Irbesartan HCT BSS

Irbesartan HCT Sandoz . Presentations of 150 mg / 12.5 mg, 300 mg / 12.5 mg and 300 mg / 25 mg film-coated tablets. 150/300 mg of irbesartan and 12.5 / 25 mg of hydrochlorothiazide. Excipients with known effects: lactose monohydrate. Therapeutic indications: Treatment of essential hypertension. This combination of fixed dose is indicated in adult patients whose blood pressure is not adequately controlled with irbesartan or hydrochlorothiazide individually. Dose: Can be taken once a day, with or without food. The adjustment of the dose with the individual components (ie, irbesartan and hydrochlorothiazide) may be recommended. Irbesartan HCT Sandoz 150 mg / 12.5 mg can be administered to patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone. Irbesartan HCT Sandoz 300 mg / 12.5 mg can be administered in patients who are not sufficiently controlled with irbesartan 300 mg or with Irbesartan HCT Sandoz 150 mg / 12.5 mg. Irbesartan HCT Sandoz 300 mg / 25 mg can be administered in patients who are not sufficiently controlled with Irbesartan HCT Sandoz 300 mg / 12.5mg. Doses greater than 300 mg irbesartan / 25 mg hydrochlorothiazide once a day are not recommended. Irbesartan HCT Sandoz is not recommended for patients with severe renal dysfunction. It is not indicated for patients with severe hepatic impairment. It is not necessary to adjust the dose in elderly patients. It is not recommended for use in children and adolescents because safety and efficacy have not been established. Contraindications: Hypersensitivity to the active substances or to any of the excipients or to other substances derived from the sulfonamide. Pregnancy. Severe renal failure. Refractory hypokalemia, hypercalcemia. Severe hepatic insufficiency, biliary cirrhosis and cholestasis. The concomitant use of angiotensin receptor blockers (ARBs) - including irbesartan - or angiotensin-converting enzyme (ACE) inhibitors with aliskiren in patients with type 2 diabetes. Precautions for use: It has rarely been associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension. There is an increased risk of severe hypotension and renal failure when patients with bilateral renal artery stenosis or stenosis of the artery of a single functional kidney are treated with ACE inhibitors or with ARA-II. When irbesartan + hydrochlorothiazide is used in patients with impaired renal function, periodic monitoring of potassium, creatinine, and serum uric acid levels is recommended. The azotemia associated with diuretic thiazides may occur in patients with renal insufficiency. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease. As with other vasodilators, special caution is recommended in patients with aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Its use is not recommended in patients with primary aldosteronism, since they generally do not respond to antihypertensive drugs that act by inhibiting the renin-angiotensin system. Thiazide therapy may alter glucose tolerance, so it may be necessary to adjust the dose of insulin or oral hypoglycemics in diabetic patients Hyperuricemia may occur or manifest gout may be precipitated in certain patients receiving thiazide therapy. As for any patient treated with diuretics, the periodic determination of serum electrolytes should be performed at appropriate intervals. The combination of lithium and irbesartan + hydrochlorothiazide is not recommended. The hydrochlorothiazide contained in this medicine may cause false-positive test results in the doping control test. In patients whose vascular tone and renal function are primarily dependent on the activity of the renin-angiotensin-aldosterone system (eg, patients with severe CHF or underlying kidney disease, including renal artery stenosis), treatment with ACE inhibitors or with ARA- II affecting this system has been associated with acute hypotension, azotemia, oliguria or rarely acute renal failure. Sulfonamides or their derivatives can cause an idiosyncratic reaction that results in transient myopia and acute angle-closure glaucoma. Caution should be exercised when co-administering ARAs, including irbesartan + hydrochlorothiazide, with other SRAA blocking agents. An increased risk of non-melanoma skin cancer (NSCLC) [basal cell carcinoma (CBC) and squamous cell carcinoma (SCC)] has been observed with exposure to increasing cumulative doses of hydrochlorothiazide in two epidemiological studies, based on the Danish National Cancer Registry. The photosensitizing effects of HCT could act as a possible mechanism of NSCLC. Special precautions for excipients: This medicine contains lactose and sodium. Pregnancy and lactation: Due to the mechanism of action of angiotensin II antagonists, a risk to the fetus can not be excluded. As for any medication that also acts directly on the RAAS, irbesartan + hydrochlorothiazide should not be used during pregnancy. Because there is no information available on the use of irbesartan + hydrochlorothiazide during lactation, it is not recommended. Common side effects: Increases in blood urea nitrogen (BUN), creatinine and creatine kinase. Dizziness, nausea / vomiting, abnormal urination, fatigue. Adverse effects with unknown frequency: headache, tinnitus, cough, dyspepsia, dysgeusia, deterioration of renal function, arthralgia, myalgia, hyperkalemia, cases of hypersensitivity reactions such as angioedema, rash, urticaria, hepatitis, abnormal liver function, thrombocytopenia, reaction anaphylactic, including anaphylactic shock, non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), electrolyte imbalance (including hypokalemia and hyponatremia), hyperuricemia, glucosuria, hyperglycemia, increased cholesterol and triglycerides, cardiac arrhythmias, anemia aplastic, bone marrow depression, neutropenia / agranulocytosis, hemolytic anemia, leukopenia, vertigo, paresthesia, agitation, transient blurred vision, xanthopsia, acute myopia and acute secondary angle closure glaucoma, respiratory distress, pancreatitis, anorexia, diarrhea, constipation, gastric irritation, sialadenitis,
loss of appetite, weakness, muscle spasms, postural hypotension, fever, depression, sleep disorders. CDS Dec 2018.