Product Overview
[Drug Name]
Generic Name: Telmisartan Tablets
Trade Name: Lilai Ke
English Name: Telmisartan Tablets
Chinese Pinyin: Telmisartan Tablets
[Ingredients]
The main ingredient of this product is telmisartan.
[Appearance]
This product is white or off-white tablets.
[Indications]
For the treatment of essential hypertension.
[Dosage and Administration]
1. Adults: Dosing should be individualized. The usual initial dose is one tablet. This product can be used in combination with thiazide diuretics such as hydrochlorothiazide, which have a synergistic antihypertensive effect. Because telmisartan takes 4 to 8 weeks to achieve its maximum effect, this should be considered when increasing the dose.
2. Patients with Renal Impairment: No dose adjustment is required for patients with mild or moderate renal impairment. Telmisartan is not eliminated by hemodialysis.
3. Patients with Hepatic Impairment: For patients with mild or moderate hepatic impairment, the daily dose of this product should not exceed one tablet.
4. Elderly: No dose adjustment is required for this product.
5. Children and Adolescents: Safety and efficacy data for this product have not been established in children and adolescents under 18 years of age.
[Adverse Reactions]
Adverse reactions are categorized by frequency as follows: Very Common (1/10); Common (1/100, 1/10); Uncommon (1/1000, 1/100); Rare (1/10,000, 1/1000); Very Rare (1/10,000). 1. Systemic Reactions: Common: Back pain (e.g., sciatica), chest pain, flu-like symptoms, and symptoms of infection (e.g., urinary tract infection including cystitis). Rare: Visual disturbances, hyperhidrosis. 2. Central and Peripheral Nervous System: Common: Dizziness. 3. Gastrointestinal System: Common: Abdominal pain, diarrhea, indigestion, and gastrointestinal disturbances. Uncommon: Visual disturbances, hyperhidrosis. 4. Musculoskeletal System: Common: Arthralgia, leg cramps or pain, myalgia. 5. Nervous System: Rare: Anxiety. 6. Respiratory System: Common: Upper respiratory tract infections including pharyngitis and rhinitis. 7. Skin and Appendages: Common: Skin abnormalities such as eczema. 8. In addition, since the marketing of telmisartan, individual case reports have occurred of erythema, pruritus, 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. Pregnant women in their second or third trimesters or breastfeeding women. 3. Patients with biliary obstructive disease. 4. Patients with severe hepatic insufficiency. 5. Patients with severe renal impairment (creatinine clearance 30 ml/min).
[Precautions]
1. Hepatic Impairment: This product should not be used in patients with cholestasis, obstructive biliary disease, or severe hepatic dysfunction. 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. 2. Renovascular Hypertension: In patients with bilateral renal artery stenosis or stenosis of the renin-angiotensin-aldosterone system, the risk of severe hypotension and renal impairment is increased with the use of medications that affect the renin-angiotensin-aldosterone system. 3. Renal Impairment and Renal Transplant Patients: This product should not be used in patients with severe renal impairment (creatinine clearance 30 ml/min, see Contraindications). For patients with renal impairment, serum potassium and creatinine levels should be monitored regularly during use. No data are available regarding the use of this product in patients shortly after a recent renal transplant. 4. Patients with Volume Depletion: For patients with volume depletion or low blood sodium levels due to strong diuretic therapy, salt restriction, nausea, or vomiting, taking this drug, especially after the first dose, may cause symptomatic hypotension. Therefore, serum sodium and blood volume levels should be corrected before using this drug. 5. Other Conditions Related to Stimulation of the Renin-Angiotensin-Aldosterone System: For patients whose vascular tone and renal function are primarily dependent on the activity of the renin-angiotensin-aldosterone system (such as those with severe congestive heart failure or renal disease including renal artery stenosis), use of this drug may affect this system.
[Special Population Use]
Precautions for Children: Safety and efficacy data for this drug have not been established in children and adolescents under 18 years of age.
Precautions for Pregnancy and Lactation: 1. Use During Pregnancy: Insufficient data exist to indicate whether this drug is suitable for use in pregnant women. Animal studies have not shown teratogenicity, but have shown embryotoxicity. Therefore, as a precaution, telmisartan should not be used during the first trimester of pregnancy. Appropriate alternative therapy should be considered before attempting pregnancy. During the second and third trimesters of pregnancy (during the second and third trimesters), drugs that directly act on the renin-angiotensin system can cause fetal harm or even death. Therefore, telmisartan is contraindicated during this period. 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]
1. Lithium. Concomitant use of lithium with angiotensin-converting enzyme inhibitors can cause reversible increases in blood lithium levels and toxic reactions. Isolated cases have also been reported when lithium is used with angiotensin II receptor antagonists. Therefore, caution is advised when using lithium with this drug. If combined use is necessary, serum potassium levels should be monitored during this period. 2. Some drugs can affect serum potassium levels or cause hyperkalemia (such as ACE inhibitors, potassium-sparing diuretics, potassium ion diuretics, potassium ion supplements, potassium-containing salt substitutes, cyclosporine A, or other drugs such as heparin sodium). If this product is used concomitantly with these drugs, it is recommended to monitor serum potassium levels. Based on experience with other drugs that affect the renin-angiotensin system, concomitant use of this product with these drugs may increase serum potassium levels (see Precautions). 3. Pharmacokinetic studies have investigated the interaction of this product with digoxin, warfarin, hydrochlorothiazide, glyburide, ibuprofen, acetaminophen, amlodipine, and other drugs. Digoxin's mean trough plasma concentration may increase by 20% (in some cases by 39%), so peak digoxin plasma concentrations should be monitored. 4. This product may enhance the antihypertensive effect of other antihypertensive drugs. Other clinical interactions have not been confirmed. 5. Based on their pharmacological properties, the following drugs may enhance the antihypertensive effect of antihypertensive drugs, including telmisartan: baclofen and amifostine. In addition, alcohol, barbiturates, sedatives, hypnotics, or antidepressants may potentiate the effects of postural hypotension.
[Pharmacological Action]
Telmisartan is a specific angiotensin II receptor (ATI) antagonist. Telmisartan displaces the angiotensin II receptor and binds with high affinity to the ATI receptor subtype (the known site of angiotensin II action). Telmisartan has no agonist effect at any site within the ATI receptor site; instead, it selectively binds to the ATI receptor, and this binding is long-lasting. Telmisartan has no affinity for other receptors, including AT2 and other less characterized AT receptors. The functions of these other receptors are unknown, and the potential for receptor overstimulation due to increased angiotensin II levels caused by telmisartan is also unknown. Telmisartan does not inhibit human plasma renin or block ion channels. Telmisartan does not inhibit angiotensin-converting enzyme II, which can also enhance the degradation of bradykinin, leading to adverse reactions. In humans, administration of 80 mg of telmisartan almost completely inhibits the angiotensin II-induced blood pressure increase. The inhibitory effect persists for 24 hours and is still detectable after 48 hours. The antihypertensive effect becomes apparent within 3 hours after the first dose of telmisartan. Maximum antihypertensive effect is achieved 4 weeks after the start of treatment and can be maintained with long-term treatment. If telmisartan treatment is abruptly discontinued, blood pressure gradually returns to pre-treatment levels over several days without rebound hypertension. In a clinical trial directly comparing two antihypertensive medications, the incidence of dry cough in the telmisartan group was significantly lower than in the ACE inhibitor group.
[Storage] Store in a dark, sealed container.
[Strength] 40 mg
[Packaging] 40 mg x 14 s/box
[Expiry Date] 24 months
[Approval Number] National Medicine Standard H20051438
[Manufacturer] Company Name: Dongzhitang Pharmaceutical (Anhui) Co., Ltd.
