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OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE 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: OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE (olmesartan medoxomil and hydrochlorothiazide tablets) is indicated for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate. OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE is not indicated for initial therapy (see 4…
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 • OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any nonmedicinal ingredient, or component of the container.
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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. 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). , those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE. 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 OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE in combination with aliskiren-containing drugs is contraindicated in these patients (see 2 CONTRAINDICATIONS). Further, coadministration of ARBs, including the “olmesartan medoxomil” component of OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE, 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.
2 Breast-feeding) 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 OLMESARTAN MEDOXOMIL / 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 OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE should be determined by the titration of the individual components. 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 OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE.
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 CLINICAL PHARMACOLOGY). The dose OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE 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). If up-titration to the maximum dose of 40 mg/25 mg daily is required, blood pressure should be closely monitored (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
Hepatic Impairment:
No adjustment of dosage is required for patients with mild hepatic impairment. 5 mg olmesartan medoxomil-hydrochlorothiazide daily should not be 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.
). Further, coadministration of ARBs, including the “olmesartan medoxomil” component of OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE, 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.
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 electrolyte 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.
PrOLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE (Olmesartan Medoxomil and Hydrochlorothiazide Tablets) Page 10 of 41 Protected B / Protégé B Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy.
OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE 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.
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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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 electrolyte 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.
PrOLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE (Olmesartan Medoxomil and Hydrochlorothiazide Tablets) Page 10 of 41 Protected B / Protégé B Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy.
OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE 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 result in hypomagnesemia. Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy. 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 […]
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 OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE is not recommended.
, patients treated with diuretics, particularly those with impaired renal function), OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE should be initiated under close medical supervision and consideration should be given to use of 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).
If up-titration to the maximum dose of 40 mg daily is required, blood pressure should be closely monitored (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions). • Hepatic Impairment: No adjustment of dosage is required for patients with mild hepatic impairment.
5 mg olmesartan medoxomil hydrochlorothiazide daily […]
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 result in hypomagnesemia. Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy. 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 parathyroid function. Thiazides may decrease PBI levels without signs of thyroid disturbance. Hyperglycemia may occur with thiazide diuretics. Insulin or oral hypoglycemic agents requirements in diabetic patients may be altered and latent diabetes mellitus may become manifest during thiazide diuretic therapy.
Gastrointestinal Sprue-like Enteropathy:
Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan and no other etiology is identified, discontinue OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE.
Hepatic/Biliary/Pancreatic No adjustment of dosage is required for patients with mild hepatic impairment. 5 mg PrOLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE (Olmesartan Medoxomil and Hydrochlorothiazide Tablets) Page 11 of 41 Protected B / Protégé B olmesartan medoxomil-hydrochlorothiazide daily should not be 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). 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.
Ophthalmologic Acute Myopia and Secondary Angle-Closure Glaucoma:
Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity 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 sulfonamide or penicillin allergy.
Renal Impaired Renal Function:
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin- […]
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