Soulpred

(Methylprednisolone Sodium Succinate)
Steroid

Presentation
Description
Indications
Dosage & Administration
Side Effects
Precautions
Contraindications
Commercial Packaging
Drug Interaction
Overdose

Solupred 2 Tablet: Each flim coated tablet contains Methylprednisolone USP 2 mg.
Solupred 4 Tablet: Each flim coated tablet contains Methylprednisolone USP 4 mg.
Solupred 8 Tablet: Each flim coated tablet contains Methylprednisolone USP 8 mg.
Solupred 16 Tablet: Each flim coated tablet contains Methylprednisolone USP 16 mg

Solupred Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water.

CLINICAL PHARMACOLOGY

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems

Solupred Tablets are indicated in the following conditions: 1. Endocrine Disorders: Primary or secondary adrenocortical insufficiency, Congenital adrenal hyperplasia, Nonsuppurative thyroiditis, Hypercalcemia associated with cancer 2. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode orexacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), Ankylosing spondylitis, Acute and subacute bursitis, Synovitis of osteoarthritis, Acute nonspecific tenosynovitis, Post-traumatic osteoarthritis, Psoriatic arthritis, Epicondylitis, Acute gouty arthritis 3. Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis), Acute rheumatic carditis 4. Dermatologic Diseases: Bullous dermatitis herpetiformis, Severe erythema multiforme (Stevens-Johnson syndrome), Severe seborrheic dermatitis, Exfoliative dermatitis, Mycosis fungoides, Pemphigus, Severe psoriasis 5. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis, Drug hypersensitivity reactions, Serum sickness, Contact dermatitis, Bronchial asthma, Atopic dermatitis 6. Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers, Herpes zoster ophthalmicus, Anterior segment inflammation,Diffuse posterior uveitis and choroiditis, Sympathetic ophthalmia, Keratitis, Optic neuritis, Allergic conjunctivitisChorioretinitis, Iritis and iridocyclitis 7. Respiratory Diseases: Symptomatic sarcoidosis, Berylliosis, Loeffler’s syndrome not manageable by other means, Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, Aspiration pneumonitis 8. Hematologic Disorders:Idiopathic thrombocytopenic purpura in adults, Secondary thrombocytopenia in adults, Acquired (autoimmune) hemolytic anemia, Erythroblastopenia (RBC anemia), Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases: For palliative management of: Leukemias and lymphomas in adults, Acute leukemia of childhood 10. Edematous States:To induce a diuresis or remission of proteinuria in the nephroticsyndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

11. GastrointestinalDiseases: To tide the patient over a critical period of the disease in: Ulcerative colitis, Regional enteritis 12.Nervous System:Acute exacerbations of multiple sclerosis

The initial dosage of Solupred Tablets may vary from 4 mg to 48 mg of Solupred per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Solupred should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Methylprednisolone for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis:In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).

Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methylprednisolone may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible body damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions and psychic disturbances including depression, euphoria, insomnia etc

Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an

enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in conjunction with corticosteroids in hypoprothombinemia. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Use in Pregnancy and Lactation Pregnancy: Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there is no controlled studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. Lactation: Methylprednisolone has not been adequately evaluated in nursing mothers.

Systemic fungal infections and known hypersensitivity to components

Solupred 2 Tablet:Each box contains 5 x 10's tablets in alu-alu blister pack.

Solupred4 Tablet:Each box contains 3 x 10's tablets in alu-alu blister pack.

Solupred 8 Tablet: Each box contains 2 x 10's tablets in alu-alu blister pack.

Solupred 16 Tablet: Each box contains 1 x 10's tablets in alu-alu blister pack

Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism ofMethylprednisolone. Estrogens including birth control pills, can increase the effect of corticosteroids by 50 %. Cyclosporin reduces the metabolism of Methylprednisolone while Methylprednisolone reduces the metabolism of Cyclosporin. Methyl prednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these interactions, the dose of Methylprednisolone may need to be lowered.

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