Spironolactone Capsules product summary

Please use it under the guidance of a doctor

[drug name]

Generic name: Spironolactone Capsules

English Name: Capsules Spironolactone

Chinese Pinyin: Jiaonang Luoneizhi

[character] this product is a capsule.

[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 of low potassium, combined with the use of diuretic drugs, enhance the diuretic effect and prevention of low potassium.

[Specification] 20mg

[usage and dosage]

1 adult

(1) in the treatment of edema disease, 40 ~ 120mg, 2 ~ 4 times, at least 5 days after serving as appropriate dosage adjustments.

(2) treatment of high blood pressure, the first day of 40 ~ 80mg, 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 a daily dose of 100 ~ 400mg, 2 ~ 4 times to take. Patients who are not suitable for surgery, then choose a smaller dose to maintain.

(4) the diagnosis of primary aldosterone. Long term test, daily 400mg, 2 ~ 4 times, for 3 to 4 weeks. Short term test, daily 400mg, 2 ~ 4 times, 4 days. The elderly are more sensitive to this drug, the beginning of dosage should be small.

2. Pediatric treatment of edema disease, start the day by 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. The maximum dose for a day 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, rare when used alone, the incidence rate increased with other diuretic drugs;

(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, functional decline;

(3) the central nervous system performance, long-term or large doses of taking this medicine can occur walking is not coordinated, headache and so on.

3 rare there:

(1) allergic reactions, rash and even respiratory 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] 

1. The following caution: (1) no urine; (2) renal insufficiency; (3) liver function, because the drug induced electrolyte disturbance can induce hepatic coma; (4) hyponatremia; (5) acid poisoning and acidosis on the one hand can aggravate or promoting the drug induced hyperkalemia; the other aspects of the drug may accentuate 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 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. The diagnosis of interference: (1) fluorescence method to determine the plasma cortisol concentration increased, so blood was taken before 4 to 7, should stop taking the medication or use other methods for determination of; (2) the following values increased, plasma creatinine and urea nitrogen (especially the original renal dysfunction), plasma renin, serum magnesium, potassium, urine 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's drug use]See [usage and dosage].

[old age medication]

Use of drugs in the elderly is 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] (1) plastic bottles, 30 / bottle, 100 / bottle; (2) aluminum-plastic packaging, 12 grain / plate / box, 12 x 2 particle board / box.

[Effective] 36 months

[executive standard] < Chinese Pharmacopoeia >2015 version two

[approval] Zhunzi H32020049