterial hypotension can lead to myocardial infarction or cerebrovascular events.

If arterial hypotension develops, the patient should be transferred to the supine position with elevated legs. If necessary, the circulatory blood pressure should be replenished by intravenous injection of 0.9% sodium chloride solution. Transient arterial hypotension is not an obstacle for further drug administration. After the RBC and BP recovery, the treatment can be continued.

Mitral stenosis/aortic stenosis/GOCMP

Perindopril, like other ACE inhibitors, should be prescribed with caution in patients with left ventricular outflow tract obstruction (aortic stenosis, GOCMP) and in patients with mitral stenosis. Amlodipine is contraindicated in patients with left ventricular outflow tract obstruction.

Kidney function disorder

Patients with renal insufficiency (KC less than 60 ml/min) are recommended to choose individual doses of perindopril and amlodipine (see section “Dosage and administration”). These patients require regular monitoring of potassium content and serum creatinine concentration (see section “Side effects”).

Patients with bilateral renal artery stenosis or artery stenosis of the uniciliary artery may have increased serum urea and creatinine concentrations during ACE inhibitor therapy, which usually subsides with therapy reversal. This effect is more often noted in patients with renal insufficiency. The additional presence of renovascular hypertension causes an increased risk of severe arterial hypotension and renal failure in these patients. Some patients with AH without signs of renal vascular lesions may have increased serum urea and creatinine concentrations, especially when concomitant administration of perindopril with a diuretic, usually minor and transient. More often this effect is observed in patients with previous renal dysfunction.

Liver function disorder

In rare

Synopsis

Tablets 5 mg + 4 mg:

Round, slightly biconvex, beveled tablets, white to almost white.

Tablets 10 mg + 4 mg:

Capsule-shaped, biconvex tablets with a ridge on one side, white to almost white.

Tablets 5 mg + 8 mg:

Round, biconvex, beveled tablets, white to almost white.

Tablets 10 mg + 8 mg:

Round, biconvex, beveled tablets, with a bevel on one side, white to almost white.

Contraindications

• High sensitivity to perindopril or other ACE inhibitors, amlodipine or other dihydropyridine derivatives, or excipients in the drug.

• Anhioneurotic edema (Quincke’s edema) in anamnesis (including against the other ACE inhibitors).
• Hereditary/idiopathic angioedema.
• Simultaneous use with aliskiren and drugs containing aliskiren in patients with diabetes and/or moderate to severe renal function impairment (GFR < 60 ml/min/1.73 m² body surface area) (see See sections “Interaction with other medicinal products” and “Pharmacological properties. Pharmacodynamics”).
• Simultaneous use with ARA II in patients with diabetic nephropathy (see “Special Indications.

– Concomitant use with neutral endopeptidase inhibitors (such as those containing sacubitril) due to the high risk of angioedema.

Extracorporeal therapy leading to blood contact with negatively charged surfaces (see “Interaction with other drugs”).

• >Veep bilateral renal artery stenosis or artery stenosis of the only functioning kidney (see Special Instructions).

• Severe arterial hypotension (systolic BP less than 90 mm Hg.
• Shock (including cardiogenic).
• Obstruction of the left ventricular exit tract (eg, clinically significant aortic stenosis).
• Hemodynamically unstable heart failure after acute myocardial infarction.

• Renal failure (creatinine clearance [CK] less than 60 ml/min).
• Pregnancy and breastfeeding.

• Age under 18 years of age (efficacy and safety not established).

Overdose

No information about overdose with Dalneva^®.

Amlodipine

Information about amlodipine overdose is limited.

Symptoms: expressed BP decrease with possible development of reflex tachycardia and excessive peripheral vasodilation (risk of severe and persistent arterial hypotension, including with the development of shock and death).

Treatment: Gastric lavage, administration of activated carbon (especially in the first 2 hours after overdose), maintenance of cardiovascular function, elevation of the lower extremities, control of blood pressure and diuresis, symptomatic and supporting therapy. To restore vascular tone – the use of vasoconstrictors (if there are no contraindications for their use), to eliminate the effects of calcium channel blockade – intravenous injection of calcium gluconate solution. Hemodialysis is ineffective.

Perindopril

The data on perindopril overdose is limited.

Symptoms: expressed BP decrease, shock, water-electrolyte imbalance, renal failure, pulmonary hyperventilation, tachycardia, palpitations, bradycardia, dizziness, restlessness, and coughing.

treatment:the emergency measures are limited to the elimination of the drug from the body: gastric lavage and/or administration of activated charcoal, followed by the restoration of the BAC.

Pregnancy use