Product Overview
[Drug Name]
Generic Name: Telmisartan Tablets
Trade Name: Logler
English Name: Telmisartan Tablets
Chinese Pinyin: Ti Mi Sha Tan Pian
[Ingredients]
The main ingredient of this product is telmisartan.
[Appearance]
This product is white or off-white tablets.
[Indications]
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. If symptomatic hypotension occurs after an overdose of this product, supportive treatment should be initiated. This product cannot be removed by hemodialysis.
2. This product may increase the antihypertensive effect of antihypertensive drugs.
3. Serum lithium levels should be monitored when used in combination with certain medications.
4. No dose adjustment is required for patients with mild to moderate renal impairment. The dose for patients with mild to moderate hepatic impairment should not exceed 40 mg per day.
5. This product is contraindicated in pregnant and breastfeeding women.
6. The safety of this product has not been established in children; use with caution in children.
[Use in Special Populations]
Precautions for use in 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 have not shown teratogenicity, but have shown embryotoxicity. Therefore, as a precaution, telmisartan should not be used during the first three months of pregnancy. Before planning pregnancy, appropriate alternative therapies should be adopted. 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 lactation: Since it is unknown whether this drug is excreted in breast milk, this drug is contraindicated during lactation.
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. There have also been isolated cases of this occurring when lithium is used with angiotensin II receptor antagonists. Therefore, caution should be exercised when lithium and this drug are used together. If combined use is necessary, serum potassium levels should be monitored during this period. 2. Some drugs can affect blood 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 needs to be used in combination with these drugs, it is recommended to monitor blood potassium levels. Based on the experience of using other drugs that affect the renin-angiotensin system, the combination of this product with the above drugs may cause an increase in blood potassium levels (see precautions). 3. Pharmacokinetic studies have studied the interaction between this product and digoxin, warfarin, hydrochlorothiazide, glibenclamide, ibuprofen, acetaminophen, amlodipine, etc. The average trough blood concentration of digoxin can be increased by 20% (in some cases by 39%), so the peak plasma concentration of digoxin must be monitored. 4. This product can enhance the antihypertensive effect of other antihypertensive drugs. Other clinical interactions have not yet been confirmed. 5. Based on their pharmacological properties, the following medications may enhance the antihypertensive effects of antihypertensive drugs, including telmisartan: baclofen and amifostine. Additionally, 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; 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, as is the potential for receptor overstimulation due to increased angiotensin II levels caused by telmisartan. Telmisartan does not inhibit human plasma renin or block ion channels. Telmisartan does not inhibit angiotensin-converting enzyme II (ACEII), 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 measurable 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
[Expiry Date] 24 months
[Approval Number] National Medicine Standard H20051847
[Manufacturer] Tianjin Huajin Pharmaceutical Co., Ltd.
