Product Overview
[Drug Name]
Generic Name: Telmisartan Dispersible Tablets
Trade Name: NaZe Telmisartan Dispersible Tablets 40mg*7 tablets*2 packs
Pinyin Full Code: NaZe TiMiShaTanFenSanPian 40mg*7Pian*2Ban
[Main Ingredient]
Telmisartan
[Indications/Main Functions]
Hypertension: For the treatment of essential hypertension in adults. Cardiovascular Risk Reduction: This product is indicated for patients aged 55 years and older who are at high risk for major cardiovascular events and cannot receive angiotensin-converting enzyme (ACE) inhibitor therapy to reduce the risk of myocardial infarction, stroke, or cardiovascular death. High risk for cardiovascular events includes a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk type 2 diabetes (insulin-dependent or non-insulin-dependent) with evidence of end-organ damage. Telmisartan may also be used concurrently with other necessary treatments (e.g., antihypertensive medications, antiplatelet agents, or lipid-lowering agents). Concomitant use of telmisartan and ACE inhibitors is not recommended.
[Specifications]
40mg*14 tablets
[Dosage and Administration]
This product can be taken with or after meals. For the treatment of essential hypertension: Dosing should be individualized. The usual initial dose is 40mg once daily. Telmisartan's antihypertensive effect is dose-dependent within the 20-80mg dose range. If optimal blood pressure is not achieved after treatment, the dose can be increased, up to a maximum of 80mg once daily. This product can be used in combination with thiazide diuretics, such as hydrochlorothiazide, which have a synergistic antihypertensive effect. Because telmisartan typically takes four to eight weeks to achieve its maximum antihypertensive effect after initiation of treatment, this should be considered when increasing the dose. For cardiovascular risk reduction: The recommended dose is 80mg once daily. It is currently unknown whether doses below 80mg of telmisartan effectively reduce the risk of cardiovascular morbidity and mortality. When initiating telmisartan therapy to reduce cardiovascular risk, close blood pressure monitoring and appropriate adjustment of antihypertensive medications are recommended, if necessary. Special Populations: Patients with Impaired Renal Function: No dose adjustment is required for patients with mild or moderate renal impairment. Experience with this drug in patients with severe renal impairment or those undergoing hemodialysis is limited. Regular monitoring of serum potassium and creatinine is recommended when using this drug in patients with renal impairment (see [Precautions]). There is no experience with the use of telmisartan in recent renal transplant recipients. Patients with Impaired Hepatic Function: Telmisartan is primarily excreted via bile, and patients with obstructive biliary disease or hepatic insufficiency may have reduced clearance of this drug. Therefore, this drug should not be used in patients with cholestasis, obstructive biliary disease, or severe hepatic dysfunction. It should be used with caution in patients with mild or moderate hepatic insufficiency. In such patients, telmisartan therapy should be initiated at a low dose and titrated slowly. For patients with mild or moderate hepatic impairment, the daily dose of this drug should not exceed 40 mg (see [Precautions]).
[Adverse Reactions]
Placebo-controlled clinical studies for the treatment of hypertension have shown that the overall incidence of adverse events with telmisartan was 41.4% and with placebo was 43.9%, similar to that with placebo. These adverse reactions were dose-independent and independent of gender, age, and race. Telmisartan's safety profile in patients undergoing cardiovascular morbidity reduction is consistent with that observed in patients undergoing antihypertensive therapy. The following adverse drug reactions are based on cumulative results from controlled clinical studies and postmarketing reports in patients undergoing antihypertensive therapy. This list also includes reports of serious adverse events and adverse events leading to discontinuation from three long-term clinical studies involving 21,642 patients who were treated with telmisartan for up to six years for cardiovascular morbidity reduction. Adverse reactions are listed according to their frequency as follows: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000); Unknown (cannot be assessed based on available data). Within each frequency group, adverse reactions are listed in descending order of severity. Infections: Occasionally: upper respiratory tract infections including pharyngitis and sinusitis, urinary tract infections including cystitis Unspecified: sepsis with fatal outcome 1 Blood and Lymphatic System Disorders: Occasionally: anemia Rare: thrombocytopenia Unspecified: eosinophilia Immune System Disorders: Rare: allergy Unspecified: allergic reaction Metabolism and Nutrition Disorders: Occasionally: hyperkalemia Rare: hypoglycemia (rarely in patients with diabetes) Psychiatric Disorders: Occasionally: depression, insomnia Rare: anxiety Nervous System Disorders: Occasionally: syncope Eye Disorders: Rare: visual impairment Ear and Labyrinth Disorders: Occasionally: syncope Cardiac Disorders: Occasionally: bradycardia Rare: tachycardia Vascular System Disorders: Occasionally: hypotension 2. Orthostatic hypotension Respiratory, Chest and Mediastinal Disorders: Occasionally: dyspnea Gastrointestinal Disorders: Common: abdominal pain, diarrhea, indigestion, flatulence, vomiting Uncommon: Dry mouth, flatulence Hepatobiliary disorders: Rare: Abnormal liver function/liver disease Skin and subcutaneous tissue disorders: Uncommon: Hyperhidrosis, pruritus, rash Rare: Erythema, angioedema (with fatal outcome). Drug rash, toxic rash, eczema Unspecified: Urticaria Musculoskeletal and connective tissue disorders: Uncommon: Arthritis, back pain (e.g., sciatica), muscle spasm Rare: Arthralgia, pain in the extremities (leg pain) Unspecified: Tendon pain (similar to tendinitis symptoms) Renal and urinary disorders: Uncommon: Renal impairment, including acute renal failure General disorders and administration site: Uncommon: Chest pain, fatigue (asthenia) Rare: Flu-like symptoms Laboratory tests: Uncommon: Increased serum creatinine Rare: Increased serum uric acid, increased liver enzymes, increased blood alkaline phosphatase, decreased hemoglobin 1 In the PRoFESS study, the incidence of sepsis was increased with telmisartan compared to placebo. This may be due to chance or may be related to an unknown mechanism (see [Pharmacology and Toxicology]). 2 It has been reported as "common" in patients whose blood pressure was already controlled and receiving telmisartan in addition to standard therapy to reduce cardiovascular morbidity. In the TRANSCEND study (N=5926, follow-up 4 years 8 months) of telmisartan for cardiovascular risk reduction, 8.4% of patients in the telmisartan group discontinued due to adverse events, compared with 7.6% in the placebo group. Serious adverse events that occurred at a 1% higher rate in the telmisartan group compared with the placebo group were intermittent claudication (7% vs. 6%) and skin ulceration (3% vs. 2%). The most frequently reported spontaneous postmarketing events include headache, dizziness, asthenia, cough, nausea, fatigue, asthenia, edema, facial edema, lower extremity edema, angioneurotic edema, urticaria, hypersensitivity, increased sweating, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, increased blood pressure, exacerbated hypertension, hypotension (including orthostatic hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including calf cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, increased uric acid, abnormal liver function or liver disease, renal injury including acute renal failure, anemia, increased CPK, allergic reactions, and tendon pain (including tendinitis and synovitis). Rare cases of rhabdomyolysis have been reported in patients treated with angiotensin II receptor inhibitors, including Micardis.
