Product Overview
[Drug Name]
Generic Name: Spironolactone Tablets
Trade Name: Shexin
English Name: Spironolactone Tablets
Chinese Pinyin: Luoneizhi Pian
[Ingredients]
Main ingredient: Spironolactone.
[Properties]
This product is a white tablet.
[Indications]
1. Edema: Used in combination with other diuretics to treat edema such as congestive edema, ascites due to cirrhosis, and renal edema. The purpose is to correct the secondary increased aldosterone secretion associated with these conditions and counteract the potassium-excreting effects of other diuretics. It is also used to treat idiopathic edema. 2. Hypertension: As an adjunctive drug for the treatment of hypertension. 3. Primary Aldosteronism: Spironolactone can be used for the diagnosis and treatment of this condition. 4. Prevention of Hypokalemia: Used in combination with thiazide diuretics to enhance the diuretic effect and prevent hypokalemia.
[Dosage and Administration]
1. Adults
① For the treatment of edema, take 40-120 mg daily in 2-4 divided doses for at least 5 consecutive days. Adjust the dose as needed.
② For the treatment of hypertension, initially take 40-80 mg daily in divided doses for at least 2 weeks, then adjust the dose as needed. It should not be used in combination with angiotensin-converting enzyme inhibitors to avoid increasing the risk of hyperkalemia.
③ For the treatment of primary aldosteronism, preoperative patients should take 100-400 mg daily in 2-4 divided doses. For patients who are not suitable for surgery, a lower maintenance dose should be used.
④ For the diagnosis of primary aldosteronism. For long-term trials, take 400 mg daily in 2-4 divided doses for 3-4 consecutive weeks. For short-term trials, take 400 mg daily in 2-4 divided doses for 4 consecutive days. Elderly individuals are more sensitive to this drug, so a lower initial dose is recommended. 2. Children: For the treatment of edematous diseases, the initial daily dose is 1-3 mg/kg or 30-90 mg/m2 per body surface area, taken as a single dose or divided into 2-4 doses. The dose can be adjusted as appropriate after 5 consecutive days. The maximum dose is 3-9 mg/kg or 90-270 mg/m2 per day.
[Adverse Reactions]
(1) Common reactions include: ① Hyperkalemia, which is the most common, especially when used alone, ingesting a high-potassium diet, taking potassium supplements or potassium-containing drugs such as penicillin potassium, and in the presence of renal impairment, oliguria, or anuria. Even when used in combination with thiazide diuretics, the incidence of hyperkalemia can still reach 8.6%-26%, and arrhythmia is often the first manifestation. Therefore, blood potassium and electrocardiogram must be closely monitored during medication; ② Gastrointestinal reactions, such as nausea, vomiting, stomach cramps, and diarrhea; there are also reports of peptic ulcers. (2) Rare symptoms include: ① Hyponatremia, which is rare when used alone, but increases in incidence when used in combination with other diuretics; ② Anti-androgen-like effects or effects on other endocrine systems. Long-term use of this drug can cause male breast development, impotence, and sexual dysfunction in men, and breast tenderness, hoarseness, increased hair growth, menstrual disorders, and decreased sexual function in women; ③ Central nervous system manifestations. Long-term or high-dose use of this drug can cause walking incoordination, headaches, etc. (3) Rare symptoms include: ① Allergic reactions, such as rashes and even difficulty breathing; ② Temporary increases in plasma creatinine and urea nitrogen, which are mainly related to excessive diuresis, insufficient effective blood volume, and decreased glomerular filtration rate; ③ Mild hyperchloremic acidosis; ④ Tumors. There are reports of 5 patients who developed breast cancer after long-term use of this drug and hydrochlorothiazide.
[Contraindications]
This drug is contraindicated in patients with hyperkalemia.
[Precautions]
(1) Use with caution in the following situations: ① Anuria; ② Renal insufficiency; ③ Hepatic insufficiency, as electrolyte imbalance caused by this drug may induce hepatic coma; ④ Hyponatremia; ⑤ Acidosis, on the one hand, acidosis may aggravate or trigger hyperkalemia caused by this drug; on the other hand, this drug may aggravate acidosis; ⑥ Those with breast enlargement or menstrual disorders. (2) Dosing should be individualized and started from the minimum effective dose to reduce the occurrence of side effects such as electrolyte imbalance. If the drug is taken once a day, it should be taken in the morning to avoid increased urination at night. (3) Before taking the drug, the patient's blood potassium concentration should be understood, but in some cases, the blood potassium concentration cannot represent the potassium content in the body. For example, when acidosis occurs, potassium is transferred from the intracellular to the extracellular and hyperkalemia is likely to occur. After the acidosis is corrected, the blood potassium can decrease. (4) This drug takes effect slowly and lasts for a long time, so the first day's dose can be increased to 2~3 times the regular dose, and the dose can be adjusted as appropriate. When used in combination with other diuretics, it can be taken 2 to 3 days before other diuretics. When this drug is added to other diuretics, the dose of other diuretics can be reduced by 50% in the first 2 to 3 days, and the dose can be adjusted as appropriate thereafter. When stopping the drug, this drug should be stopped 2 to 3 days before other diuretics. (5) If hyperkalemia occurs during medication, the drug should be stopped immediately. (6) The drug should be taken with or after meals to reduce gastrointestinal reactions and may increase the bioavailability of this drug. (7) Interference with diagnosis: ① It increases the plasma cortisol concentration determined by the fluorescence method, so this drug should be stopped or replaced by other measurement methods 4 to 7 days before blood collection; ② It increases the following measurement values: plasma creatinine and urea nitrogen (especially when there is existing renal function impairment), plasma renin, serum magnesium, potassium; urinary calcium excretion may increase, while urinary sodium excretion decreases.
[Use in special populations]
Precautions for children:
This experiment has not been conducted and there are no reliable references. Precautions during pregnancy and lactation: This drug can cross the placenta, but its effect on the fetus is not yet clear. Pregnant women should take the drug under the guidance of a physician, and the duration of use should be as short as possible. Precautions for the elderly: Elderly people are more likely to develop hyperkalemia and excessive diuresis when taking the drug. [Drug Interactions] (1) Adrenocortical hormones, especially those with strong mineralocorticoid effects, and adrenocorticotropic hormone can weaken the diuretic effect of this drug and antagonize the potassium retention effect of this drug. (2) Estrogen can cause water and sodium retention, thereby weakening the diuretic effect of this drug. (3) Non-steroidal anti-inflammatory analgesics, especially indomethacin, can reduce the diuretic effect of this drug, and increase nephrotoxicity when used in combination. (4) Sympathomimetic drugs reduce the antihypertensive effect of this drug. (5) Dopamine enhances the diuretic effect of this drug. (6) When used in combination with drugs that cause a decrease in blood pressure, both the diuretic and antihypertensive effects are enhanced. (7) When used in combination with the following drugs, the chance of developing hyperkalemia increases, such as potassium-containing drugs, stored blood (containing 30mmol/L of potassium, such as blood stored for more than 10 days containing up to 65mmol/L of potassium), angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, and cyclosporine A. (8) When used in combination with glucose-insulin solution, alkaline agents, and sodium-type potassium-lowering exchange resins, the chance of developing hyperkalemia decreases. (9) This drug prolongs the half-life of digoxin. (10) When used in combination with ammonium chloride, metabolic acidosis is likely to occur. (11) When used in combination with nephrotoxic drugs, nephrotoxicity increases. (12) Sodium carbenoxolone and licorice preparations have aldosterone-like effects and can reduce the diuretic effect of this drug.
[Pharmacological Action]
The structure of this drug is similar to that of aldosterone and it is a competitive inhibitor of aldosterone. It acts on the distal convoluted tubule and collecting duct, blocking Na+-K+ and Na+-H+ exchange. This results in increased excretion of Na+, Cl-, and water, decreased excretion of K+, Mg2+, and H+, and variable effects on Ca2+ and P3-. Because this drug only acts on the distal convoluted tubule and collecting duct, and has no effect on other segments of the renal tubule, its diuretic effect is relatively weak. Furthermore, this drug also has effects on aldosterone target organs outside the renal tubules.
[Storage] Store tightly in a dry place.
[Strength] 20mg
[Packaging] Polyethylene round bottles, 100 tablets/bottle/box.
[Expiration Period] 24 months
[Approval Number] National Medicine Standard H46020690
[Manufacturer] Company Name: Hainan Haishen Tongzhou Pharmaceutical Co., Ltd.
