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Lostad HCT 100/12.5
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Lostad HCT 100/12.5 is a combined preparation of losartan potassium and hydrochlorothiazide for the treatment of hypertension.

Pack size Box of 30 tablets, 60 tablets. Bottle of 100 tablets.
Shelf-life 36 months
Composition Losartan potassium, Hydrochlorothiazide
Dosage forms and strengths Film-coated tablet:
Losartan potassium 100 mg, Hydrochlorothiazide 12.5 mg.
Product code :

PRESCRIBING INFORMATION

Indications:

  • This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe.
  • The risk of stroke in patients with hypertension and left ventricular hypertrophy.

Dosage:

Hypertension: 1 tablet of Lostad HCT 50/12.5 (if blood pressure is not adequately controlled with losartan monotherapy or hydrochlorothiazide alone) or Lostad HCT 100/12.5 (when blood pressure is not adequately controlled with losartan 100 mg monotherapy) 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 once daily. More than one tablet of Lostad HCT 100/25 once daily is not recommended.

The usual dose is one tablet of Lostad HCT 50/12.5 once daily. More than one tablet of Lostad HCT 100/25 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 once daily. For patients who do not respond adequately to the dose mentioned above after 2 to 4 weeks of therapy, the dosage may be increased to to one tablet of Lostad HCT 100/25 once daily. The maximum dose is one tablet of Lostad HCT 100/25 once daily.

Hypertensive patients with left ventricular hypertrophy: Initiate with losartan 50 mg once daily. One tablet of Lostad HCT 50/12.5 substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, Lostad HCT 100/12.5 may be substituted, followed by Lostad HCT 100/25.

Usage:

Lostad HCT 100/12.5 is administered orally, with or without food.

Known hypersensitivity to any of the active substances or excipients of the product, to thiazides and derivatives of sulfonamides.

Manifest gout, anuria or haemodialysis patients, Addison’s disease, hypercalcemia, hyperuricemia, severe hepatic and renal insufficiency, cholestasis.

Refractory hyponatraemia.

Children and adolescents under the age of 18 years.

Losartan: Adverse effects of losartan have been reported to be usually mild and transient, and include dizziness, headache, and dose-related orthostatic hypotension.

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; Patients with volume depletion.

Reduced doses may be required in patients with renal impairment and should be considered in patients with hepatic impairment.

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.

All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis, and hypokalemia.

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.

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.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take this medicine.

When pregnancy is detected, losartan should be discontinued as soon as possible. A decision should be made whether to discontinue nursing or discontinue the drug.

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.