Product Overview
[Drug Name]
Generic Name: Telmisartan Tablets
Trade Name: Mikasu
English Name: Telmisartan Tablets
Chinese Pinyin: TiMiShaTanPian (MeiKaSu)*1HeWeiShengSuCPian (TangChenBeiJian)*1Ping
[Ingredients]
The main ingredient of this product is telmisartan.
[Appearance]
This product is a white or slightly yellowish oval tablet.
[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 dosage.
2. Patients with Renal Impairment: No dosage adjustment is required for patients with mild to moderate renal impairment. Telmisartan cannot be 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 (1/10000, 1/1000); Very Rare (1/10000). 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, excessive sweating. 2. Central and Peripheral Nervous System: Common: Dizziness. 3. Gastrointestinal System: Common: Abdominal pain, diarrhea, dyspepsia, gastrointestinal dysfunction. Rare: Visual disturbances, hyperhidrosis. 4. Musculoskeletal System: Common: Arthralgia, leg cramps or leg 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, gastric 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.
[Contraindications]
1. Hypersensitivity to the active ingredient or any of the excipients of this product. 2. Pregnant women in their second or third trimesters and breastfeeding women. 3. Patients with biliary obstructive disease. 4. Patients with severe hepatic insufficiency. 5. Patients with severe renal impairment (creatinine clearance)
[Precautions]
1. 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. 2. Renovascular hypertension: In cases of bilateral renal artery stenosis or stenosis of a single functioning kidney, the use of drugs that affect the renin-angiotensin-aldosterone system can lead to severe hypotension and renal dysfunction. 3. Renal insufficiency and renal transplant patients: This product should not be used in patients with severe renal insufficiency (creatinine clearance 30ml/min, see contraindications). 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 who have recently undergone a kidney transplant in the short term. 4. Patients with hypovolemia: For patients with hypovolemia or low blood sodium levels caused by the use of strong diuretics, salt-restricted diet, nausea or vomiting, taking this product, especially after the first dose, May cause symptomatic hypotension. Therefore, serum sodium and blood volume levels should be corrected before using this product. 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 may affect this system.
[Use in Special Populations]
Precautions for Children:
Safety and efficacy data for this product have not yet been established for children and adolescents under 18 years of age. Established.
Precautions for Pregnancy and Lactation:
1. Use During Pregnancy: Insufficient data exist to indicate whether this product is suitable for use in pregnant women. Animal studies have not demonstrated teratogenicity, but have demonstrated embryotoxicity. Therefore, as a precaution, telmisartan should not be used during the first three months of pregnancy. Appropriate alternative treatments should be considered before pregnancy is planned. 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. Once pregnancy is confirmed, this product should be discontinued as soon as possible. 2. Use during lactation: Since it is unknown whether this product is excreted in breast milk, this product is contraindicated during lactation.
Precautions for Elderly Persons:
No dose adjustment is required for this product.
[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 are also isolated cases where lithium is combined with angiotensin II receptor antagonists. Therefore, lithium and this product should be used with caution. If combined use is necessary, serum potassium levels should be monitored during coadministration.
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 to be used concomitantly with these drugs, monitoring of serum potassium levels is recommended. Based on experience with other drugs that affect the renin-angiotensin system, concomitant use of this product with these drugs may cause increases in serum potassium levels (see Precautions).
3. Pharmacokinetic studies have investigated drug interactions with digoxin, warfarin, hydrochlorothiazide, glyburide, ibuprofen, acetaminophen, and amlodipine. Digoxin can increase mean trough plasma concentrations by 20% (up to 39% in some cases), so peak plasma concentrations should be monitored.
4. This drug may enhance the antihypertensive effects of other antihypertensive drugs. Other clinical interactions have not yet been confirmed.
5. Based on their pharmacological properties, the following drugs 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 angiotensin II action site). Telmisartan has no agonist effect at any site within the ATI receptor site; it binds selectively to the ATI receptor, and this binding is long-lasting. Telmisartan has no affinity for other receptors, including AT2 and other less well-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 renal function. Telmisartan does not inhibit angiotensin-converting enzyme II (ACE II), which can also degrade 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 of the first dose of telmisartan. Maximum antihypertensive effect is achieved within 4 weeks 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 that in the ACE inhibitor group.
[Storage]
Store in a dark, airtight container.
[Strength]
80 mg
[Packaging]
80 mg x 7 s/box
[Expiry Date]
48 months.
[Approval Number]
Approval Number: National Medical Products Approval Number HJ20171003/National Medical Products Approval Number HJ20171271 (Check with the State Food and Drug Administration)
[Manufacturer]
Boehringer Ingelheim Hellas Single Member S.A. (Repackaged by Shanghai Boehringer Ingelheim Pharmaceuticals Co., Ltd.)
