Loading…
PMS-LOSARTAN-HCTZ 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: pms-LOSARTAN-HCTZ (losartan potassium and hydrochlorothiazide) is indicated for the treatment of essential hypertension in patients for whom combination therapy is appropriate. pms-LOSARTAN-HCTZ is not indicated as the initial therapy for essential hypertension, except in patients with severe essential…
Verbatim from this product's HC label. Tap a section to expand.
; 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 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. , 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 pms-LOSARTAN-HCTZ in combination with aliskiren-containing drugs is contraindicated in these patients.
Coadministration of ARBs, including pms-LOSARTAN-HCTZ, 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.
6 Drug-Herb Interactions ............................................................................................... 7 Drug-Laboratory Test Interactions ..............................................................................
24 10 CLINICAL PHARMACOLOGY............................................................................................. 1 Mechanism of Action ..................................................................................................
2 Pharmacodynamics ..................................................................................................... 3 Pharmacokinetics ........................................................................................................
26 11 STORAGE, STABILITY, AND DISPOSAL .............................................................................. 28 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................
28 PART II: SCIENTIFIC INFORMATION....................................................................................... 29 13 PHARMACEUTICAL INFORMATION .................................................................................
29 14 CLINICAL TRIALS ............................................................................................................. 1 Clinical Trials by Indication ..........................................................................................
2 Comparative Bioavailability Studies ............................................................................ 32 15 MICROBIOLOGY .............................................................................................................
33 16 NON-CLINICAL TOXICOLOGY ........................................................................................... 33 17 SUPPORTING PRODUCT MONOGRAPHS.......................................................................... 40 PATIENT MEDICATION INFORMATION..................................................................................
• 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, pms-LOSARTAN-HCTZ is also contraindicated in patients with anuria, and in patients who are hypersensitive to other sulfonamide-derived drugs.
73m2) 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).
pms-LOSARTAN-HCTZ (Losartan Potassium and Hydrochlorothiazide) Page 5 of 49
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Hydrochlorothiazide in Canada.
Know a brand we are missing in Canada? Suggest a brand →
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.
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. 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.
pms-LOSARTAN-HCTZ (Losartan Potassium and Hydrochlorothiazide) Page 11 of 49 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 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 angle-closure glaucoma may include a history of sulphonamide or penicillin allergy.
Renal Renal Impairment:
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal functions have been reported in susceptible individuals. In patients whose renal function may […]
41 pms-LOSARTAN-HCTZ (Losartan Potassium and Hydrochlorothiazide) Page 4 of 49 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Hypertension: pms-LOSARTAN-HCTZ (losartan potassium and hydrochlorothiazide) is indicated for the treatment of essential hypertension in patients for whom combination therapy is appropriate.
pms-LOSARTAN-HCTZ is not indicated as the initial therapy for essential hypertension, except in patients with severe essential hypertension (Sitting DBP ≥ 110 mmHg) for whom the benefit of a prompt blood pressure reduction exceeds the risk of initiating combination therapy in these patients (see 4 DOSAGE AND ADMINISTRATION; 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 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Because of the hydrochlorothiazide component, pms-LOSARTAN-HCTZ is also contraindicated in patients with anuria, and in patients who are hypersensitive to other sulfonamide-derived drugs.
73m2) 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).
pms-LOSARTAN-HCTZ (Losartan Potassium and Hydrochlorothiazide) Page 5 of 49 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.
1 Special Populations). 1 Dosing Considerations • Dosage must be individualized. • The fixed combination is not for initial therapy, except for severe hypertension. • The dose of pms-LOSARTAN-HCTZ should be determined by the titration of the individual components.
5 mg, or one tablet 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 pms-LOSARTAN-HCTZ 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 pms-LOSARTAN-HCTZ 100 mg/25 mg once daily. The maximum dose is one tablet of pms- LOSARTAN-HCTZ 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 […]
+8 more