Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**4.2 Posology and method of administration** **Dosage in Hypertension** The recommended dose of Atacand Plus is 1 tablet once daily. The dose of candesartan cilexetil should be titrated before switching to Atacand Plus. Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment. When clinically appropriate a direct change from monotherapy to Atacand Plus may be considered. Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy. _**Administration**_ Atacand Plus should be taken once daily with or without food. _**Use in the elderly**_ No dosage adjustment is necessary in elderly patients. _**Use in patients with intravascular volume depletion**_ Dose titration of candesartan cilexetil is recommended in patients at risk for hypotension, such as patients with possible volume depletion (an initial dose of candesartan cilexetil of 4 mg may be considered in these patients). _**Use in impaired renal function**_ In patients with mild to moderate renal impairment (ie, creatinine clearance between 30–80 ml/min/1.73 m2 BSA), a dose titration is recommended. Atacand Plus should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2 BSA). _**Use in impaired hepatic function**_ Patients with hepatic impairment: Dose titration is recommended in patients with mild to moderate chronic liver disease. Atacand Plus should not be used in patients with severe hepatic impairment and/or cholestasis. **_Use in children_** The safety and efficacy of Atacand Plus have not been established in children.
ORAL
Medical Information
**4.1 Therapeutic indications** Hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide is not sufficient.
**4.3 Contraindications** Hypersensitivity to the active substances or to any of the excipients or to sulfonamide derived drugs (hydrochlorothiazide is a sulfonamide derived drug) or to any of the excipients. Pregnancy and lactation (see section Fertility, pregnancy and lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2 BSA). Severe hepatic impairment and/or cholestasis. Refractory hypokalaemia and hypercalcaemia. Gout. The concomitant use of Atacand Plus with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section Interaction with other medicinal products and other form of interaction – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
C09DA06
candesartan and diuretics
Manufacturer Information
ASTRAZENECA SINGAPORE PTE LTD
ASTRAZENECA AB
Active Ingredients
Documents
Package Inserts
Atacand Plus Tablet PI.pdf
Approved: January 11, 2023