Telmisartan Tablets
Function and Efficacy
In placebo-controlled trials, the overall incidence of adverse events with telmisartan (41.4%) was similar to that with placebo (43.9%). The occurrence of adverse events was not related to dose, nor to the patient's gender, age, or race. The adverse reactions listed below are cumulatively obtained from 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); uncommon (1/1000, 1/100); rare (1/10000, 1/1000); very rare (1/10000) Systemic reactions: Common: back pain (such as sciatica), chest pain, flu-like symptoms, symptoms of infection (such as urinary tract infection including cystitis) Rare: visual abnormalities, hyperhidrosis Central and peripheral nervous system: Common: dizziness Gastrointestinal system: Common: abdominal pain, diarrhea, indigestion, gastrointestinal dysfunction Energy disorders 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 adnexal system: Common: skin abnormalities such as eczema In addition, since the launch of telmisartan, individual cases have reported 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, very few cases have reported angioedema, urticaria and other related adverse reactions. Laboratory findings: Compared with placebo, hemoglobin decreases or uric acid increases were occasionally found in the telmisartan treatment group. The increase in blood creatinine or liver enzymes was similar to or lower than that of placebo.
Ingredients
The main ingredient of this product is telmisartan, and its chemical name is: 4-[(1,4-dimethyl-2-propyl[2,6-di-1H-benzimidazole]-1-yl)-methyl]-[1,1-diphenyl]-2-carboxylic acid.
| Name | Description | Content | CAS NO. | Manufacturer |
|---|---|---|---|---|
| TelmisartanIngredients |
In placebo-controlled trials, the overall incidence of adverse events with telmisartan was similar to that with placebo. The occurrence of adverse events was not related to dose, and was also unrelated to the patient's gender, age, and race. The pharmacological effects of telmisartan include lowering blood pressure, and possible adverse reactions include back pain, chest pain, flu-like symptoms, infection symptoms, dizziness, abdominal pain, diarrhea, indigestion, gastrointestinal dysfunction, joint pain, leg cramps or leg pain, myalgia, etc. The laboratory found occasional decreases in hemoglobin or increases in uric acid, but increases in blood creatinine or liver enzymes were similar to or lower than placebo. More |
144701-48-4 | 109 |
Appearance
This product is white tablets.
Indication
Used to treat essential hypertension.
Usage and Dosage
Adults: Dosing should be individualized. The usual initial dose is one tablet (40 mg) once a day. Within the dose range of 20 to 80 mg, the antihypertensive effect of telmisartan is dose-related. If the ideal blood pressure is not achieved after medication, the dose can be increased, with the maximum dose being 80 mg once a day. This product can be used in combination with thiazide diuretics such as hydrochlorothiazide, which have a synergistic antihypertensive effect with this product. Because telmisartan can only exert its maximum efficacy four to eight weeks after the start of the treatment, this should be considered if the drug dose is to be increased. Patients with renal insufficiency Patients with mild or moderate renal insufficiency do not need to adjust the dose of this product. Telmisartan is not eliminated by blood filtration. Patients with hepatic insufficiency Patients with mild or moderate hepatic insufficiency should not take more than 40 mg per day. 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 (41.4%) was similar to that with placebo (43.9%). The occurrence of adverse events was not related to dose, nor to the patient's gender, age, or race. The adverse reactions listed below are cumulatively obtained from 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); uncommon (1/1000, 1/100); rare (1/10000, 1/1000); very rare (1/10000) Systemic reactions: Common: back pain (such as sciatica), chest pain, flu-like symptoms, symptoms of infection (such as urinary tract infection including cystitis) Rare: visual abnormalities, hyperhidrosis Central and peripheral nervous system: Common: dizziness Gastrointestinal system: Common: abdominal pain, diarrhea, indigestion, gastrointestinal dysfunction Energy disorders 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 adnexal system: Common: skin abnormalities such as eczema In addition, since the launch of telmisartan, individual cases have reported 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, very few cases have reported angioedema, urticaria and other related adverse reactions. Laboratory findings: Compared with placebo, hemoglobin decreases or uric acid increases were occasionally found in the telmisartan treatment group. The increase in blood creatinine or liver enzymes was similar to or lower than that of placebo.
Precautions
Patients who are allergic to the active ingredients of this product and any of the excipients; those in the second or third trimester of pregnancy and breastfeeding; patients with biliary obstructive disease; patients with severe liver dysfunction; patients with severe renal dysfunction (creatinine clearance ﹤30ml/min);
Special Population Medication
Precautions for children: The safety and efficacy data of this product have not been established for children and adolescents under 18 years old. Precautions for pregnancy and lactation: It is forbidden to use in the middle and late stages of pregnancy and for breastfeeding women. Precautions for the elderly: No dosage adjustment is required when taking this product.
Drug Interactions
1 Lithium Lithium combined with angiotensin converting enzyme inhibitors can cause reversible increases in blood lithium levels and toxic reactions. There are also individual cases caused by the combination of lithium and angiotensin II receptor antagonists. Therefore, lithium and this product should be used with caution. If combined use is necessary, blood lithium levels should be monitored during the combined use. 2 Some drugs can affect blood potassium levels or cause hyperkalemia (such as ACE inhibitors, potassium-sparing 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, this product combined with the above drugs can cause an increase in blood potassium levels (see Precautions). 3 Pharmacokinetic studies have studied the interaction of this product with digoxin, warfarin, hydrochlorothiazide, glibenclamide, ibuprofen, paracetamol, amlodipine and other drugs. It can increase the mean trough blood concentration of digoxin by 20% (in some cases by 39%), so digoxin plasma concentration must be monitored. 4 This product can enhance the antihypertensive effect of other antihypertensive drugs. Other clinically significant interactions have not yet been confirmed. 5 Based on their pharmacological properties, the following drugs can enhance the antihypertensive effect of antihypertensive drugs including telmisartan: baclofen, amifostine. In addition, alcohol, barbiturates, sedatives, hypnotics or antidepressants can enhance the orthostatic hypotensive effect. 6 When used in combination with telmisartan, the Cmax of simvastatin metabolites (simvastatin acid) is slightly increased (1.34 times) and its elimination is accelerated.
Storage
Store at room temperature, shaded and sealed
Packaging Specification
40mg
Validity Period
48 months.
Manufacturer
Yichang HEC Changjiang Pharmaceutical Co., Ltd.
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Founded in:
2001-08-08 -
Address:
No. 38, Binjiang Road, Yidu City, Yichang City, Hubei Province -
Tax NO.:
91420000730842584F -
Registered Funds:
879.9677 million yuan -
Website:
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Email: