Item nanme:Telmisartan Tablets Item character:This product is a white
Indication: hypertension
It is used for the treatment of primary hypertension in adults.
Reduce cardiovascular risk
This product is suitable for patients aged 55 years and older. Patients with high risk of serious cardiovascular events and who cannot receive ACE inhibitors can reduce the risk of myocardial infarction, stroke or cardiovascular disease.
The high risk of cardiovascular events includes coronary artery disease, peripheral artery disease, stroke, a primary cerebral ischemia attack or a high-risk type 2 diabetes (insulin dependent or non insulin dependent) history with evidence of end organ damage. Telmisartan can also be used in conjunction with other necessary treatments (such as antihypertensive drugs, antiplatelet drugs or lipid lowering drugs).
It is not recommended that telmisartan be used in conjunction with ACE inhibitors.
Item specifications: 80mg*7tab/box
Usage and dosage:This product can be taken with or after meals.
Treatment of essential hypertension:
It should be individualized. The initial dosage of telmisartan is 40 mg per time, once a day. The antihypertensive effect of telmisartan is related to the dosage in the range of 20 and 80 mg. If the blood pressure does not reach the ideal level, the maximum dose is 80mg once a day.
This product can be combined with thiazide diuretics such as hydrochlorothiazide, which has synergistic antihypertensive effect with this product. Since telmisartan usually has the greatest antihypertensive effect only four to eight weeks after the start of treatment, it should be considered when considering the dose of additional drugs.
Reduce cardiovascular risk:
The recommended dose is once a day. Whether telmisartan at doses below 80 mg can effectively reduce the risk of cardiovascular morbidity and mortality remains unclear.
When starting telmisartan treatment to reduce cardiovascular risk, it is recommended to monitor blood pressure closely and adjust antihypertensive drugs appropriately when necessary.
Special groups
Patients with impaired gastric function
There is no need to adjust the dosage for patients with mild or moderate renal impairment. The experience of this product in patients with severe renal impairment or hemodialysis is limited. In these patients, it is recommended to reduce the initial dose to "20mg once a day". It is recommended to monitor serum potassium and creatinine regularly in patients with renal impairment (see [precautions]). There is no experience of telmisartan in recent renal transplant patients.
Patients with impaired liver function
For patients with mild or moderate liver function impairment, the daily dosage of this product should not exceed 40mg (see [precautions]).
Adverse reactions In placebo-controlled trials, the total incidence of adverse events in telmisartan (41.4%) was similar to that of placebo (43.9%). The incidence and dose of adverse events were not related to the gender, age and race of the patients.
The adverse reactions listed below were cumulative from 5788 hypertensive patients who received telmisartan in clinical trials.
Adverse reactions are divided into two groups according to the frequency of occurrence:
It is very common (>1/10); common (>1/100, < 1/10); rare (>1/1000, < 1/100); rare (>1/10000, < 1/1000); very rare (< 1 / 10000)
In each frequency group, adverse reactions were listed in descending order of severity.
Infected
Common: symptoms of infection (e.g. urinary tract infections, including cystitis), upper respiratory tract infections including pharyngitis and sinusitis
Nervous system:
Rare: Anxiety
Eyes:
Rare: abnormal vision
Ear and vestibular function:
Rare: Vertigo
Gastrointestinal tract:
Common: abdominal pain, diarrhea, dyspepsia
Rare: dry mouth, flatulence
Rare: stomach discomfort
Skin and subcutaneous tissue:
Common: eczema like skin lesions
Rare: sweating
Musculoskeletal system:
Common: arthritis, back pain (such as sciatica), cramp or leg pain, muscle pain
Rare: tendinitis
Systemic response and drug site:
Common: chest pain, influenza like symptoms.
In addition, since telmisartan was listed, a few cases reported erythema, pruritus, syncope, insomnia, depression, stomach discomfort, vomiting, hypotension (including postural hypotension), bradycardia, tachycardia, liver dysfunction, liver disease, renal dysfunction including acute renal failure (see [precautions], hyperkalemia, dyspnea, anemia Reports of eosinophilia, thrombocytopenia, weakness and lack of efficacy. The frequency of these events is unknown.
As an event independent of other angiotension II receptor antagonists, there have been reports of vascular neuroedema, urticaria and other related cases.
Laboratory inspection found:
Occasionally, decreased hemoglobin or increased uric acid in blood are observed, which are more frequent during telmisartan than placebo. An increase in creatinine or an increase in creatinine was observed during telmisartan treatment, but the probability of changes in these laboratory results was similar to or slightly lower than placebo. In addition, since telmisartan was listed, there have been reports of the increase of serum creatine kinase (CPK).
Taboo: ·Allergic to the active ingredient and any excipient of the product
·Women in the second and third trimester of pregnancy and lactation
·Patients with biliary obstructive diseases
·Patients with severe liver dysfunction
Matters needing attention: Morbidity and mortality of fetus or newborn
Drugs directly acting on the renin-angiotension system can cause the development and death of embryos or newborns when applied to pregnant women. There are many cases of this type of drug reported in the literature worldwide on patients taking ACE inhibitors. When pregnancy is found, the tablet should be stopped immediately.
Drugs directly acting on the renin-angiotension system in the middle and last three months of pregnancy can cause fetal and neonatal injury, including hypotension, fetal dysplasia, no urine, reversible or irreversible renal failure and death. There are also reports of oligohydramnios, which may be due to the decrease of fetal renal function. In this case, too little amniotic fluid can cause fetal limb contracture, craniofacial deformity and lung dysplasia. There are also premature delivery, intrauterine stunt and patent ductus arteriosus, which is not clear whether these conditions are related to drug exposure.
These adverse reactions were not observed in patients who were exposed to intrauterine drugs only within the first three months of pregnancy. Most of the reports of fetal toxicity are related to the exposure of drugs in the middle and late pregnancy to patients exposed to the antagonists of angiotension receptor in the first three months of pregnancy. In addition, if the patient has already been pregnant or is considering pregnancy, the patient should be immediately stopped using the product.
In rare cases (most likely less than one thousandth pregnancy), there is no alternative to the angiotension receptor antagonist. In these rare cases, pregnant patients should be informed of the potential harm of drugs to their fetus. Meanwhile, continuous ultrasonic examination should be conducted to evaluate the amniotic membrane environment.
If too little amniotic fluid is observed, the product should be discontinued unless it is life-saving treatment for pregnant patients. According to the gestational weeks, we can carry out the stress test of uterine contraction (CST) without stress test NST or biophysical analysis BPP. But patients and doctors should know that amniotic fluid is too low only after the fetus is irreversibly injured.
The infants with a history of exposure to intrauterine angiotension II receptor antagonists should be closely observed with hypotension, oliguria and kalemia. If hypouria occurs, blood pressure and renal perfusion should be supported directly. Replacement therapy for reversing hypotension and / or renal dysfunction may be required by plasma replacement or dialysis.
2. used in the indications of "reducing cardiovascular risk"
The results of the clinical trials of the use of aceinhibitor telmisartan in reducing cardiovascular risk can not exclude that the drug may not reflect some significant role of ACE inhibitors compared with ACE inhibitors. Therefore, for the patients with this indication, ACE inhibitors should be considered first. If the drugs are stopped only due to adverse cough reactions, try to use ACE inhibitors again after cough relief.
3. Hypotension
In patients with activation of the renin-angiotension system, for example, in patients with capacity or salt failure (e.g. patients who are being treated with high-dose diuretics, salt restricted diet, inadequate blood volume due to nausea or vomiting or low blood sodium level), telmisartan, especially after initial administration, may lead to symptomatic hypotension. Therefore, before using this product, the level of blood sodium and blood volume should be corrected or the treatment dose should be reduced under close medical observation.
If hypotension occurs, the patient should be placed in a lying position. If necessary, saline can be input into the vein. Once the hypobaric response is not a taboo for further treatment, and it can be successfully continued after the blood pressure is stable.
4. Hyperkalemia
Patients with adrenaline receptor antagonists (ARB) may have hyperkalemia, especially those with progressive renal function damage, heart failure, renal replacement therapy in progress, or patients who are undergoing potassium supplement therapy, potassium retention diuretics, potassium containing salt substitutes or other drugs that may increase blood potassium concentration. For patients with high potassium risk factors, serum electrolyte level should be monitored closely during the application of this product, and possible electrolyte disorder should be found.
Hyperkalemia may be fatal in elderly patients with renal dysfunction and diabetes mellitus, and other drugs that increase potassium levels and patients with complications.
I should fully assess the benefit risk ratio before considering the use of drugs that affect the renin-angiotension aldosterone system at the same time.
The main risk factors of hyperkalemia include:
-Diabetes mellitus and renal damage, age > 70 years)
-Use in combination with one or more other drugs and / or potassium supplements that affect the renin Angiotension aldosterone system. Drugs and the drug categories that may cause hyperkalemia: salt substitutes containing potassium, potassium conserving diuretics, angiotensin converting enzyme inhibitors, angiotensin I receptor antagonists, NSAIDs (including selective COX-2 inhibitors), heparin, immunosuppressors (cyclosporin or tacrolimus), and methoxybenzidine.
-Concurrent events, especially in dehydration, acute cardiac dysfunction, metabolic acidosis, deterioration of renal function, sudden deterioration of renal condition (e.g. infectious diseases), cytolysis (e.g., acute limb ischemia rhabdomyolysis, trauma enlargement)
5. Liver function damage
Telmisartan is mainly excreted through bile, and the clearance rate of telmisartan may be reduced in patients with biliary obstruction or liver dysfunction. Therefore, this product should not be used in patients with cholestasis, obstructive biliary tract disease or severe liver dysfunction. It should be used in patients with mild to moderate liver dysfunction. In such patients, telmisartan should be treated with small dose, and the treatment dose should be adjusted slowly.
6. Renal function impairment and renal transplantation
After the treatment of renin - Angiotension aldosterone system inhibitors, the renal function of sensitive patients will change. In patients with renal function that may depend on renin-angiotension aldosterone system activity (e.g., patients with severe congestive heart failure or renal dysfunction), treatment with ACE inhibitors and ACE antagonists can lead to hypouria and / or Progressive azotemia, rare cases will appear acute renal exhaustion and / or death. Telmisartan also reported similar results.
ACE inhibitors observed an increase in serum creatinine or urea nitrogen levels in patients with unilateral or bilateral renal artery stenosis. Telmisartan was not used for a long time in patients with unilateral or bilateral renal artery stenosis, but the results are expected to be similar to those of ACE inhibitors.
It is recommended that the level of blood potassium and creatinine be detected regularly when using this product in patients with renal function impairment.
There is no experience of telmisartan in recent renal transplant patients.
7. double block renin Angiotension aldosterone system
It is reported that renal function changes (including acute renal failure) after the treatment of renin - Angiotension aldosterone system inhibition has been initiated. Double blocking of renin-angiotension aldosterone systems (such as the combination of ACE inhibitors and ACE inhibitors and ACE II receptor inhibitors) should closely monitor renal function.
Ontarget was selected. 25620 diabetes patients aged 35 years old with atherosclerosis or terminal organ damage were investigated. The patients were randomly divided into two groups: telmisartan alone, ramipril alone or two drugs combined treatment group. The median follow-up time was 56 months. Patients treated with telmisartan and remipril did not benefit from the treatment with single drug, but the incidence of renal dysfunction (e.g. acute renal failure) was not increased compared with the treatment group treated with telmisartan or remipril alone. It is not recommended to use telmisartan and ramipril in combination.
8. other conditions of activating renin Angiotension aldosterone system
For patients with vascular tension and renal function mainly dependent on renin-angiotension aldosterone system activity (such as severe congestive heart failure or occult nephropathy, including renal artery stenosis), drug treatment of the system is related to acute hypotension, hyperazotemia, oliguria or rare acute renal failure. 1. Renal vascular hypertension
Patients with bilateral renal artery stenosis or renal artery stenosis with only one kidney use drugs that affect the renin-angiotension aldosterone system may be associated with the risk of severe hypotension and renal dysfunction. Telmisartan is used for a long time in patients without unilateral or bilateral renal artery stenosis
My experience.
10. primary aldosteronism
Patients with primary aldosteronism usually have no response to antihypertensive drugs that work by inhibiting the renin-angiotension system. Telmisartan is not recommended. As with other vasodilators, caution should be taken in patients with aortic and mitral stenosis or obstructive hypertrophic cardiomyopathy.
12. sorbitol
The product contains 169mg sorbitol per 40mg tablet. Therefore, patients with genetic fructose tolerance are not allowed to take this product.
13.others
Impact on driving and operating the machine
The effect of this product on driving and operating the machine was not studied. But when driving or operating the machine, attention must be paid to the occasional dizziness and burnout during the treatment of hypotension.
Racial differences
In line with the inhibitors of ACE, the antihypertensive effect of this product and other Angiotension antagonists on black people is worse than that of other non black people, which may be due to the low renin status in plasma.
As with other antihypertensive drugs, excessive hypotension in patients with ischemic cardiomyopathy or ischemic cardiovascular disease may lead to myocardial infarction or stroke.
Medication for pregnant and lactating women: Use during pregnancy
There is insufficient information on the use of Mecca in pregnant women. Studies in animals have shown reproductive toxicity (see preclinical safety data), and the potential risk to humans is unknown. Animal studies did not show teratogenic effects, but had fetal toxicity. Therefore, as a preventive measure, telmisartan should not be used in the first three months of pregnancy. When planning pregnancy in advance, switch to an appropriate alternative treatment. In the second and third trimester of pregnancy, drugs directly acting on renin-angiotensin system will damage the developing fetus and even lead to fetal death, so telmisartan is forbidden in the second and third trimester of pregnancy. Stop using this product as soon as possible when pregnancy is found.
Use during lactation
It is not clear whether telmisartan is secreted by milk, so this product is forbidden for lactating women
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