Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
losartan potassium, Quantity: 50 mg
Alphapharm Pty Ltd
Losartan potassium
Tablet, film coated
Excipient Ingredients: lactose monohydrate; pregelatinised maize starch; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; hyprolose
Oral
30 Tablets, 10 tablets
(S4) Prescription Only Medicine
Hypertension: COZAVAN is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (e.g. thiazide diuretics). Renal Protection in Type 2 Diabetic Patients with Proteinuria: COZAVAN is indicated to delay the progression of renal disease in hypertensive type 2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio greater than or equal to 300mg/g.
Visual Identification: white to off white, oval shaped biconvex film-coated tablet with "A50" engraved on one side and a central break line on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2010-06-28
COZAVAN _losartan potassium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about COZAVAN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking COZAVAN against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT COZAVAN IS USED FOR COZAVAN belongs to a group of medicines, called angiotensin II receptor antagonists. It works to lower high blood pressure (which doctors call hypertension) by relaxing your blood vessels. In addition, COZAVAN slows the progression of kidney disease in people who have type 2 diabetes mellitus (also known as non-insulin dependent diabetes) with protein in their urine (which doctors call proteinuria). HYPERTENSION: Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at various times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays high, even when you are calm and relaxed. There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems. You may feel fine and have no symptoms, but eventually hypertension can cause stroke, heart disease or kidney failure. COZAVAN helps to lower your blood pressure. TYPE 2 DIABETES MELLITUS: Type 2 diabetes mellitus is a condition in which the body's cells do not respond to the effects of insulin or too little insulin is produced, resulting in an elevated blood (sugar) level, known as hyperglycaemia. Insulin maintains the appropriate level of glucose in the blood by transporting it into the body's cells so Read the complete document
AUSTRALIAN PRODUCT INFORMATION COZAVAN ® _losartan potassium _ 1 NAME OF THE MEDICINE Active ingredient: losartan potassium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each COZAVAN film-coated tablet contains losartan potassium 25 mg or 50 mg as the active ingredient. Losartan potassium is a white to off-white free-flowing crystalline powder. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Excipients with known effect: • Lactose monohydrate For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM COZAVAN 25 mg film-coated tablet – white to off white, oval shaped biconvex film-coated tablet with “A” engraved on one side and “25” on the other side COZAVAN 50 mg film-coated tablet – white to off white, oval shaped biconvex film-coated tablet with “A50” engraved on one side and a central break line on the other side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION COZAVAN is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (e.g. thiazide diuretics). RENAL PROTECTION IN TYPE 2 DIABETIC PATIENTS WITH PROTEINURIA COZAVAN is indicated to delay the progression of renal disease in hypertensive type 2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio ≥ 300 mg/g. 4.2 DOSE AND METHOD OF ADMINISTRATION The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ). COZAVAN can be administered once or twice daily. The total dail Read the complete document