AZAR 50/MG FC TAB 30/FC TAB

Indications

Approved Uses

Hypertension, reduction of cardiovascular risk in hypertensive patients with left ventricular hypertrophy, diabetic nephropathy in type 2 diabetes mellitus with hypertension

Dosage & Administration

Dosing by Condition

Hypertension: Initial 50 mg once daily, maintenance 25-100 mg once daily, max 100 mg/day. Diabetic nephropathy: Initial 50 mg once daily, titrate to 100 mg once daily based on blood pressure response. Cardiovascular risk reduction (LVH): Initial 50 mg once daily, may add low-dose hydrochlorothiazide and/or increase to 100 mg once daily

Initial Dose

50 mg once daily

Maintenance Dose

25-100 mg once daily

Maximum Dose

100 mg per day

Children's Dosage

Children 6-16 years: 0.7 mg/kg once daily (up to 50 mg/day), max 1.4 mg/kg/day or 100 mg/day. Not recommended in children under 6 years or in pediatric patients with GFR <30 mL/min/1.73m²

Dose Adjustment Notes

Start at 25 mg once daily in patients with intravascular volume depletion, hepatic impairment, or those on diuretics. Titrate based on blood pressure response. No initial dose adjustment required for renal impairment

How to Take

Swallow tablet whole with a glass of water. Can be taken with or without food. Take at the same time each day

Side Effects

Common Side Effects

Dizziness, hypotension, hyperkalemia, elevated serum creatinine, fatigue, upper respiratory tract infection, cough (less frequent than ACE inhibitors), back pain, diarrhea

Safety & Warnings

Contraindications

Hypersensitivity to losartan or any excipient, concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min), pregnancy (second and third trimesters), concomitant use with ACE inhibitors in patients with diabetic nephropathy

Warnings & Precautions

Fetal toxicity - discontinue immediately if pregnancy detected; risk of hypotension in volume- or salt-depleted patients; monitor renal function and electrolytes in patients with renal impairment, heart failure, or on concomitant NSAIDs; use with caution in bilateral renal artery stenosis or stenosis of artery to a solitary kidney; hyperkalemia risk especially with renal impairment, diabetes, or concomitant potassium-raising agents; not recommended in severe hepatic impairment without dose reduction

Age Restriction

Not recommended under 6 years

Drug Interactions

Interaction Severity

MAJOR: Aliskiren in diabetes/renal impairment (contraindicated - dual RAS blockade increases risk of hypotension, hyperkalemia, renal failure); ACE inhibitors in diabetic nephropathy (contraindicated - dual RAS blockade). MODERATE: NSAIDs (reduced antihypertensive effect, acute renal failure risk); potassium-sparing diuretics/potassium supplements (hyperkalemia); lithium (increased lithium toxicity); fluconazole (increased E-3174 exposure via CYP2C9 inhibition). MINOR: Rifampicin (reduced losartan efficacy via CYP induction)

Food Interaction

No restriction - can be taken with or without food

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Present in breast milk; use with caution or consider alternative

Children

Children 6-16 years: 0.7 mg/kg once daily (up to 50 mg/day), max 1.4 mg/kg/day or 100 mg/day. Not recommended in children under 6 years or in pediatric patients with GFR <30 mL/min/1.73m²

Elderly

Standard adult dosing; no initial dose adjustment required, but monitor blood pressure, renal function, and electrolytes closely

Kidney Impairment

No initial dose adjustment required for renal impairment including patients on hemodialysis. Monitor renal function and electrolytes closely

Liver Impairment

Mild-moderate hepatic impairment: consider starting dose of 25 mg once daily. Severe hepatic impairment: use with caution, start at 25 mg once daily

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near the time of the next dose. Do not double the dose

Stopping the Medicine

Safe to stop anytime, but blood pressure should be monitored after discontinuation and alternative therapy initiated if needed

Patient Counseling

Take losartan every day at the same time, with or without food. Do not stop taking it without consulting your doctor, as blood pressure may rise again. Inform your doctor immediately if you become pregnant, as this medication can harm the unborn baby. Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor. Rise slowly from sitting or lying positions to avoid dizziness. Report swelling of the face, lips, or throat immediately. Attend regular follow-up appointments for blood pressure and blood test monitoring

Monitoring Requirements

Blood pressure, serum potassium, serum creatinine and renal function (especially at initiation and after dose changes), periodic monitoring of electrolytes in high-risk patients

Pharmacology

Mechanism of Action

Selectively blocks angiotensin II type 1 (AT1) receptors, preventing angiotensin II-mediated vasoconstriction, aldosterone release, and sodium retention, resulting in vasodilation and reduced blood pressure

Onset of Action

Blood pressure reduction begins within 1 hour, peak effect at 3-6 hours after dose

Duration of Effect

24 hours

Half-Life

Losartan: 1.5-2 hours; active metabolite E-3174: 6-9 hours

Bioavailability

Approximately 33%

Metabolism

Hepatic via CYP2C9 and CYP3A4; approximately 14% converted to active carboxylic acid metabolite E-3174

Excretion

Renal clearance of losartan approximately 75 mL/min (about 13% of total clearance), active metabolite approximately 25 mL/min (about 50% of total clearance); total renal excretion ~35%

Protein Binding

>99% (losartan and active metabolite)

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: 50 mg losartan potassium

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

ARB

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