Ranbaxy-Losartan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Losartan potassium 100mg

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

Losartan potassium 100 mg

Dosage:

100 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Losartan potassium 100mg Excipient: Colloidal silicon dioxide Isopropyl alcohol Lactose Magnesium stearate   Methylene chloride Microcrystalline cellulose   Opadry white 20H58983 Pregelatinised maize starch   Purified talc

Units in package:

Blister pack, Aluminium, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Ipca Laboratories Limited

Therapeutic indications:

Ranbaxy-Losartan is indicated for the treatment of hypertension. Ranbaxy-Losartan 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 Ranbaxy-Losartan 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 Ranbaxy-Losartan is not recommended. Ranbaxy-Losartan 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.

Product summary:

Package - Contents - Shelf Life: Blister pack, Aluminium - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Aluminium - 90 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2007-10-17

Summary of Product characteristics

DATA SHEET 
RANBAXY-LOSARTAN
®

LOSARTAN POTASSIUM 
12.5 mg, 25 mg, 50 mg, & 100 mg tablets 
_PRESENTATION _
Ranbaxy-Losartan 12.5 mg tablets are white to off-white, circular,
biconvex, film-
coated tablets embossed with “L1”on one side and plain on the
other side. 

Ranbaxy-Losartan 25 mg tablets are white to off-white, circular,
biconvex, film-
coated tablets embossed with “L2”on one side and plain on the
other side. 

Ranbaxy-Losartan 50 mg tablets are white to off-white, circular,
biconvex, film-
coated tablets embossed with “L3”on one side and plain on the
other side. 
Ranbaxy-Losartan 100 mg tablets are white to off-white,
circular, biconvex, film-
coated tablets embossed with “L4”on one side and plain on the
other side. 

Do not halve the tablets.  Dose equivalence when the tablets are
divided has not 
been established. 
_THERAPEUTIC CLASS _
Ranbaxy-Losartan (losartan potassium), the first of a new class
of agents for the 
treatment of hypertension is an angiotensin II receptor (type AT
1
) antagonist. 
Ranbaxy-Losartan also provides a reduction in the combined risk of 
cardiovascular death, stroke, and myocardial infarction in
hypertensive patients 
with left ventricular hypertrophy and renal protection for type 2
diabetic patients 
with proteinuria. 
_INDICATIONS _
HYPERTENSION 
Ranbaxy-Losartan is indicated for the treatment of hypertension. 
REDUCTION IN THE RISK OF CARDIOVASCULAR MORBIDITY AND
MORTALITY IN 
HYPERTENSIVE PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY 
Ranbaxy-Losartan 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 (see Race). 
HEART FAILURE 
Ranbaxy-Losartan 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 inhib