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Cardiovascular Agents

Losartan STADA® 25 mg


Pack size:           

Box of 3 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains losartan potassium 25 mg.


Shelf-life:  

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Protect from light. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Losartan is administered orally in the management:

  • Hypertension, particularly in patients who develop cough with ACE inhibitors and to reduce the risk of stroke in patients with left ventricular hypertrophy.
    Adults:
    The usual dose is 50 mg once daily. The dose may be increased, if necessary, to 100 mg daily as a single dose or in two divided doses. The maximum hypotensive effect is achieved in about 3 to 6 weeks after initiating treatment. An initial dose of 25 mg once daily should be given to patients with intravascular fluid depletion. Similar reductions may be appropriate in patients with hepatic or renal impairment.
    Children:
    Those aged 6 years or over with hypertension may be given an initial dose of 0.7 mg/kg once daily, with a maximum of 50 mg, adjusted according to response; doses higher than 1.4 mg/kg or 100 mg daily have not been studied.
     
  • Diabetic nephropathy (as serum creatinine is 1.3 - 3.0 mg/dl in patients ≤ 60 kg and 1.5 - 3.0 mg/dl in males > 60 kg and proteinuria).
    Losartan is given in an initial dose of 50 mg once daily, increased to 100 mg once daily depending on the blood pressure.
     
  • It has also been tried in heart failure and in myocardial infarction.


Or as prescribed by physicians. 

 

  • Patients who are hypersensitive to losartan potassium or to any ingredient of the drug.
     

Mostly ADR are mild and disappear gradually with time.

Common:

  • Hypotension without reflex tachycardia.
  • Dizziness, insomnia.
  • Hyperkalemia.
  • Diarrhoea, dyspepsia.
  • Slight decreases in hemoglobin and hematocrit.
  • Back/leg pain, myalgia.
  • Hypouricemia (with large dose).
  • Cough (less than ACE inhibitors), nasal congestion, sinus disorders, sinusitis.

Less common:

  • Orthostatic hypotension effects, angina, second degree A-V block, palpitations, sinus bradycardia, tachycardia, flushing, facial edema.
  • Anxiety, ataxia, confusion, depression, dream abnormality, migraine headache, sleep disorders, vertigo, fever.
  • Alopecia, dermatitis, dry skin, bruising, erythema, photosensitivity, pruritus, rash, urticaria.
  • Gout.
  • Anorexia, constipation, flatulence, vomiting, abnormal taste, gastritis.
  • Impotence, decreased libido, polyuria, nocturia.
  • Slight increase elevations of liver function tests and bilirubin.
  • Paresthesia, tremor, arm, hip, shoulder and knee pain, joint edema, fibromyalgia, muscle weakness.
  • Blurred vision, burning and stinging eyes, conjunctivitis, decreased visual acuity.
  • Tinnitus.
  • Urinary tract infection, mild increase in urea or creatinine.
  • Dyspnea, bronchitis, pharyngeal discomfort, epistaxis, rhinitis, respiratory congestion.
  • Diaphoresis.

     

  • Losartan should be used with caution in patients with renal artery stenosis.
  • Losartan is excreted in urine and in bile and reduced doses may therefore be required in patients with renal impairment and should be considered in patients with hepatic impairment.
  • Patients with volume depletion (for example those who have received high-dose diuretic therapy) may experience hypotension; volume depletion should be corrected before starting therapy, or a low initial dose should be used.
  • Since hyperkalaemia may occur, serum-potassium concentrations should be monitored, especially in the elderly and patients with renal impairment, and the concomitant use of potassium-sparing diuretics should generally be avoided.
  • Pregnancy: When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, losartan should be discontinued as soon as possible.
  • Lactation: Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
  • No studies on the reactions on the ability to drive and use machines have been performed. However, when driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, in particular during initiation of treatment or when the dose increased.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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