Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
candesartan cilexetil, Quantity: 32 mg; hydrochlorothiazide, Quantity: 12.5 mg
Alembic Pharmaceuticals Australia Pty Ltd
Candesartan cilexetil,Hydrochlorothiazide
Tablet, uncoated
Excipient Ingredients: macrogol 8000; maize starch; carmellose calcium; lactose monohydrate; hyprolose; iron oxide yellow; magnesium stearate
Oral
30 tablets
(S4) Prescription Only Medicine
The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.
Visual Identification: Light yellow, oval biconvex uncoated mottled tablets debossed with 'L3' & '04' on either side of break line on one side & break line on one other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 6 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2012-12-05
Candesartan HCTZ Actavis _Candesartan cilexetil & hydrochlorothiazide tablets _ _(16mg/12.5mg, 32mg/12.5mg & 32mg/25mg) _ PRODUCT INFORMATION NAME OF THE MEDICINE CANDESARTAN CILEXETIL The chemical name for candesartan cilexetil is (1_RS_)‐1‐[[(Cyclohexyloxy)carbonyl]oxy]ethyl 2‐ ethoxy‐1‐[[2′‐(1_H_‐tetrazol‐5‐yl)biphenyl‐4‐yl]methyl]‐1_H_‐benzimidazole‐7‐carboxylate. Its structural formula is: C 33 H 34 N 6 O 6 Molecular weight: 611 CAS No.: 145040‐37‐5 HYDROCHLOROTHIAZIDE The chemical name is 6‐chloro‐3,4‐dihydro‐2_H_‐1,2,4‐benzothiadiazine‐7‐sulfonamide 1,1‐dioxide. Its structural formula is: C 7 H 8 ClN 3 O 4 S 2 Molecular weight: 297.7 CAS No.: 58‐93‐5 DESCRIPTION Candesartan cilexetil is a white or almost white powder and is practically insoluble in water, freely soluble in methylene chloride and slightly soluble in anhydrous ethanol. Three polymorphic forms have been identified; crystal form I, crystal form II and an amorphous form. Crystalline form I is used in Candesartan HCTZ Actavis. Hydrochlorothiazide is a white, crystalline powder. It is very slightly soluble in water, soluble in acetone, sparingly soluble in ethanol (96 per cent). It dissolves in dilute solutions of alkali hydroxides. Candesartan HCTZ Actavis– Product information Page 2 of 16 Candesartan HCTZ Actavis tablets come in three strengths and contain 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide, 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide or 32 mg of candesartan and 25 mg of hydrochlorothiazide. The tablets also contain lactose, carmellose calcium, maize starch, macrogol 8000, hydroxypropylcellulose, magnesium stearate, Pigment Blend PB‐24880 Pink (ARTG 108327; 16/12.5 mg and 32/25 mg tablets only) and yellow colouring (iron oxide yellow and lactose) in the 32/12.5 mg tablets only. The tablets are gluten free. PHARMACOLOGY Angiotensin II is the primary vasoactive hormone of the renin‐angiotensin‐aldosterone system and plays a signi Lees het volledige document