Generic Name
PrednisoloneTherapeutic Class: Analgesic, Anti Inflammatory (Glucocorticoids)
Indications:
Prednisolone 5: Each tablet contains prednisolone BP 5 mg.
Prednisolone10: Each tablet contains prednisolone BP 10 mg.
Prednisolone 20: Each tablet contains prednisolone BP 20 mg.
Prednisolone Oral Solution: Each 5 ml solution contains Prednisolone Sodium Phosphate USP equivalent to Prednisolone 5 mg.
Description:
Prednisolone Acetate is a glucocorticoid. It inhibits edema, inflammation, capillary proliferation, deposition of collagen. Therefore, swelling and pain of inflammatory conditions are decreased.
Dosage & Administration:
The initial dosage of Prednisolone may vary from 5 mg to 60 mg daily depending on the disorder being treated. Divided daily dosage is usually used.
- Allergy and anaphylaxis: Bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic edema, anaphylaxis.
- Respiratory disease: Allergic pneumonitis, asthma, occupational asthma, pulmonary aspergillosis, pulmonary fibrosis, pulmonary alveolitis, aspiration of foreign body, aspiration of stomach contents, pulmonary sarcoid, drug-induced lung disease, adult respiratory distress syndrome, spasmodic croup.
- Rheumatic disorders: Rheumatoid arthritis, polymyalgia rheumatic, juvenile chronic arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease.
- Arteritis/collagenosis: Giant cell arteritis/polymyalgia rheumatic, mixed connective tissue disease, polyarteritis nodosa, polymyositis.
- Blood disorders: Haemolytic anemia (autoimmune), leukemia (acute and lymphocytic), lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura.
- Cardiovascular disorders: Post myocardial infarction syndrome, rheumatic fever with severe carditis.
- Endocrine disorders: Primary and secondary adrenal insufficiency, congenital adrenal hyperplasia.
- Gastrointestinal disorders: Crohn's disease, ulcerative colitis, persistent celiac syndrome, autoimmune chronic active hepatitis, a multisystem disease affecting the liver, biliary peritonitis.
- Infections: Miliary tuberculosis, mumps orchitis (adult), tuberculous meningitis, rickettsial disease.
- Muscular disorders: Polymyositis, dermatomyositis.
- Neurological disorders: Infantile spasms, ShyDrager syndrome, sub-acute demyelinating polyneuropathy.
- Ocular disease: Scleritis, posterior uveitis, retinal vasculitis, pseudotumors of the orbit, malignant ophthalmic Graves disease.
- Renal disorders: Lupus nephritis, acute interstitial nephritis, minimal change glomerulonephritis.
- Skin disorders: Pemphigus Vulgaris, bullous pemphigoid, systemic lupus erythematosus, pyoderma gangrenosum.
- Miscellaneous: Sarcoidosis, hyperpyrexia, Behcet's disease, immunosuppression in organ transplantation.
Prednisolone 5: Each tablet contains prednisolone BP 5 mg.
Prednisolone10: Each tablet contains prednisolone BP 10 mg.
Prednisolone 20: Each tablet contains prednisolone BP 20 mg.
Prednisolone Oral Solution: Each 5 ml solution contains Prednisolone Sodium Phosphate USP equivalent to Prednisolone 5 mg.
Description:
Prednisolone Acetate is a glucocorticoid. It inhibits edema, inflammation, capillary proliferation, deposition of collagen. Therefore, swelling and pain of inflammatory conditions are decreased.
Dosage & Administration:
The initial dosage of Prednisolone may vary from 5 mg to 60 mg daily depending on the disorder being treated. Divided daily dosage is usually used.
The appropriate individual dose must be determined by trial and error and must be re-evaluated regularly according to the activity of the disease.
In general, the initial dosage shall be maintained or adjusted until the anticipated response is observed. The dose should be gradually reduced until the lowest dose, which will maintain an adequate clinical response is reached.
During prolonged therapy, dosage may need to be temporarily increased during periods of stress or during exacerbations of the disease. When the drug is to be stopped, it must be withdrawn gradually and not abruptly.
In general, the initial dosage shall be maintained or adjusted until the anticipated response is observed. The dose should be gradually reduced until the lowest dose, which will maintain an adequate clinical response is reached.
During prolonged therapy, dosage may need to be temporarily increased during periods of stress or during exacerbations of the disease. When the drug is to be stopped, it must be withdrawn gradually and not abruptly.
Specific dosage guidelines:
- Allergic and skin disorders: Initial doses of 5-15 mg daily are commonly adequate.
- Rheumatoid arthritis: The usual initial dose is 10-15 mg daily.
- Blood disorders and lymphoma: An initial daily dose of 15-60 mg is often necessary with reduction after an adequate clinical or hematological response.
- Acute leukemia: Higher doses may be necessary to induce remission in acute leukemia
Use in children
Corticosteroids cause growth retardation in infancy, childhood, and adolescence, which may be irreversible. Treatment should be administered where possible as a single dose on alternate days.
Side Effects:
General side-effects include leucocytosis, hypersensitivity including anaphylaxis, thromboembolism, nausea, and malaise.
Precautions:
Caution is necessary when oral corticosteroids, including Prednisolone, are prescribed in patients with the following conditions like-Tuberculosis, Hypertension, Congestive heart failure, Liver failure, Renal insufficiency, Diabetes mellitus or in those with a family history of diabetes, Osteoporosis, Patients with a history of severe affective disorders and particularly those with a previous history of steroid-induced psychoses, Epilepsy, Peptic ulceration, Previous Steroid Myopathy.
Undesirable effects may be minimized by using the lowest effective dose for the minimum period and by administering the daily requirement as a single morning dose on alternate days. Frequent patient review is required to titrate the dose appropriately against disease activity.
Use in Pregnancy & Lactation:
Use in pregnancy: There is evidence of harmful effects on pregnancy in animals.
Use in lactation: Corticosteroids are excreted in small amounts in breast milk and infants of mothers taking pharmacological doses of steroids should be monitored carefully for signs of adrenal suppression.
Interaction:
Hepatic microsomal enzyme inducers: Drugs that can cause liver enzyme induction such as phenobarbitone, phenytoin, rifampicin, rifabutin, carbamazepine, primidone, and aminoglutethimide may reduce the therapeutic efficacy of corticosteroids by increasing the rate of metabolism.
Non-steroidal anti-inflammatory drugs: Concomitant administration of ulcerogenic drugs such as indomethacin during corticosteroid therapy may increase the risk of Gl ulceration.
Anticoagulants: Response to anticoagulants may be reduced or, less often, enhanced by corticosteroids.
Vaccines: Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished.
General side-effects include leucocytosis, hypersensitivity including anaphylaxis, thromboembolism, nausea, and malaise.
Precautions:
Caution is necessary when oral corticosteroids, including Prednisolone, are prescribed in patients with the following conditions like-Tuberculosis, Hypertension, Congestive heart failure, Liver failure, Renal insufficiency, Diabetes mellitus or in those with a family history of diabetes, Osteoporosis, Patients with a history of severe affective disorders and particularly those with a previous history of steroid-induced psychoses, Epilepsy, Peptic ulceration, Previous Steroid Myopathy.
Undesirable effects may be minimized by using the lowest effective dose for the minimum period and by administering the daily requirement as a single morning dose on alternate days. Frequent patient review is required to titrate the dose appropriately against disease activity.
Use in Pregnancy & Lactation:
Use in pregnancy: There is evidence of harmful effects on pregnancy in animals.
Use in lactation: Corticosteroids are excreted in small amounts in breast milk and infants of mothers taking pharmacological doses of steroids should be monitored carefully for signs of adrenal suppression.
Interaction:
Hepatic microsomal enzyme inducers: Drugs that can cause liver enzyme induction such as phenobarbitone, phenytoin, rifampicin, rifabutin, carbamazepine, primidone, and aminoglutethimide may reduce the therapeutic efficacy of corticosteroids by increasing the rate of metabolism.
Non-steroidal anti-inflammatory drugs: Concomitant administration of ulcerogenic drugs such as indomethacin during corticosteroid therapy may increase the risk of Gl ulceration.
Anticoagulants: Response to anticoagulants may be reduced or, less often, enhanced by corticosteroids.
Vaccines: Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished.
Oestrogens: Oestrogens may potentiate the effects of glucocorticoids and dosage adjustment may be required if estrogens are added to or withdrawn from a stable dosage regimen.
Other: The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives and diuretics are antagonized by corticosteroids and the hypokalaemic effect of acetazolamide, loop diuretics, thiazide diuretics, and carbenoxolone are enhanced.
Overdose:
Reports of acute toxicity and/or death following an overdose of glucocorticoids are rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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