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GLN-OLMESARTAN 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: GLN-Olmesartan HCTZ (Olmesartan Medoxomil and Hydrochlorothiazide) is indicated for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate. GLN-Olmesartan HCTZ is not indicated for initial therapy (see 4 DOSAGE AND ADMINISTRATION). 1.1 Pediatrics Pediatrics…
Verbatim from this product's HC label. Tap a section to expand.
). 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): Reported clinical experience has not identified differences in responses between elderly and younger patients, however, greater sensitivity of some older individuals cannot be ruled out (see 4 DOSAGE AND ADMINISTRATION).
2 CONTRAINDICATIONS GLN-Olmesartan HCTZ (Olmesartan medoxomil and hydrochlorothiazide) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation , including any non-medicinal ingredient, or component of the container.
For a complete listing, see
6 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. 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.
6 Post-Market Adverse Reactions). , those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with GLN- Olmesartan HCTZ. Treatment should start 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 . If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline (see 4 DOSAGE AND ADMINISTRATION).
When electrolyte and fluid imbalances have been corrected, therapy usually can be continued without difficulty. A transient hypotensive response is not a contraindication to further treatment. - Valvular Stenosis: there is concern on theoretical grounds that patients with aortic stenosis might be at a particular risk of decreased coronary perfusion, because they do not develop as much afterload reduction.
73m2). Therefore, the use of GLN-Olmesartan HCTZ in combination with aliskiren-containing drugs is contraindicated in these patients (see 2 CONTRAINDICATIONS). Further, co-administration of ARBs, including the “olmesartan medoxomil” component of GLN-Olmesartan HCTZ, with other agents blocking the RAS, such as ACE inhibitors or aliskiren-containing drugs, is generally not recommended in other patients, since such treatment has been associated with an increased incidence of severe hypotension, renal failure and hyperkalemia.
, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal, and 9 DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin-System (RAS) with ARBs, ACE inhibitors or aliskiren-containing drugs). 2 Breast-feeding) PrGLN-Olmsesartan HCTZ (Olmesartan medoxomil and Hydrochlorothiazide Tablets) Page 5 of 44 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 GLN-Olmesartan HCTZ (olmesartan medoxomil and hydrochlorothiazide) is not for initial therapy. The dosage must be individualized. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
The dose of GLN-Olmesartan HCTZ should be determined by the titration of the individual components. 2 Recommended Dose and Dosage Adjustment Replacement Therapy Once the patient has been stabilized on the individual components as described below, GLN- Olmesartan HCTZ may be substituted if the doses on which the patient was stabilized are the same as those in the fixed combination.
5 mg and 40 mg/25 mg. A patient whose blood pressure is inadequately controlled by olmesartan medoxomil or hydrochlorothiazide alone may be switched to once daily GLN-Olmesartan HCTZ. Dosage should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.
5 mg to 40 mg/25 mg (see 10 ACTION AND CLINICAL PHARMACOLOGY). The dose of GLN-Olmesartan HCTZ is one tablet once daily. More than one tablet daily is not recommended.
Elderly:
No adjustment of dose is generally required in elderly patients (see below for dose recommendation in patients with renal impairment). 3 Pharmacokinetics, Special Populations and Conditions).
GLN-Olmesartan HCTZ (Olmesartan medoxomil and hydrochlorothiazide) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation , including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Because of the hydrochlorothiazide component, GLN-Olmesartan HCTZ (olmesartan medoxomil and hydrochlorothiazide) is 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 ARBs, ACE inhibitors or aliskiren-containing drugs).
2 Breast-feeding) PrGLN-Olmsesartan HCTZ (Olmesartan medoxomil and Hydrochlorothiazide Tablets) Page 5 of 44
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Endocrine and Metabolism Periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals. All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis and hypokalemia.
Serum and urine electrolyte determinations are important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and el ectrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting.
Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy. GLN-Olmesartan HCTZ contains olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalaemia.
Monitor serum electrolytes periodically. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. , increased ventricular irritability). Although any chloride deficit during thiazide therapy is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic alkalosis.
Dilutional hyponatremia may occur in edematous patients in hot weather. Appropriate therapy is water restriction rather than administration of salt, except in rare instances, when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice.
Thiazides have been shown to increase the urinary excretion of magnesium; this may re sult in hypomagnesemia. Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy. PrGLN-Olmsesartan HCTZ (Olmesartan medoxomil and Hydrochlorothiazide Tablets) Page 11 of 44 Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
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 […]
Hepatic Impairment:
No adjustment of dosage is required for patients with mild hepatic impairment. 5 mg olmesartan medoxomil-hydrochlorothiazide daily should not be PrGLN-Olmsesartan HCTZ (Olmesartan medoxomil and Hydrochlorothiazide Tablets) Page 6 of 44 exceeded.
Care should be exercised in patients with liver disease, especially in those patients with biliary obstructive disorders, as the majority of olmesartan is eliminated in the bile. 3 Pharmacokinetics). 5 mg once daily. The use of olmesartan medoxomil in patients with severe renal impairment is not recommended, since there is only limited experience in this patient group.
In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so GLN-Olmesartan HCTZ is not recommended. , patients treated with diuretics, particularly those with impaired renal function), GLN-Olmesartan HCTZ should be initiated under close medical supervision and consideration should be given to use o f a lower starting dose (see 7 WARNINGS AND PRECAUTIONS, Renal).
The side effects (see 7 WARNINGS AND PRECAUTIONS) of olmesartan medoxomil are generally rare and independent of dose; those of hydrochlorothiazide are most typically dose- dependent (primarily hypokalemia). , pancreatitis) do occur with hydrochlorothiazide.
Therapy with any combination of olmesartan medoxomil and hydrochlorothiazide will be associated with both sets of dose-independent side effects. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
Olmesartan Medoxomil Monotherapy The usual recommended starting dose of olmesartan medoxomil monotherapy is 20 mg once daily in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40 mg.
Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. Elderly: No adjustment of dose is generally required in elderly patients (see below for dose recommendation in patients with renal impairment).
3 Pharmacokinetics, Special Populations and Conditions). Hepatic Impairment: No adjustment of dosage is required for patients with mild hepatic impairment. Data is lacking with respect to the use of 20 mg and 40 mg olmesartan medoxomil; therefore, a lower starting dose is recommended […]
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