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Prednisone acetate Tablets

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Indication: It is used for the treatment of the allergic and autoimmune inflammatory diseases......
Usage volume: Take orally, general dosage is 1~2 tablets (5~10mg) once and ......
Product specifications: 5mg

Product introduction


[Drug Name]

Prednisone acetate Tablets
[Active Ingredient]
Prednisone acetate
[Chemical name]
17α,21-dihydroxypregna-1,4diene-3,11,20-trione 21-yl acetate
[Chemical structure]

Formula:               C12H22O11

Molecular weight: 400.47
[Character]
White tablets
[Indications]
It is used for the treatment of the allergic and autoimmune inflammatory diseases. Such as: connective tissue diseases, systemic lupus erythematosus, serious polymyositis, bronchial asthma, dermatomyositis, angitis allergic diseases, acute leukemia, malignant lymphoma etc.
[Dosage & Administration]
Take orally, general dosage is 1~2 tablets (5~10mg) once and 2~12 tablets (10~60mg) daily. Different diseases have different dosages:
(1) Initial daily dosage is 8~12 tablets (40~60mg) and reduced little by little for autoimmune diseases, including systemic lupus erythematosus, gastropathy syndrome, ulcerative colitis, autoimmune hemolytic anemia etc.
(2) Take 4~8 tablets (20~40mg) daily for drug eruptions, urticaria, bronchial asthma etc. allergic conditions. As the disease gets better, reduce 1 tablet (5mg) every two or three days.
(3) To prevent the rejection of organ transplantation, take 20 tablets (100mg) daily at 1 to 2 days before the operation and take 12 tablets (60mg) daily one week after the operation. Reduce the dosage little by little.
(4) Take 12~16 tablets (60~80mg) daily for the treatment of acute leukemia, malignant tumour. Reduce the dosage little by little.

[Adverse reaction]
Larger dose can cause diabetes, ulcer of digestive tract and para Cushing’s syndrome, and strongly inhibit hypothalamo-pituitary-adrenocortical axis. The complicated infections are the main adverse reaction.
[Contraindication]
It is inadvisable to use for patients who have H.B.P, thrombi, gastric and duodenal ulcers, psychosis, the abnormality of electrolyte metabolism, heart infarction, operation of viscera, glaucoma, etc., and it is prohibitive to use for patients who have allergic history of Prednisone acetate tablet and other corticoid drugs, and infected by fungi and virus.
[Precautions]
1. Appropriate anti-infection therapy should be given to patients who have tuberculosis, acute bacterial or viral infections.
2. Dosage should be reduced little by little until to be stopped, after a long-term usage of the drug.
3. It must be carefully used by patients who have diabetes, osteoporosis, cirrhosis of liver, renal cacergasia and bad thyroid function.

[Use in pregnancy & lactation]
Pregnant women taking the drug can depress the placental function, reduce new baby’s weight and increase the rate of dead fetus. Some animal studies have shown that the drug can cause teratogenesis. So give more considerations when using the drug in pregnant women. If a lactating mother is administered to high doses, she won’t provide breast-feeding, because hormone excreted in human breast milk will inhibit the growth of infants and adrenal functions.
[Use in children]
Hormone can inhibit the growth and development of children, so it must be carefully used. If a long-term usage of hormone is clearly needed, it is advisable to use short-acting preparation (e.g. cortisone) or mid-acting preparation (e.g. prednisone) instead of long-acting preparation (e.g. dexamethasone). Give children mid-acting preparation orally every other day can reduce the drug’s inhibitory action on their growth. Children or juvenile patients on prolonged hormone therapy should be cautiously observed, because it can increase the risks for them to have osteoporosis, avascular necrosis of the femoral head, glaucoma and cataract. The dose should be given according to the severity of the condition and response of the children as well as their age and weight. To treat the children with depressed adrenocortical function, the dose should be governed more by body surface than by body weight which can cause overdose to infants and short or fat children.
[Use in the elderly]
Easily cause high blood pressure. Senile patients especially the post-climacteric period women will be easily caused osteoporosis.
[Interaction]
(1) Combination the drug with non-steroid drugs with anti-inflammatory and analgesic potency can enlarge the ulcer.
(2) The drug can increase the risk of the toxicity of acetylaminophenol to the liver.
(3) Combination the drug with amphotericin B and carbonic anhydrase inhibitor can worsen hypokalemia; long-term combination the drug with carbonic anhydrase inhibitor can cause hypocalcemia and osteoporosis.
(4) Combination the drug with protein hormone can increase the rate of edema and worsen acne.
(5) Prolonged combination the drug with anticholinergic (like atropine) can increase the eye pressure.
(6) Combination the drug with tricyclic anti-depressants can worsen the mental disease.
(7) Combination the drug with insulin or other drugs used to lower blood-glucose levels can increase the blood-glucose levels of the patient, so adjust the dose of drugs used to lower blood glucose levels.
(8) Thyroid glands hormone can increase the metabolic clearance rate of the drug, so when the drug combines with thyroid glands hormone or anti-thyroid glands drugs, its dosage should be administered carefully.
(9) Combination the drug with contraceptive or estrogen preparations can increase its therapy effect and adverse action;
(10) Combination the drug with cardiac glycoside can strength the toxicity of digitalis and arrhythmia;
(11) Combination the drug with potassium-excreted diuretic can lead to severe hypokalemic and weaken the effect of diuretic;
(12) Combination the drug with ephedrine can improve its metabolic clearance;
(13) Combination the drug with immune inhibitor can increase the risk of infection and may induce lymphoma or other lymphocytic hyperplasia diseases;
(14) The drug can improve the metabolism and discharge of isonicid in the liver, and reduce its blood concentration and potency;
(15) The drug can improve the metabolism of mexiletine and reduce the blood concentration;
(16) Combination the drug with salicylate can reduce the plasma concentration of the latter;
(17) Combination the drug with growth hormone can inhibit somatotrophic effect of the latter.
[Overdose]
Indeterminated.
[Pharmacology and toxicology]
It is a member of corticosteriod drugs, which has anti-inflammatory, anti-allergic, anti-rheumatic and immunorepressive potencies. The effect is as follow:
1) Anti-inflammatory action: It can relieve and prevent from the reaction between tissue and the inflammation, thereby relieving the inflammation. The hormone can inhibit inflammatory cells, phagocytosis and other media’s synthesis and releasing.
2) Immunorepressive action: To prevent or inhibit the immunoreaction of cells, and delayed allergic reaction; to decrease the number of T lymphocyte, monochromatic cell, and acidophile; to reduce the combining ability of immune globulins with cell surface, and inhibit the synthesis and releasing of interleukin(IL), thereby decreasing T lymphocyte to transform to lymphoblasoid cell, and to relieve the enlargement of original immunoraction; to stop immune complex to pass through the basement membrane and reduce the concentration of complement components and immune globulins.
[Pharmacokinetics]
The drug shows its pharmaceutical action after 11-ketone is reduced to 11-hydroxy in the liver with 60 min of the half-time. It has high concentration in the liver followed by the plasma, the cerebrospinal fluid, the hydrothorax, the hydropretonium and the kidney. Most of the drug combined with the plasma proteins in the blood; free and combined metabolites are excreted in urine, some are excreted in its original form and little is excreted in breast milk.
[Strength]
5mg

[Storage]
Protect from light, store in a closed container.
[Packing]
Polyethylene bottle, 100 tablets /bottle, 500 tablets /bottle, 1000 tablets /bottle
[Shelf life]24 months