Torsemide Tablets

This product is a sulfonylurea pyridine diuretic, which acts on the thick ascending limb of the loop of Henle, inhibits the Na/K/2Cl- carrier system, and increases the excretion of Na, K, Cl- and water in the urine, but has no significant effect on the glomerular filtration rate, renal plasma flow or acid-base balance in the body.

The main ingredient of this product is torsemide, and its chemical name is: 1-isopropyl-3-[(4-m-toluamino-3-pyridyl)sulfonyl]urea

This product is white or off-white tablets.

It is used 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.

Edema caused by congestive heart failure, renal failure and kidney disease: The general initial dose is 10 mg, taken orally once a day in the morning. The dose will be adjusted according to the condition in the future, and the general maximum daily dose is not more than 200 mg. Ascites due to liver cirrhosis: The general initial dose is 10 mg, taken orally once a day in the morning, taken at the same time as an aldosterone antagonist or potassium-sparing diuretic. Primary hypertension: The general initial dose is 5 mg, taken orally once a day. If the antihypertensive effect is not achieved within 4 weeks, the dose can be increased to 10 mg, taken orally once a day. If the antihypertensive effect is still insufficient, other antihypertensive drugs should be added.

Common adverse reactions include headache, dizziness, fatigue, loss of appetite, muscle cramps, nausea and vomiting, hyperglycemia, hyperuricemia, constipation and diarrhea; long-term and large-scale use may cause water and electrolyte imbalance. Polyuria often occurs in the early stage of treatment and in older patients. Some patients may suffer from hypotension, mental disorders, thrombotic complications and cardiac or cerebral ischemia due to hemoconcentration, heart rhythm disorders, angina pectoris, acute myocardial infarction or syncope. Hypokalemia may occur in patients with low potassium diet, vomiting, diarrhea, excessive use of laxatives and abnormal liver function. Some patients may experience skin allergies, occasional itching, rash, photosensitivity reactions, and rarely dry mouth, limb paresthesia, and visual impairment.

This product is contraindicated in patients with anuria due to renal failure, patients in the pre-hepatic coma or hepatic coma, patients allergic to this product and sulfonylureas, patients with hypotension, hypovolemia, hypokalemia or hyponatremia, and patients with severe urination difficulties (such as prostatic hypertrophy).

Precautions for children: The efficacy and safety data of this product for children have not been established, and this product should be used with caution. After premature infants took another loop diuretic, edema caused by patent ductus arteriosus and hyaline membrane disease was observed, which was occasionally related to renal calcification. The stones were sometimes barely visible on X-rays, but sometimes filled the renal pelvis in a staghorn shape. Some stones can disappear on their own, and the incidence of hypercalciuria decreased after chlorothiazide was used in combination with other loop diuretics. Other premature infants with hyaline membrane disease who took another loop diuretic had an increased risk of persistent patent ductus arteriosus, which may be related to prostaglandin E-mediated effects. No studies have been conducted on the use of this product in such patients. Precautions during pregnancy and lactation: 1. Pregnant women: No embryotoxicity or teratogenicity was found in rats at a dose of 5 mg/kg/day (in terms of mg/kg and body surface area, the dose is equivalent to 15 times and 10 times the human dose of 20 mg, respectively) and rabbits at a dose of 1.6 mg/kg/day (in terms of mg/kg and body surface area, the dose is equivalent to 5 times and 1.7 times the human dose of 20 mg, respectively). When the dose of rabbits and rats was increased by 4 times and 5 times, respectively, the toxicity of the fetus and mother included a decrease in average body weight, an increase in fetal absorption, and delayed fetal ossification. Since no adequate controlled trials have been conducted in pregnant women, and the results of reproductive toxicity tests on animals do not always predict the response to humans, pregnant women must weigh the pros and cons when taking this product. 2. Lactating women: It is not yet known whether this product can be secreted in human milk. Since many drugs can be secreted in human milk, lactating women should use this product with caution. Precautions for the elderly: In the clinical trials of this product in the United States, 24% of the patients were over 65 years old, and about 4% of the patients were over 75 years old. The results showed that the efficacy and safety of this product in elderly patients did not show age-related differences compared with young patients.

1. Hypokalemia caused by this product may aggravate the adverse reactions of cardiac glycosides. 2. This product may enhance the potassium-consuming effect of salt, glucocorticoids and laxatives. 3. Nonsteroidal anti-inflammatory drugs (such as indomethacin) and probenecid may reduce the diuretic and hypotensive effects of this product. 4. This product may enhance the effect of antihypertensive drugs. 5. Continuous use of this product or co-administration with an angiotensin-converting enzyme inhibitor may cause excessive lowering of blood pressure. 6. This product may reduce the effect of antidiabetic drugs. 7. This product may aggravate the ototoxicity and nephrotoxicity of aminoglycoside antibiotics (such as kanamycin, gentamicin, tobramycin), cisplatin preparations, and cephalosporins when used in high doses. 8. This product may enhance the effects of curare-like muscle relaxants and theophylline drugs. 9. This product may reduce the effects of norepinephrine and epinephrine. 10. This product may increase the toxicity of salicylates when patients use large doses of salicylates.

Keep away from light and store in sealed container.

5mg

Tentative 24 months