Product Overview
[Drug Name]
Generic Name: Torsemide Dispersible Tablets
Trade Name: Huishun Torsemide Dispersible Tablets 10mg x 14 tablets
[Main Ingredient]
Torasemide.
[Properties]
This product is white or off-white tablets.
[Indications/Main Functions]
Indicated for patients with congestive heart failure, ascites due to cirrhosis, and edema caused by kidney disease who require rapid diuresis or cannot take oral diuretics.
[Specifications]
10mg x 14 tablets
[Dosage and Administration]
1. Congestive heart failure, edema caused by 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. 2. Cirrhosis with ascites: The initial dose is generally 10 mg, taken orally once daily in the morning. Torsemide dispersible tablets can be taken concurrently with an aldosterone antagonist or potassium-sparing diuretic. 3. Essential hypertension: The initial dose is generally 5 mg, taken orally once daily. If adequate blood pressure lowering is not achieved within 4 weeks, the dose can be increased to 10 mg orally once daily. If the blood pressure lowering effect is still insufficient, other antihypertensive medications should be added.
[Adverse Reactions]
1. Common adverse reactions include headache, dizziness, fatigue, loss of appetite, muscle cramps, nausea and vomiting, hyperglycemia, hyperuricemia, constipation, and diarrhea. 2. Long-term, high-dose use may cause fluid and electrolyte imbalances. 3. Polyuria is common in patients in the early stages of treatment and in older patients. 4. Some patients may experience hypotension, mental disturbances, thrombotic complications, and cardiac or cerebral ischemia-induced arrhythmias, angina pectoris, acute myocardial infarction, or syncope due to hemoconcentration. 5. Hypokalemia may occur with torsemide dispersible tablets in patients with a low potassium diet, vomiting, diarrhea, excessive use of laxatives, and abnormal liver function. 6. Some patients may experience skin allergies, occasionally itching, rashes, photosensitivity reactions, and rarely dry mouth, paresthesias in the limbs, and visual impairment.
[Contraindications]
1. Torsemide dispersible tablets are contraindicated in patients with anuria and renal failure. 2. Torsemide dispersible tablets are contraindicated in patients with pre-hepatic coma or hepatic coma. 3. Torsemide dispersible tablets are contraindicated in patients with hypersensitivity to this product or sulfonylureas. 4. Torsemide dispersible tablets are contraindicated in patients with hypotension, hypovolemia, hypokalemia, or hyponatremia. 5. Torsemide dispersible tablets are contraindicated in patients with severe dysuria (e.g., benign prostatic hyperplasia).
[Drug Interactions]
1. Torsemide dispersible tablets may aggravate the adverse effects of cardiac glycosides due to hypokalemia. 2. Torsemide dispersible tablets 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. Torsemide dispersible tablets may enhance the effects of antihypertensive drugs. 5. Torsemide dispersible tablets may cause excessive lowering of blood pressure if used continuously or coadministered with an angiotensin-converting enzyme inhibitor. 6. Torsemide dispersible tablets may reduce the effects of antidiabetic drugs. 7. 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.
[Precautions]
1. Patients using this product should regularly check electrolytes (especially potassium), blood glucose, uric acid, creatinine, and lipids. 2. Urinary dysfunction must be corrected before initiating treatment with this product. Elderly patients, especially at the beginning of treatment, should be carefully monitored for electrolyte and blood volume depletion and symptoms related to hemoconcentration. 3. Patients with cirrhosis and ascites should be hospitalized when using this product as a diuretic. Overly rapid diuresis in these patients may cause severe electrolyte imbalance and hepatic coma. 4. This product can be used together with aldosterone antagonists or potassium-sparing drugs to prevent hypokalemia and metabolic alkalosis. 5. Patients with benign prostatic hyperplasia have difficulty urinating. The increased urine volume caused by the use of this product can lead to urinary retention and bladder distension. 6. When starting treatment with this product or switching from other drugs to this product or starting a new auxiliary drug treatment, the alertness of some patients may be affected (such as when driving a vehicle or operating a machine). 7. This product must be injected slowly intravenously. Torsemide dispersible tablets should not be mixed with other drugs and injected intravenously, but can be diluted with normal saline or % glucose solution as needed. 8. If long-term medication is required, it is recommended to switch from intravenous administration to oral medication as soon as possible. The course of intravenous administration is limited to one week.
[Pharmacology and Toxicology]
1. This product is mainly used in the thick ascending limb of medullary canal to inhibit the Na+/K+/2CI- transport system. Clinical pharmacology studies have also confirmed that this is the site of action of this product in the human body, and it has no effect on other parts of the kidney. Therefore, the diuretic effect of this product is more related to the excretion rate of the drug in urine than to the concentration in the blood. 2. Torsemide can increase the excretion of sodium, chloride and water in urine, but does not significantly change the glomerular filtration rate, renal blood flow and acid-base balance. 3. Carcinogenic effect: () Rats and mice were given 9mg water g/day and 32mg water g/day of torasemide, respectively, and the tumor incidence did not increase significantly. This dose is equivalent to 27-96 times (in mg/kg) or 5-8 times (in body surface area) the 20mg dose for humans. (2) In rat experiments, female rats in the high-dose group were found to have significantly increased incidences of renal tubular damage, renal interstitial inflammation, renal adenoma and renal cancer, but the tumor incidence was not higher than that of historical controls. (3) In animal studies, other diuretics such as furosemide and hydrochlorothiazide also showed similar non-neoplastic renal damage in high-dose groups. (4) Mutagenicity In various in vivo and in vitro studies, torasemide and its main metabolites in humans had no mutagenic effect. 4. Reproductive toxicity: (1) Administration of 25 mg/day of torasemide (75 times and 13 times the human dose of 20 mg in terms of mg/kg and body surface area, respectively) had no effect on the reproductive capacity of female and male rats. (2) Administration of 5 mg/kg/day of torasemide to rats (15 times and 10 times the human dose of 20 mg/day in terms of mg/kg and body surface area, respectively) and 1.6 mg/kg/day of torasemide to domestic rabbits (5 times and 1.7 times the human dose of 20 mg/kg/day in terms of mg/kg and body surface area, respectively) did not show fetal toxicity or teratogenicity. (3) Fetal and maternal toxicity (decreased mean body weight, increased number of resorbed placentas and delayed fetal ossification) was observed when a larger dose of 4 times or 5 times that of the dose .
