KINGLYUAN NUOJINPING Telmisartan Tablets For Hypertension 20mg*14

[Drug Name]
Generic Name: Telmisartan Tablets
Trade Name: Nojinping
English Name: Telmisartan Tablets
Chinese Pinyin: Timishatan Pian

[Ingredients]
The main ingredient of this product is telmisartan, whose chemical name is 4-[(1,4-dimethyl-2-propyl[2,6-di-1H-benzimidazol-1-yl)methyl]-[1,1-biphenyl]-2-carboxylic acid.

[Properties]
This product is a white or off-white tablet.

[Indications]
For the treatment of essential hypertension.

[Dosage and Administration]
Adults:
Dosage should be individualized. The usual initial dose is one 40 mg tablet once daily. Within the 20-80 mg dose range, the antihypertensive effect of telmisartan is dose-dependent. If optimal blood pressure is not achieved after treatment, the dose may be increased, up to a maximum of 80 mg (i.e., two 40 mg tablets or one 80 mg tablet) once daily. This product can be used in combination with thiazide diuretics, such as hydrochlorothiazide, which have a synergistic antihypertensive effect. Because telmisartan does not reach its maximum effect until four to eight weeks after the start of treatment, this should be considered when increasing the dose.
Patients with Renal Impairment:
No dose adjustment is required for patients with mild or moderate renal impairment. Telmisartan is not eliminated by hemofiltration.
Patients with Hepatic Impairment:
For patients with mild or moderate hepatic impairment, the daily dose of this product should not exceed 40 mg.
Elderly:
No dose adjustment is required.
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]
In placebo-controlled clinical trials, the overall incidence of adverse events was 41.4% for telmisartan and 43.9% for placebo. These adverse reactions were dose-independent and unrelated to gender, age, and race. The following adverse reactions are cumulatively reported in 5,788 hypertensive patients treated with telmisartan in clinical trials. The frequency of adverse reactions is as follows: Very common (≥1/10); Common (≥1/100, 1/10); Uncommon (≥1/1000, 1/100); Rare (≥1/10,000, 111,000); Very rare (1/10,000). Within each frequency group, adverse reactions are listed in descending order of severity. Infections: Common: symptoms of infection (e.g., urinary tract infections, including cystitis), upper respiratory tract infections including pharyngitis and sinusitis Psychiatric: Uncommon: anxiety Eyes: Uncommon: abnormal vision Ear and vestibular function: Uncommon: vertigo Gastrointestinal: Common: abdominal pain, diarrhea, indigestion Uncommon: dry mouth, flatulence Rare: stomach discomfort Skin and subcutaneous tissue: Common: eczematous skin lesions Uncommon: excessive sweating Musculoskeletal: Common: arthritis, back pain (e.g., sciatica), leg cramps or leg pain, myalgia Uncommon: tendonitis Systemic reactions and application site: Common: chest pain, flu-like symptoms. In addition, since telmisartan was marketed, there have been rare case reports of erythema, pruritus, syncope, insomnia, depression, gastric discomfort, vomiting, hypotension (including orthostatic hypotension), bradycardia, tachycardia, abnormal liver function, liver disease, renal impairment including acute renal failure (see [Precautions]), hyperkalemia, dyspnea, anemia, eosinophilia, thrombocytopenia, asthenia, and lack of efficacy. The frequency of these events is unknown. Angioedema, urticaria, and other related cases have been reported as events independent of other angiotensin II receptor antagonists. Laboratory Findings: Decreased hemoglobin or increased blood uric acid may occasionally be observed, occurring more frequently with telmisartan than with placebo. Increased creatinine or elevated liver enzymes may be observed with telmisartan, but the incidence of these laboratory changes is similar to or slightly lower than with placebo. In addition, since telmisartan was marketed, elevated blood creatine phosphokinase (CPK) levels have been reported. Placebo-controlled clinical trials showed an overall adverse event incidence of 41.4% for telmisartan and 43.9% for placebo. These adverse reactions were dose-independent and unrelated to gender, age, and race. The following adverse reactions are cumulatively reported in 5,788 hypertensive patients treated with telmisartan in clinical trials. The incidence of adverse reactions is categorized as follows: Very common (≥1/10); Common (≥1/100, 1/10); Uncommon (≥1/1,000, 1/100); Rare (≥1/10,000, 111,000); Very rare (1/10,000). Within each frequency group, adverse reactions are listed in descending order of severity. Infections: Common: symptoms of infection (e.g., urinary tract infections, including cystitis), upper respiratory tract infections including pharyngitis and sinusitis Psychiatric: Uncommon: anxiety Eyes: Uncommon: abnormal vision Ear and vestibular function: Uncommon: vertigo Gastrointestinal: Common: abdominal pain, diarrhea, indigestion Uncommon: dry mouth, flatulence Rare: stomach discomfort Skin and subcutaneous tissue: Common: eczematous skin lesions Uncommon: excessive sweating Musculoskeletal: Common: arthritis, back pain (e.g., sciatica), leg cramps or leg pain, myalgia Uncommon: tendonitis Systemic reactions and application site: Common: chest pain, flu-like symptoms. In addition, since telmisartan was marketed, there have been rare case reports of erythema, pruritus, syncope, insomnia, depression, gastric discomfort, vomiting, hypotension (including orthostatic hypotension), bradycardia, tachycardia, abnormal liver function, liver disease, renal impairment including acute renal failure (see [Precautions]), hyperkalemia, dyspnea, anemia, eosinophilia, thrombocytopenia, asthenia, and lack of efficacy. The frequency of these events is unknown. Angioedema, urticaria, and other related cases have been reported as events independent of other angiotensin II receptor antagonists. Laboratory Findings: Decreased hemoglobin or increased blood uric acid may occasionally be observed, occurring more frequently with telmisartan than with placebo. Increased creatinine or elevated liver enzymes may be observed with telmisartan, but the incidence of these laboratory changes is similar to or slightly lower than with placebo. In addition, since telmisartan was launched, there have been reports of elevated blood creatine phosphokinase (CPK).

[Contraindications]
1. This product is contraindicated in patients with allergies to any of the active ingredients or excipients. 2. This product is contraindicated in women in the second and third trimesters of pregnancy and during lactation. 3. This product is contraindicated in patients with biliary obstructive disease. 4. This product is contraindicated in patients with severe liver impairment.

[Precautions]
1. Hepatic Impairment: Telmisartan is primarily excreted via bile and should not be used in patients with cholestasis, biliary obstruction, or severe hepatic impairment (see [Contraindications]). These patients have reduced hepatic clearance of telmisartan. Telmisartan should be used with caution in patients with mild to moderate hepatic impairment. 2. Renovascular Hypertension: Patients with bilateral renal artery stenosis or unilateral renal artery stenosis may be at increased risk of severe hypotension and renal insufficiency with the use of drugs that affect the renin-angiotensin-aldosterone system. 3. Renal Impairment and Renal Transplant Patients: Patients with renal impairment should have their serum potassium and creatinine levels monitored regularly during the use of telmisartan. There is no experience with the use of telmisartan in recent renal transplant recipients. 4. Hypovolemia: Symptomatic hypotension, particularly after the first dose, may occur in patients with volume and/or sodium depletion due to strong diuretic therapy, salt restriction, diarrhea, or vomiting. Therefore, these conditions should be corrected before administering Micardis. Volume and/or sodium depletion should also be corrected before administering Micardis. 5. Other Conditions That Activate the Renin-Angiotensin-Aldosterone System: In patients whose vascular tone and renal function are primarily dependent on the activity of the renin-angiotensin-aldosterone system (e.g., severe congestive heart failure or latent renal disease, including patients with renal artery stenosis), medications that affect this system have been associated with acute hypotension, hyperazotemia, oliguria, or rarely, acute renal failure. 6. Primary Aldosteronism: Antihypertensive drugs that block the renin-angiotensin system are generally ineffective in patients with primary aldosteronism, so telmisartan is not recommended for such patients. 7. Aortic and Mitral Stenosis, Hypertrophic Obstructive Cardiomyopathy: As with other vasodilators, telmisartan should be used with caution in patients with aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy. 8. Hyperkalemia: Use of medications that affect the renin-angiotensin-aldosterone system may result in hyperkalemia. Hyperkalemia can be fatal in the elderly, patients with renal impairment, diabetes, concomitant use of other medications that increase potassium levels, and/or patients with comorbidities. The benefit-risk ratio should be assessed before considering concomitant use of medications that affect the renin-angiotensin-aldosterone system. The main risk factors for hyperkalemia are: diabetes, renal impairment, age (70 years), and concomitant use of one or more other medications that affect the renin-angiotensin-aldosterone system and/or potassium supplements. Drugs or therapeutic classes that may cause hyperkalemia include: potassium-containing salt substitutes, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, nonsteroidal anti-inflammatory drugs (including selective COX-2 inhibitors), heparin, immunosuppressants (cyclosporine or tacrolimus), and trimethoprim. Concurrent events, particularly dehydration, acute cardiac decompensation, metabolic acidosis, worsening renal function, sudden worsening of renal conditions (e.g., infectious diseases), and cytolysis (e.g., acute limb ischemia, rhabdomyolysis, and extended trauma). Close monitoring of serum potassium is recommended in high-risk patients. (See [Drug Interactions]) 9. Sorbitol: Each 40 mg tablet of this product contains 169 mg of sorbitol. Therefore, patients with hereditary fructose intolerance should not take this product. 10. Other: Consistent with angiotensin-converting enzyme inhibitors, this product and other angiotensin antagonists have less antihypertensive effects in blacks than in non-blacks, possibly because this population often has low plasma renin levels. As with other antihypertensive drugs, excessive blood pressure reduction in patients with ischemic cardiomyopathy or ischemic cardiovascular disease may lead to myocardial infarction or stroke. 11. Effects of Driving and Operating Machinery: The effects of this product on driving and operating machinery have not been studied. However, caution should be exercised when driving or operating machinery, as dizziness and fatigue may occasionally occur during antihypertensive therapy.

[Special Population Use]
Precautions for 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:
This product is contraindicated in women during the second and third trimesters of pregnancy and during lactation.
Precautions for Elderly:
No dose adjustment is required for this product.

[Drug Interactions]
Interaction studies have only been conducted in adults. Drugs or therapeutic classes that may cause hyperkalemia: Potassium-containing salt substitutes, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, nonsteroidal anti-inflammatory drugs (including selective COX-2 inhibitors), heparin, immunosuppressants (cyclosporine or tacrolimus), and trimethoprim. The development of hyperkalemia depends on associated risk factors. The risk is increased with the combination of the above-mentioned treatments. The risk is particularly high when ACE inhibitors or NSAIDs are used concomitantly with potassium-sparing diuretics or potassium-containing salt substitutes, but the risk is lower with ACE inhibitors if precautions are strictly adhered to. Concomitant use is not recommended: 1. Potassium-sparing diuretics or potassium supplements: Angiotensin II receptor antagonists reduce potassium losses caused by diuresis. Potassium-sparing diuretics such as spironolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may significantly increase serum potassium. If concomitant use is due to documented hypokalemia, caution should be used and serum potassium levels should be monitored frequently. 2. Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported with the concomitant use of lithium and ACE inhibitors, but this rarely occurs with concomitant use of angiotensin receptor antagonists. If concomitant use is necessary, careful monitoring of serum lithium levels is recommended. Concomitant medications requiring caution: 1. Nonsteroidal anti-inflammatory drugs: Nonsteroidal anti-inflammatory drugs (acetylsalicylic acid at anti-inflammatory doses, COX-2 inhibitors, and non-selective nonsteroidal anti-inflammatory drugs) may reduce the antihypertensive effect of angiotensin II receptor antagonists. In some patients with impaired renal function (such as dehydrated patients or elderly patients with renal impairment), the combined use of angiotensin II receptor antagonists and drugs that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, coadministration should be used with caution, especially in the elderly. Patients should be volume-replenished, and regular monitoring of renal function should be considered at the initiation of concurrent therapy and thereafter. 2. Diuretics (thiazide or loop diuretics): Prior high-dose diuretic therapy may lead to volume depletion and the risk of hypotension when initiating telmisartan therapy. Concomitant medications that must be considered: 1. Other antihypertensive drugs: The blood pressure-lowering effect of telmisartan may be enhanced by concomitant use of other antihypertensive drugs. Based on their pharmacological properties, the following medications can be expected to potentiate the antihypertensive effects of all antihypertensive medications, including telmisartan: baclofen and amistin. Furthermore, alcohol, barbiturates, anesthetics, or antidepressants may exacerbate orthostatic hypotension. 2. Corticosteroids (systemic route): Reduces antihypertensive efficacy.

[Pharmacological Action]
Telmisartan is an orally active, specific angiotensin II receptor (AT1) antagonist. It binds to the AT1 subtype of angiotensin II receptor (the known site of angiotensin II action) with high affinity and long-lasting binding, but lacks any partial agonist effect. The potential for receptor overstimulation due to increased angiotensin II levels caused by telmisartan is unknown. Telmisartan can decrease blood aldosterone levels. Telmisartan does not inhibit plasma renin or block ion channels. Angiotensin-converting enzyme (ACE) kinase II also degrades bradykinin. Because telmisartan does not inhibit ACE, adverse effects due to enhanced bradykinin action are not expected. Telmisartan has no affinity for other receptors, including AT2 and other less characterized AT receptors whose functions are still unclear. In humans, administration of 80 mg of telmisartan almost completely inhibits the angiotensin II-induced blood pressure increase, with the inhibitory effect persisting for 24 hours and still measurable after 48 hours. The antihypertensive effect gradually becomes apparent within 3 hours after the first dose of telmisartan. Maximum antihypertensive effect is achieved 4 weeks after the start of treatment and is maintained with long-term treatment. Ambulatory blood pressure monitoring shows that the antihypertensive effect persists for more than 24 hours after dosing, including the 4 hours before the next dose. This finding was confirmed in placebo-controlled clinical trials: the trough-to-peak ratio of telmisartan after 40 mg and 80 mg doses remained consistently above 80%. There is a clear dose-time dependence for return to baseline SBP. Data on DBP are conflicting in this regard. Telmisartan lowers systolic and diastolic blood pressure in patients with hypertension without affecting heart rate. Telmisartan's antihypertensive effects are comparable to those of other representative antihypertensive drugs. (Clinical studies have compared telmisartan with amlodipine, atenolol, enalapril, hydrochlorothiazide, losartan, and lisinopril.) If telmisartan treatment is abruptly discontinued, blood pressure gradually returns to pre-treatment levels over several days, without rebound hypertension. In a direct clinical trial comparing two antihypertensive drugs, the incidence of dry cough was significantly lower in patients treated with telmisartan compared with those treated with angiotensin-converting enzyme inhibitors. The effect of telmisartan on mortality and cardiovascular morbidity is currently unknown. Toxicology: At doses used in preclinical safety studies, comparable to clinically effective doses, it caused decreases in red blood cell indices (erythrocytes, hemoglobin, and hematocrit), altered renal hemodynamics (increased blood urea nitrogen and creatinine), and increased serum potassium in normotensive animals. Renal tubular dilation and atrophy have been observed in dogs. Gastrointestinal mucosal damage (erosion, ulceration, or inflammation) has also been observed in rats and dogs. These adverse pharmacological reactions are known from preclinical studies to be common to both ACE inhibitors and angiotensin II antagonists and can be prevented with oral salt supplementation. Increased plasma renin activity and juxtaglomerular cell hypertrophy/proliferation have been observed in both species. These changes are also common to ACE inhibitors and other angiotensin II antagonists and are not clinically specific. Animal studies have shown potential adverse effects of telmisartan on fetal postnatal development, including weight loss, delayed eye opening, and increased mortality. In vitro studies have not demonstrated mutagenicity or mutagenic activity. No carcinogenicity has been observed in studies in mice or rats.

Storage: Store tightly closed.

Strength: 20 mg

Packaging: 20 mg * 14 tablets

Shelf life: 24 months.

Approval number: National Medicine Standard H20041252

Manufacturer: Zhejiang Jinliyuan Pharmaceutical Co., Ltd.