Pivesyl Plus indications
Treatment of essential hypertension.
Pivesyl Plus 5 mg/1.25 mg: Subjects whose blood pressure is not adequately controlled by Perindopril (Pivesyl Plus) alone.
Pivesyl Plus 10 mg/2.5 mg: Substitution therapy in patients already controlled with Perindopril (Pivesyl Plus) and Indapamide (Pivesyl Plus) given concurrently at the same dose level.
Pivesyl Plus description
Each Pivesyl Plus 2.5 mg tablet contains Perindopril (Pivesyl Plus) argnine 2.5 mg, Indapamide (Pivesyl Plus) 0.625 mg and excipients.
Each Pivesyl Plus 5 mg tablet contains Perindopril (Pivesyl Plus) arginine 5 mg and Indapamide (Pivesyl Plus) 1.25 mg. It also contains the following excipients: Hydrophobic colloidal silica 0.25 mg, lactose monohydrate 61.55 mg, magnesium stearate 0.45 mg and microcrystalline cellulose 22.5 mg.
Each Pivesyl Plus 10 mg tablet contains Perindopril (Pivesyl Plus) arginine 10 mg and Indapamide (Pivesyl Plus) 2.5 mg.
Pivesyl Plus dosage
Pivesyl Plus 5 mg/1.25 mg Tablet: If blood pressure is not controlled after 1 month of treatment, the dose should be titrated to one 5 mg/1.25 mg tablet/day as a single dose, preferably to be taken in the morning and before a meal. When clinically appropriate, direct change from monotherapy to 5 mg/1.25 mg film-coated tablet may be considered.
Pivesyl Plus 10 mg/2.5 mg Tablet: One 10 mg/2.5 mg as a single dose, preferably to be taken in the morning and before a meal.
Elderly: In elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Pivesyl Plus 5 mg/1.25 mg and 10 mg/2.5 mg if renal function is normal and after considering blood pressure response.
Renal Impairment: In severe renal impairment (creatinine clearance <30 mL/min), treatment is contraindicated.
In moderate renal impairment (creatinine clearance <60 mL/min), treatment is contraindicated to Pivesyl Plus 10 mg/2.5 mg.
Pivesyl Plus 5 mg/1.25 mg Tablet: In patients with moderate renal impairment (creatinine clearance 30-60 mL/min), it is recommended to start treatment with the adequate dosage of the free combination.
In patients with creatinine clearance ≥60 mL/min, no dose modification is required.
Usual medical follow-up will include frequent monitoring of creatinine and potassium.
Hepatic Impairment: In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose modification is required.
Pivesyl Plus interactions
Avoid Pivesyl Plus with lithium, potassium-sparing diuretics (eg, spironolactone, triamterene), potassium salts.
Caution in use of Pivesyl Plus with the following drugs: Other medicines for treating high blood pressure; procainamide; allopurinol; terfenadine or astemizole; corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis; immunosuppressants used for the treatment of autoimmune disorders or following transplant surgery to prevent rejection (eg, cyclosporin); medicines for the treatment of cancer; erythromycin by injection; halofantrine; pentamidine; injectable gold; vincamine; bepridil; sulfopride; medicines used for heart rhythm problems (eg, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol); digoxin or other cardiac glycosides; baclofen; medicines used to treat diabetes eg, insulin or metformin; calcium, including calcium supplements; stimulant laxatives (eg, senna); nonsteroidal anti-inflammatory drugs (eg, ibuprofen) or high-dose salicylates (eg, aspirin); amphotericin B by injection; medicines to treat mental disorders eg, depression, anxiety, schizophrenia (eg, tricyclic antidepressants, neuroleptics); tetracosactide.
Pivesyl Plus side effects
The administration of Perindopril (Pivesyl Plus) inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by Indapamide (Pivesyl Plus). Two percent (2%) of the patients on treatment with Pivesyl Plus 2.5 mg/0.625 mg, 4% of the patients on treatment with Pivesyl Plus 5 mg/1.25 mg and 6% of the patients on treatment with Pivesyl Plus 10 mg/2.5 mg experience hypokalaemia (potassium level <3.4 micromol/L).
The following undesirable effects could be observed during treatment and ranked under the following frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Blood and the Lymphatic System Disorders: Very Rare: Thrombocytopenia, leucopenia/neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia. Anaemia has been reported with ACE inhibitors in specific circumstances (patients who have had kidney transplants, patients undergoing haemodialysis).
Psychiatric Disorders: Uncommon: Mood or sleep disturbances.
Nervous System Disorders: Common: Paraesthesia, headache, dizziness, vertigo. Very Rare: Confusion.
Eye Disorders: Common: Vision disturbance.
Ear and Labyrinth Disorders: Common: Tinnitus.
Vascular Disorders: Common: Hypotension whether orthostatic or not.
Cardiac Disorders: Very Rare: Arrhythmia including bradycardia, ventricular tachycardia, atrial fibrillation, angina pectoris and myocardial infarction possibly secondary to excessive hypotension in high-risk patients.
Respiratory, Thoracic and Mediastinal Disorders: Common: A dry cough has been reported with the use of ACE inhibitors. It is characterised by its persistence and by its disappearance when treatment is withdrawn. An iatrogenic aetiology should be considered in the presence of this symptom. Dypsnoea. Uncommon: Bronchospasm. Very Rare: Eosinophilic pneumonia, rhinitis.
Gastrointestinal Disorders: Common: Constipation, dry mouth, nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhoea, epigastric pain, anorexia, abdominal pains, taste disturbance. Very Rare: Pancreatitis.
Hepato-Biliary Disorders: Very Rare: Hepatitis either cytolytic or cholestatic. Not known: In case of hepatic insufficiency, there is a possibility of onset of hepatic encephalopathy.
Skin and Subcutaneous Tissue Disorders: Common: Rash, pruritus, maculopapular eruptions. Uncommon: Angioedema of face, extremities, lips, mucous membranes, tongue, glottis and/or larynx, urticaria. Hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions. Purpura, possible aggravation of preexisting acute disseminated lupus erythematosus. Very Rare: Erythema multiforme, toxic epidermic necrolysis, Stevens-Johnson syndrome. Cases of photosensitivity reactions have been reported.
Musculoskeletal, Connective Tissue and Bone Disorders: Common: Muscle cramps.
Renal and Urinary Disorders: Uncommon: Renal insufficiency. Very Rare: Acute renal failure.
Reproductive System and Breast Disorders: Uncommon: Impotence.
General Disorders and Administration Site Conditions: Common: Asthenia. Uncommon: Sweating.
Investigations: Potassium depletion with particularly serious reduction in levels of potassium in some at risk populations. Reduced sodium levels with hypovolaemia causing dehydration and orthostatic hypotension. Increase in uric acid levels and in blood glucose levels during treatment. Slight increase in urea and in plasma creatinine levels, reversible when treatment is stopped. This increase is more frequent in cases of renal artery stenosis, arterial hypertension treated with diuretics, renal insufficiency. Increased levels of potassium, usually transitory. Rare: Raised plasma calcium levels.
Pivesyl Plus contraindications
Linked to Perindopril (Pivesyl Plus): Pivesyl Plus should never be used in cases of hypersensitivity to Perindopril (Pivesyl Plus) or to any other angiotensin-converting enzyme inhibitors; previous history of angioneurotic oedema (Quincke's oedema) linked to treatment with an angiotensin-converting enzyme inhibitor; hyperkalemia; pregnancy; lactation.
Pivesyl Plus 2.5 mg: Hereditary or idiopathic angioneurotic oedema.
Pivesyl Plus 2.5 mg/5 mg is generally not recommended in combinations with potassium-sparing diuretics, potassium salts, lithium; bilateral renal artery stenosis or single functioning kidney; increased potassium levels.
Linked to Indapamide (Pivesyl Plus): Pivesyl Plus should never be used in cases of hypersensitivity to sulphonamides; severe renal failure (creatinine clearance <30 mL/min), hepatic encephalopathy, severe impairment of liver function; hypokalaemia.
As a general rule, use of Pivesyl Plus is not recommended in combination with non-antiarrhythmic drugs producing Torsade de pointes.
Linked to Pivesyl Plus 2.5 mg: Hypersensitivity to any of the excipients.
As there is a lack of available data, Pivesyl Plus 2.5 mg must not be used in dialysis patients; patients with untreated decompensated cardiac insufficiency.
Active ingredient matches for Pivesyl Plus:
Indapamide/Perindopril in Vietnam.
| Unit description / dosage (Manufacturer) | Price, USD |
| Pivesyl Plus 1 Blister x 30 Tablet | |
List of Pivesyl Plus substitutes (brand and generic names): | |
| Peryndopryl + Indapamid Servier (Poland) | |
| Pontea (Bulgaria) | |
| Predonium (Hong Kong, Portugal) | |
| Predonium 30's (Servier) | |
| Predonium tab 30's (Servier) | |
| Pregamon Plus-Humanity (Georgia) | |
| Pregin Plus-Humanity (Georgia) | |
| Prelectal (Italy) | |
| Prenewel (Czech Republic, Estonia, Latvia, Lithuania, Slovenia) | |
| Prenix (Poland) | |
| Prenix N (Poland) | |
| Prestarium (Bulgaria, Czech Republic, Denmark, Estonia, Georgia, Latvia, Lithuania, Poland, Romania, Russian Federation, Slovakia) | |
| Tablet; Oral; Perindopril Erbumine 2 mg (Les lab. servier) | |
| Tablet; Oral; Perindopril Erbumine 4 mg (Les lab. servier) | |
| Tablet; Oral; Perindopril Erbumine 8 mg (Les lab. servier) | |
| Prestarium 10mg - 30 Tablets (Les lab. servier) | $ 45.00 |
| Prestarium 5mg - 30 Tablets (Les lab. servier) | $ 25.00 |
| Prestarium Combi (Georgia, Latvia) | |
| Prestarium Combi Arginine (Estonia) | |
| Prestarium Forte Combi (Slovakia) | |
| Prestarium neo combi (Czech Republic) | |
| Prestarium neo forte (Czech Republic) | |
| Prestarium Plus (Poland) | |
| Pretanix Komb 4 mg/1.25 mg (Hungary) | |
| Pretanix Komb Forte (Hungary) | |
| Pretanix Komb Forte 8 mg/2.5 mg (Hungary) | |
| Pretanix Komb. (Hungary) | |
| Preterax (Austria, Belgium, Costa Rica, Dominican Republic, El Salvador, France, Greece, Guatemala, Honduras, Ireland, Italy, Luxembourg, Malta, Mexico, Myanmar, Nicaragua, Panama, Peru, Philippines, Portugal, Singapore, South Africa, Spain, Taiwan, Turkey, Vietnam) | |
| Tablet; Oral; Indapamide 0.625 mg; Perindopril Erbumine 2 mg (Servier) | |
| Preterax 30's (Servier) | $ 32.22 |
| Preterax 28's (Servier) | |
| Preterax tab 30's (Servier) | $ 36.18 |
| Preterax tab 10 mg/2.5 mg 30's (Servier) | |
| Preterax tab 5 mg/1.25 mg 30's (Servier) | |
| Preterax tab 2.5 mg/0.625 mg 30's (Servier) | |
| Preterax 10 (Argentina) | |
| Preterax 5 (Argentina) | |
| Preterax Argenine (Malta, Oman) | |
| Preterax Forte | |
| Tablet; Oral; Indapamide 1.25 mg; Perindopril Erbumine 4 mg | |
| PRETERAX N (Germany) | |
| PRETERAX N 2,5mg/0,625mg (Germany) | |
| Preterax-2.5/0.625 (Luxembourg) | |
| Preterax-5/1.25 (Luxembourg) | |
| Preterax-Arginin (Austria) | |
| Preterax-Arginin 2,5 mg/0,625 mg (Austria) | |
See 372 substitutes for Pivesyl Plus | |
References
- DailyMed. "INDAPAMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "indapamide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- PubChem. "PERINDOPRIL". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
