Lostad T50

Lostad T50 Adverse Reactions

losartan

Manufacturer:

Stellapharm

Distributor:

HK Medical Supplies
/
Health Express
Full Prescribing Info
Adverse Reactions
In clinical trials, the most common adverse event was dizziness.
The frequency of adverse reactions listed as follows is defined using the following convention: Very common (≥ 1/10); common (≥ 1/100, to < 1/10); uncommon (≥ 1/1,000, to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
The following adverse reactions are listed based on indication: Hypertension: Nervous system disorders: Common: Dizziness.
Uncommon: Somnolence, headache, sleep disorders.
Ear and labyrinth disorders: Common: Vertigo.
Cardiac disorders: Uncommon: Palpitations, angina pectoris.
Vascular disorders: Uncommon: (Orthostatic) hypotension (including dose-related orthostatic effects) (Especially in patients with intravascular depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics).
Gastrointestinal disorders: Uncommon: Abdominal pain, obstipation.
Skin and subcutaneous tissue disorders: Uncommon: Rash.
General disorders and administration site conditions: Uncommon: Asthenia, fatigue, oedema.
Investigations: Common: Hyperkalaemia.
Rare: Increased alanine aminotransferase (ALT) (Usually resolved upon discontinuation).
Hypertensive patients with left-ventricular hypertrophy: Nervous system disorders: Common: Dizziness.
Ear and labyrinth disorders: Common: Vertigo.
General disorders and administration site conditions: Common: Asthenia, fatigue.
Chronic Heart Failure: Blood and lymphatic system disorders: Common: Anaemia.
Nervous system disorders: Common: Dizziness.
Uncommon: Headache.
Rare: Paraesthesia.
Cardiac disorders: Rare: Syncope, atrial fibrillation, cerebrovascular accident.
Vascular disorders: Common: (Orthostatic) hypotension (including dose-related orthostatic effects) (Especially in patients with intravascular depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics).
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnea, cough.
Gastrointestinal disorders: Uncommon: Diarrhoea, nausea, vomiting.
Skin and subcutaneous tissue disorders: Uncommon: Urticaria, pruritus, rash.
Renal and urinary disorders: Common: Renal impairment, renal failure.
General disorders and administration site conditions: Uncommon: Asthenia, fatigue.
Investigations: Common: Increase in blood urea, serum creatinine, and serum potassium.
Uncommon: Hyperkalaemia (Common in patients who received 150 mg losartan instead of 50 mg).
Hypertension and type 2 diabetes with renal disease: Nervous system disorders: Common: Dizziness.
Vascular disorders: Common: (Orthostatic) hypotension (including dose-related orthostatic effects) (Especially in patients with intravascular depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics).
General disorders and administration site conditions: Common: Asthenia, fatigue.
Investigations: Common: Hypoglycaemia, hyperkalaemia.
Post-marketing experience: Blood and lymphatic system disorders: Not known: Anaemia, thrombocytopenia.
Immune system disorders: Rare: Hypersensitivity reactions, anaphylactic reactions, angiooedema (Including swelling of the larynx, glottis, face, lips, pharynx, and/or tongue (causing airway obstruction); in some of these patients angiooedema had been reported in the past in connection with the administration of other medicines, including ACE inhibitors), and vasculitis (Including Henoch-Schönlein purpura).
Psychiatric disorders: Not known: Depression.
Nervous system disorders: Not known: Migraine, dysgeusia.
Ear and labyrinth disorders: Not known: Tinnitus.
Respiratory, thoracic and mediastinal disorders: Not known: Cough.
Gastrointestinal disorders: Not known: Diarrhoea.
Hepatobiliary disorders: Rare: Hepatitis.
Not known: Pancreatitis, liver function abnormalities.
Skin and subcutaneous tissue disorders: Not known: Urticaria, pruritus, rash, photosensitivity.
Musculoskeletal and connective tissue disorders: Not known: Myalgia, arthralgia, rhabdomyolysis.
Reproductive system and breast disorders: Not known: Erectile dysfunction / impotence.
General disorders and administration site conditions: Not known: Malaise.
Investigations: Not known: Hyponatraemia.
The following additional adverse reactions occurred more frequently in patients who received losartan than placebo (frequencies not known): Back pain, urinary tract infection, and flu-like symptoms.
Renal and urinary disorders: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function including renal failure have been reported in patients at risk; these changes in renal function may be reversible upon discontinuation of therapy.
Paediatric population: The adverse reaction profile for paediatric patients appears to be similar to that seen in adult patients. Data in the paediatric population are limited.
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