Peristar 2mg. 4mg. 8mg Tablet

PERISTAR is indicated for:

• Mild to moderate hypertension and
• Heart failure not adequately controlled by conventional therapy with diuretics and digitalis and in whom vasodilatation is indicated.

PERISTAR should be taken before meals at the same time every day.

Mild to moderate hypertension

The recommended dosage is 4 mg orally taken in the morning before breakfast which can be increased to a single dose of 8 mg if necessary after one month of treatment. In the elderly patients and in cardiac failure substantially lower dosage should be used because of impaired clearance. Insulin and non-insulin dependent diabetics can be treated with the usual doses.

Congestive heart failure

The treatment should be initiated under close medical supervision. Initial dose of 2 mg orally as a single dose in the morning which may, in most instances, be increased to 4 mg (once blood pressure acceptability has been demonstrated).

Concomitant diuretic therapy in hypertension

Caution is recommended in patients who are currently being treated with diuretics. As the effects of ACE inhibitors may be potentiated in a situation where hypovolaemia may occur, the diuretic therapy should be discontinued prior to initiation of therapy with PERISTAR. In the case of combination with a diuretic it is not advisable to prescribe a potassium salt or a potassium sparing agent before assay of blood potassium and attention should be paid to possible overdosage of the diuretic.

Renal insufficiency

In patients with renal insufficiency, the dosage of PERISTAR must be adjusted in relation to the severity of the insufficiency. The following dosages may be recommended:

Creatinine clearance Recommended dosage

• Between 30 and 60 ml/min 2 mg per day
• Between 15 and 30 ml/min 2 mg per day every other day
• < 15 ml/min 2 mg on day of dialysis

Perindopril is dialysable (70 ml/min).

• Sensitivity to any of the components of PERISTAR.
• Patients with a history of angioedema related to previous ACE-inhibitor therapy or angiotensin receptor blocker.
• Hereditary or idiopathic angioedema.
• Aortic stenosis.
• Hypertrophic obstructive cardiomyopathy.
• Severe renal function impairment (creatinine clearance below 30 ml/min).
• Renal artery stenosis in patients with a single kidney.
• Concomitant therapy with potassium sparing diuretics such as spironolactone, triamterene, amiloride.
• Porphyria.

Should a woman become pregnant while receiving an ACE inhibitor, the treatment must be stopped promptly and changed to a different medicine (see PREGNANCY AND LACTATION). If a woman is contemplating pregnancy, a different class of medicine should be used (see PREGNANCY AND LACTATION).

PERISTAR should be used with caution in the following conditions:

• Cerebrovascular disease or ischemic heart disease u2013 Reduction in blood pressure could aggravate these conditions and may result in myocardial infarction and cerebrovascular incidents.
• Volume depleted patients (e.g. by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting) u2013 Although it may occur in normovolumic patients, hypotension is more likely in volume depleted patients. A sudden reduction in angiotensin II may result in sudden and severe hypotension. There is also an increased risk of PERISTAR induced renal failure, especially in those with congestive heart failure.
• Patients at a high risk of symptomatic hypotension e.g. patients with salt or volume depletion with or without hyponatraemia should have these conditions corrected before therapy with PERISTAR. Monitoring is required after initiating therapy.
• Autoimmune disease, especially systemic lupus erythematosus, other collagen vascular disease or scleroderma: Increase the risk for development of neutropenia or agranulocytosis.
• In acute myocardial infarction, treatment with PERISTAR should not be initiated in patients with evidence of renal dysfunction (serum creatinine concentrations exceeding 177 u03bcmol/l or proteinuria exceeding 500 mg/24 hours). If renal dysfunction develops during treatment (serum creatinine concentrations exceeding 177 u03bcmol/l or doubling of the pre-treatment value) then PERISTAR may need to be withdrawn (see CONTRA-INDICATIONS).
• In acute myocardial infarction, patients may develop persistent hypotension and/or impaired renal function.
• Hypotension in acute myocardial infarction - Treatment with PERISTAR must not be initiated in acute myocardial infarction patients who are at risk of further serious haemodynamic deterioration after treatment with a vasodilator. These include patients with systolic blood pressure of 100 mmHg or lower or cardiogenic shock. During the first 3 days following the infarction, the dose should be reduced if the systolic blood pressure is 120 mmHg or lower. Maintenance doses should be reduced to 2 mg if systolic blood pressure is 100 mmHg or lower. If hypotension persists (systolic blood pressure less than 90 mmHg or more than 1 hour) then PERISTAR should be withdrawn.
• Bone marrow depression u2013 Increased risk of agranulocytosis and neutropenia.
• Diabetes mellitus u2013 Increased risk of hyperkalaemia, as well as hypoglycaemia may occur.
• Hyperkalaemia u2013 PERISTAR may cause an increase in serum potassium levels.
• Renovascular disease u2013 PERISTAR should not be used in patients with renovascular disease or suspected renovascular disease but it may be used cautiously in severe resistant hypertension in such patients. In this instance PERISTAR should only be used under specialist supervision. The elderly, patients with peripheral vascular diseases or generalised atherosclerosis may have asymptomatic renovascular disease (see DOSAGE AND DIRECTIONS).
• Renal artery stenosis, bilateral or in one kidney or renal transplant u2013 Increased risk of renal function impairment may cause increases in blood urea and serum creatinine concentrations, which may be reversible upon discontinuation of therapy. There is also an increased risk of agranulocytosis and neutropenia when immunosuppressants are concurrently administered.
• Renal function impairment u2013 Decreased elimination of PERISTAR resulting in an increased risk of hyperkalaemia. These patients may require lower doses.
• Anaphylactoid reactions have occurred in patients using ACE inhibitors, including PERISTAR, during desensitising protocols involving for example, hymenoptera venom.
• Anaphylactoid reactions have been reported in patients exposed to either high-flux membrane dialysis or low-density lipoprotein apheresis with dextran sulphate absorption.
• Hypersensitivity / angioedema - If angioedema of the face, extremities, lips, tongue, glottis and/or larynx is observed in patients treated with PERISTAR, PERISTAR should be discontinued promptly. These patients should be monitored to ensure complete resolution of symptoms.
• Angioedema associated with laryngeal oedema may be fatal. Where there is involvement of the tongue, glottis or larynx, it is likely to cause airway obstruction, and appropriate emergency therapy should be administered. This may include the administration of adrenaline and/or the maintenance of a patent airway. The patient should be under close medical supervision until complete and sustained resolution of symptoms has occurred. These patients should never receive any PERISTAR, ACE-Inhibitors or angiotensin-receptor blockers again.
• PERISTAR causes a higher rate of angioedema in black patients than in non-black patients.
• Safety and efficacy in children has not been established.
• Concomitant therapy with potassium sparing diuretics such as spironolactone, triamterene, amiloride may lead to hyperkalaemia, which may be severe and lead to cardiac conduction abnormalities, dysrythmias and cardiac arrest.

Concomitant use of PERISTAR with:

• Diuretics, alcohol and hypotension-producing medications u2013 The antihypertensive effect is additive. Dosage adjustments may be necessary during concurrent use or when one medicine is discontinued.
• Loop, thiazide or related diuretics u2013 u201cFirst dose hypotensionu201d may occur (see DOSAGE AND DIRECTIONS FOR USE).
• Indomethacin and non-steroidal anti-inflammatory medicines (NSAIDs) - reduce the antihypertensive effects of PERISTAR. Blood pressure monitoring should be increased when any NSAID is added or discontinued in a patient treated with PERISTAR.
• Potassium supplements or potassium sparing diuretics such as spironolactone, triamterene or amiloride u2013 Concurrent administration may result in hyperkalaemia.
• Lithium u2013 Increases in lithium concentrations have been reported. Frequent monitoring of serum lithium concentrations is recommended.

Use of PERISTAR limited to the first trimester does not appear to present a significant risk to the foetus, but foetal exposure after this time has been associated with teratogenicity and severe toxicity in the foetus and newborn, including death. PERISTAR crosses the placenta. Foetal exposure to ACE inhibitors during the second and third trimester can cause hypotension, renal failure, anuria, skull hypoplasia, hyperkalaemia and oliguria. Oligohydramnios may occur resulting in pulmonary hypoplasia, limb contractures and craniofacial deformation.

Infants who have been exposed in utero to PERISTAR should be closely monitored. Peritoneal dialysis may be of some benefit in the clearance of PERISTAR from the neonatal circulation. Safety in lactation has not been established.

Caution when driving or performing tasks requiring alertness because of possible dizziness.

Side effects:

Cardiac disorders

• Less frequent: Hypotension (dizziness, light-headedness or fainting); chest pain; congestive heart failure.
• The following have been reported but the frequency is unknown: Palpitations.

Immune system disorders

• Less frequent: Hypersensitivity/angioedema reactions: angioedema of the face, which may be fatal, extremities, lips, tongue, glottis and/or larynx and intestinal angioedema. A symptom complex has been reported which may include: fever, vasculitis, myalgia, arthritis/arthralgia, a positive antinuclear antibodies (ANA), elevated erythrocyte sedimentation rate, eosinophilia and leucocytosis. Rash, photosensitivity or other dermatological manifestations may occur.

Blood disorders

• Less frequent: Hyperkalaemia; neutropenia or agranulocytosis (fever and chills).

Nervous system disorders

• Frequent: Headache; dizziness.
• Less frequent: Fatigue; paraesthesia.
• The following have been reported but the frequencies are unknown: Mood and/or sleep disturbances.

Endocrine disorders

• Less frequent: Pancreatitis.

Respiratory disorders

• Frequent: Dry, persistent cough.

Gastrointestinal disorders

• Less frequent: Diarrhoea; nausea; stomach pain.
• The following have been reported but the frequency is unknown: Unspecific digestive disorders.

Reproductive system disorders

• The following have been reported but the frequency is unknown: Sexual disorders.

Musculoskeletal disorders

• The following has been reported but the frequency is unknown: Asthenia.

Renal disorders

• Less frequent: Uraemia; increased creatinine concentrations; renal dysfunction; reversible acute renal failure.

Skin disorders

• Less frequent: Rash; erythema multiforme; toxic epidermal necrolysis; photosensitivity; alopecia.

General disorders

• Less frequent: Dysgeusia (loss of taste).

Symptoms of overdose: Severe hypotension, electrolyte disturbances and renal failure.

Treatment of overdose: Treatment is symptomatic and supportive. Activated charcoal may be given in severe overdosage if the patient presents within 1 hour of ingestion. Treatment consists of volume expansion to correct hypotension and treating dehydration and electrolyte imbalances. PERISTAR is removable by haemodialysis.