Osartan-HZ 50 mg+12.5 mg (Tablet)

Indications

• Treatment of hypertension
• Risk reduction of stroke in patients with hypertension and left ventricular hypertrophy

Pharmacology

• Angiotensin II vasoconstrictor
• Aldosterone secretion stimulation
• Vasoconstrictor and aldosterone-secreting effects inhibition
• Thiazide diuretic effect on renal tubular mechanisms
• Increased excretion of Sodium and Chloride
• Reduced plasma volume and increased plasma renin activity
• Increased aldosterone secretion and urinary Potassium loss
• Non-inhibition of ACE by Losartan or its active metabolite
• Reversible, competitive inhibition of the AT1 receptor by Losartan

Dosage

• Usual starting dose of 50/12.5
• Increased dosage for non-responding patients
• Antihypertensive effect attained within three weeks
• No initial dosage adjustment for elderly patients
• Maximum dose restriction for elderly patients
• Severe hypertension starting dose of 50/12.5

Administration

• Can be administered with other antihypertensive agents
• Can be administered with or without food

Interaction

• No significant drug-drug pharmacokinetic interactions with Losartan Potassium
• Increased serum potassium with concomitant use of potassium-sparing diuretics
• Interaction with non-steroidal anti-inflammatory drug Indomethacin
• Interactions with Thiazide diuretics and alcohol, barbiturates, or narcotics
• Antidiabetic drug dosage adjustment may be required
• Additive effect or potentiation with other antihypertensive drugs
• Impaired absorption of Hydrochlorothiazide in the presence of anionic exchange resins

Contraindications

• Hypersensitivity to any component of the product
• Anuria or hypersensitivity to other sulfonamide-derived drugs

Side Effects

• Symptomatic hypotension including dizziness
• Occasional hyperkalaemia
• Reported angioedema
• Possible vertigo and gastro-intestinal disturbances
• Reported cases of hepatitis, atrial fibrillation, and cerebrovascular accident
• Rare reports of pancreatitis, anaphylaxis, and depression

Pregnancy & Lactation

• Avoidance in pregnancy unless essential
• Adversely affect fetal and neonatal blood pressure control and renal function
• Not recommended in breastfeeding

Precautions & Warnings

• Hypersensitivity caution
• Periodic determination of serum electrolytes
• Risk of hypokalemia
• Impaired renal function caution
• Symptomatic hypotension risk

Use in Special Populations

• Usual regimens of therapy for renal impairment
• Loop diuretics preferred for severe renal impairment
• Not recommended for titration in patients with hepatic impairment
• Safety and effectiveness not established in pediatric patients

Overdose Effects

• Manifestations of losartan and hydrochlorothiazide overdose
• Possible hypotension, tachycardia, and bradycardia
• Supportive treatment for symptomatic hypotension

Therapeutic Class

• Combined antihypertensive preparations

Storage Conditions

• Storage temperature below 30°C
• Keep out of the reach of children

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