Losartan 100 mg 14 tablets

Losartan 100 mg 14 tablets

Composition:
Active substance:
Each tablet contains:
Losartan potassium - 100 mg.
Excipients:
Lactose monohydrate, Microcrystalline cellulose (Avicel PH 102), Pregelatinized starch, Colloidal silicon dioxide (Aerosil 200), Magnesium stearate; Subcoat: Hypromellose, Macrogols, Dichloromethane, Ethanol 96 %; Film coat: Hypromellose, Macrogols, Titanium dioxide, Talc, Ethanol 96 %, Purified water.
Description:
Losartan is an angiotensin II receptor (AT1) antagonist that lowers blood pressure by blocking angiotensin II, preventing vasoconstriction and sodium retention.
It is used to treat essential hypertension, chronic heart failure, reduce stroke risk in patients with left ventricular hypertrophy, and slow the progression of kidney damage in type 2 diabetes with proteinuria.
Indications:
- Hypertension: adults and children 6-18 years.
- Renal disease in type 2 diabetes: adults with hypertension and proteinuria ≥0.5 g/day.
- Chronic heart failure: adults intolerant to ACE inhibitors, LVEF ≤40%, clinically stable.
- Reduction of stroke risk: hypertensive patients with LVH confirmed by ECG.
Dosage and Administration:
Adults:
- Hypertension: start/maintenance 50 mg once daily, may increase to 100 mg once daily (morning).
- Diabetic nephropathy: start 50 mg, may increase to 100 mg based on response.
- Heart failure: start 12.5 mg, titrate weekly to 25, 50, 100, max 150 mg once daily.
- Stroke risk reduction: start 50 mg, adjust or add low-dose hydrochlorothiazide as needed.
Special populations:
- Volume depletion: start 25 mg once daily.
- Renal impairment/hemodialysis: no adjustment.
- Hepatic impairment: lower dose; severe impairment - contraindicated.
- Elderly >75: consider 25 mg start; usually no adjustment.
- Children 6-18 years: dose per body weight, max 100 mg/day.
Administration:
Swallow tablets with water.
May be taken with or without food.
Contraindications:
- Hypersensitivity to losartan or excipients.
- Severe hepatic impairment.
- Concomitant aliskiren in diabetes or renal impairment (GFR <60 ml/min/1.73 m²).
- Children <6 years, GFR <30 ml/min/1.73 m², hepatic impairment.
Precautions:
- Hypersensitivity: monitor for angioedema.
- Hypotension and electrolyte imbalance: correct prior to dosing; cautious initiation/titration.
- Electrolytes: monitor potassium and creatinine, avoid potassium-sparing agents or supplements.
- Pregnancy: not recommended; discontinue if pregnancy detected.
- Lactation: not recommended.
- Ethnicity: antihypertensive effect may be reduced in black patients.
- Dizziness/somnolence possible; caution when driving/operating machinery.
Side Effects:
Common: dizziness, headache, somnolence, sleep disorders, dysgeusia, cough, dyspnea, abdominal pain, constipation, diarrhea, nausea, vomiting, anemia, pancreatitis, hepatitis, liver function abnormalities, skin reactions (rash, pruritus).
Uncommon/rare: anaphylaxis, angioedema, vasculitis, depression, palpitations, angina, syncope, atrial fibrillation, hypotension, vertigo, tinnitus.
Pregnancy and Breastfeeding:
Pregnancy: not recommended; monitor fetus if exposed in 2nd/3rd trimester.
Breastfeeding: not recommended; prefer agents with established safety.
Storage:
Store in a dry place, ≤30 °C.
Keep out of reach of children.
Packaging:
Carton box with 2 blisters, 7 tablets each, 14 tablets total + leaflet.