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LOSARTAN HCT is a brand name for Hydrochlorothiazide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hypertension: LOSARTAN HCT / LOSARTAN HCT DS (losartan potassium and hydrochlorothiazide) is indicated for: • the treatment of essential hypertension in patients for whom combination therapy is appropriate LOSARTAN HCT / LOSARTAN HCT DS is not indicated as the initial therapy for essential hypertension, except in…
Verbatim from this product's HC label. Tap a section to expand.
and 14 CLINICAL TRIALS). 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (>65 years of age): No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out (see 4 DOSAGE AND ADMINISTRATION).
2 CONTRAINDICATIONS • Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see
5 Post Market Adverse Reactions). The photosensitizing action of hydrochlorothiazide may be a possible mechanism for NMSC (see 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity – Hydrochlorothiazide). Patients taking hydrochlorothiazide should be informed of the potential risk of NMSC.
They LOSARTAN HCT and LOSARTAN HCT DS (Losartan Potassium and Hydrochlorothiazide Tablets) Page 9 of 50 Protected B / Protégé B should be advised to regularly check their skin for new lesions as well as changes to existing ones, and to promptly report any suspicious skin lesions.
g. a broad spectrum sunscreen with a SPF of 30 or higher, clothing, and a hat) when exposed to sunlight or UV light to minimize the risk of skin cancer. 5 Post Market Adverse Reactions).
Cardiovascular Hypotension:
Occasionally, symptomatic hypotension has occurred after administration of losartan, in some cases after the first dose. It is more likely to occur in patients who are volume- depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting.
In these patients, because of the potential fall in blood pressure, therapy should be started under close medical supervision. Similar considerations apply to patients with ischemic heart or cerebrovascular disease, in whom an excessive fall in blood pressure could result in myocardial infarction or cerebrovascular accident.
Valvular Stenosis:
There is concern on theoretical grounds that patients with aortic stenosis might be at particular risk of decreased coronary perfusion when treated with vasodilators because they do not develop as much afterload reduction. 73m2). Therefore, the use of losartan potassium and hydrochlorothiazide tablets in combination with aliskiren-containing drugs is contraindicated in these patients.
, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal, and 9 DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin-System (RAS) with ACEIs, ARBs or aliskiren-containing drugs). LOSARTAN HCT and LOSARTAN HCT DS (Losartan Potassium and Hydrochlorothiazide Tablets) Page 5 of 50 Protected B / Protégé B 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions When used in pregnancy, angiotensin receptor (AT1) blockers (ARB) can cause injury or even death of the developing fetus.
When pregnancy is detected, LOSARTAN HCT/ LOSARTAN HCT DS should be discontinued as soon as possible (see 7 WARNINGS AND PRECAUTIONS, Special Populations). 1 Dosing Considerations • Dosage must be individualized. • The fixed combination is not for initial therapy, except for severe hypertension.
• The dose of LOSARTAN HCT/ LOSARTAN HCT DS should be determined by the titration of the individual components. 5 mg, or one tablet LOSARTAN HCT DS 100 mg/25 mg once daily may be substituted if the doses on which the patient was stabilized are the same as those in the fixed combination.
The maximum dose is one tablet LOSARTAN HCT DS 100 mg/25 mg once daily. 5 mg once daily. 5 mg after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of LOSARTAN HCT DS 100 mg/25 mg once daily. The maximum dose is one tablet of LOSARTAN HCT DS 100 mg/25 mg once daily.
Losartan Monotherapy:
The usual starting dose of losartan monotherapy is 50 mg once daily. Dosage should be adjusted according to blood pressure response. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. The usual dose range for losartan is 50 to 100 mg once daily.
A dose of 100 mg daily should not be exceeded, as no additional antihypertensive effect is obtained with higher doses. LOSARTAN HCT and LOSARTAN HCT DS (Losartan Potassium and Hydrochlorothiazide Tablets) Page 6 of 50 Protected B / Protégé B In most patients taking losartan 50 mg once daily, the antihypertensive effect is maintained.
• Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Because of the hydrochlorothiazide component, LOSARTAN HCT/ LOSARTAN HCT DS is also contraindicated in patients with anuria, and in patients who are hypersensitive to other sulfonamide-derived drugs.
73 m2) is contraindicated (see 7 WARNINGS AND PRECAUTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal, and 9 DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin-System (RAS) with ACEIs, ARBs or aliskiren-containing drugs).
LOSARTAN HCT and LOSARTAN HCT DS (Losartan Potassium and Hydrochlorothiazide Tablets) Page 5 of 50 Protected B / Protégé B
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Hydrochlorothiazide in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Co-administration of ARBs, including losartan potassium and hydrochlorothiazide tablets, with other agents blocking the RAS, such as ACEIs or aliskiren- containing drugs, is not recommended in any patients, as adverse outcomes cannot be excluded.
Endocrine and Metabolism Metabolism:
Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy. Thiazides may decrease serum PBI levels without signs of thyroid disturbance. LOSARTAN HCT and LOSARTAN HCT DS (Losartan Potassium and Hydrochlorothiazide Tablets) Page 10 of 50 Protected B / Protégé B Thiazides have been shown to increase excretion of magnesium; this may result in hypomagnesemia.
Thiazides may decrease urinary calcium excretion. Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcemia may be evidence of hidden hyperparathyroidism.
Thiazides should be discontinued before carrying out tests for parathyroid function. Increases in cholesterol, triglyceride and glucose levels may be associated with thiazide diuretic therapy.
Hepatic/Biliary/Pancreatic Patients with Liver Impairment:
Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan and its active metabolite in cirrhotic patients after administration of losartan potassium, a lower dose should be considered for patients with hepatic impairment, or a history of hepatic impairment (see 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY).
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.
Immune Hypersensitivity:
Sensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported in patients treated with hydrochlorothiazide.
Anaphylactic reactions, angioedema (involving swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, and/or tongue and pharynx, requiring intubation/tracheotomy in some cases) have been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with ACE inhibitors.
Vasculitis, including Henoch-Schoenlein purpura, has been reported rarely. Ophthalmologic Choroidal Effusion, Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulphonamide, can cause an idiosyncratic reaction, resulting in choroidal effusion, acute transient myopia and acute angle-closure glaucoma.
Symptoms include acute onset of decreased visual acuity, blurred vision or ocular pain and typically occur within hours LOSARTAN HCT and LOSARTAN HCT DS (Losartan Potassium and Hydrochlorothiazide Tablets) Page 11 of 50 Protected B / Protégé B to weeks of drug initiation.
Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Risk factors for developing acute […]
In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. This can be evaluated by measuring the blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours.
If it is not, either twice daily administration with the same total daily dosage, or an increase in the dose should be considered. If blood pressure is not adequately controlled with losartan alone, a non- potassium-sparing diuretic may be administered concomitantly.
For patients with volume-depletion, a starting dose of 25 mg once daily should be considered (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular - Hypotension and 9 DRUG INTERACTIONS).
Diuretic Treated Patients:
In patients receiving diuretics, losartan therapy should be initiated with caution, since these patients may be volume-depleted and thus more likely to experience hypotension following initiation of additional antihypertensive therapy.
Whenever possible, all diuretics should be discontinued two to three days prior to the administration of losartan, to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular - Hypotension and 9 DRUG INTERACTIONS, Diuretics).
If this is not possible because of the patient’s condition, losartan should be administered with caution and the blood pressure monitored closely. Thereafter, the dosage should be adjusted according to the individual response of the patient.
Dosage Adjustment in Renal Impairment:
No initial dosage adjustment in losartan is usually necessary for patients with renal impairment, including those requiring hemodialysis. However, appropriate monitoring of these patients is recommended. The usual regimens of therapy with LOSARTAN HCT / LOSARTAN HCT DS may be followed as long as the patient’s creatinine clearance is >30 mL/min.
In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so LOSARTAN HCT / LOSARTAN HCT DS is not recommended.
Patients with Liver Impairment:
Since dosage adjustment of losartan is required in patients with liver impairment, and thiazide diuretics may precipitate hepatic coma, a fixed combination product such as LOSARTAN HCT / LOSARTAN HCT DS is not advisable (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic - Patients with Liver Impairment).
Geriatrics (>65 years of age):
No initial dosage adjustment is necessary for most elderly patients. 4 Geriatrics). 4 Administration LOSARTAN HCT / LOSARTAN HCT DS are for oral administration LOSARTAN HCT / LOSARTAN HCT DS may be administered with or without food, however it should be taken consistently with respect to food intake at about the same time every day.
5 Missed Dose If a dose is missed, an extra dose should not be taken. The usual schedule must be resumed. 5 OVERDOSAGE No specific information is available on the treatment of overdosage with losartan potassium and hydrochlorothiazide tablets.
Treatment is symptomatic and supportive.
Losartan:
Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia. If symptomatic hypotension should […]
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