Product Overview
[Drug Name]
Generic Name: Torasemide Tablets
Trade Name: Suzhong Pharmaceutical/Tosai
English Name: Torasemide Tablets
Chinese Pinyin: Torasemide Tablets
[Ingredients]
The main ingredient of this product is torsemide, chemically known as 1-isopropyl-3-[(4-m-toluamino-3-pyridyl)sulfonyl]urea.
[Properties]
This product is a white or off-white tablet.
[Indications]
For patients with congestive heart failure, ascites due to liver cirrhosis, and edema caused by kidney disease; it can also be used for patients with essential hypertension.
[Dosage and Administration]
For edema caused by congestive heart failure, renal failure, and kidney disease: The initial dose is generally 10 mg, taken orally once daily in the morning. The dose can be adjusted based on the patient's condition, generally not exceeding 200 mg per day. For ascites due to liver cirrhosis: The initial dose is generally 10 mg, taken orally once daily in the morning, taken concurrently with an aldosterone antagonist or potassium-sparing diuretic. Essential hypertension: The general initial dose is 5 mg, taken orally once daily. If adequate antihypertensive effect is not achieved within 4 weeks, the dose can be increased to 10 mg, taken orally once daily. If the antihypertensive effect is still insufficient, other antihypertensive medications should be added.
[Adverse Reactions]
Common adverse reactions include headache, dizziness, fatigue, loss of appetite, muscle cramps, nausea and vomiting, hyperglycemia, hyperuricemia, constipation, and diarrhea. Long-term and high-dose use may cause fluid and electrolyte imbalances. Polyuria is common in the early stages of treatment and in older patients. Some patients may experience hypotension due to hemoconcentration, mental disturbances, thrombotic complications, and cardiac or cerebral ischemia leading to arrhythmias, angina pectoris, acute myocardial infarction, or syncope. Hypokalemia may occur in patients with a low-potassium diet, vomiting, diarrhea, excessive use of laxatives, and abnormal liver function. Some patients may experience skin allergies, occasionally itching, rash, and photosensitivity reactions. Rarely, dry mouth, paresthesias in the limbs, and visual impairment may occur.
[Contraindications]
This drug is contraindicated in patients with anuria due to renal failure, patients in the pre-hepatic coma or hepatic coma, patients allergic to this drug or sulfonylureas, patients with hypotension, hypovolemia, hypokalemia, or hyponatremia, and patients with severe dysuria (e.g., benign prostatic hyperplasia).
[Precautions]
1. Patients using this drug should regularly check their blood electrolytes (especially potassium), blood glucose, uric acid, creatinine, and lipids. 2. Urinary dysfunction must be corrected before starting treatment with this drug. Elderly patients, especially those at the beginning of treatment, should be carefully monitored for symptoms related to electrolyte and blood volume depletion and hemoconcentration. 3. Patients with cirrhosis and ascites should be hospitalized when using this drug as a diuretic. Overly rapid diuresis in these patients can cause severe electrolyte imbalances and hepatic coma. 4. This drug can be used with an aldosterone antagonist or potassium-sparing medication to prevent hypokalemia and metabolic alkalosis. 5. Patients with benign prostatic hyperplasia may experience dysuria. Increased urine volume with this drug may lead to urinary retention and bladder distension. 6. When initiating treatment with this drug, switching from other medications to this drug, or starting a new treatment...
[Use in Special Populations]
Precautions for Children:
The efficacy and safety data for Torsemide (torsemide tablets) in children have not been established; therefore, this drug should be used with caution.
[Precautions for 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 more than 4-fold in rabbits and 5-fold in rats, 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 this drug should be considered when administered to pregnant women. 2. Breastfeeding Women: It is not known whether this product is excreted in human breast milk.
[Precautions for Elderly Patients]
In clinical trials of this product 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 product in elderly patients compared with younger patients.
[Drug Interactions]
1. Hypokalemia caused by this product may exacerbate the adverse effects of cardiac glycosides. 2. This product may enhance the potassium-wasting effects of salt, glucocorticoids, and laxatives. 3. Nonsteroidal anti-inflammatory drugs (e.g., indomethacin) and probenecid may reduce the diuretic and antihypertensive effects of this product. 4. This product may enhance the effects of antihypertensive drugs. 5. Continuous use of this product or initiation of concomitant use with an angiotensin-converting enzyme inhibitor may result in excessive lowering of blood pressure. 6. This product may reduce the effect of antidiabetic drugs. 7. This product, when used in high doses, may exacerbate the ototoxicity and nephrotoxicity of aminoglycoside antibiotics (e.g., kanamycin, gentamicin, tobramycin), cisplatin preparations, and cephalosporins. 8. This product may enhance the effects of curare-like muscle relaxants and theophylline-like drugs. 9. This product may reduce the effects of norepinephrine and epinephrine. 10. This product may increase the toxicity of salicylates when used in patients taking high doses of salicylates.
[Pharmacological Action]
This product is a sulfonylurea pyridine diuretic that acts on the thick ascending limb of the loop of Henle, inhibiting the Na+/K+/2Cl- carrier system and increasing urinary excretion of Na+, K+, Cl-, and water. However, it has no significant effect on glomerular filtration rate, renal plasma flow, or acid-base balance.
[Storage] Store in a dark, sealed container. [Specification] 10mg x 12 tablets
[Packaging] Box
[Expiration Date] 24 months
[Approval Number] National Medicine Standard H20050525
[Manufacturer] Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
