Amosar 50 mg 30 tablets

Amosar 50 mg 30 tablets

Composition:

Active Ingredient: Each film-coated tablet contains Losartan Potassium — 50 mg.
Excipients:
Lactose, calcium phosphate, microcrystalline cellulose, colloidal silicon dioxide, povidone, sodium stearyl fumarate, quinoline yellow, polyethylene glycol, titanium dioxide, cellulose.

Product Description:

• Amosar is an antihypertensive agent that acts as a specific, selective angiotensin II receptor antagonist (type AT₁).
• By blocking AT₁ receptors in various tissues (including vascular smooth muscle, adrenal glands, kidneys, and heart), losartan prevents and reverses the vasoconstrictor effects of angiotensin II, suppresses its stimulatory effect on aldosterone secretion by the adrenal cortex, and reduces systemic vascular resistance and pulmonary capillary pressure.
• The drug does not inhibit angiotensin-converting enzyme (ACE) and does not cause bradykinin accumulation, making dry cough a rare occurrence.
• It provides a long-acting hypotensive effect lasting 24 hours or more.

Indications for Use:

• Arterial Hypertension: To lower blood pressure and reduce the risk of associated cardiovascular morbidity and mortality (including reduction of combined incidence of stroke and myocardial infarction).
• Renal Protection in Type 2 Diabetic Patients: In hypertensive patients with proteinuria — to delay the progression of renal insufficiency, reduce the risk of end-stage renal disease (ESRD), decrease proteinuria, and lower mortality rates.
• Chronic Heart Failure: As part of combination therapy in patients who cannot tolerate ACE inhibitors or when ACE inhibitor therapy is ineffective.

Method of Administration and Dosage:

• Administered orally, with or without food.
• Tablets should be swallowed whole with a glass of water.
• Arterial Hypertension: The standard starting and maintenance dose is 50 mg once daily.
  If needed to reach target blood pressure, the dose may be increased to a maximum of 100 mg once daily (or split into 50 mg twice daily).
• Patients with Volume Depletion: In patients receiving high-dose diuretic therapy, a lower starting dose of 25 mg once daily may be considered.
• Renal Protection in Type 2 Diabetes: The starting dose is 50 mg once daily, which may be increased to 100 mg once daily based on blood pressure response.
• Chronic Heart Failure: The starting dose is 12.5 mg once daily, titrated upward (doubling the dose at 2-week intervals) to the standard maintenance dose of 50 mg once daily.

Contraindications:

• Hypersensitivity to losartan or any of the excipients.
• Severe hepatic impairment.
• Pregnancy and lactation.
• Children and adolescents under 18 years of age.
• Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment.

Precautions:

• Hypotension: Symptomatic hypotension may occur in patients with intravascular volume depletion (e.g., those on high-dose diuretics).
  Volume correction is recommended prior to initiating treatment.
• Hepatic Impairment: In patients with a history of liver disease or cirrhosis, plasma concentrations of losartan are significantly increased; lower doses are recommended.
• Renal Impairment: In patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, there is an increased risk of elevated blood urea nitrogen and serum creatinine levels.
• Electrolyte Monitoring: Regular monitoring of serum potassium levels is required, particularly in elderly patients and those with renal impairment.
  Concomitant use of potassium-sparing diuretics or potassium supplements should be avoided.

Adverse Reactions / Side Effects:

• Nervous System: Frequently — headache, dizziness, insomnia.
• Cardiovascular System: Uncommonly — orthostatic hypotension, palpitations, vasculitis.
• Gastrointestinal System: Uncommonly — diarrhea, nausea, vomiting, abdominal pain; rarely — elevated ALT/AST levels, hepatitis.
• Musculoskeletal System: Uncommonly — myalgia, arthralgia, back pain, muscle cramps.
• Urinary System: Rarely — renal dysfunction, elevated serum creatinine and urea levels.
• Laboratory Parameters: Frequently — hyperkalemia.
• Allergic Reactions: Rarely — angioedema (including swelling of the face, lips, pharynx, and/or tongue), urticaria, skin rash, pruritus.

Pregnancy and Lactation:

• Contraindicated during pregnancy.
• When pregnancy is detected, losartan should be discontinued immediately and alternative antihypertensive therapy initiated, as exposure to angiotensin II receptor antagonists during the 2nd and 3rd trimesters induces fetotoxicity and fetal death.
• It is unknown whether losartan is excreted in human milk.
• Breastfeeding should be discontinued if the drug is required.

Storage Conditions:

Store in a dry, dark place at a temperature not exceeding 30 °C.
Keep out of reach of children.

Packaging:

Cardboard carton containing 3 blister packs of 10 tablets (total of 30 tablets) with an official patient information leaflet.