Prolix

Prolix

prednisone

Manufacturer:

Lloyd

Distributor:

PNSV Asia
Full Prescribing Info
Contents
Prednisone.
Description
Tablet: Each tablet contains prednisone 20 mg.
Prednisone is a synthetic corticosteroid that has potent anti-inflammatory and immunosuppressive actions.
Prednisone is used in a wide variety of clinical circumstances and disorders where its immunosuppressive properties may be beneficial.
Suspension: Each 5 mL (1 teaspoonful) contains prednisone 10 mg.
Action
Pharmacology: Pharmacodynamics: Tablet: The actions of prednisone as a strong anti-inflammatory agent account for its numerous beneficial effects in controlling manifestations of a wide range of clinical disorders.
Prednisone delivers broad and potent anti-inflammatory effects through multiple mechanisms.
Prednisone inhibits the production of inflammatory substances.
Prednisone has advantage over the other steroids because it exerts little effect on renal reabsorption while possessing very potent anti-inflammatory actions. It has very minimal salt-retaining properties.
Like other corticosteroids, prednisone is metabolized mainly in the liver but is also metabolized in other tissues. Prednisone is readily absorbed from the gastrointestinal tract following oral administration and is rapidly distributed to all body tissues.
In the liver, it is rapidly converted into a more active form, prednisolone, which has greater anti-inflammatory and less salt-retaining actions. Peak plasma concentration is obtained 1 to 2 hours after oral administration.
In the prednisolone form, it has a biological half-life of about 12-36 hours, so dosage may be adjusted to the functional pattern of circadian rhythm to decrease risk of adrenal insufficiency. Prednisone is extensively bound to plasma proteins. It is excreted in the urine as free and conjugated metabolites together with proportion of unchanged prednisolone. Small amounts of prednisolone are excreted in breast milk.
Pharmacodynamics: Suspension: Prednisone is a synthetic steroid which has advantage over the other steroids because it exerts little effect on renal reabsorption while possessing very potent anti-inflammatory effects. It has very minimal salt-retaining properties.
Prednisone is well-absorbed in the gastrointestinal tract following oral administration. In the liver, it is rapidly converted into a more active form, prednisolone, which has greater anti-inflammatory and less salt-retaining actions.
In the prednisolone form, it has a biological half-life of about 12-36 hours, so dosage may be adjusted to the functional pattern of circadian rhythm to decrease risk of adrenal insufficiency. Prednisone is used in a wide variety of clinical circumstances and disorders where its immunosuppressive properties may be beneficial.
Indications/Uses
Prednisone is indicated in a wide variety of clinical circumstances or disorders affecting the endocrine, nervous, cardiovascular, renal (e.g. nephrotic syndrome), gastrointestinal, skin and integumentary systems, ocular and respiratory system of inflammatory and allergic origin (e.g. bronchial asthma and skin allergies).
Suspension: Prednisone is also useful in rheumatic, collagen, neoplastic, hematologic and autoimmune disorders such as autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, inflammatory bowel diseases, systemic lupus erythematosus and some cases of Hashimoto's thyroiditis.
Dosage/Direction for Use
Dosage may vary depending on the severity of the disorder and the response of the patient.
Prednisone is usually taken at 5-60 mg daily in divided doses or as a single dose after breakfast or as a double dose on alternate days. Some patients may temporarily require higher dose to control the disease. Dosage is reduced gradually or tapered off as soon as symptoms diminish. Or as prescribed by the physician.
Tablet: As an immunosuppressive agent, the usual dose range for prednisone is 10-100 mg orally, daily.
5-25 mg daily in divided doses may be given for primary and secondary adrenocortical insufficiency.
10-20 mg/m2 body surface may be administered daily in divided doses in adrenogenital syndromes.
Overdosage
Tablet: Prednisone overdose may include symptoms such as fever, muscle or joint pain, nausea, dizziness, fainting, difficulty of breathing. Prolonged overuse can manifest as moon face, obesity, unusual hair growth, acne, loss of sexual function and muscle wasting. Large doses of prednisone may produce Cushingoid symptoms typical of adrenal cortex hyperactivity.
Adverse events should be treated symptomatically, with the prednisone dosage reduced or slowly withdrawn or tapered off whenever possible to prevent adrenal insufficiency.
Contraindications
Systemic fungal infections, glaucoma, gastric and duodenal ulcers, certain viral infections, acute infections uncontrolled by antibiotic therapy and severe psycho-neuroses.
Special Precautions
High doses or chronic therapy with prednisone should be undertaken with great caution in patients with heart disease, hypertension, renal dysfunction, peptic ulcer, systemic fungal infection, history of psychotic disorders, diabetes mellitus, epilepsy, tuberculosis, osteoporosis, glaucoma, hypothyroidism, myasthenia gravis, hepatic failure, diverticulitis, colitis and viral diseases like herpes.
Patients who receive high dose or those on long term therapy should also be monitored for the following adverse effects: hyperglycemia, glucosuria, sodium retention with edema, hypertension, osteoporosis and fungal infection.
Treatment should not be abruptly stopped. Dosage should be reduced or slowly withdrawn or tapered off to prevent adrenal insufficiency. Treatment regimen should always be under medical supervision. Before therapy is initiated, cardiovascular function and psychologic status should be assessed.
Use In Pregnancy & Lactation
Tablet: Studies have shown that the use of corticosteroids in pregnancy had no adverse effects on the fetus in terms of psychological development or growth. It was reported that prolonged or repeated high doses increased the risk of intra-uterine growth retardation but this did not seem to be a problem following short term therapy. Use of prednisone in pregnancy and lactation necessitates the consideration of potential benefits of the drug weighed against the possible risks to the mother and the fetus.
Adverse Reactions
Adverse effects such as adrenal suppression may occur when prednisone is used chronically.
Some adverse reactions include gastrointestinal distress, nausea, peptic ulcer, behavioral disturbances, fluid and electrolyte imbalance, visual disturbances, growth retardation, skin atrophy, moon face, Cushingoid state, hirsutism and muscle atrophy.
Drug Interactions
The effect of prednisone may be reduced by anticonvulsants, phenobarbital, phenytoin, antihistamines, barbiturates, ephedrine, primidone and rifampicin.
The efficacy of hypoglycemics, diuretics, salicylates and anticholinesterases may be reduced by prednisone.
Prednisone when taken with azathioprine provides salutary effects. Aspirin and estrogen may enhance the effect of prednisone. The dose of prednisone is reduced when taking cyclosporine, an immunosuppressant.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
H02AB07 - prednisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Tab 20 mg (pink film coated, round, biconvex, bisected on one side and plain on the other side) x 100's. Oral susp 10 mg/5 mL x 60 mL.
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