Oral Solution P-Cort Oral Solution

5 mg/5 ml
50 ml bottle: ৳ 60.00
Also available as:

Indications

Allergy and anaphylaxis: Bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis.
Respiratory disease: Allergic pheumonitis, 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 rheumatica, juvenile chronic arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease.
Arteritis/collagenosis: Giant cell arteritis/polymyalgia rheumatica, mixed connective tissue disease, polyarteritis nodosa, polymyositis.
Blood disorders: Haemolytic anaemia (autoimmune), leukaemia (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, multisystem disease affecting liver, biliary peritonitis.
Infections: Military tuberculosis, mumps orchitis (adult), tuberculous meningitis, rickettsial disease.
Muscular disorders: Polymyositis, dermatomyositis:
Neurological disorders: Infantile spasms, ShyDrager syndrome, sub-acute demyelinating polyneuropathy.
Ocular disease: Sclertis, posterior uveitis, retinal vasculitis, pseudo tumours of the orbit, malignant ophthalmic Graves disease.
Renal disorders: Lupus nephritis, acute intersititial nephritis, minimal change glomerulonephritis.
Skin disorders: Pemphigus vulgaris, bullous pemphigoid, systemic lupus erythematosus, pyoderma gangrenosum.
Miscellaneous: Sarcoidosis, hyperpyrexia, Behcets disease, immunosuppression in organ transplantation.

Therapeutic Class

Glucocorticoids

Pharmacology

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

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 activity of the disease. In general, 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. The 5 mg and 2 mg tablets are preferably used for tapering dose. 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.

Intermittent dosage regimen: A single dose of Prednisolone in the morning on alternate days or at longer intervals is acceptable therapy for some patients. When this regimen is practical, the degree of pituitary-adrenal suppression can be minimized.

Specific dosage guidelines:
  • Allergic and skin disorders: initial doses of 5-15 mg daily are commonly adequate.
  • Collagenosis: Initial doses of 20-30 mg daily are frequently effective. Those with more severe symptoms may require higher doses.
  • Rheumatoid arthritis: The usual initial dose is 10-15 mg daily. The lowest daily maintenance dose compatible with tolerable symptomatic relief is recommended.
  • Blood disorders and lymphoma: An initial daily dose of 15-60 mg is often necessary with reduction after an adequate clinical or hematological response. Higher doses may be necessary to induce remission in acute leukaemia.
  • Tapering: Dosage should be tapered down with 5 mg and 2 mg tablets after the treatment period.
Children:
  • Acute asthma: Children aged 18 months to 12 years: 0.5-2 mg/kg/day (max 40 mg) once daily for up to a total of 3 days or longer if necessary. Prednisolone should be taken in the morning after food. No gradual decrease of the dose is required. Children aged 12-18 years: 40-50 mg once daily for at least 5 days.
  • Other indications for children: Initial dosage: 0.5 mg/kg/day in three or four divided doses after food. This dosage can be doubled or tripled if necessary.
  • Maintenance dosage: 0.125 to 0.25 mg/kg/day

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 oestrogens are added to or withdrawn from a stable dosage regimen.
  • Other: The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives and diuretics are antagonised by corticosteroids and the hypokalaemic effect of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced.

Contraindications

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation

Side Effects

General side-effects include leucocytosis, hypersensitivity including anaphylaxis, thromboembolism, nausea, and malaise.

Pregnancy & Lactation

There is evidence of harmful effects on pregnancy in animals. 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.

Precautions & Warnings

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 Special Populations

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.

Overdose Effects

Report of acute toxicity and/or death following overdose of glucocorticoids are rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.