Product Overview
[Drug Name]
Generic Name: Telmisartan Capsules
Trade Name: Yijiangshi Telmisartan Capsules 40mg*28 capsules
Pinyin Code: YiShi TiMiShaTanJiaoNang 40mg*14Li*2Ban
[Main Ingredients]
The main ingredient of this product is telmisartan, chemical name: 4-[(2-n-propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)-benzimidazol-1-yl)methyl]-diphenyl-2-carboxylic acid. Molecular formula: C33H30N4O2. Molecular weight: 514.63.
[Properties]
This product is a capsule containing white or off-white granules and powder.
[Indications/Main Functions]
For the treatment of essential hypertension.
[Precautions]
Hepatic Impairment: This product should not be used in patients with cholestasis, biliary obstructive disease, or severe hepatic impairment, as telmisartan is largely excreted via bile, and clearance of this product may be reduced in these patients. This product should be used with caution in patients with mild to moderate hepatic impairment. Renovascular Hypertension: In cases of bilateral renal artery stenosis or stenosis of the renal artery of a single functioning kidney, the risk of severe hypotension and renal insufficiency is increased with the use of drugs that affect the renin-angiotensin-aldosterone system. Renal Insufficiency and Renal Transplant Patients: This product should not be used in patients with severe renal insufficiency (creatinine clearance <30 ml/min, see Contraindications). In patients with renal insufficiency, serum potassium and creatinine levels should be monitored regularly during use. There are no data on the use of this product in patients shortly after a recent renal transplant. Patients with Volume Depletion: This product, especially after the first dose, may cause symptomatic hypotension in patients with volume depletion or hyponatremia due to strong diuretic therapy, salt restriction, nausea, or vomiting. Therefore, serum sodium and volume levels should be corrected before using this product. Other Conditions Associated with Stimulation of the Renin-Angiotensin-Aldosterone System: In patients whose vascular tone and renal function depend primarily on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or underlying renal disease including renal artery stenosis), the use of medicinal products that affect this system may cause acute hypotension, hyperazotemia, oliguria, or rarely, acute renal failure. Primary Aldosteronism: Antihypertensive drugs that inhibit the renin-angiotensin-aldosterone system are generally ineffective in patients with primary aldosteronism. Therefore, this product is not recommended for use in such patients. Aortic or Mitral Stenosis, Obstructive Hypertrophic Cardiomyopathy: As with other vasodilators, this product should be used with caution in patients with aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy. Electrolyte Imbalance: Hyperkalemia. Use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalemia, particularly in patients with renal insufficiency and/or heart failure, and in patients with diabetes mellitus. For patients at risk, serum potassium levels should be closely monitored while taking this product. Based on experience with other medicinal products that affect the renin-angiotensin system, coadministration of this product with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other medicinal products that increase serum potassium levels (e.g., heparin) may increase serum potassium levels. Therefore, caution should be exercised when using this product with this product (see Drug Interactions). Patients with diabetes mellitus and additional cardiovascular risk factors, such as those with coronary artery disease (CAD), may increase the risk of fatal myocardial infarction and unexpected cardiovascular death when using antihypertensive medications such as angiotensin receptor blockers or ACE inhibitors. CAD may be undiagnosed in patients with diabetes mellitus due to asymptomatic CAD. Therefore, before using this product, patients with diabetes should undergo an appropriate diagnostic evaluation, such as an exercise compliance test, to detect the presence of CAD and initiate appropriate treatment. Other: Similar to ACE inhibitors, the antihypertensive effect of this medication and other angiotensin antagonists is less in blacks than in other ethnic groups. This may be related to the higher prevalence of low renin status in black hypertensive patients. As with other antihypertensive medications, excessive blood pressure reduction can cause myocardial infarction or stroke in patients with ischemic heart disease or ischemic cardiovascular disease. Effects on driving and operating machinery: The effects of this medication on driving and operating machinery have not been studied. However, caution is advised when driving or operating machinery, as antihypertensive therapy can sometimes cause dizziness and drowsiness.
[Drug Interactions]
1. Hypersensitivity to the active ingredient or any of the excipients of this product. 2. Pregnant women in their second or third trimesters or breastfeeding mothers. 3. Patients with biliary obstructive disease. 4. Patients with severe hepatic insufficiency. 5. Patients with severe renal insufficiency (creatinine clearance <30 ml/min).
[Specifications]
40 mg x 28 Capsules
[Dosage and Administration]
Adults should be individually dosed. The usual dose is 40 mg once daily. Telmisartan's antihypertensive effect is dose-dependent within a dose range of 20-80 mg. If optimal blood pressure is not achieved after treatment, the dose may be increased, up to a maximum of 80 mg once daily. This product can be used in combination with thiazide diuretics, such as hydrochlorothiazide, which have a synergistic antihypertensive effect. Since telmisartan takes four to eight weeks to achieve its maximum effect after treatment, this should be considered when increasing the dose. Patients with Renal Impairment: No dose adjustment is required for patients with mild or moderate renal impairment. Telmisartan is not eliminated by hemofiltration. Patients with Hepatic Impairment: The daily dose of this drug should not exceed 40 mg. Elderly patients do not require dose adjustment. Children and Adolescents: Safety and efficacy data for this drug have not been established in children and adolescents under 18 years of age.
[Adverse Reactions]
In placebo-controlled trials, the overall incidence of adverse events was similar with telmisartan (41.4%) and placebo (43.9%). The incidence of adverse reactions was not dose-related and was not associated with gender, age, or race. The adverse reactions listed below are cumulatively reported in 5,788 hypertensive patients treated with telmisartan in clinical trials. Adverse reactions are classified by frequency as follows: very common (>1/10); common (>1/100, <1/10); rare (>1/1000, <1/100); Systemic reactions: Common: back pain (such as sciatica), chest pain, flu-like symptoms, symptoms of infection (such as urinary tract infection including cystitis). Rare: abnormal vision, sweating. Central and peripheral nervous system: Common: dizziness. Gastrointestinal system: Common: abdominal pain, diarrhea, indigestion, gastrointestinal dysfunction. Rare: dry mouth, flatulence. Musculoskeletal system: Common: joint pain, leg cramps or leg pain, myalgia. Rare: tenosynovitis-like symptoms. Psychiatric system: Rare: anxiety. Respiratory system: Common: upper respiratory tract infection including pharyngitis and rhinitis. Skin and appendages: Common: skin abnormalities such as eczema. Rare: Hypoglycemia (rarely in patients with diabetes); Rare: Angioedema (with fatal consequences); Rare: Acrodynia (leg pain). Unknown: Sepsis, including fatal outcomes (in the PRoFESS study, the incidence of sepsis was increased with telmisartan compared to placebo, which may be due to chance or related to currently unknown mechanisms). Additionally, since the marketing of telmisartan, isolated case reports have occurred of pruritus, erythema, syncope, insomnia, depression, stomach discomfort, vomiting, hypotension, bradycardia, tachycardia, dyspnea, eosinophilia, thrombocytopenia, asthenia, and decreased work efficiency. Similar to other angiotensin II antagonists, angioedema, urticaria, and other related adverse reactions have been reported in rare cases. Laboratory Findings: Decreases in hemoglobin or increases in uric acid were rarely observed in the telmisartan treatment group compared to placebo. Elevations in blood creatinine or liver enzymes were similar to or lower with telmisartan than with placebo.
[Contraindications]
1. Hypersensitivity to the active ingredient or any of the excipients. 2. Pregnant women in their second or third trimester or breastfeeding mothers. 3. Patients with biliary obstructive disease. 4. Patients with severe hepatic insufficiency. 5. Patients with severe renal insufficiency (creatinine clearance <30 ml/min).
