Lostad HCT 100/12.5

Rx

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.

• 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.
• Losartan should be used with caution in patients with renal artery stenosis.
• Reduction doses may be required in patients with renal impairment and should be considered in patients with hepatic impairment.
• Lostad HCT is not recommended for patients with hepatic impairment who require titration with losartan. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease.
• Patients with volume depletion, volume depletion should be corrected before starting therapy, or a low initial dose should be used.
• Periodic determination of serum electrolytes should be performed.
• Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.
• Since hyperkalaemia may occur, serum-potassium concentrations should be monitored, especially in the elderly.
• Hyperuricemia may occur or frank gout may be precipitated.
• Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
• Thiazide therapy may impair glucose tolerance and hyperglycemia.
• Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma.
• Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
• The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.
• 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, taking into account the importance of the drug to the mother.
• Patients should be aware of how they react to drug before driving or operating machinery.