Product Overview
[Drug Name]
Generic Name: Irbesartan Tablets
Trade Name: NuoDe Pharmaceuticals Irbesartan Tablets 0.15g*14 Tablets
Pinyin Full Code: NuoDeYaoYe EBeiShaTanPian 0.15g*14 Tablets
[Main Ingredient]
The main ingredient of this product is irbesartan, whose chemical name is: 2-butyl-3-[4-[2-(1H-tetrazol-5-yl)phenyl]benzyl]-1,3-diazaspiro-[4.4]non-1-en-4-one. Molecular Formula: C25H28N6O. Molecular Weight: 428.54
[Properties]
This product is a white or off-white film-coated tablet. After removing the coating, it appears white or off-white.
[Indications/Main Functions]
Treatment of essential hypertension. Treatment of type 2 diabetic nephropathy with hypertension.
[Precautions]
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): Compared with single-agent therapy, dual blockade of the RAAS increases the risk of hypotension, hyperkalemia, and renal dysfunction. Therefore, concomitant use of this drug with angiotensin-converting enzyme inhibitors (ACEIs) or aliskiren is not recommended. This drug is contraindicated in patients with diabetes or moderate to severe renal impairment (GFR less than 60 ml/min/1.73 m²). Concomitant use of this drug with aliskiren is contraindicated. This drug should not be used in combination with angiotensin-converting enzyme inhibitors (ACEIs) in patients with diabetic nephropathy. General Precautions: For 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 ACE inhibitors or angiotensin II receptor antagonists that affect this system has been associated with acute hypotension, azotemia, oliguria, and, rarely, acute renal failure. As with any antihypertensive medication, excessive blood pressure reduction in patients with ischemic cardiomyopathy or ischemic cardiovascular disease may result in myocardial infarction or stroke. Fetal/neonatal morbidity and mortality: Although there is no experience with the use of this drug in pregnant women, in utero exposure to ACE inhibitors during the second and third trimesters has been reported to result in harm and mortality to the developing fetus. Therefore, like any drug that directly acts on the renin-angiotensin aldosterone system, this drug should not be used during pregnancy. If pregnancy is discovered during treatment, this drug must be discontinued as soon as possible. Hypotension-depleted patients: In hypertensive patients without other comorbidities. This drug may rarely cause hypotension: Similar to ACE inhibitors, in patients with sodium depletion/depletion, such as those receiving high-dose diuretics and/or salt restriction or undergoing hemodialysis. Symptomatic hypotension may occur; before initiating irbesartan therapy, correct volume depletion and/or sodium depletion or consider a lower starting dose. Renovascular Hypertension: Patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are at increased risk of severe hypotension and renal insufficiency when using drugs that affect the renin-angiotensin-aldosterone system. Increases in serum creatinine and/or blood urea nitrogen have been reported. Although there is no experience with irbesartan in patients with unilateral or bilateral renal artery stenosis, similar effects with angiotensin II receptor antagonists should be considered. Renal Impairment and Kidney Transplantation: When irbesartan is used in patients with impaired renal function, regular monitoring of serum potassium and creatinine is recommended. There is no experience with irbesartan in patients with recent renal transplantation. Hypertensive Patients with Type 2 Diabetes and Kidney Disease: Analyses of studies in patients with advanced renal disease have shown inconsistent effects of irbesartan on renal and cardiovascular events across all subgroups. In particular, women and non-white populations appear to benefit less from irbesartan. Hyperkalemia: As with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalemia may occur with the use of this drug, particularly in patients with renal impairment, significant proteinuria due to diabetic nephropathy, and/or heart failure. Close monitoring of serum potassium levels is recommended in these patients. Lithium: Concomitant use of this drug with lithium is not recommended. Aortic and mitral stenosis, hypertrophic obstructive cardiomyopathy: As with other vasodilators, caution should be exercised when using this drug 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-angiotensin system. Therefore, this drug is not recommended for these patients. Race: As with angiotensin-converting enzyme inhibitors, irbesartan and other angiotensin antagonists are significantly less effective in lowering blood pressure in blacks than in non-blacks, possibly due to the higher prevalence of low renin levels in hypertensive patients in blacks. Effects on Ability to Drive and Use Machines: Based on its pharmacodynamic properties, irbesartan is unlikely to affect the ability to drive and use machines. During treatment, dizziness or drowsiness should be considered when driving or using machines. Lactose: Patients with rare hereditary disorders of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not use this drug. Pediatric Population: Irbesartan has been studied in pediatric patients aged 6 to 16 years; current data are insufficient to support expanded use in children until further data are available (see Adverse Reactions, Pharmacology and Toxicology, and Pharmacokinetics). Use in patients with psoriasis or a history of psoriasis: Careful consideration should be given as this drug may exacerbate psoriasis.
[Drug Interactions]
Known hypersensitivity to the components of this product. Pregnancy (4th to 9th month). Lactation. Patients with diabetes or moderate to severe renal impairment (GFR less than 60 ml/min/1.73 m²) should not use this product in combination with aliskiren. Patients with diabetic nephropathy should not use this product in combination with angiotensin-converting enzyme inhibitors (ACEIs).
[Specifications]
0.15g x 14 tablets
[Dosage and Administration]
The recommended initial and maintenance dose is 150 mg daily. Dietary considerations have no impact on dosing. Generally, 150 mg of irbesartan once daily provides better 24-hour blood pressure control than 75 mg. However, for certain patients, particularly those undergoing hemodialysis and those over 75 years of age, a 75 mg initial dose may be considered. For patients whose blood pressure is not effectively controlled with 150 mg of irbesartan once daily, the dose can be increased to 300 mg, or other antihypertensive medications can be added. Adding a diuretic, such as hydrochlorothiazide, has been shown to have an additive effect. For hypertensive patients with type 2 diabetes, the initial treatment dose should be 150 mg once daily, increasing to 300 mg once daily as a maintenance dose for renal disease. Clinical studies have demonstrated that Ambroxol® benefits the kidneys in hypertensive patients with type 2 diabetes. In studies, irbesartan was added to other antihypertensive medications, if necessary, to lower patients' blood pressure to target values. Renal Impairment: No dose adjustment is required for patients with renal impairment, but a lower initial dose (75 mg) may be considered for patients undergoing hemodialysis. Hypovolemia: Patients with hypovolemia and/or sodium should correct their hypovolemia before using Ambroxol®. Hepatic Impairment: No dose adjustment is required for patients with mild to moderate hepatic impairment. There is currently no clinical experience in patients with severe hepatic impairment. Elderly Patients: Although a starting dose of 75 mg may be considered for patients over 75 years of age, no dose adjustment is generally required for elderly patients. Pediatric Population: The safety and efficacy of Ambroxol® in children aged 0-18 years have not been established. No dosage recommendation can be made based on available data.
[Adverse Reactions]
The incidence of the following adverse reactions is defined as follows: Very common (≥1/10); Common (≥1/100); Uncommon (≥1/1000, <1/100); Rare (≥1/10,000, <1/1000); Very rare (<1/10,000). For hypertension: In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan group (56.2%) and the placebo group (56.5%). The incidence of treatment discontinuation due to clinical or laboratory adverse events was lower in the irbesartan group (3.3%) than in the placebo group (4.5%). Adverse events were not related to dose (within the recommended dose range), gender, age, race, or treatment duration. In placebo-controlled trials, 1,965 patients received irbesartan and the following adverse drug reactions were reported: Nervous system disorders - Common: dizziness; Infrequent: postural dizziness Cardiac disorders - Infrequent: tachycardia, edema Vascular disorders - Infrequent: flushing Respiratory, chest, diaphragmatic disorders - Infrequent: cough Gastrointestinal disorders - Common: nausea, vomiting; Infrequent: diarrhea, dyspepsia, heartburn Reproductive system and breast disorders - Infrequent: sexual dysfunction Systemic disorders and administration site conditions - Common: fatigue; Infrequent: chest pain Examination: Common: Significant increases in plasma creatine kinase levels were commonly observed in the irbesartan treatment group (1.7%), but none of the increases were related to clinically recognizable skeletal muscle events. Hypertension and Type 2 Diabetes with Renal Disease: In addition to the adverse drug reactions mentioned under Hypertension, orthostatic dizziness and orthostatic hypotension were reported in 0.5% (i.e., rare) of diabetic hypertensive patients with microalbuminuria and normal renal function, exceeding the placebo group. In diabetic hypertensive patients with chronic renal insufficiency and significant proteinuria, the following adverse reactions were reported in >2% of patients, exceeding the placebo group. Neurologic Disorders - Very Common: Dizziness; Common: Orthostatic Dizziness Vascular Disorders - Common: Orthostatic Hypotension Skeletal Muscle, Connective Tissue, and Bone Disorders - Common: Skeletal Muscle Pain Investigations: Hyperkalemia occurred more frequently in diabetic patients treated with irbesartan than in those treated with placebo. In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalemia (≥5.5 mEq/L) occurred in 29.4% (very common) of patients taking irbesartan 300 mg compared to 22% of those taking placebo. Among diabetic hypertensive patients with chronic renal insufficiency and significant proteinuria, hyperkalemia (≥5.5 mEq/L) occurred in 46.3% of patients receiving irbesartan 300 mg (very common), compared to 26.3% of patients receiving placebo. Among hypertensive patients with progressive diabetic nephropathy treated with irbesartan, hemoglobin decreases occurred in 1.7% of patients (common), but these were not clinically significant. In addition, the following adverse reactions have been reported since the marketing of irbesartan: Immune system disorders - very rare: As with other angiotensin II receptor antagonists, cases of hypersensitivity reactions such as rash, urticaria, angioedema, anaphylaxis, and anaphylactic shock have been reported. Blood and lymphatic system disorders - thrombocytopenia. Skin and subcutaneous tissue disorders - psoriasis, photosensitivity. Metabolic and Nutritional Disorders - Hyperkalemia; Neurologic Disorders - Headache, vertigo; Ear and Labyrinth Disorders - Tinnitus; Gastrointestinal Disorders - Anorexia; Hepatobiliary Disorders - Elevated liver enzymes, hepatitis, jaundice; Skeletal Muscle, Connective Tissue, and Bone Disorders - Myalgia, arthralgia; Renal and Urinary Tract Disorders - Renal impairment, including isolated cases of renal failure in at-risk patients.; Systemic Disorders - Asthenia. See Precautions. Pediatric Population: In a randomized trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred during the 3-week double-blind period: headache (7.9%), hypotension (2.2%), dizziness (1.9%), and cough (0.9%). During the 26-week open-label period of the trial, the most common laboratory abnormalities observed were increased creatinine (6.5%) and elevated CK values in 2% of pediatric recipients.
[Contraindications]
Known hypersensitivity to the components of this product. 4th to 9th months of pregnancy. Breastfeeding. Patients with diabetes or moderate to severe renal impairment (GFR less than 60ml/min/1.73m²) should not use this product in combination with aliskiren. Patients with diabetic nephropathy should not use this product in combination with angiotensin-converting enzyme inhibitors (ACEIs):
