Product Overview
[Drug Name]
Generic Name: Irbesartan and Hydrochlorothiazide Dispersible Tablets
Trade Name: Taishikang Irbesartan and Hydrochlorothiazide Dispersible Tablets (28 Tablets)
Pinyin Full Code: TaiShiKangEBeiShaTanQingLZuoZuoFenSanPian28Pian
[Main Ingredients]
This product is a combination preparation. Each tablet contains 150mg of irbesartan and 12.5mg of hydrochlorothiazide.
[Appearance]
This product is a white to off-white tablet.
[Indications/Main Functions]
For the treatment of essential hypertension. This fixed-dose combination is used to treat patients whose blood pressure is not effectively controlled with irbesartan or hydrochlorothiazide alone.
[Specifications]
28 tablets
[Dosage and Administration]
One tablet once daily. Take on an empty stomach or with a meal. It is indicated for the treatment of patients whose blood pressure is not effectively controlled with irbesartan or hydrochlorothiazide alone. Patients are recommended to adjust their dosage of the individual components (i.e., irbesartan or hydrochlorothiazide). This combination is indicated for patients whose blood pressure cannot be effectively controlled with hydrochlorothiazide or irbesartan 150 mg alone. Once-daily doses greater than irbesartan 300 mg/hydrochlorothiazide 25 mg are not recommended. If necessary, this product can be used in combination with other antihypertensive drugs (see [Drug Interactions]).
[Adverse Reactions]
See the package insert for details.
[Contraindications]
During the 4th to 9th month of pregnancy (see [Use in Pregnant and Lactating Women]). During lactation (see [Use in Pregnant and Lactating Women]). Patients with known hypersensitivity to the active ingredient or any of the excipients in this product, or to other sulfonamide derivatives (hydrochlorothiazide is a sulfonamide). The following contraindications are associated with hydrochlorothiazide: severe renal impairment (creatinine clearance <30 ml/min); refractory hypokalemia, hypercalcemia; severe hepatic impairment, biliary cirrhosis, and cholestasis.
[Precautions]
Hypotension - Volume Depletion: This combination is rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension. Symptomatic hypotension may occur in patients with volume and sodium depletion due to the use of potent diuretics, severe salt restriction in the diet, or diarrhea and vomiting. These conditions should be corrected before treatment with this combination. Renal Artery Stenosis - Renovascular Hypertension: Patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney may be at risk of severe hypotension and renal insufficiency when treated with angiotensin-converting enzyme inhibitors or angiotensin I receptor antagonists. Although this condition has not been observed in studies with this product, this effect should be considered during use. Renal Impairment and Kidney Transplantation: When this product is used in patients with renal impairment, regular monitoring of serum potassium, creatinine, and uric acid is recommended. There is no experience with the use of this product in patients who have recently undergone renal transplantation. This product should not be used in patients with severe renal insufficiency (creatinine clearance <30 ml/min, see [Contraindications]). Thiazide diuretics may cause azotemia in patients with renal impairment. No dose adjustment is required for patients with renal impairment and creatinine clearance ≥30 ml/min. However, caution should be exercised in patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min but <60 ml/min). Hepatic Impairment: Because minor alterations in fluid and electrolyte balance may precipitate hepatic coma in patients with hepatic impairment, caution should be exercised when using thiazide diuretics in such patients. There is no experience with the use of this combination in patients with hepatic impairment. Aortic and mitral stenosis, hypertrophic obstructive cardiomyopathy: As with other vasodilators, caution should be exercised in patients with aortic and mitral stenosis and hypertrophic obstructive cardiomyopathy. Primary Aldosteronism: Patients with primary aldosteronism generally do not respond to antihypertensive drugs that inhibit the renin-vasodilator system, so this combination is not recommended for these patients. Metabolic and Endocrine Effects: Thiazide diuretic therapy may impair glucose tolerance, and diabetic patients may require adjustments in insulin and oral hypoglycemic medication doses. Symptoms of occult diabetes mellitus may develop during thiazide diuretic therapy. Increased cholesterol and triglyceride levels have been associated with thiazide diuretic therapy. However, at the 12.5 mg dose contained in the combined formulation, this effect is minimal or absent. Hyperuricemia and even gout may occur in some patients receiving thiazide diuretics. Electrolyte Abnormalities: As with any patient receiving diuretic therapy, serum electrolytes should be measured regularly. Thiazide diuretics, including hydrochlorothiazide, can cause fluid or electrolyte abnormalities (hypokalemia, hyponatremia, and hypochloremic alkalosis). Signs of fluid or electrolyte abnormalities include dry mouth, thirst, weakness, lethargy, drowsiness, irritability, muscle cramps and pain, muscle fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting. Thiazide diuretics may induce hypokalemia, but coadministration with irbesartan can reduce diuretic-induced hypokalemia. Hypokalemia is most likely to occur in patients with cirrhosis, those with significant diuretic effects, those taking inadequate oral electrolytes, and those taking concomitant corticosteroids or ACTH. Conversely, irbesartan in this product may induce hyperkalemia, particularly in patients with renal impairment and/or heart failure and diabetes mellitus. Appropriate serum concentration monitoring is recommended in these patients. Potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes should be used with caution when coadministered with this product (see Drug Interactions). There is no evidence that irbesartan will reduce or prevent diuretic-induced hyponatremia. Decreases in blood chloride are generally mild and do not require treatment. Thiazide diuretics may reduce renal calcium excretion, causing intermittent, mild elevations in patients without known abnormalities of calcium metabolism. Significant hypercalcemia suggests underlying hyperparathyroidism. Thiazide diuretics should be discontinued when parathyroid function tests are being performed. Thiazide diuretics have been shown to increase magnesium excretion and may cause hypomagnesemia. Antistimulant Testing: The hydrochlorothiazide in this product may cause positive antistimulant testing results. General Precautions: In patients whose vascular tone and renal function depend primarily on the activity of the renin-angiotensin-aldosterone system (such as those with severe congestive heart failure or renal disease, including renal artery stenosis), treatment with angiotensin-converting enzyme inhibitors or angiotensin I receptor antagonists may cause acute hypotension, azotemia, oliguria, or rarely, acute renal failure. As with any antihypertensive drug, excessive blood pressure reduction in patients with ischemic cardiomyopathy or ischemic cardiovascular disease may lead to myocardial infarction or stroke. Hypersensitivity reactions to hydrochlorothiazide can occur in patients with or without a history of allergies or asthma, but those with such a history are more susceptible. Exacerbations or activation of systemic lupus erythematosus have been reported in patients taking thiazide diuretics. This combination is not recommended during the first trimester of pregnancy. Effects on Driving and Operating Machines: The effects of this product on driving and operating machines have not been studied. However, based on its pharmacodynamic properties, it is unlikely to affect these abilities. The potential for dizziness and fatigue during antihypertensive therapy should be considered when driving or operating machines. Athletes should use this product with caution.
