Perigard Plus indications
Treatment of essential hypertension.
Perigard Plus 5 mg/1.25 mg: Subjects whose blood pressure is not adequately controlled by Perindopril (Perigard Plus) alone.
Perigard Plus 10 mg/2.5 mg: Substitution therapy in patients already controlled with Perindopril (Perigard Plus) and Indapamide (Perigard Plus) given concurrently at the same dose level.
Perigard Plus description
Each Perigard Plus 2.5 mg tablet contains Perindopril (Perigard Plus) argnine 2.5 mg, Indapamide (Perigard Plus) 0.625 mg and excipients.
Each Perigard Plus 5 mg tablet contains Perindopril (Perigard Plus) arginine 5 mg and Indapamide (Perigard 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 Perigard Plus 10 mg tablet contains Perindopril (Perigard Plus) arginine 10 mg and Indapamide (Perigard Plus) 2.5 mg.
Perigard Plus dosage
Perigard 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.
Perigard 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 Perigard 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 Perigard Plus 10 mg/2.5 mg.
Perigard 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.
Perigard Plus interactions
Avoid Perigard Plus with lithium, potassium-sparing diuretics (eg, spironolactone, triamterene), potassium salts.
Caution in use of Perigard 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.
Perigard Plus side effects
The administration of Perindopril (Perigard Plus) inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by Indapamide (Perigard Plus). Two percent (2%) of the patients on treatment with Perigard Plus 2.5 mg/0.625 mg, 4% of the patients on treatment with Perigard Plus 5 mg/1.25 mg and 6% of the patients on treatment with Perigard 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.
Perigard Plus contraindications
Linked to Perindopril (Perigard Plus): Perigard Plus should never be used in cases of hypersensitivity to Perindopril (Perigard 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.
Perigard Plus 2.5 mg: Hereditary or idiopathic angioneurotic oedema.
Perigard 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 (Perigard Plus): Perigard 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 Perigard Plus is not recommended in combination with non-antiarrhythmic drugs producing Torsade de pointes.
Linked to Perigard Plus 2.5 mg: Hypersensitivity to any of the excipients.
As there is a lack of available data, Perigard Plus 2.5 mg must not be used in dialysis patients; patients with untreated decompensated cardiac insufficiency.
Active ingredient matches for Perigard Plus:
Indapamide/Perindopril in Serbia.
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
