Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Losartan potassium 12.5mg;
Merck Sharp & Dohme (New Zealand) Limited
Losartan potassium 12.5 mg
12.5 mg
Film coated tablet
Active: Losartan potassium 12.5mg Excipient: Carnauba wax Hyprolose Hypromellose Indigo carmine Lactose monohydrate Magnesium stearate Microcrystalline cellulose Starch as pregelatinized corn starch 1500 Titanium dioxide
Blister pack, PVC/PE/PVDC, sample, 15 tablets
Prescription
Prescription
Divi's Laboratories Limited
Hypertension COZAAR is indicated for the treatment of hypertension. Reduction in the Risk of Cardiovascular Morbidity and Mortality in Hypertensive Patients with Left Ventricular Hypertrophy COZAAR is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy Heart Failure COZAAR is indicated for the treatment of heart failure in patients who cannot tolerate an ACE inhibitor. Switching patients with heart failure who are stable on an ACE inhibitor to COZAAR is not recommended. Renal Protection in Type 2 Diabetic Patients with Proteinuria COZAAR is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine, end stage renal disease (need for dialysis or renal transplantation) or death; and to reduce proteinuria.
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC, sample - 15 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, aluminium, sample - 15 tablets - 18 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/PVDC - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, aluminium - 30 tablets - 18 months from date of manufacture stored at or below 30°C
1997-05-06
CONSUMER MEDICINE INFORMATION COZAAR TM _losartan potassium _ 12.5 mg, 25 mg, 50 mg and 100 mg tablets WHAT IS IN THIS LEAFLET This leaflet answers some common questions about COZAAR. It does not contain all the available information. 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 COZAAR 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 COZAAR IS USED FOR COZAAR lowers high blood pressure, which doctors call hypertension. If you have high blood pressure and a thickening of the left ventricle, the heart’s main pumping chamber, your doctor has prescribed COZAAR to help lower the risk of cardiovascular events, such as stroke. It is also used to treat heart failure. COZAAR also provides kidney protection by delaying the worsening of kidney disease in type 2 diabetic patients with protein in their urine (proteinuria). Kidney disease can be measured by testing the urine for protein. HIGH BLOOD PRESSURE Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different 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. COZAAR helps to lower your blood pressure. THICKENING OF THE LEFT CHAMBER OF THE HEART High blood pressure causes the heart to work harder. Over time, this may cause the heart to thicken. A thickenin Прочитайте повний документ
NEW ZEALAND DATA SHEET 1 PRODUCT NAME COZAAR™ 12.5 mg tablet COZAAR™ 25 mg tablet COZAAR™ 50 mg tablet COZAAR™ 100 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION COZAAR 12.5 mg tablet: Each tablet contains 12.5 mg of losartan potassium. COZAAR 25 mg tablet: Each tablet contains 25 mg of losartan potassium. COZAAR 50 mg tablet: Each tablet contains 50 mg of losartan potassium. COZAAR 100 mg tablet: Each tablet contains 100 mg of losartan potassium. LIST OF EXCIPIENTS WITH KNOWN EFFECT: • lactose (as monohydrate). For the full list of excipients, see Section 6.1. Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. 3 PHARMACEUTICAL FORM COZAAR 12.5 mg tablet: An oval blue tablet marked 11 on one side and plain on the other, containing 12.5 mg of losartan potassium. Dimensions are 8.178 mm x 4.419 mm. COZAAR 25 mg tablet: An oval white tablet marked 951 on one side and plain on the other, containing 25 mg of losartan potassium. Dimensions are 8.18 mm x 4.42 mm. COZAAR 50 mg tablet: An oval white scored tablet marked 952 on one side and plain on the other, containing 50 mg of losartan potassium. Dimensions are 10.312 mm x 5.563 mm. S-WPC-MK0954-T-032018 Page 1 of 14 NEW ZEALAND DATA SHEET COZAAR 100 mg tablet: A teardrop shaped white tablet marked 960 on one side and plain on the other, containing 100 mg of losartan potassium. Dimensions are 11.633 mm x 7.112 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION COZAAR is indicated for the treatment of hypertension. REDUCTION IN THE RISK OF CARDIOVASCULAR MORBIDITY AND MORTALITY IN HYPERTENSIVE PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY COZAAR is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by t Прочитайте повний документ