Camelon 4/Camelon 8

Each tablet contains: Methylprednisolone 4 mg and 8 mg.
Camelon 4: White round flat tablet, odorless, Breakline-CP.
(The breakline is only to facilitate ease of swallowing for the patient, not for dose splitting.)
Excipients/Inactive Ingredients: Microcrystalline Cellulose 102. Pregelatinized Starch, Povidone K25, Crospovidone, Colloidal Silicon Dioxide, Talc, Magnesium Stearate.

Pharmacology: Camelon 4: Pharmacodynamics: Naturally occurring glucocorticoids (Hydrocortisone), 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 disorder of many organ systems. It has greater anti-inflammatory potency than Prednisolone to induce sodium and water retention. The relative potency of Methylprednisolone to Hydrocortisone is at least four to one. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.
Pharmacokinetics: Absorption: Methylprednisolone is rapidly absorbed and the maximum plasma Methylprednisolone concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. The absolute bioavailability of Methylprednisolone in normal healthy subjects is generally high (82% to 89%) following oral administration.
Distribution: Methylprednisolone is widely distributed into the tissues, crosses the blood-brain barrier, and is secreted in breast milk. Its apparent volume of distribution is approximately 1.4 L/kg. The plasma protein binding of Methylprednisolone in humans is approximately 77%.
Metabolism: In humans, Methylprednisolone is metabolized in the liver to inactive metabolites, the major ones are 20β-hydroxymethylprednisolone and 20β-hydroxymethylprednisolone. Metabolism in the liver occurs primarily via the CYP3A4 enzyme. For a list of drug interactions based on CYP3A4-mediated metabolism see INTERACTIONS.
Methylprednisolone, like many CYP3A4 substrates, may also be a substrate for the ATP-binding cassette (ABC) transport protein p-glycoprotein, influencing tissue distribution and interactions with other medicines.
Elimination: The mean elimination half-life for total Methylprednisolone is in the range of 1.8 to 5.2 hours. Methylprednisolone clearance is altered by concurrent administration of Troleandomycin, Erythromycin, Rifampicin, Anticonvulsants and Theophylline. No dosing adjustments are necessary in renal failure.
(Pharmacodynamic and pharmacokinetic data are obtained from the clinical data of the innovator product, MEDROL Tablet).
Camelon 8: Methylprednisolone, a semisynthetic derivative of the natural renal cortex hormone, cortisol.
Methylprednisolone has glucocorticoid actions.
In common with other glucocorticoids, Methylprednisolone influences the metabolism in almost all tissues. These effects are vital to maintain the body's homeostasis and to regulate the activities of the immune system.

Camelon 4: CAMELON 4 Tablets are indicated in the following conditions: 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 mineralocorticoid supplementation is of particular importance.
Congenital adrenal hyperplasia; Non-suppurative 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 require low-dose maintenance therapy); Ankylosing spondylitis; Psoriatic arthritis; Acute and subacute bursitis; Epicondylitis; Synovitis of osteoarthritis; Acute gouty arthritis; Acute non-specific tenosynovitis; Post-traumatic osteoarthritis.
Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus; Systemic dermatomyositis (polymyositis); Acute rheumatic carditis.
Dermatologic Diseases: Bullous dermatitis herpetiformis; Severe erythema multiforme (Stevens-Johnson syndrome); Severe seborrheic dermatitis; Exfoliative dermatitis; Pemphigus; Mycosis fungoides; Severe psoriasis.
Allergic 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; Keratitis; Allergic conjunctivitis; Optic neuritis; Chorioretinitis; Iritis and iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis; Berylliosis; Loeffler'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: Leukemias and lymphomas in adults; Acute leukemia of childhood.
Edematous States: 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 Diseases: To tide the patient over a critical period of the diseases in: Ulcerative colitis; Regional enteritis.
Nervous System: Acute exacerbation of multiple sclerosis.
Miscellaneous: Tuberculous meningitis with subarachnoid block of impending block when used concurrently with appropriate antituberculous chemotherapy; Trichinosis with neurologic or myocardial involvement.
Camelon 8: CAMELON is indicated for the treatment in the conditions include: bronchial asthma (usually where other drugs, e.g. sympathomimetics or theophylline, fail to produce the desired result or there is marked bronchial hypersensitivity), allergic rhinitis, urticaria, eczema or dermatitis, acute rheumatic fever, rheumatoid arthritis, acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura in adults, myeloblastosis, lymphogranulomatosis, ulcerative colitis, nephrotic syndrome, skin diseases, lupus erythematosus, dermatomyositis.
CAMELON may also be used for suppression of the immune response after transplantations, as an adjuvant in treatment with cytostatic agents or in radiotherapy, for substitution in primary adrenocortical insufficiency and after adrenalectomy.

Camelon 4: The initial dosage of CAMELON 4 Tablets may vary from 4 mg to 48 mg as Methylprednisolone per day depending on the specific disease entity being treated. In situations less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. Clinical situation in which high dose therapy may be indicated include multiple sclerosis (160 mg/day for a week followed by 64 mg every other 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, CAMELON 4 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 a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrement at appropriate time interval until the lowest dosage which will maintain an adequate clinical response is reacted. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situation which may make dosage adjustment necessary are changes in clinical status secondary to remission or exacerbation in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situation not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of CAMELON 4 for a period of time consistent with the patient's condition.
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.
Alternate Day Therapy (ADT). Alternate day therapy 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 effect of corticosteroid, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
Elderly patient: 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.
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.
Camelon 8: Treatment is initiated with comparatively high doses that are reduced in the further course of treatment until a satisfactory result has been reached.
Subsequent to successful initiation of treatment, the daily dose is reduced gradually until the minimum dose required for maintenance.
Treatment for children should be limited to the minimum dosage for the shortest possible time.
Initial doses: Adults: 4-80 mg daily.
Children: 0.8-1.1 mg/kg body weight.
Maintenance doses: Adults : 4-8 mg daily, the dosage may be increased up to 16 mg daily.
Children: 2-4 mg daily, the dosage may be increased up to 8 mg daily.
Substitution doses: 4-8 mg (in Addison's disease, as an adjuvant to mineralocorticoid therapy), in stressful situation, up to 16 mg daily.
In hypothyroid patients or patients with hepatic cirrhosis comparatively low doses may be sufficient and a general dose reduction may be necessary.
Treatment must only be interrupted or stopped on medical advice.
After prolonged treatment, particularly with comparatively high doses, CAMELON must not be discontinued abruptly, but gradually.
The entire daily dose should be taken early in the morning with sufficient amounts of liquid, during or immediately after a meal.
In the event of shock or other peracute situations, glucocorticoids must be administered intravenously.

Camelon 4: 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.

Camelon 4: Systemic fungal infections and known hypersensitivity to components. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.
Camelon 8: Hypersensitivity to Methylprednisolone or other glucocorticoids.
Gastric ulcers, osteoporosis, psychiatric disorders, amebiasis, systemic mycosis infection, poliomyelitis, narrow or open-angle glaucoma and viral diseases.

Camelon 4: Warnings: 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.
While on corticosteroid 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 of Methylprednisolone 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 patients 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.
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 low-dose corticosteroids might reduce mortality, especially in patients with vasopressor-dependent septic shock.
Immune System: Allergic reactions (e.g., angioedema) may occur.
Because rare instances of skin reactions and anaphylactic/anaphylactoid reactions have occurred in patients receiving corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
This medicine does not contain lactose or lactose produced from cow's milk.
Endocrine: In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
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 & ADMINISTRATION).
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 occurring during that period, hormone therapy should be reinstituted.
A steroid "withdrawal syndrome", seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of glucocorticoids. This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss, and/or hypotension. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels.
Because glucocorticoids can produce or aggravate Cushing'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.
Particular care is required when considering the use of systemic corticosteroids in patients with diabetes mellitus (or a family history of diabetes) and frequent patient monitoring is necessary.
Psychiatric: 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 ADVERSE REACTIONS). Symptoms typically emerge within a few days or weeks of starting treatment. Most reactions recover after either dose reduction or withdrawal, 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.
Nervous System: Corticosteroids should be used with caution in patients with seizure disorders.
Corticosteroids should be used with caution in patients with myasthenia gravis (see myopathy statement in Musculoskeletal as follows).
Although controlled clinical studies have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE & ADMINISTRATION).
There have been reports of epidural lipomatosis in patients taking corticosteroids, typically with long-term use at high doses.
Ocular: Corticosteroids should be used cautiously in patient with ocular herpes simplex because of possible corneal perforation.
Prolonged use 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.
Corticosteroid therapy has been associated with central serous chorioretinopathy, which may lead to retinal detachment.
Cardiac: Adverse effects of glucocorticoids on the cardiovascular system, such as dyslipidemia and hypertension, may predispose treated patients with existing cardiovascular risk factors to additional cardiovascular effects, if high doses and prolonged courses are used. Accordingly, corticosteroids should be employed judiciously in such patients and attention should be paid to risk modification and additional cardiac monitoring if needed. Low dose and alternate day therapy may reduce the incidence of complications in corticosteroid therapy.
Systemic corticosteroids should be used with caution, and only if strictly necessary, in cases of congestive heart failure.
Vascular: Thrombosis including venous thromboembolism has been reported to occur with corticosteroids. As a result corticosteroids should be used with caution in patients who have or may be predisposed to thromboembolic disorders.
Corticosteroids should be used with caution in patients with Hypertension.
Gastrointestinal: High doses of corticosteroids may produce acute pancreatitis. There is no universal agreement on whether corticosteroids per se 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.
Glucocorticoid therapy may mask peritonitis or other signs or symptoms associated with gastrointestinal disorders such as perforation, obstruction or pancreatitis. In combination with NSAIDs, the risk of developing gastrointestinal ulcers is increased.
Corticosteroids should be used with caution in non-specific ulcerative colitis it there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer.
Hepatobiliary: Hepatobiliary disorders have been reported which may be reversible after discontinuation of therapy. Therefore, appropriate monitoring is required.
Musculoskeletal: An acute myopathy has been reported with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with anticholinergics, such as neuromuscular blocking drugs (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 recognized adverse effects associated with a long-term use of large doses of glucocorticoid.
Renal and Urinary: Caution is required in patients with systemic sclerosis because an increased incidence of scleroderma renal crisis has been observed with corticosteroids, including Methylprednisolone.
Corticosteroids should be used with caution in patients with renal insufficiency.
Investigations: Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt, and water retention, and increased excretion of potassium. These effects 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: Systemic corticosteroids are not indicated for, and therefore, should not be used to treat, traumatic brain injury; a multicenter study revealed an increased mortality at 2 weeks and 6 months after injury in patients administered Methylprednisolone Sodium Succinate compared to placebo.
A causal association with Methylprednisolone Sodium Succinate treatment has not been established.
Other: 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 intermittent therapy should be used.
The lowest possible dose of corticosteroid should be used to control the condition under treatment and when reduction in dosage is possible, the reduction should be gradual.
Aspirin and non-steroidal anti-inflammatory agents should be used cautiously in conjunction with corticosteroids.
Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
In post-marketing reports of innovator product, tumor lysis syndrome (TLS) has been reported in patients with malignancies, including hematological malignancies and solid tumors, following the use of systemic corticosteroids alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS, such as patients with tumors that have a high proliferative rate, high tumor burden and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precautions should be taken.
Precautions: 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.
Camelon 8: Should be used with caution in patients with severe hypertension and cardiac insufficiency.
Prolonged use may produce subcapsular cataracts, glaucoma and may enhance the establishment of infections due to fungi or viruses.
In long-term treatment, ophthalmological control should be carried out every 3 months.
Diabetic patients under treatment with Methylprednisolone must be re-examined for their blood and urine sugar values.
Like other glucocorticoids, Methylprednisolone may mask signs of infection.
After prolonged treatment, Methylprednisolone must not be discontinued abruptly, but gradually.
In patients with stressful situation, dosage can be increased.
In patients given corticosteroid should not receive smallpox vaccination or other kind of vaccination, particularly high-dose vaccine to prevent neurological complication possibility.
Prolonged used in children should be with caution because this drug may inhibit their growth and development.
The use in patients with TBC-laten or tuberculin reactivity must be monitored carefully, because of the risk of reactivation.
The effect of glucocorticoids may be potentiated in patients with hypothyroid or hepatic cirrhosis.
Effects on ability to drive and use machines: Camelon 4: The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated.
Undesirable effects, such as dizziness, vertigo, visual disturbances and fatigue are possible after treatment with corticosteroids. If affected, patients should not drive or operate machinery.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION for further information.
Use in Children: Camelon 4: 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 & ADMINISTRATION).
Infants and children on prolonged corticosteroid therapy are at special risk from raised intracranial pressure.
High doses of corticosteroids may produce pancreatitis in children. Host defenses are impaired in patient receiving large doses of glucocorticoids and this effect increases susceptibility to fungus infection as well as bacterial and viral infections.

Camelon 4: Fertility: Corticosteroids have been shown to impair fertility.
Pregnancy: Since adequate human reproductive studies have not been done with methylprednisolone, this medicinal product should be used during pregnancy only after a careful assessment of the benefit-risk ratio to the mother and fetus.
Some corticosteroids readily cross the placenta. One retrospective study found an increased incidence of low birth weights in infants born to mothers receiving corticosteroids. In humans, the risk of low birth weight appears to be dose related and may be minimized by administering lower corticosteroid doses. Infants born to mothers, who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency, although neonatal adrenal insufficiency appears to be rare in infants who were exposed in utero to corticosteroids.
There are no known effects of corticosteroids on labor and delivery.
Lactation: Corticoids are excreted in breast milk and mothers taking the drug should not be breast feed.
This medicinal product should be used during breastfeeding only after a careful assessment of the benefit-risk ratio to the mother and infant.
Camelon 8: This drug should be used during pregnancy only if clearly needed.
Not recommended for pregnant women and nursing mothers.

Camelon 4: ADRs by SOC and CIOMS frequency category listed in order of decreasing medical seriousness within each frequency category and SOC. (See Table 1.)


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Camelon 8: Depending on the dosage and duration of treatment, glucocorticoids may give rise to the following side effects: moon face, trunk obesity, muscular weakness, hypertension, osteoporosis, reduced glucose tolerance, diabetes mellitus, disorders of sex hormone secretion, peptic ulcer, impairment of antibody response, retarded of growth in children, glaucoma, cataract, thrombosis and pancreatitis.
Central nervous system: headache, vertigo, increased intracranial pressure with papilledema.
Electrolyte disturbance and fluid retention.
Dermatologic and immunologic disturbance.

Camelon 4: Methylprednisolone is a cytochrome P450 enzyme (GYP) substrate and is mainly metabolized by the CYP3A4 enzyme. CYP3A4 is the dominant enzyme of the most abundant CYP subfamily in the liver of adult humans. It catalyzes 6β-hydroxylation of steroids, the essential Phase I metabolic step for both endogenous and synthetic corticosteroids. Many other compounds are also substrates of CYP3A4, some of which (as well as other drugs) have been shown to alter glucocorticoid metabolism by induction (upregulation) or inhibition of the CYP3A4 enzyme.
CYP3A4 Inhibitors: Drugs that inhibit CYP3A4 activity generally decrease hepatic clearance and increase the plasma concentration of CYP3A4 substrate medications, such as Methylprednisolone. In the presence of a CYP3A4 inhibitor, the dose of Methylprednisolone may need to be titrated to avoid steroid toxicity.
CYP3A4 Inducers: Drugs that induce CYP3A4 activity generally increase hepatic clearance, resulting in decreased plasma concentration of medications that are substrates for CYP3A4. Coadministration may require an increase in Methylprednisolone dosage to achieve the desired result.
CYP3A4 Substrates: In the presence of another CYP3A4 substrate, the hepatic clearance of Methylprednisolone may be affected, with corresponding dosage adjustments required. It is possible that adverse events associated with the use of either drug alone may be more likely to occur with co-administration.
Non-CYP3A4-Mediated Effects: Other interactions and effects that occur with Methylprednisolone are described in Table 2 as follows.
Table 2 provides a list and descriptions of the most common and/or clinically important drug interactions or effects with Methylprednisolone. (See Table 2.)


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Camelon 8: Concomitant administration with cardiac glycosides may potentiate/increase glycoside effect.
Concomitant administration with diuretics may potentiate/increase potassium-depleting effect.
The hypoglycaemic effect on antidiabetic agents and the anticoagulant effect of coumarin derivatives may be reduced by glucocorticoids.
Concomitant administration with Rifampicin, Phenytoin or Barbiturates may reduce corticosteroid effect.
Concomitant administration with Acetosal may potentiate/increase the clearance of chronic high-dose Acetosal.
Convulsions have been reported with concurrent use of Methylprednisolone and Cyclosporin.
Concomitant administration with Ketoconazole and Troleandomycin may inhibit the metabolism of Methylprednisolone and thus, decrease its clearance.

Store below 30°C.

Corticosteroid Hormones

H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.

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