GMP Certified / Spironolactone Tablets 25mg

• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 25mg
• Model NO.: Tablet
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Spironolactone Tablets 25mg
Strength	25mg
Packing	3*10 tablets /box
Origin	China

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 Packaging design by our team
 Registration service by our team
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Product name:
Spironolactone Tablets 25mg

Character:
This product is a film coated tablet, white or white after removing the coating.

Indications:
(1) edematous diseases: combined with other diuretics, it is used to treat edema diseases such as congestive edema, cirrhosis ascites, renal edema, etc. Its purpose is to correct the secondary increase in aldosterone secretion accompanied by the above diseases, and counter the potassium excretion effect of other diuretics. It is also used in the treatment of idiopathic edema.
(2) Hypertension: as an adjunct drug for the treatment of hypertension.
(3) Primary hyperaldosteronism: spironolactone can be used for the diagnosis and treatment of this disease.
(4) Prevention of hypokalemia: combined with thiazide diuretics to enhance diuretic effect and prevent hypokalemia.

Adverse reactions:
(1) Clinically significant adverse reactions [4]
hyperkalemia
Spironolactone causes hyperkalemia. The increased risk is seen in patients with impaired kidney function or who use potassium supplements, potassium salt substitutes, or potassium-increasing medications, such as angiotensin-converting enzyme inhibitors and angiotensin receptor blockers.
Serum potassium was monitored within 1 week of spironolactone initiation and then periodically thereafter. When spironolactone is used in combination with other drugs that cause hyperkalemia or in patients with impaired kidney function, more frequent monitoring may be required. If hyperkalemia occurs, reduce the dose or discontinue spironolactone administration to treat hyperkalemia.
Hypotension and worsening kidney function
Excessive diuretics can lead to symptomatic dehydration, low blood pressure, and worsening kidney function, especially in patients who are salt deficient or taking angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers. Concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSaids) may also cause deterioration of renal function. Regular monitoring of volume status and renal function.
Electrolyte and metabolic abnormalities
In addition to causing hyperkalemia, spironolactone can also cause hyponatremia, hypomagnesemia, hypocalcemia, hypochloremia, alkalosis, and hyperglycemia. Asymptomatic hyperuricemia may occur, and gout rarely occurs. Serum electrolytes, uric acid and blood sugar were monitored regularly.
Gynecomastia
Spironolactone can cause gynecomastia. In RALES, patients with heart failure were treated with an average dose of 26mg once daily, causing gynecomastia in about 9% of male subjects. The risk of gynecomastia increases in a dose-dependent manner, with onset ranging from 1-2 months to more than a year. Gynecomastia is usually reversible.
Fluid and electrolyte balance changes
Spironolactone can cause sudden changes in fluid and electrolyte balance that may lead to liver damage, impaired neurological function in patients with cirrhosis and ascites, worsening of hepatic encephalopathy and coma.
(2) Other adverse reactions (frequency unknown)
Digestive system: Stomach bleeding, ulcers, gastritis, diarrhea and cramps, nausea, vomiting.
Reproductive system: Decreased libido, inability to achieve or maintain erections, irregular menstruation or amenorrhea, postmenopausal bleeding, breast and nipple pain.
Blood: leukopenia (including agranulocytosis), thrombocytopenia
Hypersensitivity: fever, urticaria, maculopapular or erythema rash, allergic reactions, vasculitis
Metabolism: Hyperkalemia, electrolyte disturbance, hyponatremia, hypovolemia.
Musculoskeletal: Leg cramps.
Nervous system/Psychosis: lethargy, confusion, ataxia, dizziness, headache, lethargy.
Kidney: Renal insufficiency (including renal failure). Skin: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), hair loss, pruritus.

Pharmacology and toxicology:
Pharmacological action
Spironolactone and its active metabolites are specific antagonists of aldosterone, acting primarily through competitive binding to receptors at aldosterone-dependent sodium-potassium exchange sites in the distal curvature of renal tubules. Spironolactone can increase the excretion of sodium and water, and has the effect of preserving potassium. Based on the above mechanism of action, spironolactone acts as both a diuretic and an antihypertensive agent, and can be administered alone or in combination with other diuretics that act on the proximal renal tubules.
Toxicological study
Genotoxicity:
Spironolactone and potassium canliate had no mutagenic effects on bacteria and yeast. In vitro experiments of mammalian cells, when there was no metabolic activation system, spironolactone and potassium canliate had no mutagenic effect. Some mammalian cell tests of spironolactone were negative when metabolically activated systems were present, while others were inconclusive (but slightly positive). When a metabolically activated system is present, potassium canliate is mutagenic in some mammalian cell tests, inconclusive in others, and negative in others.
Reproductive toxicity:
The female rats were given spironolactone 15 mg/kg/ day and 50 mg/kg/ day orally, and no effects on mating and fertility were observed, but the incidence of stillbirth was slightly increased at 50 mg/kg/ day. Female rats were given spironolactone 100 mg/kg/ day by intraperitoneal injection for seven consecutive days, during which the estrous interval was prolonged, and during the observation period of two weeks after the administration, the estrous interval was constant, resulting in an extended duration of the estrous cycle. The above changes are associated with delayed ovarian follicle development and lower circulating estrogen levels, which may reduce mating, fertility, and reproduction. When male and female mice were kept in the same cage, the female mice were given spironolactone 100 mg/kg/ day by intraperitoneal injection for two consecutive weeks, while the male mice were not given spironolactone, which showed that the number of successful mating of mice was decreased (due to inhibition of ovulation), the number of embryo implantation of pregnant mice was decreased (due to inhibition of implantation), and the dose of 200 mg/kg could also prolong the sexual maturity period.
In the study of teratogenicity in mice and rabbits, spironolactone was administered at a dose of 20 mg/kg/ day, and no teratogenicity or other embryonic toxicity was observed in mice. 20 mg/kg could increase the incidence of embryonic reabsorption and reduce the number of live births in rabbits. According to the body surface area, the dose in mice was significantly lower than the maximum recommended dose in humans, while the dose in rabbits was close to the maximum recommended dose in humans. Since spironolactone has antiandrogenic activity is required for male morphological development, spironolactone may adversely affect male sex differentiation during embryogenesis. The rats were given spironolactone 200 mg/kg/ day from the 13th to the 21st day of gestation (during late embryonic development and fetal development), and the male fetus was feminized. When spironolactone was administered 50 mg/kg/ day and 100 mg/kg/ day in the third trimester of pregnancy, changes in the reproductive system of the offspring were observed, including weight and dose-dependent reduction of the ventral prostate and seminal vesicle glands in male fetuses, enlargement of the ovaries and uterus in female fetuses, and other manifestations of endocrine dysfunction that persisted into adulthood. Spironolactone is known to have endocrine effects when used in animals, including progestational and antiandrogenic effects.
Carcinogenicity:
The carcinogenicity of spironolactone was observed by oral administration of spironolactone in rats, which led to the proliferation of endocrine organs and liver. In an 18-month rat trial with doses of 50 mg/kg/ day, 150 mg/kg/ day, and 500 mg/kg/ day, there was a statistically significant increase in benign thyroid and testicular adenomas, and in male rats, there was an increase in dose-related hepatic proliferative changes (including hepatocyte hypertrophy and proliferative nodules). In a 24-month trial of homogeneic rats, spironolactone was administered at doses of 10 mg/kg/ day, 30 mg/kg/ day, 100 mg/kg/ day, and 150 mg/kg/ day. Proliferative effects included a significant increase in hepatocellular adenomas and testicular stromal cell tumors in male rats, and a significant increase in follicular cell adenomas and cancers in male and female rats. There was also a statistically significant increase in benign endometrial interstitial polyps in female rats, but no dose correlation was observed. There was no increase in tumor at 100mg/kg/ day, which is 5 times the recommended daily dose of 200mg/ day based on body surface area.

Storage:
Seal and store in a dry place no more than 30ºC.