Product Overview
[Drug Name]
Generic Name: Torasemide Capsules
Trade Name: Lizhi
English Name: TORASEMIDE CAPSULES
Chinese Pinyin: Tuolasaimi Jiaonang
[Ingredients]
Main ingredient: Torasemide, Chemical Name: N-[[(1-methylethyl)amino]carbonyl]-4-[(3-methylphenyl)amino]-3-pyridinesulfonamide. Chemical Structure: Molecular Formula: C₁₆H₂O₄N₄O₃S Molecular Weight: 348.43
[Properties]
This product is a hard capsule containing white or off-white granules and powder.
[Indications]
Edema caused by congestive heart failure
[Dosage and Administration]
For oral administration, the starting dose is 10 mg (1 capsule) once daily. The dose can be increased to 20 mg (2 capsules) once daily as needed.
[Adverse Reactions]
1. Common adverse reactions include headache, dizziness, fatigue, loss of appetite, muscle cramps, nausea and vomiting, hyperglycemia, hyperuricemia, constipation, and diarrhea. Long-term, high-dose use may cause fluid and electrolyte imbalances.
2. Polyuria is common in patients at the beginning of treatment and in older patients. Some patients may experience hypotension, mental confusion, thrombotic complications, and cardiac or cerebral ischemia leading to erratic heart rhythms, angina, acute myocardial infarction, or syncope due to hemoconcentration. Hypokalemia may occur in patients with a low-potassium diet, vomiting, diarrhea, excessive laxative use, and abnormal liver function.
3. Some patients may experience skin allergies, occasionally itching, rash, and photosensitivity reactions. Rarely, dry mouth, limb paresthesias, and visual disturbances may occur.
[Contraindications]
1. This product is contraindicated in patients with a known hypersensitivity to torsemide or sulfonylureas. 2. This product is contraindicated in patients with anuria.
[Precautions]
1. Patients using Torsemide Capsules (Lizhi) should regularly check their blood electrolytes (especially potassium), blood glucose, uric acid, creatinine, and blood lipids. 2. Urinary dysfunction must be corrected before starting treatment with Torsemide Capsules (Lizhi). Elderly patients, especially those at the beginning of treatment, should be carefully monitored for electrolyte and blood volume deficiencies and symptoms related to hemoconcentration. 3. Patients with cirrhosis and ascites should be hospitalized when using Torsemide Capsules (Lizhi) for diuresis. Overly rapid diuresis in these patients can cause severe electrolyte imbalances and hepatic coma. 4. Torsemide Capsules (Lizhi) can be used with aldosterone antagonists or potassium-sparing drugs to prevent hypokalemia and metabolic alkalosis. 5. Patients with benign prostatic hyperplasia (BPH) may experience difficulty urinating. Increased urine volume from using Torsemide Capsules (Lizhi) can lead to urinary retention and bladder distension. 6. When initiating treatment with torasemide capsules (Lizhi), switching to torasemide capsules (Lizhi) from other medications, or starting a new adjunctive medication, some individuals may experience impaired alertness (e.g., while driving a vehicle or operating machinery).
[Use in Special Populations]
Precautions for Children:
The efficacy and safety data for this drug in children have not been established; it should be used with caution. Edema due to patent ductus arteriosus and hyaline membrane disease has been observed in premature infants taking other loop diuretics, occasionally associated with nephrocalcinosis. The stones are sometimes barely visible on X-rays, but sometimes appear staghorn and fill the renal pelvis. Some stones resolve spontaneously. The incidence of hypercalciuria is reduced when chlorothiazide is used in combination with other loop diuretics. Other premature infants with hyaline membrane disease who take other loop diuretics have an increased risk of persistent patent ductus arteriosus, possibly related to prostaglandin E-mediated effects. The use of this drug in such patients has not been studied.
[Precautions During Pregnancy and Lactation]
1. Pregnant Women: No embryotoxic or teratogenic effects were observed in rats at doses up to 5 mg/kg/day (equivalent to 15 times and 10 times the 20 mg human dose, measured in mg/kg and body surface area, respectively) and in rabbits at doses up to 1.6 mg/kg/day (equivalent to 5 times and 1.7 times the 20 mg human dose, measured in mg/kg and body surface area, respectively). However, when the dose was increased by 4-fold and 5-fold in rabbits and rats, respectively, fetal and maternal toxicity included decreased mean body weight, increased fetal resorptions, and delayed fetal ossification. Because adequately controlled studies have not been conducted in pregnant women, and because results of reproductive toxicity studies in animals are not always predictive of human responses, the risks and benefits of using this drug in pregnant women must be carefully considered. 2. Lactating Women: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, this drug should be used with caution in lactating women.
Elderly Precautions:
In clinical trials conducted in the United States, 24% of patients were over 65 years of age, and approximately 4% were over 75 years of age. The results showed no age-related differences in the efficacy and safety of this drug in elderly patients compared with younger patients.
[Drug Interactions]
1. No new or unexpected adverse reactions were observed in patients with essential hypertension using this drug in combination with beta-blockers, ACE inhibitors, and calcium channel blockers, and in patients with congestive heart failure using this drug in combination with digitoxin, ACE inhibitors, and nitrates. 2. This drug had no effect on the plasma protein binding of glyburide and warfarin, the anticoagulant effect of phenprocoumon (a related coumarin derivative), or the pharmacokinetics of digoxin or carvedilol (a vasodilator and beta-blocker). In healthy volunteers, coadministration of this drug with spironolactone decreased the renal clearance of spironolactone and increased its AUC, but clinical experience indicates that no dose adjustment of either drug is necessary. 3. Because salicylates compete with this product for renal tubular secretion, salicylate toxicity may be observed in high-dose salicylate groups following concomitant use with this product. Although drug interaction studies with nonsteroidal anti-inflammatory drugs (NSAIDs) have not been conducted, concomitant use of these drugs with furosemide may occasionally lead to renal dysfunction. 4. Like many diuretics, indomethacin partially inhibits the natriuretic effect of this product. This effect has been observed in patients with sodium restriction (50 mEq/day) but not in patients with normal sodium intake (150 mEq/day). 5. Cimetidine and spironolactone have no effect on the pharmacokinetics or diuretic effect of this product. Concomitant administration of digoxin increases the AUC of this product by 50%, but no dose adjustment is required. 6. While human drug interaction studies have not been conducted with this product and cholestyramine, in animal studies, cholestyramine decreased the oral absorption of this product, and concomitant use of these two drugs is not recommended. 7. Concomitant use of probenecid may reduce the secretion of this drug into the proximal convoluted tubule, thereby diminishing its diuretic effect. 8. Other diuretics are known to reduce the renal clearance of lithium, increasing the risk of lithium toxicity. Therefore, caution is advised when these two drugs are used together. Drug interaction studies have not been conducted on the combined use of this drug with lithium. 9. Other diuretics may increase the potential ototoxicity of aminoglycoside antibiotics and ethacrynic acid, particularly in patients with renal impairment. Interaction studies with these drugs have not been conducted.
[Pharmacological Action]
Pharmacological Action: This drug primarily acts in the thick ascending limb of the loop of Henle, inhibiting the Na+/K+/2Cl- transport system. Clinical pharmacology studies have confirmed this site of action in humans, with no effects elsewhere in the kidney. Therefore, the diuretic effect of this drug is more closely related to the drug's urinary excretion rate than its blood concentration. Torsemide increases urinary excretion of sodium, chloride, and water but does not significantly alter glomerular filtration rate, renal blood flow, or acid-base balance. Toxicological Effects: Carcinogenicity: Administration of torsemide at 9 mg/kg/day and 32 mg/kg/day torsemide to rats and mice, respectively, did not significantly increase tumor incidence. These doses are equivalent to 27-96 times (in mg/kg) or 5-8 times (based on body surface area) the 20 mg human dose. In rat studies, high-dose female rats showed significantly increased tubular damage, renal interstitial inflammation, and the incidence of renal adenomas and renal cancers, but the tumor incidence was not higher than that of historical controls. Similar non-neoplastic renal damage has been observed in animal studies with other diuretics, such as furosemide and hydrochlorothiazide, at high doses. Mutagenicity: Torsemide and its major human metabolite were not mutagenic in various in vitro and in vivo studies. These tests included the Ames test (with or without S9), the human lymphocyte chromosome aberration and sister chromatid exchange tests, the hamster bone marrow micronucleus aberration test, and the unscheduled DNA synthesis test in mice and rats. Reproductive toxicity: Administration of 25 mg/kg/day of torasemide (75 times and 13 times the 20 mg human dose, measured in mg/kg and body surface area, respectively) had no effect on the reproductive capacity of either male or female rats. Administration of 5 mg/kg/day of torasemide to rats (15 times and 10 times the 20 mg human dose, measured in mg/kg and body surface area, respectively) and 1.6 mg/kg/day of torasemide to rabbits (5 times and 1.7 times the 20 mg human dose, measured in mg/kg and body surface area, respectively) did not result in fetal or teratogenic effects. Fetal and maternal toxicity (decreased mean body weight, increased number of resorbed placentas, and delayed fetal ossification) was observed at higher doses (4 times that of rats and 5 times that of rabbits, respectively).
[Storage] Store in a dry, airtight container away from light.
[Strength] 10mg
[Packaging] Aluminum-plastic packaging, 10 tablets/box.
[Expiry Date] 24 months
[Approval Number] National Medicine Standard H20050526
[Manufacturer] Zhejiang Chengyi Pharmaceutical Co., Ltd.
