Loranta

Loranta

losartan

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical
Full Prescribing Info
Contents
Losartan potassium.
Description
Each 50-mg tablet and 100-mg tablet contains Losartan potassium 50 mg, 100 mg.
Action
Pharmacology: Pharmacodynamics: Losartan potassium is an angiotensin II receptor (type AT1) antagonist with antihypertensive activity due mainly to selective blockade of AT1 receptors and the consequent reduced pressor effect of angiotensin II.
Pharmacokinetics: Losartan potassium is readily absorbed from gastrointestinal tract after oral doses, but undergoes substantial first pass metabolism. It is metabolized primarily by cytochrome P450 isoenzyme CYP2C9 and CYP3A4 to an active metabolite, which has greater pharmacological activity than losartan potassium. Losartan potassium and its metabolite are more than 98% bound to plasma proteins. Although food may decrease the absorption rate of losartan potassium and peak concentration achievement, the therapeutic effect is not altered. Losartan potassium is excreted in the urine, and in the faeces via bile, as unchanged drug and metabolites.
Indications/Uses
LORANTA is indicated for the treatment of hypertension.
LORANTA is indicated for the renal protection in Type 2 diabetic patients with proteinuria by delaying the progression of renal disease, this is measured from a reduction in the combined incidence of doubling of serum creatinine, at the end stage of renal disease (need for dialysis or renal transplantation) or death, and reduction of proteinuria.
LORANTA is indicated for reduction in the risk of cardiovascular morbidity and mortality rate in hypertensive patients with left ventricular hypertrophy, which is measured by reduction of the combined incidence of cardiovascular death, stroke and myocardial infarction in hypertensive patients with left ventricular hypertrophy. However, there is an evidence that the benefit associated with such Losartan potassium-based antihypertensive therapy does not apply to black patients with hypertension and left ventricular hypertrophy although the treatment regimens effectively lower blood pressure in black patients.
Dosage/Direction for Use
LORANTA may be used alone or in combination with other antihypertensive agents.
Hypertension: Monotherapy: The usual starting dose in adult is 50 mg of Losartan potassium once daily and the maintenance dose can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg. The maximal antihypertensive effect is attained in 3-6 weeks after initiation of therapy.
In patients with possible depletion of intravascular volume (e.g. patients treated with high-dose diuretics), an initial dose of 25 mg once daily is recommended. In patients with a history of hepatic impairment, the lower dose should be considered.
No initial dosage adjustment is necessary for elderly patients, patients with renal impairment and patients on dialysis. However, the use of Losartan potassium is not recommended in patient with renal impairment who has serum creatinine > 3.0 - 4.0 mg/dL.
Combination therapy: In patients with an inadequate blood pressure control by Losartan potassium monotherapy or hydrochlorothiazide (HCTZ) 25 mg/day monotherapy or in patients with HCTZ induced hypokalemia, the combination therapy of Losartan potassium and HCTZ can be used. Dosage of the combination can be initiated with 50 mg of Losartan potassium and 12.5 mg of HCTZ daily as the fixed combination. In patients with an inadequate blood pressure control by Losartan potassium 100 mg monotherapy, dosage of the fixed combination may be increased to 100 mg of Losartan potassium and 12.5 mg of HCTZ once daily. If blood pressure is not desirely controlled after 3 weeks (or after 2-4 weeks of therapy in those with severe hypertension), dosage may be increased to 100 mg of Losartan potassium and 25 mg of HCTZ once daily. Additional increases using the fixed combination are not recommended.
The combination of Losartan potassium and HCTZ is not recommended for use in patients with creatinine clearances of 30 mL/minute or less nor in those with hepatic impairment or intravascular volume depletion (e.g. patients receiving high dose diuretic).
Renal protection in Type 2 diabetes patients with proteinuria: The usual initial dose is 50 mg of losartan potassium once daily. The dosage may be increased to 100 mg once daily based on blood pressure response. Losartan potassium may be administered with other antihypertensive agents (e.g. diuretics, calcium channel blockers, alpha-blockers, beta-blockers and centrally acting agents) as well as with insulin and other hypoglycemic drugs (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Reduction in the risk of cardiovascular morbidity and mortality rate in hypertensive patients with left ventricular hypertrophy: The usual initial dose is 50 mg of losartan potassium once daily. A low dose of HCTZ can be added. The introduced dose of losartan potassium may be increased to 100 mg once daily based on blood pressure response.
Hepatic impairment: In patients with a history of hepatic impairment, the lower dose should be considered.
Renal impairment: In patients with a history of renal impairment, the lower dose should be considered.
Pediatric use: Losartan potassium is not recommended in pediatric patients younger than 6 years of age, in pediatric patients with glomerular filtration rate below 30 mL/min/1.73 m2, in pediatric patients with hepatic impairment, or in neonates because of inadequate established safety and effectiveness data.
For pediatric patients 6 years of age and older who can swallow tablets, the recommended dose is 25 mg once daily in patients weighed ≥ 20 to < 50 kg. The dosage may be increased to maximum of 50 mg once daily. The initial dose for patients > 50 kg is 50 mg of Losartan potassium once daily. The dosage may be increased to a maximum of 100 mg once daily.
For pediatric patients with intravascular volume depletion, these conditions should be corrected prior to administration of Losartan potassium.
Overdosage
The most likely manifestation of overdosage are hypotension and tachycardia; bradycardia, which occur from parasympathetic (vagal) stimulation. If hypotension occurs, supportive treatment should be instituted.
Neither Losartan potassium nor its active metabolite can be removed by hemodialysis.
Contraindications
LORANTA is contraindicated in patients who are hypersensitive to Losartan potassium or any components of this drug.
Warnings
Losartan potassium is prohibited in pregnancy.
If lethargy or nausea, vomiting occur, consult the physician.
If angioedema of the face, lips, tongue, glottis, larynx occurs or to cause airway obstruction, treatment with losartan potassium should be promptly discontinued and consult the physician.
Impairment of renal function may occur, so use with caution.
The development of hyperkalemia may occur, concomitant use of potassium supplement or potassiumsparing diuretics is not recommended.
Special Precautions
In patients who are intravascularly volume-depleted (e.g. those treated with high-dose diuretics), symptomatic hypotension may occur. A lower starting dose should be used.
Use with caution in patients with pre-existing renal insufficiency.
Low dose of Losartan potassium should be administered in patients with hepatic impairment due to a significant increase of plasma concentrations of Losartan potassium.
Use In Pregnancy & Lactation
Pregnancy: Losartan potassium is contraindicated in pregnant women. When used in pregnancy especially during the second and third trimesters, drug that acts directly on the renin-angiotensin system may harm fetus organ or cause death. When pregnancy is detected, Losartan potassium should be discontinued immediately.
Lactation: It is not known whether Losartan potassium is excreted in human milk. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account for the importance of the drug to the mother.
Adverse Reactions
In general, side effects are mild and transient so the discontinuation of therapy is not required. The frequently reported side effect during Losartan potassium treatment was headache, dizziness.
Others: asthenia/fatigue, edema-swelling, abdominal pain, chest pain, diarrhea, dyspepsia, nausea, insomnia, pharyngitis, swelling of the face, lips, pharynx and/or tongue, angioedema including swelling of the larynx and glottis; causing airway obstruction, cough, fever, orthostatic effects, hypersensitivity, anaphylactic reactions, hepatitis, liver function abnormalities, vomiting, anemia, thrombocytopenia, musculoskeletal pain, arthralgia, palpitation, tachycardia, back pain, cramps, migraine, dysgeusia, urticaria, rash, vasculitis, including Henoch - Schoennlein purpura.
Hyperkalemia may occur, however the condition is usually resolved upon discontinuation of therapy.
Elevations of ALT may occur in patients with hypotension and electrolyte/fluid imbalance, however the condition is usually resolved upon discontinuation of therapy.
Drug Interactions
Losartan potassium has no clinically significant drug interactions with hydrochlorothiazide, digoxin, warfarin, cimetidine, ketoconazole, erythromycin and phenobarbital.
Concomitant use of Losartan potassium and potassium-sparing diuretics (e.g. spironolactone triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium.
As like other antihypertensive agents, the antihypertensive effect of Losartan potassium may be decreased by indomethacin, the non-steroidal anti-inflammatory drug.
Concomitant use of rifampin and fluconazole may reduce levels of active metabolites.
Serum lithium levels should be monitored carefully, if co-administered with Losartan potassium.
In some patients with renal impairment who are being treated with non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-II inhibitors), the concomitant use of Losartan potassium may result in further deterioration of renal function. These effects are usually reversible.
Storage
Store below 30°C, 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
FC tab 50 mg (white oval, biconvex, scored and engraved with "L" and "T" on one side and engraved with "
Click on icon to see table/diagram/image
" logo on the other side) x 3 x 10's, 30 x 10's. 100 mg (white oval, biconvex, scored and engraved with "LT" over "100" on one side and engraved with "
Click on icon to see table/diagram/image
" logo on the other side) x 3 x 10's, 30 x 10's.
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