Methylprednisolone
Visa No.: 893110906724
Product: Menison 16mg
API: Methylprednisolon
Product Category: Anti-inflammatories
Version approved leaflet: 34450e/QLD-ĐK_ 28/11/2024
INDICATIONS
- Endocrine disorders
- Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone are the preferred agents; synthetic analogues may be used in combination with mineralocorticoids when necessary; in children, mineralocorticoid supplementation is important).
- Congenital adrenal hyperplasia.
- Non-suppurative thyroiditis.
- Hypercalcaemia associated with malignancy.
- Non-endocrine disorders
1. Rheumatic disorders
As adjunctive therapy for short-term use (to manage acute episodes or exacerbations) in:
- Psoriatic arthritis.
- Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
- Ankylosing spondylitis.
- Acute and subacute bursitis.
- Acute non-specific tenosynovitis.
- Acute gouty arthritis.
- Post-traumatic osteoarthritis.
- Synovitis associated with osteoarthritis.
- Epicondylitis.
2. Collagen vascular diseases
Used during exacerbations or as maintenance therapy in selected cases of:
- Systemic lupus erythematosus.
- Systemic dermatomyositis (polymyositis).
- Acute rheumatic carditis.
- Polymyalgia rheumatica.
- Giant cell arteritis.
3. Dermatological diseases
- Pemphigus.
- Dermatitis herpetiformis.
- Severe erythema multiforme (Stevens–Johnson syndrome).
- Exfoliative dermatitis.
- Mycosis fungoides.
- Severe psoriasis.
- Severe seborrhoeic dermatitis..
4. Allergic conditions:
Control of severe or intractable allergic conditions that have failed to respond to conventional therapy, including:
Seasonal or perennial allergic rhinitis.
Drug hypersensitivity reactions.
Serum sickness.
Contact dermatitis.
Bronchial asthma.
- Atopic dermatitis (atopic eczema).
5. Ophthalmic diseases
Severe acute and chronic inflammatory and allergic conditions of the eye and its adnexa, including:
- Allergic marginal corneal ulceration.
- Allergic conjunctivitis.
- Herpes zoster keratitis.
- Keratitis.
- Anterior uveitis.
- Chorioretinitis.
- Diffuse posterior uveitis and choroiditis.
- Optic neuritis.
- Sympathetic ophthalmia.
- Iritis and iridocyclitis.
6. Respiratory diseases
- Symptomatic sarcoidosis.
- Disseminated or fulminant pulmonary tuberculosis, when used concomitantly with appropriate antituberculous chemotherapy.
- Loeffler’s syndrome not manageable by other means.
- Aspiration pneumonitis.
- Berylliosis.
7. Haematological disorders:
- Idiopathic thrombocytopenic purpura in adults
- Pure red cell aplasia
- Secondary thrombocytopenia in adults.
- Congenital hypoplastic anaemia (erythroid type).
- Acquired (autoimmune) haemolytic anaemia.
8. Neoplastic diseases:
- Palliative management of:
- Leukaemia and lymphoma in adults.
- Acute leukaemia in children.
9. Oedematous conditions:
To promote diuresis and reduce proteinuria in nephrotic syndrome without uraemia, or nephrotic syndrome associated with systemic lupus erythematosus.
10. Gastrointestinal diseases
- To manage critical phases of disease in:
- Ulcerative colitis.
- Regional enteritis (Crohn’s disease).
11. Nervous system disorders
- Acute exacerbations of multiple sclerosis.
- Cerebral oedema associated with brain tumours.
12. Organ transplantation
13. Other indications
Tuberculous meningitis with subarachnoid block or impending block, when used concomitantly with appropriate antituberculous chemotherapy.
- Trichinosis with involvement of the myocardium or nervous system.
DOSAGE AND ADMINISTRATION
The initial dose of methylprednisolone tablets may vary depending on the specific condition being treated. For less severe conditions, lower doses are generally sufficient, whereas higher initial doses may be required in certain patients. Conditions requiring high doses include: Multiple sclerosis: 200 mg/day, Cerebral oedema: 200–1,000 mg/day, Organ transplantation: up to 7 mg/kg/day
If an adequate clinical response is not achieved after an appropriate period of time, methylprednisolone should be discontinued and alternative therapy instituted. When discontinuing treatment after prolonged therapy, the dose must be tapered gradually; abrupt withdrawal should be avoided. Once a favourable response is achieved, the maintenance dose should be determined by gradually reducing the initial dose in small increments at appropriate intervals until the lowest dose that maintains adequate clinical response is reached. Continuous monitoring is required to assess dose adequacy.
Dose adjustments may be necessary in response to changes in clinical status, such as disease remission or exacerbation, inpidual patient response, or exposure to stress not directly related to the underlying disease. In the latter situation, a temporary increase in the dose of methylprednisolone may be required, depending on the patient’s condition.
Dose adjustments may be necessary in response to changes in clinical status, such as disease remission or exacerbation, inpidual patient response, or exposure to stress not directly related to the underlying disease. In the latter situation, a temporary increase in the dose of methylprednisolone may be required, depending on the patient’s condition.
It should be emphasized that dosage requirements are variable and must be inpidualised according to the disease being treated and the patient’s response to therapy..
Alternate-day therapy (ADT):
Alternate-day therapy is a corticosteroid dosing regimen in which twice the daily dose is administered every other morning (one day on, one day off). The objective of this regimen is to provide long-term pharmacological benefit while minimizing adverse effects associated with corticosteroid therapy, including:
Suppression of the hypothalamic–pituitary–adrenal axis
Cushingoid features
Withdrawal syndrome
Growth suppression in children
CONTRAINDICATIONS
Methylprednisolone is contraindicated in patients with:
- Systemic fungal infections
- Hypersensitivity to methylprednisolone or to any excipients of the product
The use of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.
WARNINGS AND PRECAUTIONS
This medicine is for prescription use only.
Read the instructions for use carefully before use.
If further information is required, consult a physician or pharmacist.
Keep out of reach of children.
