|Name||irbesartan (伊貝沙坦)||Irbesartan and hydrochlorothiazide|
|Dosing||(1) Treatment of essential hypertension: 150mg once daily. Maximum: 300 mg daily.
(2) Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen: Initiate at 150mg qd and titrate up to 300mg qd as the preferred maintenance dose.
(3) Haemodialysis patients & elderly greater than 75 years old: initiate with 75 mg once daily.
|Initial therapy: The usual starting dose is CoAprovel 150/12.5mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 300/25mg tablet once daily as needed to control blood pressure.ered in patients insufficiently controlled by CoAprovel 300mg/12.5mg.|
|Administration||For oral use||For oral use|
|Indication||1. Aprovel is indicated in adults for the treatment of essential hypertension.
2. Aprovel is indicated for the treatment of renal disease in adult patients with
hypertension and type 2 diabetes mellitus as part of an antihypertensive
medicinal product regimen
|(1) Essential hypertension. The fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
(2) Indicated as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
|Adverse Reactions||Dizziness, nausea/ vomiting, fatigue, musculoskeletal pain, orthostatic hypotension, hyperkalaemia, increase in plasma creatine kinase. For uncommon, rare and very rare undesirable effects, please refer to the full prescribing information.||Dizziness, nausea/vomiting, abnormal urination, fatigue, increases in BUN, creatinine & creatinine kinase. For uncommon, rare and very rare undesirable effects, please refer to the full prescribing information.|
|Contradication||Pregnancy and lactation. Hypersensitivity to the active substance. Co-administration with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (GFR <60ml/min/1.73m2).||Pregnancy and lactation, hypersensitivity to the active substance. Hydrochlorothiazide is contraindicated with severe renal dysfunction (creatinine clearance <30ml/min), refractory hypokalemia, hypercalcaemia, severe hepatic impairment, biliary cirrhosis and cholestasis. Co-administration with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (GFR <60ml/min/1.73m2).|
|Warnings/ Precautions||Intravascular volume depletion, renovascular hypertension, renal impairment, kidney transplantation, primary aldosteronism, co-administration with ACE inhibitors, angiotensin II receptor blockers and aliskiren, patients at risk of developing hyperkalaemia, aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy.||Intravascular volume depletion, renovascular hypertension, renal impairment, kidney transplantation, co-administration with ACE inhibitors, angiotensin II receptor blockers and aliskiren, hepatic impairment, primary aldosteronism, patients at risk of aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy, electrolyte imbalance, photosensitivity reactions associated with thiazide diuretics, secondary acute angle-closure glaucoma, galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, non-melanoma skin cancer.|
|Drugs/ Food Interactions||Diuretics & other antihypertensives, ACE inhibitors, angiotensin II receptor blockers and aliskiren-containing products, lithium, potassium supplements and potassium-sparing diuretics, NSAIDs.||Other antihypertensives, ACE inhibitors, angiotensin II receptor blockers and aliskiren-containing products, lithium, potassium supplements and K-sparing diuretics, NSAIDs. Hydrochlorothiazide may interact with the following drugs: alcohol, barbiturates, narcotics, antidiabetics, cholestyramine, corticosteroids, NSAIDs, pressor amines, skeletal muscle relaxants, antigout medication & calcium salt, carbamazepine.|
|Mechanism of Action||Irbesartan is a selective angiotensin-II receptor antagonist||(1) Irbesartan is a selective angiotensin-II receptor antagonist
(2) Hydrochlorothiazide is a thiazide diuretic
|Product details - Product Description||Aprovel 150 mg film-coated tablets/ Aprovel 300 mg film-coated tablets||CoAprovel 150 /12.5 mg tablets, CoAprovel 300 /12.5 mg tablets, CoAprovel 300 /25 mg tablets|
|Product details - Characistics|
|Reference||Aprovel PI (CCDSV15– EMA SmPC 20 Nov.2018)||CoAprovel PI (CCDS v11-15 _ EMA SmPC 11 Mar. 2019)|