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Cardiovascular Agents

Lostad HCT 50/12,5 mg

 

Pack size:

Box of 3 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains losartan potassium 50 mg and hydrochlorothiazide 12.5 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

  • Lostad HCT is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating therapy in these patients.

    Hypertension
    Dose titration by clinical effect: A patient whose blood pressure is not adequately controlled with losartan monotherapy or hydrochlorothiazide alone, may be switched to one tablet of Lostad HCT 50/12,5 mg once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to one tablet of Lostad HCT 100/25 mg once daily.
    The usual dose is one tablet of Lostad HCT 50/12,5 mg once daily. More than one tablet of Lostad HCT 100/25 mg once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy.

    Severe hypertension
    The starting dose is one tablet of Lostad HCT 50/12,5 mg once daily. For patients who do not respond adequately to one tablet of Lostad HCT 50/12,5 mg after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of Lostad HCT 100/25 mg once daily. The maximum dose is one tablet of Lostad HCT 100/25 mg once daily.
     
  • Lostad HCT is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients.
    Treatment should be initiated with losartan 50 mg once daily. One tablet of Lostad HCT 50/12,5 mg substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, Lostad HCT 100/12,5 mg may be substituted, followed by Lostad HCT 100/25 mg.
     
  • Lostad HCT is administered orally, with or without food.


Or as prescribed by physicians.

 

  • Hypersensitivity to losartan or to any ingredient of the drug.
  • Hypersensitivity to thiazides and derivatives of sulfonamides, manifest gout, anuria, Addison's disease, hypercalcemia, hyperuricemia, severe hepatic and renal insufficiency (creatinine clearance < 30 ml/minute).
  • Refractory hyponatremia.
  • 2nd and 3rd trimester of pregnancy.

 

Losartan

  • Adverse effects of losartan have been reported to be usually mild and transient, and include dizziness, headache, and dose-related orthostatic hypotension.
  • Hypotension may occur particularly in patients with volume depletion (for example those who have received high-dose diuretics).
  • Impaired renal function and, rarely, rash, urticaria, pruritus, angioedema, and raised liver enzyme values may occur.
  • Hyperkalaemia, myalgia, and arthralgia have been reported.
  • Losartan appears less likely than ACE inhibitors to cause cough.
  • Other adverse effects that have been reported with angiotensin II receptor antagonists include respiratory-tract disorders, back pain, gastrointestinal disturbances, fatigue, and neutropenia.
  • Rhabdomyolysis has been reported rarely.

Hydrochlorothiazide

  • Weakness.
  • Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation.
  • Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.
  • Purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema.
  • Hyperglycemia, glycosuria, hyperuricemia.
  • Muscle spasm.
  • Restlessness.
  • Renal failure, interstitial nephritis.
  • Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis.
  • Transient blurred vision, xanthopsia.

     

  • 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.
  • Lostad HCT is not recommended for patients with hepatic impairment who require titration with losartan.
  • Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals. All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: Hyponatremia, hypochloremic alkalosis, and hypokalemia.
  • Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
  • Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
  • Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
  • Thiazide therapy may impair glucose tolerance. Dosage adjustment of antidiabetic agents, including insulin, may be required.
  • Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy. Because losartan decreases uric acid, losartan in combination with hydrochlorothiazide attenuates the diuretic-induced hyperuricemia.
  • In diabetic patients, dosage adjustments of insulin or oral hypoglycemic agents may be required. Hyperglycemia may occur with thiazide diuretics. Thus latent diabetes mellitus may become manifest during thiazide therapy.
  • The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.
  • Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.
  • Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
  • Renal impairment: This fixed combination is not recommended for use in patients with creatinine clearances of 30 ml/minute or less, because loop diuretics are preferred to thiazides.
  • Hepatic impairment: This fixed combination should not be used for initial titration in patients with hepatic impairment, because the appropriate starting dose of losartan potassium (25 mg once daily) is not available as a fixed-ratio preparation.
  • 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: It is not known whether losartan is excreted in human milk, but significant levels of losartan and its active metabolite were shown to be present in rat milk. Thiazides appear in human milk. 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 is increased.

     

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