Product Overview
[Drug Name]
Generic Name: Telmisartan Tablets
Trade Name: An Nei Qiang
English Name: Telmisartan Tablets
Chinese Pinyin: Timishatan Pian
[Ingredients]
Chinese Pinyin: Ti Mi Sha Tan Pian. The main ingredient of this product is telmisartan, whose chemical name is: 4-[methyl]-[1,1-diphenyl]-2-carboxylic acid. Its structural formula is: Molecular Formula: C33H30N4O2
[Properties]
This product is a white or slightly yellowish oval tablet.
[Indications]
For the treatment of essential hypertension.
[Dosage and Administration]
Dosage should be individualized for adults. The usual initial dose is one tablet once daily. Telmisartan's antihypertensive effect is dose-dependent within a dose range of 20 to 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. Because telmisartan does not reach its maximum effect until four to eight weeks after the start of 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 through hemofiltration. Patients with Hepatic Impairment: For patients with mild or moderate hepatic impairment, the daily dose of this product should not exceed 40 mg. Elderly: No dose adjustment is required for this product. Children and Adolescents: Safety and efficacy data for this product have not been established for children and adolescents under 18 years of age.
[Adverse Reactions]
In placebo-controlled trials, the overall incidence of adverse events with telmisartan was similar to that with placebo. The incidence of adverse events was not related to dose and was unrelated to the patient's 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; Common; Uncommon; Rare; Very rare Systemic reactions: Common: back pain, chest pain, flu-like symptoms, infection symptoms Rare: visual abnormalities, sweating Central and peripheral nervous systems: 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 system: Common: skin abnormalities such as eczema In addition, since telmisartan has been on the market, individual cases have reported the occurrence of erythema, itching, syncope, insomnia, depression, stomach discomfort, vomiting, hypotension, bradycardia, tachycardia, dyspnea, eosinophilia, thrombocytopenia, weakness and decreased work efficiency. Similar to other angiotensin II antagonists, angioedema, urticaria, and other related adverse reactions have been reported in rare cases.
[Contraindications]
1. Hypersensitivity to the active ingredient or any of the excipients of this product. 2. Women in their second or third trimesters of pregnancy and breastfeeding. 3. Patients with biliary obstructive disease. 4. Patients with severe hepatic insufficiency. 5. Patients with severe renal insufficiency (creatinine clearance 30 ml/min).
[Precautions]
Hepatic Insufficiency
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 the clearance of this product may be reduced in these patients. This product should be used with caution in patients with mild to moderate hepatic insufficiency.
Renovascular Hypertension
In patients with bilateral renal artery stenosis or unilateral renal artery stenosis of a 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. For patients with renal insufficiency, blood potassium levels and blood creatinine values should be checked regularly during the use of this product. There is no data on the use of this product in patients in the short term after a recent renal transplant.Volume-depleted patients For patients with volume depletion or low blood sodium levels caused by strong diuretic therapy, salt restriction, nausea or vomiting, the use of this product, especially after the first dose, may cause symptomatic hypotension. Therefore, blood sodium and blood volume levels should be corrected before using this product.Other conditions related to stimulation of the renin-angiotensin-aldosterone system For patients whose vascular tone and renal function depend primarily on the activity of the renin-angiotensin-aldosterone system, the use of drugs that can affect this system can cause acute hypotension, hyperazotemia, oliguria, or rarely, acute renal failure. Primary aldosteronism Antihypertensive drugs that inhibit the renin-angiotensin-aldosterone system are usually ineffective for patients with primary aldosteronism, so this product is not recommended for such patients. Aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy As with the use of other vasodilators, patients with aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy should be particularly careful when using this product. Electrolyte imbalance: hyperkalemia The use of drugs that affect the renin-angiotensin-aldosterone system may cause hyperkalemia, especially in patients with renal impairment and/or heart failure and diabetes. However, for patients at risk, blood potassium levels should be closely monitored during the use of this product. Based on experience with other drugs that affect the renin-angiotensin system, the concomitant use of this product with potassium-sparing diuretics, potassium ion supplements, potassium-containing salt substitutes or other drugs that can increase blood potassium levels can cause increases in blood potassium levels, so caution should be exercised when used in combination with this product. Sorbitol Each 40 mg tablet of this product contains 169 mg of sorbitol. Therefore, this product should not be used by patients with hereditary fructose intolerance. Other Uses Similar to angiotensin-converting enzyme inhibitors, this product and other angiotensin antagonists have a lower blood pressure-lowering effect in blacks than in other ethnic groups. This may be related to the higher prevalence of low renin in hypertensive individuals in blacks. As with other antihypertensive drugs, 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 product on driving and operating machinery have not been studied. However, caution is advised when driving or operating machinery, as antihypertensive treatment can sometimes cause dizziness and drowsiness.
[Use in Special Populations]
Precautions for Children:
Safety and efficacy data for this product have not been established for children and adolescents under 18 years of age.
Precautions for Pregnancy and Lactation:
1. Use During Pregnancy: Insufficient data exist to indicate whether this product can be used in pregnant women. Animal studies did not demonstrate teratogenicity, but did demonstrate embryotoxicity. Therefore, as a precaution, telmisartan should not be used during the first three months of pregnancy. Appropriate alternative therapies should be adopted before planning pregnancy. During the second and third trimesters of pregnancy (during the second and third months), drugs that directly act on the renin-angiotensin system can cause fetal harm or even death. Therefore, telmisartan is contraindicated. Once pregnancy is confirmed, this drug should be discontinued as soon as possible. 2. Use during Breastfeeding: Since it is unknown whether this drug is excreted in breast milk, this drug is contraindicated during breastfeeding.
Precautions for Elderly Patients:
No dose adjustment is required for this drug.
[Drug Interactions]
Lithium
The combined use of lithium and angiotensin-converting enzyme inhibitors can cause reversible increases in blood lithium levels and toxic reactions. There are also isolated cases caused by the combined use of lithium and angiotensin II receptor antagonists. Therefore, lithium and this drug should be used with caution. If combined use is necessary, blood lithium levels should be monitored during co-administration.
Some drugs can affect blood lithium levels or cause hyperkalemia: If this drug is to be used with these drugs, monitoring blood potassium levels is recommended. Based on experience with other drugs that affect the renin-angiotensin system, concomitant use of this drug with these drugs may result in elevated serum potassium levels. Pharmacokinetic studies have investigated the interaction of this drug with digoxin, warfarin, hydrochlorothiazide, glyburide, ibuprofen, paracetamol, and amlodipine. Digoxin plasma concentrations may be increased by 20%; therefore, digoxin plasma concentrations should be monitored. This drug may potentiate the antihypertensive effects of other antihypertensive drugs. Other clinically significant interactions have not been demonstrated. Based on their pharmacological properties, the following drugs may potentiate the antihypertensive effects of antihypertensive drugs, including telmisartan: baclofen and amifostine. Additionally, alcohol, barbiturates, sedatives, hypnotics, or antidepressants may enhance the orthostatic hypotensive effect. Simvastatin metabolites exhibit a slightly increased Cmax and accelerated elimination when coadministered with telmisartan.
[Pharmacological Actions]
Telmisartan is an orally active, specific angiotensin II receptor antagonist. Telmisartan replaces angiotensin II and binds with high affinity to the AT1 receptor subtype. Telmisartan has no partial agonist effect at the AT1 receptor site. Telmisartan selectively binds to the AT1 receptor, and this binding is long-lasting. Telmisartan has no affinity for other receptors. The functions of these other receptors are unknown, and the potential receptor overstimulation effects caused by telmisartan-induced increases in angiotensin II levels are also unknown. Telmisartan can cause a decrease in blood aldosterone levels. Telmisartan does not inhibit human plasma renin or block ion channels. Telmisartan does not inhibit angiotensin-converting enzyme, which can also degrade bradykinin, and therefore does not cause adverse reactions due to enhanced bradykinin action. Administration of 80 mg of telmisartan to humans almost completely inhibits the increase in blood pressure caused by angiotensin II. The inhibitory effect lasts for 24 hours and is still measurable after 48 hours. The antihypertensive effect becomes increasingly apparent within 3 hours after the first dose of telmisartan. The maximum antihypertensive effect is achieved 4 weeks after the start of treatment and can be maintained with long-term treatment. Ambulatory blood pressure monitoring showed that the blood pressure-lowering effect persisted for more than 24 hours after dosing, including the four hours before the next dose. This result was confirmed in placebo-controlled clinical trials: after taking 40 mg and 80 mg of telmisartan, the trough-to-peak ratio remained consistently above 80%. There was a clear dose-time dependence for return to baseline SBP. Data regarding DBP were inconsistent. In patients with hypertension, telmisartan lowered both systolic and diastolic blood pressure without affecting pulse rate. The antihypertensive effect of telmisartan was comparable to that of other representative antihypertensive drugs. If telmisartan treatment was abruptly discontinued, blood pressure gradually returned to pre-treatment levels over several days without rebound hypertension. In a direct clinical trial comparing two antihypertensive drugs, the incidence of dry cough was significantly lower in the telmisartan group than in the ACE inhibitor group. The effect of telmisartan on improving mortality and cardiovascular disease morbidity is currently unknown.
[Storage] Please store at room temperature below 30°C. Strength: 80mg
Packaging: 80mg x 14s/box
Expiration: 24 months
Approval Number: National Medicine Standard H20070149
Manufacturer: Suzhou Dawnray Pharmaceutical Co., Ltd.
