LOPOT Tablet

See the package insert about the details below:

- Hypertension

It may be used alone or in combination with other antihypertensive agents, including diuretics.

- Hypertensive patients with Left Ventricular Hypertrophy

- Nephropathy in Type 2 Diabetic Patients

For the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio 300mg/g) in patients with type 2 diabetes and a history of hypertension.

Dosage & Administration

Adult Hypertensive Patients

Losartan Potassium may be administered with other antihypertensive agents, and with or without food.

Dosing must be individualized. The usual starting dose of Losartan Potassium is 50mg one daily, with 25mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) and patients with a history of hepatic impairment. Losartan Potassium can be administered once or twice daily with total daily doses ranging 25-100mg.

If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. The effect of losartan is substantially present within 1 week but in some studies the maximal effect occurred in 3-6 weeks.

If blood pressure is not controlled by Losartan Potassium alone, a low dose of a diuretic may be added. Hydrochlorothiazide has been shown to have an additive effect.

No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis.

Pediatric Hypertensive Patients ≥6 years of age

See the package insert.

Nephropathy in Type2 Diabetic Patients

The usual starting dose is 50mg once daily. The dose should be increased to 100mg once daily based on blood pressure response. Losartan Potassium may be administered with insulin and other commonly used hypoglycemic agents (e.g. sulfonylureas, glitazones and glucosidase inhibitors).

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

Digestive: Diarrhea, Dyspepsia

Musculoskeletal: Muscle cramps, , myalgia, leg pain, back pain

Nervous system/Psychiatric: Dizziness, insomnia

Respiratory: Nasal congestion, cough, upper respiratory infection, Sinus disorder.

No significant drug-drug pharmacokinetic interactions have been found in interaction studies with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. In humans, ketoconazole, an inhibitor of P450 3A4, did not affect the conversion of losartan to the active metabolite after intravenous administration of losartan.

Pregnancy (see "Special precautions".)

Pregnancy Categories C (first trimester) and D (second and third trimesters).

Lactation (See the package insert about the details.)

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

Fetal/Neonatal Morbidity and Mortality:

Drugs that act directly on the rennin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, Losartan Potassium should be discontinued as soon as possible.

The use of drugs that act directly on the rennin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death.

Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported.

Precautions

Impaired Hepatic/Renal Function: see the package insert about the details.

Losartan potassium, the first of a new class of agents for the treatment of hypertension is an angiotensinⅡreceptor (type AT1) antagonist.

AngiotensinⅡ, a potent vasoconstrictor, is the primary active hormone of the renin-angiotensin system, and a major determinant of the pathophysiology of hypertension. AngiotensinⅡbinds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and elicits several important biological actions, including vasoconstriction and the release of aldosterone. AngiotensinⅡalso stimulates smooth muscle cell proliferation. A second angiotensinⅡreceptor has been identified as the AT2 receptor subtype, but it plays no known role in cardiovascular homeostasis.