Methylon® Tablet 4 mg, each tablet contains : Methylprednisolone 4 mg.
Methylon® with active ingredient Methylprednisolone is available in tablet 4 mg.
- Endocrine disorders
- Primary or secondary adrenocortical insufficiency (Hydrocortisone or Cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralcorticoids supplementation is of particular importance
- Congenital adrenal hyperplasia
- Nonsuppurative thyroiditis
- Hypercalcemia associated with cancer
- Rheumatic disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in :
- Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may required low-dose maintenance therapy)
- Ankylosing spondylitis
- Psoriatic arthritis
- Acute and subacute bursitis
- Synovitis of osteoarthritis
- Acute gouty arthritis
- Acute nonspesific tenosynovitis
- Post-traumatic osteoarthritis
- Collagen disorders
During an exacerbation or as maintenance therapy in selected cases of : Systemic lupus erythematosus, systemic dermatomyositis (polymyositis) and acute rheumatic carditis.
- Dermatologic diseases
- Bullous dermatitis herpetiformis
- Severe erythema multiforme (Steven-Johnson syndrome)
- Severe seborrhoeic dermatitis
- Exfoliative dermatitis
- Mycosis fungoides
- Severe psoriasis
- Allergy states
Control of severe or incapacitating allergic condition intractable to adequate trials of conventional treatments :
- Seasonal or perennial allergic rhinitis
- Drug hypersensitivity reactions
- Serum sickness
- Bronchial asthma
- Contact dermatitis
- Atopic dermatitis
- 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
- Allergic conjunctivitis
- Optic neuritis
- Iritis and iridocylitis
- Respiratory diseases
- Symptomatic sarcoidosis
- Leoffler’s syndrome not manageable by other means
- Fulminating or disseminated pulmonary tuberculosis when use concurrently with appropriate antituberculous chemotherapy
- Aspiration pneumonitis
- Hematologic disorders
- Idiopathic thrombocytopenic purpura in adults
- Secondary thrombocytopenia in adults
- Acquired (autoimmune) hemolytic anemia
- Erythroblastopenia (RBC anemia)
- Congenital (erythroid) hypoplastic anemia
- Neoplastic diseases : For palliative management of leukemia and lymphomas in adults and acute leukemia in childhood.
- Edematous state : To induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia, or the idiopathic type or that due to lupus erythematosus.
- Gastrointestinal disease : To tide the patient over a critical period of the diseases in ulcerative colitis and regional enteritis.
- Nervous system : Acute exacerbations of multiple sclerosis.
- Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
- Trichinosis with neurologic or myocardial involvement.
DOSAGE AND ADMINISTRATIONS :
- Initial dose : Varies between 4 – 48 mg Methylprednisolone daily, 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. Clinical situations in which high dose therapy may be indicated include multiple sclerosis (160 mg/day for a week, followed by 64 mg/day for 1 month have been shown to be effective). If after a reasonable period of time there is a lack of satisfactory clinical response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. If after long-term therapy the drug is to be stopped; it is recommended that it be withdrawn gradually rather than abruptly.
- After favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decreasement 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.
IT SHOULD BE EMPHASISED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.
- ADT (Alternate Day Therapy) : ADT is a corticosteroid dosing regimen in which twice the usual daily dose of corticosteroid is administered every other morning. The purpose of this mode of therapy is to provide a patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticosteroids, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms and growth suppression in children.
- 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 corticosteroids in old age, particularly osteoporosis, diabetes, hypertension, susceptibility to infection and thinning of skin.
- 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.
There is no clinical syndrome of acute overdosage with corticosteroids. Reports of acute toxicity and/or death following overdosage of corticosteroids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic. Methylprednisolone is dialyzable.
Systemic fungal infection and known hypersensitivity to components.
WARNINGS AND PRECAUTIONS :
- Immunosuppressant effects/increased susceptibility to infections
- Corticosteroids may increase susceptibility to infection, may mask some sign of infection and new infections may appear during their use. There may be decreased resistance and inability to localized infection when corticosteroids are used.
- Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids.
- Similarly, corticosteroids should be used with great care in patients with known or suspected parasitic infections such as strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosupperssion may lead to strongyloides hyperinfection and dissemination with widespread larval migration, often accompained by severe enterocolitis and potentially fatal gram-negative septicemia.
- The role of corticosteroids in septic shock has been controversial, with early studies reporting both beneficial and detrimental effects. More recently, supplemental corticosteroids have been suggested to be beneficial in patients with established septic shock who exhibit adrenal insufficiency. However, their routine use in septic shock is not recommended and a systematic review concluded that short-course, high dose corticosteroids did not support their use. However, meta-analyses and a review suggest that longer courses (5 – 11 days) of lowdose corticosteroids might reduce mortality, especially in those with vasopressor-dependent septic shock.
- While on corticosteroids therapy, patients should not be vaccinated against smallpox. Other immunization procedure should not be undertaken in patients who are on corticosteroids, especially on high doses, because of possible hazards of neurological complication and lack of antibody response.
- The use Methylon® Tablets in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with appropriate antituberculosis regimen.
- If corticosteroids are indicated in patient with latent tuberculosis or tuberculin reactivity, close observation if necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
- Blood and lymphatic system
Aspirin and nonsteroidal anti-inflammatory agents should be used cautiously in conjuction with corticosteroids in patients with hypoprothrombinemia.
- Immune system
Allergic reactions (e.g. angioedema) may occur.
- Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic-pituitary-adrenal (HPA) suppression (secondary adrenocortical insufficiency). The degree and duration of adrenocortical insufficiency produced is variable among patients and depends on the dose, frequency, time of administration and duration of glucocorticoid therapy. This effect may be minimized by the use of alternate-day therapy (see DOSAGE AND ADMINISTRATIONS).
- In addition, acute adrenal insufficiency leading to a fatal outcome may occur if glucocorticoids are withdrawn abruptly.
- Drug-induced adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation stress occuring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or mineralocorticoid should be administered concurrently.
- Because glucocorticoid can produce or aggravate Chusing’s syndrome, glucocorticoids should be avoided in patients with Cushing’s disease. There is an enhanced effect of corticosteroids on patients with hypothyroidism.
- Metabolism and nutrition
Corticosteroids, including Methylprednisolone, can increase blood glucose, worsen pre-existing diabetes and predispose those on long-term corticosteroid therapy to diabetes mellitus.
- Psychic derangements may appear when corticosteroids are used ranging from euphoria, insomnia, mood swings, personality changes and severe depression to frank psychotic manifestation. Also existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Potentially severe psychiatric adverse reactions may occur with systemic steroids (see section ADVERSE REACTIONS). Symptoms typically emerge within a few days or weeks of starting treatment. Most reaction recover after either dose reduction or withdrawl, although specific treatment may be necessary. Psychological effects have been reported upon withdrawal of corticosteroids; the frequency is unknown. Patients/caregivers should be encouraged to seek medical attention if psychological symptoms develop in the patient, especially if depressed mood or suicidal ideation is suspected. Patients/caregivers should be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids.
- In patients on corticosteroids therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after stressful situation is indicated.
- Nervous system
- Corticosteroids should be used with caution in patients with seizure disorders.
- Corticosteroids should be used with caution in patients with myasthenia gravis.
Corticosteroids should be use cautiously in patient with ocular herpes simplex because of possible corneal perforation. Prolonged used of corticosteroids may produce posterior subcapsular cataracts and nuclear cataracts (particularly in children), exophthalmos or increased intraocular pressure, which may result in glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Systemic corticosteroids should be used with caution and only if strictly necessary, in cases of congestive heart failure.
Corticosteroids should be used with caution in patients with hypertension.
There is no universal agreement on whether corticosteroids are responsible for peptic ulcer encountered during therapy; however, glucocorticoid therapy may mask the symptoms of peptic ulcer so that perforation or hemorrhage may occur without significant pain. Corticosteroid should be used with caution in non specific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer.
There is an enhanced effect of corticosteroids on patients with cirrhosis.
An acute myopathy has been reported with the use of high doses of corticosteroids, most often occuring in patients with disorders of neuromuscular transmission (e.g. myasthenia gravis) or in patients receiving concomitant therapy with anticholinergics, such as neuromuscular blocking agent (e.g. Pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevations of creatine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Osteoporosis is a common but infrequently recognize adverse effects associated with a long-term use of large doses of glucocorticoid.
- Renal and urinary
Corticosteroids should be used with caution in patients with renal insufficiency.
Average and large doses of Hydrocortisone or Cortisone can cause elevation blood pressure, salt and water retention and increased excretion of potassium. These affects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
- Injury, poisoning and procedural complications
High doses of systemic corticosteroids should not be used for the treatment of traumatic brain injury.
Because complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermitten therapy should be used.
The lowest possible dose of corticosteroids should be used to control the condition under treatment and when reduction in dosage is possible, the reduction should be gradual.
- Use in children
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
Growth may be suppressed in children receiving long-term daily, divided doses glucocorticoid therapy and use of such regimen should be restricted to the most urgent indication. Alternate day glucocorticoid therapy usually avoids or minimizes these side effects (see DOSAGE AND ADMINISTRATIONS).
- Carcinogenesis, mutagenesis, impairment of fertility
There is no evidence that corticosteroid are carcinogenic, mutagenic or impair fertility. Host defenses are impaired in patient receiving large doses of glucocorticoid and this effect increases susceptibility to fungus infection as well as bacterial and viral infections.
Some animal studies have shown that corticosteroids, when administered to the mother at high doses, may cause fetal malformations.
Adequate human reproductive studies have not been done with corticosteroids. Therefore the use of this drug 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.
Since there is inadequate evidence of safety in human pregnancy, this drug should be used in pregnancy only if clearly needed. Infants born of mothers who have received substantial doses of corticosteroid during pregnancy should be carefully observed for signs of hypoadrenalism.
Corticosteroids readily cross the placenta. One retrospective study found an increased incidence of low birth weights in infants born of mothers receiving corticosteroid. Although neonatal adrenal insufficiency appears to be rare in infants who were exposed in utero to corticosteroids, those exposed to substantial doses of corticosteroid should be carefully observed and evaluated for signs of adrenal insufficiency.
There are no known effects of corticosteroid on labor and delivery.
Corticoids are excreted in breast milk and mothers taking the drug should not be breast feed.
- Effects on ability to drive and use machines.
The effect of corticosteroids on the ability to drive or use machinery has not been evaluated.
There is no evidence to suggest that corticosteroids may affect the ability to drive and use machines. No deleterious effects of corticosteroids on driving or operating machinery is expected.
Convulsions have been reported with concurrent use of Methylprednisolone and Cyclosporine. Since concurrent administration of these agents result in a mutual inhibition of metabolism, it is possible that convulsion and other adverse events associated with the individual use of either drug may be more apt to occur.
Methylon® Tablet 4 mg Box, 10 strip @ 10 tablet Reg. No. DKL0302333510A1
STORE BELOW 30oC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia