Lostad HCT 50mg/12.5mg (3 blisters x 10 tablets/box)

Indications

• For the treatment of hypertension, for patients in whom combination therapy is appropriate,
• For reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy.

Contraindications

• Hypersensitivity to losartan, sulfonamide-derived substances (as hydrochlorothiazide) or to any of the excipients,
• Therapy resistant hypokalaemia or hypercalcaemia,
• Severe hepatic impairment; cholestasis and biliary obstructive disorders,
• Refractory hyponatraemia,
• Symptomatic hyperuricaemia/gout,
• 2^nd and 3^rd trimester of pregnancy,
• Severe renal impairment (glomerular filtration rate < 30ml/min),
• Anuria,
• The concomitant use of Lostad HCT 50/12.5 with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m²).

Compositon/Ingredients

Dosage and administration

Hypertension

• The usual starting and maintenance dose is one tablet of Lostad HCT 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5mg) once daily.
• For patients who do not respond adequately to Lostad HCT 50/12.5, the dosage may be increased to losartan 100mg and hydrochlorothiazide 25mg once daily or two tablets of Lostad HCT 50/12.5 once daily. The maximum dose is losartan 100 mg and hydrochlorothiazide 25mg once daily or two tablets of Lostad HCT 50/12.5 once daily. In general, the antihypertensive effect is attained within three weeks after initiation of therapy.
• Lostad HCT 50/12.5 should not be initiated in patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics).
• Lostad HCT 50/12.5 is not recommended for patients with severe renal impairment (creatinine clearance ≤ 30ml/min) or for patients with hepatic impairment.
• No initial dosage adjustment of Lostad HCT 50/12.5 is necessary for elderly patients. Losartan 100mg and hydrochlorothiazide 25mg should not be used as initial therapy in elderly patients.

Reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy.

• The usual starting dose is 50mg of losartan once daily.
• If goal blood pressure is not reached with losartan 50mg, therapy should be titrated using a combination of losartan and a low dose of hydrochlorothiazide (12.5mg) and, if needed, the dose should then be increased to losartan 100mg/hydrochlorothiazide 12.5mg once daily.

Precaution

• When pregnancy is discovered, Lostad HCT 50/12.5 must be discontinued as soon as possible.

Losartan

• Patients with a history of angioedema (swelling of the face, lips, throat, and/or tongue) should be closely monitored.
• Hypotension and intravascular volume depletion: Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Lostad HCT 50/12.5
• Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. Therefore, the plasma concentrations of potassium and creatinine clearance values should be closely monitored, especially patients with heart failure and a creatinine clearance between 30 – 50 ml/min should be closely monitored.
• Concomitant administration of drugs that increase serum potassium levels may lead to hyperkalemia.
• The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan/ hydrochlorothiazide is not recommended.
• Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, Lostad HCT 50/12.5 should be used with caution in patients with a history of mild to moderate hepatic impairment. Lostad HCT 50/12.5 is contraindicated in patients with severe hepatic impairment due to no therapeutic experience.
• As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function, including renal failure, have been reported (in particular, in patients whose renal function is dependent on the renin-angiotensin-aldosterone system, such as those with severe cardiac insufficiency or preexisting renal dysfunction).
  As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy. Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
• There is no experience in patients with recent kidney transplantation.
• Patients with primary aldosteronism generally will not respond to antihypertensive drugs products acting through inhibition of the renin-angiotensin system. Therefore, the use of Lostad HCT 50/12.5 is not recommended.
• As with any antihypertensive agents, excessive blood pressure decrease in patients with ischaemic cardiovascular and cerebrovascular disease could result in a myocardial infarction or stroke.
• As with other drugs acting on the renin-angiotensin system, there is a risk of severe arterial hypotension, and (often acute) renal impairment in patients with heart failure, with or without renal impairment.
• As with other vasodilators, special caution is indicated in patients with aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
• Losartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
• Angiotensin II receptor antagonists (AIIRAs) should not be initiated during pregnancy.
• There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia, and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended
  If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

Hydrochlorothiazide

• As with all antihypertensive therapy, symptomatic hypotension may occur in some patients. Patients should be observed for clinical signs of fluid or electrolyte imbalance, e.g., volume depletion, hyponatremia, hypochloremic alkalosis, hypomagnesemia, or hypokalemia which may occur during intercurrent diarrhea or vomiting. Periodic determination of serum electrolytes should be performed at appropriate intervals in such patients. Dilutional hyponatraemia may occur in oedematous patients in hot weather.
• Metabolic and endocrine effects: Thiazide therapy may impair glucose tolerance. Latent diabetes mellitus may become manifest during thiazide therapy.
• Thiazides may decrease urinary calcium excretion and may cause intermittent and slight elevation of serum calcium. Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.
• Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
  Thiazide therapy may precipitate hyperuricemia and/or gout in certain patients. Because losartan decreases uric acid, losartan in combination with hydrochlorothiazide attenuates the diuretic induced hyperuricemia.
• Non-melanoma skin cancer: An increased risk of non-melanoma skin cancer (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) with increasing cumulative dose of hydrochlorothiazide has been observed in epidemiological studies. Photosensitizing actions of hydrochlorothiazide could act as a possible mechanism for non-melanoma skin cancer.
  Patients taking hydrochlorothiazide should be informed of the risk of non-melanoma skin cancer and advised to take preventive measures to reduce sun and artificial UVA exposure. Patients should regularly check their skin for any new lesions and promptly report any suspicious skin lesions to a physician for evaluation. The use of hydrochlorothiazide may also need to be reconsidered in patients who have experienced previous non-melanoma skin cancer
• Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, as it may cause intrahepatic cholestasis, and since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
  Lostad HCT 50/12.5 is contraindicated for patients with severe hepatic impairment.
• In patients receiving thiazides, hypersensitivity reactions may occur with or without a history of allergy or bronchial asthma. Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazides.
• Lostad HCT 50/12.5 contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Safety and effectiveness in children have not been established.
• In clinical studies, there were no clinically significant differences in the efficacy and safety profiles of Lostad HCT 50/12.5 in older (≥ 65 years) and younger patients (< 65 years).
• Drugs that act directly on the renin-angiotensin system can cause damage and even death to the developing fetus. When pregnancy is detected, Lostad HCT 50/12.5 must be discontinued as soon as possible.
• The use of Lostad HCT 50/12.5 during breastfeeding is not recommended.
• 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.

Storage

Store at temperature below 30°C, protect from light.