Protace 5mg

Tablet
Ramipril
Unimed Unihealth MFG. Ltd

Other Strength:
- Protace 2.5mg
- Protace-H 2.5mg+12.5mg

Alternative:
- Ramoril 5mg
- Ripril 5mg
- Acecard 5mg
- Ramil 5mg



Protace
Presentation
Protace-2.5 tablet: Blue, round-convex shaped, film coated tablet; each tablet contains amipril BP 2.5mg.

Protace-5 tablet: Orange, round-convex shaped, film coated tablet; each tablet contains Ramipril BP 5mg.

Indications
Protace is indicated in the treatment of mild to moderate hypertension. Congestive heart failure as adjunctive therapy to diuretics with or without cardiac glycosides. Protace has been shown to reduce mortality when administered to patients surviving acute myocardial infarction with clinical evidence of heart failure.

Dosage and administration
Hypertension: The recommended initial dosage in patients not on diuretics and without congestive heart failure is 1.25mg ramipril once a day. Dosage should be increased incrementally at intervals of 1-2 weeks, based on patient response, up to a maximum of 10mg once a day. A 1.25mg dose will only achieve a therapeutic response in a minority of patients. The usual effective dose range is 2.5 – 5mg as a single daily dose. If the patient response is still unsatisfactory at a dose of 10mg ramipril, combination treatment is recommended. Diuretic-treated patients: The diuretic should be discontinued 2-3 days before beginning therapy with ramipril to reduce the likelihood of symptomatic hypotension. It may be resumed later if required.

Cardiac failure: In hypertensive patients who also have congestive heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed after treatment with ACE inhibitors. In these patients therapy should be started at a dose of
1.25mg under close medical supervision in hospital.

Congestive heart failure: Recommended initial dose: In patients stabilised on diuretic therapy the initial dose is 1.25mg once daily. Depending on the patient’s response, the dose may be increased. It is recommended that the dose, if increased, be doubled at intervals of 1 to 2 weeks. If a daily dose of 2.5mg or more is required, this may be taken as a single dose or as two divided doses.

Maximum permitted daily dose: 10mg. In order to minimise the possibility of symptomatic hypotension, patients on previous high dose
diuretics should have the diuretic dose reduced before starting ramipril. Post myocardial infarction: Initiation of therapy: Treatment must be started in hospital between day 3 and day 10 following AMI the starting dose is 2.5mg twice a day which is increased to 5mg twice a day after 2 days. If the initial 2.5mg dose is not tolerated a dose of 1.25mg twice a day should be given for two days before increasing to 2.5mg and 5mg twice a day. If the dose cannot be increased to 2.5mg twice a day treatment should be withdrawn.

Maintenance dose: 2.5mg to 5mg twice a day.

Dosage adjustment in renal impairment: The usual dose of ramipril is recommended for patients with a creatinine clearance >30 ml/min (serum creatinine <165 micromol/litre). For patients with a creatinine clearance <30 ml/min (serum creatinine >165 micromol/litre) the initial dose is 1.25mg ramipril once daily and the maximum dose 5mg ramipril once daily. In patients with severe renal impairment (creatinine clearance <10 ml/min and serum creatinine of 400-650 micromol/litre), the recommended initial dose is also 1.25mg ramipril once a day, but the maintenance dose should not exceed 2.5mg ramipril once a day.

Dosage in hepatic impairment: Treatment with ramipril should be initiated at a dose of 1.25mg under close medical supervision in patients with impaired liver function.

Elderly: Caution in elderly patients with concomitant use of diuretics, congestive heart failure or renal or hepatic insufficiency. The dose should be titrated according to need for the control of blood pressure.

Children: Ramipril has not been studied in children, and therefore use in this age group is not recommended. Ramipril should be taken with a glass of water. Food intake has no marked effect on the extent of absorption.

Contra-indications, warnings, etc.
Contra-indications: Ramipril is contra-indicated in patients who are hypersensitive to ramipril. It is contra-indicated in patients with a history of angioneurotic oedema, haemodynamically relevant renal artery stenosis, hypotensive or haemodynamically unstable patients and in pregnancy and lactation.

Warnings: Ramipril should not be used in patients with aortic or mitral valve stenosis or outflow obstruciton. Precautions: Assessment of renal function: Evaluation of the patient should include assessment of renal function prior to initiation of therapy and during treatment. Impaired liver function: Particular caution and close monitoring should be applied to patients with impaired liver function. Symptomatic hypotension: In patients with uncomplicated hypertension, symptomatic hypotension has been observed rarely after the initial dose of ramipril as well as after increasing the dose of ramipril. It is more likely to occur in patients who have been volume-and salt-depleted by prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhoea, vomiting or in patients with severe heart failure. Therefore, in these patients, diuretic therapy should be discontinued and volume and/ or salt depletion should be corrected before initiating therapy with ramipril. If symptomatic hypotension occurs, the patient should be placed in a supine position and, if necessary, receive an intravenous infusion of physiological saline. Intravenous atropine may be necessary if there is associated bradycardia. Treatment with ramipril may usually be continued following restoration of effective blood volume and blood pressure.

Surgery/anaesthesia: In patients undergoing surgery or during anaesthesia with agents producing hypotension, ramipril may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by appropriate treatment.

Agranulocytosis and bone marrow depression: In patients on angiotensin converting enzyme inhibitors agranulocytosis and bone marrow depression have been seen rarely, as well as a reduction in red cell count, haemoglobin content and platelet count. They are more frequent in patients with renal impairment, especially if they have a collagen vascular disease. Regular monitoring of white blood cell counts and protein levels in urine should be considered in patients with collagen vascular disease (e.g. lupus, erythematosus and scleroderma), especially associated with impaired renal function and concomitant therapy particularly with corticosteroids and antimetabolites. Patients on allopurinol, immunosuppressants and other substances that may change the blood picture also have increased likelihood of other blood picture changes.

Drug interactions: Combination with diuretics or other antihypertensive agents may potentiate the antihypertensive response to ramipril. Adrenergic-blocking drugs should only be combined with ramipril under careful supervision. Potassium sparing diuretics (spironolactone, amiloride, triameterene) or potassium supplements may increase the risk of hyperkalaemia. Ramipril may attenuate the potassium loss caused by thiazidetype diuretics. If concomitant use of these agents is indicated, they should be given with caution and serum potassium should be monitored regularly. When antidiabetic agents (insulin and sulphonylurea derivatives) are used concurrently, the possibility of increased blood-sugar reduction must be considered. If ramipril is given with lithium, an increase in serum lithium concentration may occur. When ACE inhibitors are administered simultaneously with non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid and indomethacin), attenuation of the antihypertensive effect may occur.

Use in pregnancy and lactation: Pregnancy should be excluded before start of treatment with ramipril and avoided during treatment; exposure of the mother to ACE inhibitors in mid or late pregnancy has been associated with oligohydramnios and neonatal hypotension with anuria or renal failure. From animal experiments it is know that use of ramipril may cause a decreased utero-placental perfusion. There is also a potential risk of fetal or postnatal effect as ACE inhibitors also influence the local renin-angiotensin system. In peri-post natal studies increased renal pelvic dilatation was observed in the first generation offspring. However, ramipril was not fetotoxic in studies althoug ACE inhibitors have shown fetotoxicity in some species. Ramipril should not be used during lactation.

Effects on ability to drive and use machines: In individual cases, treatment with ramipril may affect the ability to drive and operate machinery. After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.

Side-effects: Generally, adverse reactions have been mild and transient, and have not required discontinuation of therapy. The most frequently reported adverse reactions are nausea, dizziness and headache. Cardiovascular: Symptomatic hypotension accompanied by dizziness, weakness and nausea may occur after the initial dose of ramipril and after an increase in the dose of ramipril. Renal: Treatment with ramipril may impair renal function. Gastrointestinal: Treatment with ramipril may be associated with symptoms in the digestive tract, e.g. dryness of the mouth, irritation or inflammation of the oral mucosa, digestive disturbance, constipation, diarrhoea, nausea, and vomiting, (gastritis-like) stomach pain, upper abdominal discomfort (sometimes with increased levels of pancreatic enzymes), increases in hepatic enzymes and/or serum bilirubin, jaundice due to impaired excretion of bile pigment (chloestatic jaundice), other forms of impaired liver function, and hepatitis. Allergic: Hypersensitivity reactions accompanied by pruritus, rash, shortness of breath and sometimes fever may occur, but usually resolve spontaneously after withdrawal of ramipril. Respiratory tract: A dry tickling cough may occur. This is possibly due to the desired ACE inhibition as are the following adverse effects: rhinitis, sinusitis, bronchitis and, especially in patients with tickling cough, bronchospasm. Other adverse reactions: Disturbances of balance, headache, nervousness, restlessness, tremor, sleep disorders, confusion, loss of appetite, depressed mood, felling of anxiety, paraesthesiae, taste change, taste reduction and sometimes loss of taste, muscle cramps, erectile impotence and reduced sexual desire may occur.

Overdose: In case of overdosage prolonged hypotension is to be expected. Treatment with an intravenous infusion of physiological saline and/or angiotensin II may be required.

Pharmaceutical precautions
Store in a cool and dry place, protected from light.

Package quantities
Protace-2.5 tablet: Cartons containing 30 tablets in blisters.
Protace-5 tablet: Cartons containing 30 tablets in blisters.

এই পাতাটি ১৮৩ বার দেখা হয়েছে