Amosar 100 mg 30 tablets

Amosar 100 mg 30 tablets

Composition:
Each tablet contains:
Losartan potassium 100 mg.
Excipients:
Lactose monohydrate, calcium phosphate anhydrous, microcrystalline cellulose (Prosolv 90), croscarmellose sodium, povidone K30, sodium stearyl fumarate, colloidal silicon dioxide (Aerosil 200), Opadry Pink film coating (including titanium dioxide).
Product Description:
Amosar is an antihypertensive medicinal product belonging to the class of angiotensin II receptor antagonists (ARBs).
Losartan selectively blocks AT1 receptors, preventing vasoconstriction and aldosterone secretion, thereby reducing blood pressure and providing cardiovascular and renal protection.
Indications for Use:
Treatment of essential hypertension in adults and in children and adolescents aged 6–18 years.
Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day.
Treatment of chronic heart failure in adult patients intolerant to ACE inhibitors.
Reduction in the risk of stroke in hypertensive patients with ECG-documented left ventricular hypertrophy.
Method of Administration and Dosage:
- Hypertension:
The usual starting and maintenance dose is 50 mg once daily.
The dose may be increased to 100 mg once daily, if required.
- Hypertension with type 2 diabetes and proteinuria:
Starting dose 50 mg once daily, adjustable to 100 mg.
- Heart failure:
Initial dose 12.5 mg once daily with gradual titration up to a maximum of 150 mg daily.
- Paediatric use:
Recommended dose is 25–50 mg once daily depending on body weight and blood pressure response.
Contraindications:
- Hypersensitivity to losartan or any excipients.
- Pregnancy.
- Severe hepatic impairment.
- Concomitant use with aliskiren in patients with diabetes or renal impairment.
Precautions:
- Risk of hypotension in volume-depleted patients.
- Monitoring of renal function and serum electrolytes.
- Caution in heart failure and valvular stenosis.
- Contains lactose.
Adverse Reactions (Side Effects):
Most commonly reported adverse reactions include dizziness, hypotension (including orthostatic hypotension) and fatigue.
Possible adverse reactions:
- Nervous system disorders:
headache, somnolence, paraesthesia, migraine, taste disturbances.
- Cardiovascular disorders: 
palpitations, angina pectoris, syncope, atrial fibrillation, rarely stroke.
- Gastrointestinal disorders: 
nausea, vomiting, diarrhoea, abdominal pain.
- Respiratory disorders: 
cough, dyspnoea.
- Skin and hypersensitivity reactions: 
rash, pruritus, urticaria, photosensitivity, angioedema.
- Hepatobiliary disorders: 
increased liver enzymes, rarely hepatitis.
- Renal and urinary disorders: 
renal impairment, increased creatinine levels, acute renal failure, hyperkalaemia.
- Musculoskeletal disorders: 
myalgia, arthralgia.
- General disorders: 
oedema, impotence, flu-like symptoms.
Pregnancy and lactation:
Pregnancy: contraindicated due to risk of fetal injury or death.
Breastfeeding: not recommended; alternative therapies with established safety are preferred.
Storage conditions:
Store at a temperature not exceeding 25 °C, in a dry place.
Keep out of reach of children.
Packaging:
Carton box containing 3 blisters of 10 tablets and a package leaflet.