Indications
Hypertension: Losan is indicated
for the treatment of hypertension. It may be used alone or in combination with
other antihypertensive agents (eg. thiazide diuretics).
Renal Protection in Type-2
Diabetic Patients with Proteinuria: Losan is indicated to delay the progression
of renal disease in hypertensive type-2 diabetics with proteinuria, defined as
urinary albumin to creatinine ratio >300 mg/g.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Pharmacology
Losartan Potassium is the first
non-peptide orally active angiotensin II receptor blocker. It binds to the AT1
receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland,
kidneys and the heart) and reduces several important biological actions
including vasoconstriction and the release of aldosterone responsible for
hypertension.
Dosage & Administration
The usual starting and
maintenance dose is 50 mg once daily for most patients. If the antihypertensive
effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended
prior to increasing the dose. For patients with intravascular volume-depletion
(e.g., those treated with high-dose diuretics), a starting dose of 25 mg once
daily should be considered. Losartan Potassium can be administered once or
twice daily. The total daily dose ranges from 25 mg to 100 mg.
Patients upto 75 years: No
initial dosage adjustment is necessary for this group of patients.
Patients over 75 years: Presently
there is limited clinical experience in this group; a lower starting dose of 25
mg once daily is recommended.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Interaction
Rifampicin and fluconazole reduce
levels of active metabolite of Losan. Concomitant use of Losan and
hydrochlorothiazide may lead to potentiation of the antihypertensive effects.
Concomitant use of potassium-sparing diuretics (eg, spironolactone,
triamterene, amiloride), potassium supplements or salt substitutes containing
potassium may lead to increases in serum potassium. The antihypertensive effect
of losartan may be attenuated by the non-steroidal anti-inflammatory drug
indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an
anti-inflammatory drug and a thiazide diuretic at the same time increases the
risk of renal impairment.
Contraindications
Losartan Potassium is contraindicated
in pregnant women and in patients who are hypersensitive to any component of
this product. Losartan Potassium should not be administered with Aliskiren in
patients with diabetes.
Side Effects
The side effects with the use of
Losan are mild and transient in nature. The most common side effects are
dizziness, diarrhea, nasal congestion, cough, upper respiratory infection.
Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea,
headache & pharyngitis.
Pregnancy & Lactation
Pregnancy Category D. The risk to
the fetus increases if Losartan Potassium is administered during the second or
third trimesters of pregnancy. It is not known whether Losartan Potassium is
excreted in human milk, as many drugs are excreted in human milk and because of
the potential for adverse effects on the nursing infant, a decision should be
made whether to discontinue nursing or discontinue the drug, taking into
account the importance of the drug to the mother.
Precautions & Warnings
Use of Losan during the second
and third trimesters of pregnancy reduces fetal renal function and increases
fetal and neonatal morbidity and death. In patients who are intravascularly
volume-depleted (e.g., those treated with high-dose diuretics), symptomatic
hypotension may occur. Plasma concentration of Losan is significantly increased
in cirrhotic patients. Changes in renal function including renal failure have
been reported in renal impaired patient.
Use in Special Populations
Use in renal impairment: No
initial dosage adjustment is necessary in patients with mild renal impairment
(i.e. creatinine clearance 20-50 ml/min). For patients with moderate to severe
renal impairment (i.e. creatinine clearance <20 ml/min) or patients on
dialysis, a lower starting dose of 25 mg (one Araten-50 tablet) once daily is
recommended. Use in patients with intravascular volume depletion: For the very
small proportion of patients who have intravascular volume depletion (e.g.
those treated with high-dose diuretics), a starting dose of 25 mg (one
Araten-50 tablet) once daily is recommended.
Use in hepatic impairment: A
lower dose should be considered for patients with a history of hepatic
impairment. Araten may be administered with other antihypertensive agents.
Araten may be administered with or without food.Contra-indications, warnings,
etc. Contra-indications: Losan is contra-indicated in pregnancy and in patients
who are hypersensitive to losartan. Warnings: Based on pharmacokinetic data
which demonstrate significantly increased plasma concentrations of losartan in
cirrhotic patients, a lower dose should be considered for patients with a
history of hepatic impairment. Other drugs that affect the
renin-angiotensin-aldosterone system may increase blood urea and serum
creatinine in patients with bilateral renal artery stenosis of the artery to a
solitary kidney. Similar effects have been reported with losartan; these
changes in renal function may be reversible upon discontinuation of therapy.
Losan should not be used with potassium-sparing diuretics.
Therapeutic Class
Angiotensin-ll receptor blocker
Storage Conditions
keep in a dry place away from
light and heat. Keep out of the reach of children.
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