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PRO-IRBESARTAN-HCTZ is a brand name for Irbesartan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: and 14 CLINICAL TRIALS). The dosage may be increased after 2 - 4 weeks of therapy to a maximum of 300/25 mg once daily. PRO-IRBESARTAN- HCTZ is not recommended as initial therapy in patients with intravascular volume depletion (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). DOSE ADJUSTMENT IN SPECIAL POPULATION…
Verbatim from this product's HC label. Tap a section to expand.
). • as initial therapy 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 14 CLINICAL TRIALS and 4 DOSAGE AND ADMINISTRATION).
PRO-IRBESARTAN-HCTZ is not indicated as initial therapy in patients with mild to moderate essential hypertension. 1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of PRO-IRBESARTAN-HCTZ in patients <18 years of age have not been established.
1 Special Populations). 1 Special Populations). 2. Contraindications PRO-IRBESARTAN-HCTZ 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
5 Post- For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669). PRO-IRBESARTAN-HCTZ (Irbesartan and hydrochlorothiazide) Page 8 of 52 Market Adverse Reactions).
The photosensitizing action of hydrochlorothiazide may be a possible mechanism for NMSC (see 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity). 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). Cardiovascular Hypotension Occasionally, symptomatic hypotension has occurred after administration of irbesartan, 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 (see 4 DOSAGE AND ADMINISTRATION).
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 PRO-IRBESARTAN-HCTZ in combination with aliskiren-containing drugs is contraindicated in these patients (see 2 CONTRAINDICATIONS). The use of PRO-IRBESARTAN-HCTZ in combination with an ACE inhibitor is contraindicated in patients with diabetic nephropathy (see 2 CONTRAINDICATIONS).
1 Special Populations). 1 Special Populations). 2. Contraindications PRO-IRBESARTAN-HCTZ 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. • Patients who are hypersensitive to other sulphonamide-derived drugs, because of the hydrochlorothiazide component. • Patients with anuria. 1 Special Populations).
1 Special Populations). 73m2) (7 see WARNINGS AND PRECAUTIONS, Renal, and 9 DRUG INTERACTIONS). • Combination with angiotensin converting enzyme (ACE) inhibitors in patients with diabetic nephropathy (see 7 WARNINGS AND PRECAUTIONS, Renal, and 9 DRUG INTERACTIONS).
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (due to lactose component of the PRO-IRBESARTAN-HCTZ tablets). PRO-IRBESARTAN-HCTZ (Irbesartan and hydrochlorothiazide) Page 5 of 52 3.
Serious Warnings and Precautions Box When used in pregnancy, angiotensin receptor (AT1) blockers (ARB) can cause injury and even death of the developing fetus. 1 Special Populations). 4. 1 Dosing Considerations • Dosage must be individualized.
• The fixed combination is not for initial therapy except for severe hypertension. • The dose of PRO-IRBESARTAN-HCTZ (irbesartan/hydrochlorothiazide) should be determined by the titration of the individual components. • Use of PRO-IRBESARTAN-HCTZ in patients with liver impairment is not advisable.
2 Recommended Dose and Dosage Adjustment). 5 mg or 300/25 mg once daily may be substituted if the doses on which the patient was stabilized are the same as those in the fixed combination. Irbesartan Monotherapy The recommended dose of irbesartan is 150 mg once daily.
). The use of PRO-IRBESARTAN-HCTZ in combination with an ACE inhibitor is contraindicated in patients with diabetic nephropathy (see 2 CONTRAINDICATIONS). Further, co-administration of ARBs, including the irbesartan component of PRO-IRBESARTAN-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.
Driving and Operating Machinery The effect of irbesartan on the ability to drive and use machinery has not been studied, but based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability. When driving vehicles or PRO-IRBESARTAN-HCTZ (Irbesartan and hydrochlorothiazide) Page 9 of 52 operating machinery, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
Endocrine and Metabolism Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalemia, hyponatremia and hypochloremic alkalosis). Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
Calcium excretion is decreased by thiazides which may cause intermittent and slight elevation of serum calcium. , vitamin D therapy) is prescribed, serum calcium levels should be monitored, and calcium dosage adjusted accordingly. Marked hypercalcemia suggests the possibility of hyperparathyroidism.
Thiazides should be discontinued before carrying out tests for parathyroid function. Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesemia. Hyperuricemia may occur, and an acute attack of gout may be precipitated in certain patients receiving thiazide therapy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Further, co-administration of ARBs, including the irbesartan component of PRO-IRBESARTAN-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.
Driving and Operating Machinery The effect of irbesartan on the ability to drive and use machinery has not been studied, but based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability. When driving vehicles or PRO-IRBESARTAN-HCTZ (Irbesartan and hydrochlorothiazide) Page 9 of 52 operating machinery, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
Endocrine and Metabolism Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalemia, hyponatremia and hypochloremic alkalosis). Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
Calcium excretion is decreased by thiazides which may cause intermittent and slight elevation of serum calcium. , vitamin D therapy) is prescribed, serum calcium levels should be monitored, and calcium dosage adjusted accordingly. Marked hypercalcemia suggests the possibility of hyperparathyroidism.
Thiazides should be discontinued before carrying out tests for parathyroid function. Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesemia. Hyperuricemia may occur, and an acute attack of 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 serum PBI levels without signs of thyroid disturbance. PRO-IRBESARTAN-HCTZ may induce hypoglycemia, particularly in patients treated for diabetes.
Therefore, dose adjustment of antidiabetic treatment such as repaglinide or insulin may be required (see 8 ADVERSE REACTIONS). Insulin requirements in diabetic patients may be altered and latent diabetes mellitus may become manifest during thiazide diuretic therapy.
Gastrointestinal Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, including Irbesartan/hydrochlorothiazide. These patients presented with abdominal pain, (with or without nausea, vomiting and diarrhoea).
Symptoms resolved after discontinuation of angiotensin II receptor antagonists. Intestinal angioedema should be included in the differential diagnosis of patients treated with angiotensin II receptor antagonists presenting with abdominal pain.
If intestinal angioedema is diagnosed, PRO-IRBESARTAN-HCTZ should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred. Hepatic/Biliary/Pancreatic […]
In patients whose blood pressure is not adequately controlled, the daily dose may be increased to 300 mg. 5 mg once daily (see 1 INDICATIONS and 14 CLINICAL TRIALS). The dosage may be increased after 2 - 4 weeks of therapy to a maximum of 300/25 mg once daily.
PRO-IRBESARTAN- HCTZ is not recommended as initial therapy in patients with intravascular volume depletion (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). DOSE ADJUSTMENT IN SPECIAL POPULATION Diuretic Treated Patients In patients receiving diuretics, irbesartan 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 2 - 3 days prior to the administration of irbesartan to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, and 9 DRUG INTERACTIONS). If this is not possible because of the patient’s condition, irbesartan should be administered with caution and the blood pressure monitored closely.
The recommended starting dose of irbesartan is 75 mg once daily in hypovolemic patients (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). Thereafter, the dosage should be adjusted according to PRO-IRBESARTAN-HCTZ (Irbesartan and hydrochlorothiazide) Page 6 of 52 the individual response of the patient.
Geriatric No initial dosage adjustment in irbesartan is necessary for most elderly patients. 1 Special Populations). Renal Insufficiency No initial dosage adjustment in irbesartan is generally necessary in patients with renal impairment, although due to the apparent greater sensitivity of hemodialysis patients, an initial dose of 75 mg is recommended in this group of patients.
The usual regimens of therapy with PRO-IRBESARTAN-HCTZ 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 PRO-IRBESARTAN-HCTZ is not recommended.
Hepatic Insufficiency No initial dosage adjustment in irbesartan is generally necessary in patients with mild to moderate hepatic impairment. Since thiazide diuretics may precipitate hepatic coma, the use of a fixed combination product such as PRO-IRBESARTAN-HCTZ is not advisable.
4 Administration PRO-IRBESARTAN-HCTZ may be administered with or without food, however it should be taken consistently with respect to food intake. 5 Missed Dose Patients should be instructed to take PRO-IRBESARTAN-HCTZ at the next scheduled dose and not take two doses at the same time if they miss a dose.
5. Overdosage No specific information is available on the treatment of overdosage with PRO-IRBESARTAN-HCTZ (irbesartan/hydrochlorothiazide). The patient should be closely monitored, and the treatment should be symptomatic and […]
Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. Thiazides may decrease serum PBI levels without signs of thyroid disturbance. PRO-IRBESARTAN-HCTZ may induce hypoglycemia, particularly in patients treated for diabetes.
Therefore, dose adjustment of antidiabetic treatment such as repaglinide or insulin may be required (see 8 ADVERSE REACTIONS). Insulin requirements in diabetic patients may be altered and latent diabetes mellitus may become manifest during thiazide diuretic therapy.
Gastrointestinal Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, including Irbesartan/hydrochlorothiazide. These patients presented with abdominal pain, (with or without nausea, vomiting and diarrhoea).
Symptoms resolved after discontinuation of angiotensin II receptor antagonists. Intestinal angioedema should be included in the differential diagnosis of patients treated with angiotensin II receptor antagonists presenting with abdominal pain.
If intestinal angioedema is diagnosed, PRO-IRBESARTAN-HCTZ should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred. Hepatic/Biliary/Pancreatic Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations in fluid and electrolyte balance may precipitate hepatic coma.
Immune Hypersensitivity Reaction Sensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma. PRO-IRBESARTAN-HCTZ (Irbesartan and hydrochlorothiazide) Page 10 of 52 Systemic Lupus Erythematosus Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
Ophthalmologic Choroidal effusion, Secondary Acute Angle-Closure Glaucoma and/or Acute Myopia Hydrochlorothiazide is a sulfonamide. 5 Post-Market Adverse Reactions). 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 sulfonamide or penicillin allergy. Renal Azotemia Azotemia may be precipitated or increased by hydrochlorothiazide. Cumulative effects of the drug may develop in patients with impaired renal function.
If increasing azotemia and oliguria occur during treatment of severe progressive renal impairment the diuretic should be discontinued. Renal Impairment As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAAS), changes in renal function have been seen in susceptible individuals.
In patients whose renal function may depend on the activity of the RAAS, such as patients with bilateral renal artery stenosis, unilateral renal artery stenosis to a solitary kidney, or severe congestive heart failure, treatment with agents that inhibit this system has been associated with oliguria, progressive azotemia, and rarely, acute renal failure and/or death.
In susceptible patients, concomitant diuretic use may further increase risk. 73m2) (see 2 CONTRAINDICATIONS and 9 DRUG INTERACTIONS). The use of ARBs including the irbesartan component of PRO-IRBESARTAN-HCTZ in combination with an ACE inhibitor is contraindicated in patients with diabetic […]