TEVA-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.
Verbatim from this product's HC label. Tap a section to expand.
); Skin: psoriasis (and psoriasis exacerbation), toxic epidermal necrolysis; Non-melanoma skin cancer: Some pharmacoepidemiological studies have suggested a higher risk of squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) of the skin with increasing use of hydrochlorothiazide.
A systematic review and meta-analysis undertaken by Health Canada suggested, with important uncertainty, that the use of hydrochlorothiazide for several years (>3 years) could lead to: Product Monograph – TEVA-IRBESARTAN HCTZ Page 21 of 58 Unclassified / Non classifié • 122 additional cases (95% CI, from 112 to 133 additional cases) of SCC per 1000 treated patients compared with non-use of hydrochlorothiazide (meta-analysis of 3 observational studies); • 31 additional cases (95% CI, from 24 to 37 additional cases) of BCC per 1000 treated patients compared with non-use of hydrochlorothiazide (meta-analysis of 2 observational studies).
9. 2 Drug Interactions Overview Irbesartan does not substantially induce or inhibit the following isoenzymes: CYP 1A1, 1A2, 2A6, 2B6, 2D6, 2E1. There was no induction or inhibition of CYP 3A4. 4 Drug-Drug Interactions). , those identified as contraindicated).
Table 4 :
Established or Potential Drug-Drug Interactions Proper/Commonname Source of Evidence Effect Clinical comment Alcohol, barbiturates or narcotics C Potentiation of orthostatic hypotension may occur. Avoid alcohol, barbiturates or narcotics, especially with initiation of therapy.
Agents increasing Serum Potassium RCS Based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of irbesartan with potassium- sparing diuretics, potassium supplements, salt substitutes containing potassium or other potassium-raising medicinal products may lead to Product Monograph – TEVA-IRBESARTAN HCTZ Page 22 of 58 Unclassified / Non classifié Proper/Commonname Source of Evidence Effect Clinical comment increases in serum potassium, sometimes severe.
Such co- administration requires close monitoring of serum potassium. Concomitant thiazide diuretic use may attenuate any effect that irbesartan may have on serum potassium. Amphotericin B T Amphotericin B increases the risk of hypokalemia induced by thiazide diuretics Monitor serum potassium level.
g. g. repaglinide) CT Thiazide-induced hyperglycemia may compromise blood sugar control. Depletion of serum potassium augments glucose intolerance. May induce hypoglycemia. Irbesartan has the potential to inhibit OATP1B1. In a clinical study, co- administration of irbesartan and repaglinide, 300 mg irbesartan once daily for 4 days then followed by a single dose of 2 mg repaglinide, 1 hour after irbesartan (with consideration of the Tmax difference between the two drugs), increased the Cmax and AUC of repaglinide (substrate of OATP1B1) by Monitor glycemic control, supplement potassium if necessary, to maintain appropriate serum potassium levels.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dose adjustment of antidiabetic treatment such as repaglinide may be required (see WARNINGS AND PRECAUTIONS). 3-fold, respectively. g. guanethidine, methyldopa, beta-blockers, vasodilators, calcium channel blockers, diuretics, ACE inhibitors, ARB, and direct renin inhibitors).
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.
Antineoplastic drugs, including cyclophosphamide and methotrexate C Concomitant use of thiazide diuretics may reduce renal excretion of cytotoxic agents and enhance their myelosuppressive effects. Hematological status should be closely monitored in patients receiving this combination.
Dose adjustment of cytotoxic agents may be required. Beta-blockers C The hyperglycaemic effect of beta-blockers may be enhanced by thiazides. , cholestyramine CT Bile acid sequestrants bind thiazide diuretics in the gut and impair gastrointestinal absorption by 43-85%.
Administration of thiazide 4 hours after a bile acid sequestrant reduced absorption of hydrochlorothaizide by 30- 35%. Give thiazide 2-4 hours before or 6 hours after the bile acid sequestrant. Maintain a consistent sequence of administration.
Monitor blood pressure, and increase dose of thiazide, if necessary. Calcium and vitamin D supplements C Thiazides decrease renal excretion of calcium and increase calcium release from bone. Monitor serum calcium, especially with concomitant use of high doses of calcium Product Monograph – TEVA-IRBESARTAN HCTZ Page 24 of 58 Unclassified / Non classifié Proper/Commonname Source of Evidence Effect Clinical comment supplements.
Dose reduction or withdrawal of calcium and/or vitamin D supplements may be necessary. Carbamazepine C Carbamazepine may cause clinically significant hyponatremia. Concomitant use with thiazide diuretics may potentiate hyponatremia. Monitor serum sodium levels.
Use with caution. If possible, another class of diuretics […]