PRED 1 Tablet: Bluish round scored tablet.
Each tablet contains: Prednisone 1 mg.
PRED 5 Tablet: White round tablet.
Each tablet contains: Prednisone 5 mg.
PRED 10 Tablet: White round tablet.
Each tablet contains: Prednisone 10 mg.
PRED 20 Film-Coated Tablet: Blue green round tablet.
Each film-coated tablet contains: Prednisone 20 mg.
PRED 30 Film-Coated Tablet: Orange oblong tablet.
Each film-coated tablet contains: Prednisone 30 mg.
PRED 50 Tablet: Yellowish oblong tablet.
Each tablet contains: Prednisone 50 mg.
PRED 10 Suspension: Orange suspension in round amber bottle.
Each 5 mL (1 teaspoonful) contains: Prednisone 10 mg.
Corticosteroid.
Pharmacology: Pharmacodynamics: Prednisone is a biologically inert glucocorticoid which is converted to prednisolone in the liver. It has the same chemical relationship to prednisolone as cortisone has to hydrocortisone.
Prednisone is a non-fluorinated glucocorticoid for systemic therapy.
Prednisone shows a dose-dependent effect on the metabolism of almost all tissues. Under physiological conditions, these effects are vital to maintain homoeostasis of the organism at rest and under stress, as well as for the control of the activities of the immune system.
In doses typically prescribed for PRED, prednisone has an immediate anti-inflammatory (antiexudative and antiproliferative) effect and a delayed immunosuppressive effect. It inhibits chemotaxis and the activity of immune cells as well as the release and effect of mediators of inflammatory and immune reactions, e.g. of lysosomal enzymes, prostaglandins and leucotrienes.
Prolonged therapy with high doses results in impaired response of the immune system and of the adrenal cortex. The mineralotropic effect that is pronounced in hydrocortisone is still detectable in prednisone and may require monitoring of serum electrolyte levels.
Pharmacokinetics: In general, corticosteroids are readily absorbed from the gastrointestinal tract. They are also well absorbed from sites of local application and are rapidly distributed to all body tissues. They cross the placenta and may be excreted in small amounts in breast milk. Metabolism is mainly in the liver but also occurs in the kidneys, while excretion is through the urine.
PRED is indicated for the treatment of endocrine, rheumatic and collagen disorders; dermatologic, ophthalmic, respiratory and neoplastic diseases; allergic and edematous states.
Generally 5-25 mg daily to a maximum of 60 mg daily in divided doses or as prescribed by the physician.
Acute intoxications with PRED are not known. In case of overdosing, an increase in undesirable effects, especially endocrine, metabolic and electrolyte-related effects, can be expected.
There is no known antidote for prednisone.
Gastric and duodenal ulcers, systemic fungal infections, certain viral infections and hypersensitivity to glucocorticoids, glaucoma, live vaccines, and psychoses or severe psychoneuroses.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Pregnancy: During pregnancy, PRED should only be used when the benefits outweigh the potential risks. The lowest effective dose of PRED needed to maintain adequate disease control should be used.
Animal studies indicate that administration of pharmacological doses of glucocorticoids during pregnancy may increase the fetus risk of intrauterine growth retardation, adult cardiovascular and/or metabolic disease and may have an effect on the glucocorticoid receptor density, and neurotransmitter turnover or neurobehavioral development.
Prednisone has caused cleft palate formation in animal experiments. There is an ongoing discussion on the possibility of an increased risk of oral cleft formation in the human fetus as a result of the administration of glucocorticoids during the first trimester. If glucocorticoids are administered towards the end of pregnancy, there is a risk of atrophy of the fetal adrenal cortex, which may necessitate replacement therapy in the newborn, which has to be slowly reduced.
Breastfeeding: Glucocorticoids pass in small amounts into breast milk (up to 0.23% of an individual dose). For doses up to 10 mg daily, the amount taken via breast milk lies below the detection threshold. So far, no damage to infants has been reported. Nevertheless, glucocorticoids should only be prescribed when the benefits to mother and child outweigh the risks. Because the milk/plasma concentration ratio increases with doses above 10 mg/day (e.g. 25% of the serum concentration are found in the breast milk with 80 mg prednisone daily), it is recommended to discontinue breastfeeding in such cases.
Fluid and electrolyte disturbances, psychiatric disturbances, Cushingoid state, hirsutism, visual disturbances, growth retardation, skin atrophy, facial erythema, aseptic osteonecrosis, and amenorrhea.
Cardiac glycosides: The effect of the glycosides can be enhanced by potassium deficiency.
Saluretics/laxatives: Potassium excretion is enhanced.
Antidiabetic agents: The blood sugar lowering effect is reduced.
Coumarin derivatives: The efficacy of coumarin anticoagulants may be reduced or enhanced.
Non-steroidal antiphlogistic/antirheumatic agents, salicylates and indomethacin: The risk of gastrointestinal haemorrhages is increased.
Non-depolarising muscle relaxants: Muscle relaxation may be prolonged.
Atropine and other anticholinergics: The concurrent use of PRED may result in additional increases in intraocular pressure.
Praziquantel: Glucocorticoids may lower the praziquantel concentrations in the blood.
Chloroquine, hydroxychloroquine, mefloquine: There is an increased risk of occurrence of myopathies, cardiomyopathies.
Somatropin: The efficacy of somatropin may be reduced.
Estrogens (e.g. oral contraceptives): May enhance the efficacy of glucocorticoids.
Liquorice: Inhibition of the metabolism of glucocorticoids is possible.
Rifampicin, phenytoin, barbiturates, bupropion and primidone: The efficacy of glucocorticoids is reduced.
Cyclosporine: The blood levels of cyclosporine are increased. There is an increased risk of seizures.
Amphotericin B: The risk of hypokalaemia may be increased.
Cyclophosphamide: The effects of cyclophosphamide may be enhanced.
ACE inhibitors: Increased risk of occurrence of blood count changes.
CYP3A inhibitors: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Aluminium and magnesium antacids: The absorption of glucocorticoids is reduced.
Store at temperatures not exceeding 30°C.
H02AB07 - prednisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Pred 20 FC tab 20 mg
100's;500's
Pred 30 FC tab 30 mg
100's
Pred 10 oral susp 10 mg/5 mL
30 mL x 1's;60 mL x 1's
Pred 10 tab 10 mg
100's;500's