PREDLONE 25
-
Chemical Name:
Prednisolone -
Therapeutic Category:
Anti-inflammatory drugs -
Pharmacologic Category:
Corticosteroid, Systemic -
Pharmaceutical Form:
Ampoule -
Composition:
Prednisolone 25mg/2ml
PREDLONE
Tablets, Syrup, Injection (Ampoule)
Prednisolone
1.PROPERTIES:
Prednisolone is a glucocorticoid. It’s the drug of choice for all conditions in which systemic corticosteroid therapy is indicated except adrenal-deficiency states.
Prednisolone is more potent than cortisone because 5 mg of Prednisolone is equivalent in anti-inflammatory to about 25 mg of cortisone acetate.
Prednisolone has also anti-allergic and immunosuppressive properties in addition to its effects in the management of anaphylactic shock.
2.INDICATIONS:
Endocrine Disorders: Primary or secondary adrenocortical insufficiency.
Rheumatic Disorders: As adjunctive therapy for short-term administration.
Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus; Acute rheumatic carditis, Systemic dermatomyositis.
Dermatologic Diseases: Pemphigus; Severe erythema multiform (Stevens-Johnson syndrome); Exfoliative dermatitis; Bullous dermatitis herpetiformis; Severe seborrheic dermatitis; Severe psoriasis; Mycosis fungoides.
Allergic States: Control of severe or incapacitating allergic in bronchial asthma; Contact dermatitis; Atopic dermatitis; Seasonal or perennial allergic rhinitis; Drug hypersensitivity reactions.
Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye.
Gastrointestinal Diseases: Ulcerative colitis (systemic therapy); Regional enteritis (systemic therapy).
Respiratory Diseases: Symptomatic sarcoidosis; Berylliosis; Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; Loeffler's syndrome not manageable by other means; Aspiration pneumonitis.
Hematologic Disorders: Acquired (autoimmune) hemolytic anemia; Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated); Secondary thrombocytopenia in adults; Erythroblastopenia (RBC anemia); Congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases: For palliative management of: Leukemias and lymphomas in adults; Acute leukemia of childhood.
Edematous States: To induce diuresis or remission of proteinuria in the nephrotic syndrome.
Nervous System: Acute exacerbation of multiple sclerosis.
Miscellaneous: Pleurisy of tuberculosis.
3.CONTRAINDICATIONS:
- Gastric and duodenal ulcers.
- Systemic fungal infections.
- Acute infections.
- Osteoporosis.
- Pregnancy and lactation: Should be given with caution to pregnant and lactating women and under the physician’s instructions.
- Tuberculosis.
4.PRECAUTIONS:
- Prednisolone should be used with caution in patients with hypertension, congestive heart failure, diabetes mellitus, glaucoma, chronic renal failure and ocular herpes simplex.
- Discontinuation of treatment should be carried out by gradual reduction of dosage because withdrawal may result in acute adrenal insufficiency.
- During prolonged treatment of Prednisolone, patients should be examined regularly.
- Prednisolone may mask some signs of infections and new infections may appear during their use.
5.SIDE EFFECTS:
Prolonged treatment with high doses of Prednisolone may give arise to the following side effects: Peptic ulceration and hemorrhage, spontaneous fracture, disturbances of electrolytes, hyperglycemia, delayed wound healing, increased liability to infection, Cushing-syndrome. If the administration is discontinued these symptoms are reversed.
6.DRUG INTERACTIONS:
- Phenobarbitone and Phenytoin increase the metabolism of Prednisolone and reduce its therapeutic effects.
- There may be an increased incidence of gastro-intestinal bleeding and ulceration when Prednisolone is given with non-steroidal anti-inflmmatory agents.
- Prednisolone decreases the serum concentrations of salicylates.
7.DOSAGE & ADMINSTRATION:
- Parenteral route:
I.M. or I.V. Infusion:
The dosage depends on the severity of the condition and the response of patient.
The initial dosage varies from 25 to 100 mg/day depending on the disease being treated.
Locally infiltration or intra-articular:
Dosage and frequency of Predlone injection vary depending on the condition being treated and the site of injection: 10-50 mg/day.
-Oral route:
5 - 60 mg/day of Predlone tablets or syrup as a single dose after breakfast or in divided doses.
8.PACKAGING & COMPOSITION:
- PREDLONE 5 – Tablets: A pack of 20 or 30 tablets in a glass container. Each tablet contains Prednisolone 5 mg.
- PREDLONE 20 – Tablets: A pack of 20 tablets in a glass container. Each tablet contains Prednisolone 20 mg.
- PREDLONE 50 – Tablets: A pack of 20 tablets in a glass container. Each tablet contains Prednisolone 50 mg.
- PREDLONE – Syrup: A pack of glass bottle of 100 mL. Each 5 mL contains Prednisolone Sodium Phosphate 5mg.
- PREDLONE 25 – Injection: A pack of 5 or 25 ampoules of 2 mL. Each ampoule (2 mL) contains Prednisolone Sodium Phosphate equivalent to Prednisolone 25 mg.
9.STORAGE CONDITIONS:
- Store PREDLONE – Tablets at temperature between (15 – 30)°C.
- Store PREDLONE – Syrup at temperature below 25°C.
- Store PREDLONE – Injection in refrigerator at temperature between (2 – 8)°C. Protect from light.
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