Tanzaril

Tanzaril

losartan

Manufacturer:

Teva Pharma

Distributor:

DKLL
Full Prescribing Info
Contents
Losartan potassium.
Description
Tanzaril, the first of a new class of antihypertensives, is an angiotensin II receptor (type AT1) antagonist.
Each tablet contains losartan potassium 50 mg.
Indications/Uses
Hypertension: Tanzari is used for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.
Prevention of Cardiovascular Morbidity and Mortality in Hypertensive Patients with Left Ventricular Hypertrophy: Tanzaril is used to reduce the risk of cardiovascular morbidity and mortality in terms of a reduction in combined incidence of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy.
Renal Protection in Type 2 Diabetic Patients with Proteinuria: Tanzaril is used 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.
Dosage/Direction for Use
Hypertension: 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.
Some patients may receive an additional benefit by increasing the dose to 100 mg once daily.
For patients with intravascular volume depletion (e.g. Those treated with high dose diuretics) or hepatic impairment, a starting dose of 25 mg once daily should be considered.
No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis. A lower dose should be considered for patients with a history of hepatic impairment.
There is insufficient safety information with the use of Tanzaril in patients with renal impairment who have serum creatinine >3.0-4.0 mg/dL. Therefore, the use of Tanzaril in these patients is not recommended. If Tanzaril is needed to be used, renal function and serum potassium must be closely monitored.
Tanzaril may be administered with other antihypertensive agents.
Tanzaril may be administered with or without food.
Prevention of Cardiovascular Morbidity and Mortality in Hypertensive Patients with Left Ventricular Hypertrophy: The usual starting dose is 50 mg once daily. A low dose of hydrochlorothiazide should be added and/or the dose of Tanzaril should be increased to 100 mg once daily based on blood pressure response.
Renal Protection in Type 2 Diabetic Patients with Proteinuria: The usual starting dose is 50 mg once daily. The dose may be increased to 100 mg once daily based on blood pressure response. Tanzaril may be administered with other antihypertensive agents (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used hypoglycemic agents (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Contraindications
Tanzaril is contraindicated in patients who are hypersensitive to any component of this product and during pregnancy.
Warnings
This drug is prohibited in pregnant woman.
Consult physician if lethargy or nausea, vomiting occur.
If angioedema involving swelling of the face, lips, pharynx and/or tongue occurs, discontinue the drug and consult physician immediately.
Impairment of renal function may occur, so use with caution.
Development of hyperkalemia may occur, concomitant use of potassium supplement or potassium sparing diuretic is not recommended.
Special Precautions
In patients who are intravascularly volume-depleted (e.g. those treated with high-dose diuretics), symptomatic hypotension may occur. These conditions should be corrected prior to administration of Tanzaril, or a lower starting dose should be used.
Changes in renal function including renal failure have been reported in susceptible individuals: Use with precautions in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Tanzaril is not recommended in pediatric patients under 6 years of age as no data are available.
Use in Pregnancy: This drug is prohibited in pregnant women.
Use In Pregnancy & Lactation
Use in Pregnancy: This drug is prohibited in pregnant women.
Side Effects
Tanzaril has been found to be generally well tolerated; side effects have usually been mild and transient in nature and have not required discontinuation of therapy.
Dizziness, headache, orthostatic hypotension, chest pain, fatigue, and hypokalemia have been reported in patients using losartan. Rash was rarely reported.
The following additional adverse reactions have been reported: Hypersensitivity: Anaphylactic reactions, angioedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx and/or tongue has been reported rarely in patients treated with losartan some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schoenlein purpura, has been reported rarely.
Hepatitis (reported rarely), Liver function abnormalities, Anemia, Myalgia, Migraine, Cough, Urticaria, Pruritus.
Drug Interactions
Losartan is metabolized to active metabolite by CYP 2C9 and 3A4. Interaction with drugs that increase or inhibit the activity of CYP 2C9 or 3A4 should be taken into consideration.
Rifampin and fluconazole have been reported to reduce levels of active metabolite. The clinical consequences of these interactions have not been evaluated.
Concomitant use of potassium-sparing diuretic (e.g. spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.
Non-steroidal anti-inammatory drugs (NSAIDs) including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) may reduce the effect of diuretics and other antihypertensive drugs. Therefore, the antihypertensive effect of angiotensin II receptor antagonists may be attenuated by NSAIDs including selective COX-2 inhibitors.
Storage
Store below 30°C and protect from light.
ATC Classification
C09CA01 - losartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Tab 50 mg x 3 x 10's. 100 mg x 3 x 10's.
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