Telmisartan Tablets

Angiotensin I (AI) is catalyzed by angiotensin converting enzyme (ACE, kininase II) to generate angiotensin (AⅡ). AⅡ is the main pressor substance of the renin-angiotensin system (RAS), which has the effects of constricting blood vessels, promoting the synthesis and release of aldosterone, exciting the heart, and reabsorb sodium by the kidney. Telmisartan selectively blocks the binding of AⅡ to AT1 receptors on most tissues (such as vascular smooth muscle and adrenal glands), thereby inhibiting the vasoconstriction and aldosterone secretion of AⅡ. AT2 receptors also exist in most tissues, and the effect of AT2 on cardiovascular is still unclear. The binding force of telmisartan to AT1 is much higher than that of AT2 (greater than 3000 times).

The main ingredient of this product is telmisartan, and its other scientific name is: 4-[(1,4-dimethyl-2-propyl[2,6-di-1H-benzimidazolyl]-1-yl)methyl]-[1,1-biphenyl]-2-carboxylic acid.

This product is white tablets.

Used to treat essential hypertension.

Adults: 40mg-80mg once a day. The time of taking is not affected by diet. Patients with mild or moderate renal dysfunction and the elderly do not need to adjust the dose. Patients with mild or moderate hepatic dysfunction should not take more than 40mg/day. For children: The safety and efficacy data of this product have not yet been established.

More than 3,700 cases have been evaluated for the safety of telmisartan, including 1,900 cases treated for more than 6 months and more than 1,300 cases treated for more than 1 year. Adverse reactions are usually mild and can recover on their own, and very few require discontinuation of the drug. In placebo-controlled trials, including 1,041 cases treated with different doses (20-160 mg) of telmisartan for more than 12 weeks, the total adverse reactions were similar to those in the placebo group. The incidence of adverse reactions was 1% higher than that in the placebo group. The incidence of adverse reactions was 1% higher than that in the placebo group, including flu symptoms, dyspepsia, myalgia, urinary tract infection, abdominal pain, headache, dizziness, pain, fatigue, cough, hypertension, chest pain, nausea and edema of the limbs. In placebo-controlled trials, 2.8% of 1,455 patients treated with telmisartan discontinued the drug due to adverse reactions, and 6.1% of 380 patients treated with placebo discontinued the drug due to adverse reactions. The occurrence of adverse reactions was not related to the dose, patient gender, age and race. In six placebo-controlled trials, the incidence of cough in the treatment group and the placebo group was the same at 1.6%. The following supplementary information is provided: Among the 3,500 patients taking telmisartan, 0.3% of the patients experienced adverse reactions. The specific circumstances are as follows, but it cannot be said that these adverse reactions are related to taking telmisartan: Autonomic nervous system: impotence, sweating, flushing; systemic: allergies, fever, leg pain and discomfort; cardiovascular: palpitations, dependent edema, angina, tachycardia, leg edema and abdominal ECG; CNS: insomnia, drowsiness, migraine, dizziness, paresthesia, spontaneous muscle contraction, hypoesthesia; gastrointestinal: flatulence, constipation, gastritis, Vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific gastrointestinal discomfort; Metabolism: gout, high blood cholesterol, diabetes; Muscle and bone: arthritis, joint and leg pain; Nerve: mental anxiety, depression, nervousness; Resistance mechanism: infection, fungal infection, suppuration and otitis media; Respiratory system: asthma, bronchitis, rhinitis, dyspnea and epistaxis; Skin: dermatitis, rash, eczema and pruritus; Urinary system: frequent urination, cystitis; Vascular: cerebrovascular disease; Special senses: visual abnormalities, conjunctivitis, tinnitus and ear pain. One case of angioedema has been reported.

Patients who are allergic to this product or any of the excipients in the tablets are contraindicated.

Precautions for children: For children and adolescents under 18 years old, the safety and efficacy data of this product have not been established. Precautions for pregnancy and lactation: 1. Use during pregnancy: There is not enough data to show whether this product can be used in pregnant women. Animal experiments did not show teratogenicity, but showed embryotoxicity. Therefore, for the sake of caution, do not use telmisartan in the first three months of pregnancy. Before planning pregnancy, appropriate alternative therapies should be taken. In the middle and late stages of pregnancy (during the second and third months), drugs that directly act on the renin-angiotensin system can cause damage to the fetus or even death, so telmisartan is contraindicated in the middle and late stages of pregnancy. Once pregnancy is confirmed, this product should be discontinued as soon as possible. 2. Use during lactation: Since it is not known whether this product is excreted through breast milk, this product is contraindicated during lactation. Precautions for the elderly: No dosage adjustment is required when taking this product.

1. 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 the 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 the elimination is accelerated.

Store at room temperature, protected from light, and sealed.

40mg

48 months.