APOTEX-Amlodipine/Atorvastatin 5/40 amlodipine (as besilate)+atorvastatin (as ca propylene glycol solvate) 5 mg/40 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 7 mg (Equivalent: amlodipine, Qty mg); atorvastatin calcium propylene glycol solvate, Quantity: 44 mg (Equivalent: atorvastatin, Qty mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; calcium acetate; iron oxide yellow; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Amlodipine and atorvastatin combination tablets are indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,The indications for amlodipine are:,1. Hypertension: Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor.,2. Angina: Amlodipine is indicated for the first line treatment of chronic stable angina. Amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs,The indications for atorvastatin are:,1. Atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. Atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see CLINICAL TRIALS, Prevention of Cardiovascular Disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Product summary:

Visual Identification: White to off-white, oval, biconvex, coated tablet. Engraved "5/40" on one side, "APO" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-07-10