Spironolactone Tablets product summary

Please read the instructions carefully and use it under the guidance of a doctor.

[drug name]

Generic name: Spironolactone Tablets

English Name: Tablets Spironolactone

Chinese Pinyin: Pian Luoneizhi

[character] this product is a white film.

[indications]

1. Edema diseases and other diuretic combination treatment of congestive edema, ascites due to cirrhosis, renal edema edema disease, its purpose lies in correcting these diseases associated with secondary aldosterone secretion, and against other diuretic excretion of potassium role. Also for idiopathic edema treatment.

2 high blood pressure is the auxiliary medicine for the treatment of hypertension.

3 primary aldosteronism spironolactone can be used for the diagnosis and treatment of the disease.

4 prevention and treatment of low potassium in combination with the use of diuretics, enhanced diuretic effect and prevention of low potassium.

[Specification] 20mg

[usage and dosage]

1 adult

(1) treatment of edema disease, 40 ~ 120mg daily (2 ~ 6), 2 ~ 4 times to take, at least 5 days, after the appropriate dose adjustments.

(2) treatment of hypertension, the beginning of daily 40 ~ 80mg (2 ~ 4), divided doses, at least 2 weeks, after the appropriate dose adjustments, not with angiotensin converting enzyme inhibitors in combination, so as not to increase the chance of occurrence of potassium.

(3) in the treatment of primary aldosterone, preoperative patients with daily dosage of 100 ~ 400mg (5 ~ 20), divided into 2 ~ 4 times. Patients who are not suitable for surgery, then choose a smaller dose to maintain.

(4) diagnosis of primary aldosteronism. Long term test, 400 mg per day (20 pieces), 2 ~ 4 times, for 3 to 4 weeks. Short test, 400 mg per day (20 pieces), 2 ~ 4 times to take, for four consecutive days. The elderly to this medicine is sensitive, began to appropriate dosage is too small.

2. Children with treatment of edema disease, starting the day according to weight 1 to 3 mg / kg or according to the body surface area of 30 to 90 mg / m2, single or divided into 2 to 4 times taking, and even served 5 days discretion to adjust the dose. Maximum dose for daily 3 ~ 9mg / kg or 90 ~ 270mg/m2.

[adverse reactions]

1 common:

(1) hyperkalemia. The most common, especially drug alone, eating a high potassium diet, potassium and agent or potassium containing drugs such as penicillin potassium and renal function damage, oliguria, anuria; even in combination with thiazide diuretics, hyperkalemia incidence is still up to 8.6% ~ 26% and often to arrhythmia as the first manifestation, so during the course of medication must close follow-up serum potassium and ECG.

(2) gastrointestinal reactions, such as nausea, vomiting, stomach cramps and diarrhea, are reported to cause peptic ulcer.

2 rare to have:

(1) hyponatremia, when used alone, is rare, and the incidence of other diuretic drug use increased.

(2) the anti androgen effect or of other endocrine system, long-term use of this drug in men can cause male breast development, impotence, sexual dysfunction, in women can cause breast pain, sound thicker, hair growth, menstrual disorders, sexual function decline; central nervous system manifestations, long-term or high-dose taking this medicine can occur walking uncoordinated, headache, etc..

3 rare there:

(1) allergic reactions, rash and even breathing difficulties.

(2) transient plasma creatinine, urea nitrogen increased, mainly with excessive diuretic, effective blood volume deficiency, caused by the decline in glomerular filtration rate.

(3) mild acidosis.

(4) tumor, there are reports of 5 patients with long-term use of this drug and the occurrence of breast cancer.

[taboo] patients with high potassium were disabled.

[note] [note]

1 the following caution:

(1) no urine.

(2) renal insufficiency.

(3) liver function is not full, because the drug caused by electrolyte disorder can induce hepatic coma.

(4) hyponatremia.

(5) acid poisoning, on the one hand, acid poisoning can aggravate or promote the drug induced by high potassium, on the other hand, this medicine can aggravate acid poisoning.

(6) breast enlargement or menstrual disorders.

2 medication should be individualized, starting from the minimum effective dose, to reduce the occurrence of side effects such as electrolyte disorders, such as a daily dose of medication should be in the morning, so as not to increase the frequency of urination at night.

Should be aware of before 3. Drug serum potassium concentration, but in some serum potassium concentration and can not represent the body's total potassium content, such as acidosis K from the intracellular transfer to the extracellular and prone to hyperkalemia, correcting acidosis blood potassium can decline.

4. The drug has slower, and maintained for a long time, so initial dose can be increased to conventional dose of 2 ~ 3 times, after discretion to adjust the dose. When combined with other diuretics, ahead of other diuretics 2 ~ 3 days taking. Has been applied in the other diuretics and use the drug, other diuresis medicine dose during the first 2 to 3 days can be reduced 50%, after discretion to adjust the dose. In the withdrawal, the drug should precede the other diuretics for 2 to 3 days, stop drug.

5 medication during the period such as the emergence of high potassium, should be stopped immediately.

6 to reduce the gastrointestinal tract reaction, and may improve the bioavailability of the drug.

7 diagnosis of interference:

(1) the fluorescence method was used to measure the plasma cortisol concentration, so it should be discontinued 4 to 7 days before taking the blood and other methods should be used.

(2) to increase the following values, plasma creatinine and urea nitrogen (especially the original renal damage), plasma renin, serum magnesium, potassium; urinary calcium excretion may increase, and urinary sodium excretion decreased.

8 athletes with caution.

[pregnant women and breastfeeding women medication]

The drug can be passed through the placenta, but the impact on the fetus is not clear. Pregnant women should be used under the guidance of doctors, and medication time should be as short as possible.

[children] see [usage].

[elderly medication] the elderly medication more prone to high potassium and excessive diuretic.

There is no reliable reference to the test and no reliable references.

[storage] seal in the dry place to save.

[packing] plastic bottle packaging, 100 / bottle.

[Effective] 36 months

[executive standard] < Chinese Pharmacopoeia >2015 version two

[approval] Zhunzi H32020050