Prestarium A, 10 mg 30 pcs

How to take, the dosage

Orally, 1 tablet a day, in the morning, before meals.
For dispersible tablets: put the tablet on the tongue to dissolve on the tongue, then swallow with saliva.
Arterial hypertension: the initial dose is 5 mg per day, after a month can be increased to 10 mg/day.
Be careful in patients concomitantly receiving diuretics.
The initial dose for patients with significant activity of the renin-angiotensin-aldosterone system (RAAS) is 2.5 mg daily.
In elderly people the treatment should be started with 2.5 mg per day, in a month after the therapy start the dose can be increased to 5 mg per day and then to 10 mg per day.
Heart failure: The initial dose is 2.5 mg/day, after two weeks the dose can be increased to 5 mg/day.
In severe heart failure, as well as in high-risk patients, start treatment under close supervision. Prevention of recurrent stroke (with indapamide):begin with 2.5 mg/d for two weeks, then 5 mg/d for two weeks before indapamide.
IBS: 5 mg/d, after 2 weeks, if well tolerated and taking into account renal function, the dose may be increased to 10 mg per day. Elderly patients start with 2.5 mg/day for one week, then 5 mg/day for the next week, then up to 10 mg/day. Renal failure: creatinine clearance (CK,ml/min) ⩾60: 5 mg/day; 30 < CK < 60: 2.5 mg/day; 15 < CK < 30: 2.5 mg every other day; patients on hemodialysis, or CK < 15: 2.5 mg on dialysis day.
Age before 18 years of age: not recommended.

Interaction

Contraindicated with:aliskiren (in patients with diabetes and/or impaired renal function); APA II in patients with diabetic nephropathy; extracorporeal therapy; combination of valsartan + sacubitril.

Do not recommend with:aliskiren (in patients without diabetes or renal dysfunction), APA II, estramustine, potassium-saving diuretics (triamterene, amiloride) or potassium salts, potassium-containing products and supplements, lithium drugs.

With special caution:. hypoglycemic agents (insulin, oral hypoglycemic agents except glyptins), baclofen, potassium-saving diuretics, potassium-saving diuretics (eplerenone, spironolactone), nonsteroidal anti-inflammatory drugs (NSAIDs) including acetylsalicylic acid ≥3 g/day, racecadotril, mTOR inhibitors (e.g., sirolimus, everolimus temsirolimus), alteplase.

With definite caution: hypotensive drugs, vasodilators, glyptins (linagliptin, saxagliptin, sitagliptin, wildagliptin), tricyclic antidepressants, antipsychotics (neuroleptics) and general anesthesia agents, sympathomimetics, gold drugs.

Drugs that cause hyperkalemia: Aliskiren, potassium salts, potassium-saving diuretics, IAPPs, ARA II, NSAIDs, heparins, immunosuppressants such as cyclosporine or tacrolimus, trimethoprim, sulfamethoxazole/trimethoprim (Co-trimoxazole).

Special Instructions

Ensensitivity/angioneurotic edema:The drug should be stopped and the patient should be observed until the signs of edema disappear completely. Angioneurotic edema accompanied by laryngeal edema may be fatal. Co-administration with the combination valsartan + sacubitril (contraindicated; use of one drug at least 36 hours after discontinuation of the other), or with other neprilysine inhibitors (e.g., ratsecadotril), or with mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) or with glyptins (linagliptin, saxagliptin, sitagliptin, vildagliptin) – increases the risk of angioedema (e.g., swelling of the tongue, vocal folds, or larynx with or without airway obstruction).

Anaphylactoid reactions in hemodialysis using high-flow membranes:Prescribing a different class of hypotensive drug or using a different type of dialysis membrane.

Anaphylactoid reactions during low-density lipoprotein apheresis:In rare cases, life-threatening anaphylactoid reactions may develop. Temporarily discontinue iAPP therapy before each procedure.

Anaphylactoid reactions during desensitization: Stop iAPP therapy temporarily before each procedure. Such reactions may have developed again if treatment was accidentally or inadvertently resumed.

Neutropenia/agranulocytosis/thrombocytopenia/anemia:With particular caution use in patients with systemic connective tissue disease, against the background of taking immunosuppressants, allopurinol or procainamide. Periodically monitor the leukocyte count in blood.

Peripheral hyperaldosteronism:The use of drugs whose action is based on inhibition of the RAAS is not recommended: patients are not susceptible.

Pregnancy: Discontinue the drug and, if necessary, prescribe alternative therapy.

Hypotension: Careful monitoring at the start of therapy and in dose selection in patients at increased risk of symptomatic arterial hypotension (with decreased RBC, in patients with severe renin-dependent hypertension, symptomatic or severe heart failure) and in patients with CHD or cerebrovascular disease. Transient hypotension is not an obstacle for further use of the drug, and therapy may be continued after recovery of the RBC and BP.

Mitral stenosis/aortic stenosis/hypertrophic cardiomyopathy: With caution.

Stable IBS: If unstable angina develops within the first month, the benefits and risks should be evaluated before continuing therapy.

Kidney function impairment:control of creatinine and potassium. Treatment of patients with renal artery stenosis(s) or renovascular hypertension should be initiated under close medical supervision with low doses of the drug and further adequate dose selection.

Hepatic dysfunction:in rare cases, the syndrome of cholestatic jaundice with progression to fulminant liver necrosis, sometimes with fatal outcome. In case of jaundice or significant increase in liver enzymes discontinue the drug.

Ethnic differences:In the Negro race, perindopril is less effective and the risk of angioedema is higher.

Dry c cough. Surgery/anesthesia:Stop treatment the day before surgery.

Hyperkalemia: Regular blood potassium control in renal failure, decreased renal function, age >70 years, diabetes mellitus, dehydration, acute heart failure, metabolic acidosis, co-administration of potassium-saving diuretics, potassium salts and aldosterone antagonists or ARA II.

Patients with diabetes: During the first month of therapy, monitor blood glucose. Kidney transplantation:There are no data on use.

Renovascular hypertension: increased risk of hypotension and renal failure in patients with bilateral renal artery stenosis or artery stenosis of the single kidney. Use of diuretics may be a risk factor. Deterioration of renal function may be observed with minor changes in serum creatinine concentration, even in patients with unilateral renal artery stenosis.

Lactase deficiency, galactose intolerance, glucose-galactose malabsorption syndrome: should not be taken.

Phenylketonuria (for dispersible tablets): should not be taken.

Driving vehicles, machinery. With caution due to the risk of hypotension

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Contraindications

• Hypersensitivity to perindopril, or to any of the excipients, other ACEs; history of angioedema (Quincke’s edema) associated with ACEs (see section Cautionary Note);
• Hereditary/idiopathic angioedema; pregnancy and lactation (see section Cautionary Notes).
• Current use with aliskiren and drugs containing aliskiren in patients with diabetes mellitus and/or moderate to severe renal function impairment (glomerular filtration rate (GFR) < 60 mL/min/1.73m² body surface area) (see Interactions with aliskiren and drugs containing aliskiren).
• co-administration with angiotensin II receptor antagonists (ARA II) in patients with diabetic nephropathy (see Specific Note);
• co-administration with combination therapy containing valsartan + sacubitril (see Specific Note).
• Extracorporeal therapy that brings the blood into contact with negatively charged surfaces (see Interactions).

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Side effects

Frequently:dizziness, headache, paresthesia, vertigo, visual disturbance, tinnitus, hypotension, cough, shortness of breath, abdominal pain, constipation, diarrhea, taste disorder (dysgeusia), dyspepsia, nausea, vomiting, skin itching, skin rash, muscle spasms, asthenia.

Infrequent:. eosinophilia, hypoglycemia, hyperkalemia, hyponatremia, mood lability, sleep disturbance, drowsiness, fainting, palpitations, tachycardia, vasculitis, bronchospasm, dry mouth, urticaria, angioedema of face, lips, extremities, mucous membranes, tongue, of the vocal folds and/or larynx, photosensitivity reactions, pemphigoid, increased sweating, arthralgia, myalgia, renal failure, erectile dysfunction, chest pain, malaise, peripheral edema, fever, increased blood urea and creatinine concentrations, fall.

Pseldom: aggravation of psoriasis, increased liver enzyme activity and blood bilirubin concentration.

Very rare: .agranulocytosis or pancytopenia, decreased hemoglobin and hematocrit, leukopenia/neutropenia, hemolytic anemia in patients with congenital deficiency of glucose-6-phosphate dehydrogenase, thrombocytopenia, confusion, angina pectoris, arrhythmia, myocardial infarction and stroke, eosinophilic pneumonia, rhinitis, pancreatitis, hepatitis (cholestatic or cytolytic), erythema multiforme, acute renal failure.

Frequency unknown: Rainault syndrome. Inadequate antidiuretic hormone secretion syndrome (SNSADH) has been reported when coadministered with other ACE inhibitors. SNSADH can be considered a very rare possible complication associated with treatment with ACE inhibitors, including perindopril.

Pregnancy use

Contraindicated.

Similarities

Perineva, Prestarium A, Perindopril