Company: Takeda UK Ltd.
Legal category: Prescription. GMS. Sport prohibited.
Active ingredients: Candesartan cilexetil/hydrochlorothiazide 8mg/12.5mg, 16mg/12.5mg, 32mg/12.5mg, 32mg/25mg.
Description: 8mg/12.5mg: White, oval tablets with a score with 8 C on both sides. 16mg/12.5mg: Light pink, oval tablets with a score with 16│C on both sides. 32mg/12.5mg: Light yellow, oval tablets with 32│C1 on both sides. 32mg/25mg: Light pink, oval tablets with 32│C2 on both sides.
Presentation: 8mg/12.5mg-28, €15.81; 16mg/12.5mg-28, €19.22; 32mg/12.5mg-28, €24.63; 32mg/25mg-28, €24.63.
Indication: Essential Hypertension, where monotherapy with candesartan cilexetil or hydrocholorothiazide (HCTZ) is not sufficient.
Pharmacology: Candesartan is an angiotensin II receptor antagonist, selective for AT1 receptors, with tight binding to and slow dissociation from the receptor. It has no agonist activity. Hydrochlorothiazide inhibits the active reabsorption of sodium, mainly in the distal kidney tubules, and promotes the excretion of sodium, chloride and water. The renal excretion of potassium and magnesium increases dose-dependently, while calcium is reabsorbed to a greater extent. Hydrochlorothiazide decreases plasma volume and extracellular fluid and reduces cardiac output and blood pressure. During long-term therapy, reduced peripheral resistance contributes to the blood pressure reduction.
Dosage: Adult: 1 tablet once daily. Titrate candesartan cilexetil dose before switching to Blopress Plus (esp. in renal impairment and volume depleted patients). When clinically appropriate a direct change from monotherapy to Blopress Plus may be considered. Mild-moderate renal impairment: Initially 4mg candesartan. Mild to moderate hepatic impairment: Initially, 2mg candesartan. Elderly: As per adults. Children: Safety and efficacy not established.
Contraindications: Hypersensitivity to any component of Blopress Plus. Pregnancy, lactation. Severe hepatic impairment and/or cholestasis. Severe renal impairment. Refractory hypokalaemia and hypercalcaemia. Gout.
Special precautions: Not recommended: Primary aldosteronism. Renal impairment: Monitor potassium, creatinine and uric acid levels. No experience in patients with a recent kidney transplant. Caution: Renal artery stenosis (risk of increased blood urea and serum creatinine), impaired hepatic function or progressive liver disease, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Correct intravascular volume and/or sodium depletion before starting treatment. Hypotension may occur during anaesthesia and surgery. Monitor serum electrolytes. Discontinue before carrying out tests for parathyroid function. May impair glucose tolerance. Hypersensitivity reactions to HCTZ may occur (particularly if history of allergy or bronchial asthma). Exacerbation or activation of SLE reported with thiazides. Contains lactose.
Drug interactions: Caution: Skeletal muscle relaxants, drugs associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid derivates), calcium supplements, Vitamin D, beta-blockers, diazoxide, anticholinergic agents (e.g. atropine, beperiden), amantadine, cytotoxic drugs (e.g. cyclophosphamide, methotrexate), steroids or adrenocorticotropic hormone (ACTH), antidiabetic drugs (incl. insulin), pressor amines (e.g. adrenaline), iodinated contrast media, lithium, K+ -sparing diuretics, K+ supplements, salt substitutes containing K+, or other medicinal products that may increase K+ levels. Possible interaction with NSAIDs. Antihypertensive effect may be enhanced by other antihypertensives. Absorption of HCTZ is reduced by colestipol or cholestyramine.
Adverse drug reactions: Dizziness/vertigo, hyperglycaemia, hyperuricaemia, electrolyte imbalance (incl. hyponatraemia and hypokalaemia), glycosuria, weakness, increases in cholesterol and triglycerides.
Full prescribing information and references available from Takeda UK Ltd. Telephone: +44 (1628) 537900. Fax: +44 (1628) 526615.