LOSARTAN GPO Tablet

1. Treatment of hypertension.

2. Reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy.

3. Renal protection in type 2 diabetic patients with proteinuria.

Losartan potassium is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine, and stage renal disease (need for dialysis or real transplantation) or death: and to reduce proteinuria.

Dosage

Losartan potassium may be administered with or without food and it may be administered with other antihypertensive agents.

Hypertension

The usual starting ad maintenance dose is 50mg 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 100mg once daily.

For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25mg 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 losartan potassium in patients with renal impairment who have serum creatinine >3-4mg/dL. Therefore, the use of losartan potassium in these patients is not recommended. If losartan potassium is needed to be used, renal function and serum potassium must be closely monitored.

See the package insert about the details below:

- Reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy.

- Renal protection in type 2 diabetic patients with proteinuria.

Pediatric use

For pediatric patients aged 6-16 years, the recommended dose is 0.7mg/kg once daily.

See the package insert about the details.

In patients who are hypersensitive to any component of this product.

The most common drug-related side effects were dizziness, asthenia/fatigue, vertigo, hypotension, and hyperkalemia.

Other side-effects are

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.

Gastrointestinal: hepatitis (reported rarely), liver function abnormalities, vomiting

Hematologic: anemia, thrombocytopenia (reported rarely)

Musculoskeletal: myalgia, arthralgia

Nervous System/Psychiatric: migraine, dysgeusia

Respiratory: cough

Skin: urticaria, pruritus, erythroderma

Concomitant use of potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.

Lithium excretion may be reduced. (See the package insert about the details.)

NSAIDs including COX-2 inhibitors may reduce the effect of diuretics and other antihypertensive drugs. (See the package insert about the details.)

See the package insert about the details below:

Pregnancy

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. When pregnancy is detected, losartan potassium should be discontinued as soon as possible.

Lactation

A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Warning

1. This drug is prohibited in pregnant women.

2. Consult physician if lethargy, or nausea, vomiting occur.

3. If angioedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx and/or tongue occurs, discontinue the drug and consult physician immediately.

4. Impairment of renal function may occur, so use with caution.

5. Development of hyperkalemia may occur, concomitant use of potassium supplement or potassium sparing diuretic is not recommended.

Precautions

1. 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 losartan potassium or a lower starting dose should be used.

Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed.

2. A lower dose should be considered for patients with a history of hepatic impairment.

3. As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported in susceptible individuals: these changes in renal function may be reversible upon discontinuation of therapy. Other drugs that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Similar effects have been reported with losartan potassium, these changes in renal function may be reversible upon discontinuation of therapy.

Losartan potassium is an angiotensinⅡreceptor (typeAT1) antagonist. Losartan potassium 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.