Plot 1 Junaid Dosunmu Street,Central Business District, Alausa, P.0. Box 3560 Ikeja, Lagos, Nigeria.
Tel: + 234-1-774-1205
AstraZeneca, Silk Court, Silk Road Business Park, Macclesfield, Cheshire SK10 2NA, England.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: 04-0012): Lisinopril (as dihydrate) 20 mg and hydrochlorothiazide 12.5 mg.
Essential hypertension where combination therapy is appropriate
Anuria, hypersensitivity to any component of the product or to sulphonamide-derived drugs, angio-oedema with ACE inhibitors. Idiopathic or hereditary angio-oedema.
See also “Pregnancy” under “Precautions/Warnings”.
Symptomatic hypotension may occur; caution in fluid or electrolyte depleted patients and in patients with ischaemic heart or cerebrovascular disease, aortic stenosis, hypertrophic cardiomyopathy, and those at risk of symptomatic hypotension and patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Patients with a history of angio-oedema or black hypersensitive patients, may be at increased risk of angio-oedema with an ACE inhibitor. Anaphylactoid reactions have been seen during desensitisation treatment and in patients undergoing certain haemodialysis procedures. Cough has been reported with ACE inhibitors.
Thiazides may not be appropriate in renal impairment and are ineffective at creatinine clearance less than 30 mL/min. Use in dialysis patients not recommended. Hypotension may occur during surgery/anaesthesia. Caution in hepatic disease and diabetes.
Use in pregnancy not recommended. Discontinue as soon as possible unless considered life saving for the mother. In women who are breast-feeding take account of the potential for serious reactions. No paediatric experience.
Use of other antihypertensives, potassium sparing diuretics, potassium supplements, potassium containing salt substitutes, tubocurarine, indomethacin (and other NSAIDs in patients with compromised renal function) and lithium.
Mostly mild and transient: dizziness, headache, diarrhoea, fatigue, taste disturbance, sleep disturbance, dry cough, nausea, rash, hypotension including orthostatic hypotension, vertigo, asthenia, rhinitis, sinusitis. Palpitations and impotence rarely observed, Angio-oedema also rarely reported; discontinue lisinopril promptly. Increases (usually reversible) in blood urea, serum creatinine, liver enzymes and serum bilirubin. Bone marrow depression manifest as anaemia and/or leucopenia and/or thrombocytopenia.
Agranulocytosis has rarely been reported, casual relationship not established. Small decreases in haemoglobin and haematocrit have occurred. Hyper- or hypokalaemia. Vomiting, dry mouth, indigestion, gout, chest discomfort, muscle cramps and weakness, paraesthesia. A symptom complex which may include one or more of fever, rash, vasculitis, myalgia, arthralgia/arthritis, positive ANA, elevated ESR eosinophilia and leucocytosis.
Rash, photosensitivity or other dermatological manifestations including psoriasis, pemphigus, toxic epidermal neurolysis, Stevens-Johnson Syndrome and erythema multiforme, have been reported. Other side effects and metabolic/endocrine effects reported with hydrochlorothiazide or lisinopril alone are potential effects with ‘Zestoretic’.
Dosage & Administration
Usually one tablet daily, maximum two tablets. If possible, discontinue diuretic therapy 2-3 days prior to initiating ‘Zestoretic,’ otherwise start with 5 mg lisinopril alone. Do not use as initial therapy in patients with renal impairment
Store in a cool place free from mointure or direct sunlight. Keep out of the reach of children