Description
COMPOSITION :
Each caplet of Prednox contains 4 mg of Methylprednisolone.
Each caplet of Prednox 16 contains 16 mg of Methylprednisolone.
ACTIONS :
Methylprednisolone, a glucocorticoid, is an adrenocortical steroid which is readily absorbed from the GI Tract.
INDICATIONS :
For all cases where therapy with glucocorticoid is required, eg endocrine disorders, rheumatic disorders, dermatological disease,
collagen diseases, hematologic disorders, gastrointestinal diseases.
DOSAGE :
The initial dosage of Prednox may vary from 4 – 48 mg methylprednisolone/day depending on the specific disease
entity being treated.
Children: In general, dosage for children should be based upon clinical response and is at the discretion of the clinician.
Treatment should be limited to the minimum dosage for the shortest period of time. If possible, treatment should be
administered as a single dose on alternate days.
Elderly : Treatment of elderly patients, particularly if long-term, should be planned bearing in mind the more serious
consequences of the common side effects of corticosteroid in old age, particularly osteoporosis, diabetes, hypertension,
susceptibility to infection and thinning of skin.
CONTRAINDICATIONS :
Systemic fungal infections and known hypersensitivity to any of the components of Prednox.
WARNINGS :
Corticosteroids may mask some signs of infection and new infections may appear during their use.
Prolonged use of corticosteroids may produce posterior sub-capsular cataracts, glaucoma with possible damage to the optic
nerves and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Growth may be suppressed in children receiving long-term daily divided dose of glucocorticoid therapy and use of such regimen
should be restricted to the most urgent indication. Since there is inadequate evidence of safety in human pregnancy, the use
of Prednox in pregnancy, nursing mothers, or women of childbearing potential requires that the benefits of the drug be
carefully weighed against the potential risk to the mother and embryo or fetus.
PRECAUTIONS :
Corticosteroids should be used with caution in nonspecific ulcerative colitis if there is a probability of impending perforation,
abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer, renal insufficiency;
hypertension; osteoporosis or myasthenia gravis.
SIDE EFFECTS:
Fluid and Electrolyte Disturbances :
Sodium retention; Congestive heart failure in susceptible patients.
Musculoskeletal: Muscle weakness; steroid myopathy; osteoporosis.
Gastrointestinal : Peptic ulceration with possible perforation and hemorrhage.
Dermatologic : Impaired wound healing; thin fragile skin.
Neurological : Increased intracranial pressure; pseudotumor cerebri.
Endocrine : Development of Cushingoid state; suppression of growth in children.
Ophthalmic : Posterior subcapsular cataracts; glaucoma.
INTERACTIONS :
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Drugs that induce hepatic
enzymes, eg. phenobarbital, phenytoin and rifampicin may increase the clearence of methylprednisolone and may require
increase in methylprednisolone dose to achieve the desired response.
STORAGE :
Keep in a dry and cool place. Protect from light.
PACKING :
Prednox : Boxes of 10 x 10’s caplets. Reg. No. DKL 9821012604 A1.
Prednox 16 : Boxes of 5 x 10’s caplets. Reg. No. DKL 9821012604 C1.
On doctor’s prescriptions only.