Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
hydrochlorothiazide, Quantity: 12.5 mg; candesartan cilexetil, Quantity: 32 mg
Arrotex Pharmaceuticals Pty Ltd
Candesartan cilexetil,Hydrochlorothiazide
Tablet, uncoated
Excipient Ingredients: carmellose calcium; hyprolose; iron oxide red; iron oxide yellow; lactose monohydrate; magnesium stearate; aluminium magnesium silicate; propylene glycol
Oral
30, 7
(S4) Prescription Only Medicine
The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.
Visual Identification: Yellow, uncoated oval shaped tablets debossed with J and 07 separated by score line on one side and plain with score line on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-12-18
ASARTAN HCT™ 16/12.5, 32/12.5 & 32/25 CONSUMER MEDICINE INFORMATION Candesartan cilexetil and hydrochlorothiazide tablets WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about ASARTAN HCT. It does not contain all the information that is known about ASARTAN HCT. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ASARTAN HCT against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ASARTAN HCT IS USED FOR ASARTAN HCT is used to treat high blood pressure. Candesartan cilexetil is a type of medicine called an angiotensin II - receptor antagonist (or blocker). It mainly works by causing relaxation of blood vessels. Hydrochlorothiazide is a type of medicine called a diuretic. It works by reducing the amount of excess fluid in the body. Using these two medicines together will lower your blood pressure more than using either one on its own. Your doctor will have explained why you are being treated with ASARTAN HCT and told you what dose to take. YOU MUST FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR CAREFULLY. They may differ from the information contained in this leaflet. Your doctor may prescribe this medicine for another use. ASK YOUR DOCTOR IF YOU WANT MORE INFORMATION. ASARTAN HCT is not known to be addictive. ASARTAN HCT is only available with a doctor’s prescription. BEFORE YOU TAKE IT _ _ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ASARTAN HCT IF YOU HAVE AN ALLERGY TO: any medicine containing candesartan cilexetil or hydrochlorothiazide; any of the ingredients listed at the end of the leaflet; any medicine containing an angiotensin II receptor antagonist (or blocker); or any sulphur drugs (sulphonamides) such as some antibiotics or some medicines to treat diabetes. Some of the symptoms of an allergic r Read the complete document
Page 1 of 15 PRODUCT IN FO R M ATI O N ASARTAN HCT TM 16/12.5, 32/12.5 & 32/25 TABLETS NAME OF THE MEDICINE Active ingredient: candesartan cilexetil and hydrochlorothiazide Chemical names Candesartan cilexetil: (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 Hydrochlorothiazide: 6-Chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulphonamide 1, 1-dioxide CAS numbers Candesartan cilexetil: 145040-37-5 Hydrochlorothiazide: 58-93-5 Molecular weights Candesartan cilexetil: 611 Hydrochlorothiazide: 297.7 Molecular formula Candesartan cilexetil: C 33 H 34 N 6 O 6 Hydrochlorothiazide: C 7 H 8 ClN 3 S 2 O 4 Chemical structures Candesartan cilexetil: Hydrochlorothiazide: Page 2 of 15 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. The pKa & log P values of candesartan cilexetil are 3.8 & 0.05 respectively. Hydrochlorothiazide is a sulfonamide derived drug. It is a white, or almost white crystalline powder and is very slightly soluble in water, soluble in acetone, sparingly soluble in ethanol (96%).It dissolves in dilute solutions of alkali hydroxides. The pKa & log P values of hydrochlorothiazide are 7.9 & -0.268 respectively. ASARTAN HCT 16/12.5 contains 16 mg candesartan cilexetil and 12.5 mg of hydrochlorothiazide. ASARTAN HCT 32/12.5 contains 32 mg candesartan cilexetil and 12.5 mg of hydrochlorothiazide. ASARTAN HCT 32/25 contains 32 mg candesartan cilexetil and 25 mg of hydrochlorothiazide. ASARTAN HCT 16/12.5, 32/12.5 and 32/25 tablets also contain following inactive ingredients: carmellose calcium, hydroxypropylcellulose, iron oxide red, iron oxide yellow (16/12.5 mg & 32/25 mg tablets only), lactose, magnesium stearate, aluminium magnesium silicate and propylene glycol. PHARMACOLOGY PHARMACODYNAMICS Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone s Read the complete document