Losar Plus 100/25 mg 8 tablets

Description

A fixed-dose combination of an angiotensin II receptor blocker (losartan) and a thiazide diuretic (hydrochlorothiazide), designed for patients with essential hypertension not adequately controlled by either component alone.

Indicated for the treatment of essential hypertension in patients not adequately controlled with losartan or hydrochlorothiazide alone.

Indications for Use

Treatment of essential hypertension in patients whose blood pressure is not adequately controlled on monotherapy with losartan or hydrochlorothiazide.

Dosage and Method of Administration

Tablets should be swallowed with water, with or without food.

Not recommended as initial therapy.

Dose titration with individual components is advised.

Usual maintenance dose: 1 tablet of Losartan 50 mg / HCTZ 12.5 mg once daily.

If needed, dose can be increased to 1 tablet of Losar Plus 100/25 mg once daily (maximum dose).

Full antihypertensive effect usually achieved in 3–4 weeks.

Special Populations:

Renal impairment: Contraindicated if creatinine clearance <30 ml/min.

Hemodialysis patients: Not recommended.

Hepatic impairment: Contraindicated in severe hepatic dysfunction.

Children and adolescents (<18 years): Not recommended.

Contraindications

Hypersensitivity to losartan, hydrochlorothiazide, or any excipients

Severe renal impairment, anuria

Severe hepatic impairment

Refractory electrolyte disturbances (hypokalemia, hypercalcemia, hyponatremia)

Symptomatic hyperuricemia/gout

Pregnancy and breastfeeding

Concomitant use with aliskiren in patients with diabetes or impaired renal function (GFR <60 mL/min/1.73 m²)

Precautions

Do not initiate during pregnancy. Discontinue immediately if pregnancy occurs.

Risk of symptomatic hypotension in volume- or sodium-depleted patients (e.g., diarrhea, vomiting, salt restriction).

Monitor serum electrolytes (especially potassium) and renal function regularly.

Increased risk of hyperkalemia when used with potassium-sparing diuretics, supplements, or salt substitutes.

Risk of photosensitivity and non-melanoma skin cancer — advise sun protection.

Possible psychiatric effects (insomnia, anxiety, depression), exacerbation of systemic lupus erythematosus.

Contains lactose — contraindicated in patients with lactose intolerance, galactosemia, or glucose-galactose malabsorption.

Side Effects

Common: Headache, dizziness, cough, fatigue, muscle cramps, dyspepsia, hyperkalemia

Rare: Angioedema, hyponatremia, elevated ALT, hypotension

Very rare: Hepatitis, rhabdomyolysis, photosensitivity, skin reactions

Hydrochlorothiazide: Nausea, vomiting, photosensitivity, electrolyte imbalance, hyperlipidemia, rash, decreased libido, elevated uric acid

Pregnancy and Lactation

Pregnancy: Contraindicated. May cause fetal injury or death.

Breastfeeding: Not recommended. May reduce milk production. Use alternative treatments.

Storage Conditions

Store below 30°C in a dry, dark place. Keep out of reach of children.

Packaging

Carton box containing 1 blister strip of 8 tablets and a patient information leaflet.