Camelon 125

Methylprednisolone.

Each vial contains: Methylprednisolone Sodium Succinate equivalent to Methylprednisolone 125 mg.
Each ampoule of solvent contains: Water for injection ad 2 mL and Benzyl Alcohol (as preservative) 18 mg.

Pharmacology: Methylprednisolone is a glucocorticoid prednisolone derivative which has the same effect and usage with its parent agents. It does not have sodium retention activity like other glucocorticoids. Methylprednisolone is an intermediate acting corticosteroid, classified as an adrenocorticoid, anti-inflammatory and immunosuppressant category.
Adrenocorticoid Effect: Like adrenocorticoids, Methylprednisolone diffuses across the membrane and concurrently with cytoplasmic receptor forms specific complex. These complexes then enter the cell nucleus, bind to DNA and stimulate transcription of messenger RNA (mRNA) and subsequent protein synthesis of various enzymes thought to be responsible to the effect of systemic adrenocorticoid. However, Methylprednisolone may suppress transcription of mRNA in some cells (e.g., lymphocytes).
Glucocorticoid Effects: Anti-inflammatory (steroidal): Glucocorticoid decrease and prevent tissue responses to inflammatory processes, thereby reducing the inflammation symptoms without affecting underlying cause.
Glucocorticoids inhibit accumulation of inflammatory cells, including macrophages and leucocytes at the inflammation site. Methylprednisolone also inhibits phagocytosis, lysosomal enzyme release, synthesis or release of several chemical mediator of inflammation. Although the exact mechanism has not completely been understood, the possible effect is blocking macrophage inhibitory factor (MIF), inhibits macrophage localization, reduction or dilatation permeability of inflammed capillaries and reduction of leucocyte adherence in the capillary endothelium, inhibits oedema formation and leucocyte migration, and increase synthesis of lipomodulin (macrocortin), an inhibitor of phospholipase A2-mediator arachidonic acid release from phospholipid membrane and subsequent inhibition of the synthesis of arachidonic acid mediators derivative (prostaglandins, thromboxane and leucotrienes). Immunosuppressant actions may also influence anti-inflammatory effect.
Immunosuppressant: Mechanism of action of immunosuppressants have not been completely understood, but may involve prevention or suppression of cell-mediated (delayed hypersensitivity) immune reaction as well as more specific treatment that influence immune response. Glucocorticoids reduce thymus lymphocyte concentration (T-lymphocyte), monocyte and eosinophil. Methylprednisolone also decreases immunoglobulin binding to cell surface receptors and inhibits synthesis and/or release of interleukins, thereby decreasing T-lymphocyte blastogenesis and reducing expansion of primary immune response. Glucocorticoids may also decrease passage of immune complexes through basement membranes, and decrease concentration of complement components and immunoglobulin.

When oral therapy is not possible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, CAMELON powder for injection is indicated for i.v. or i.m., use in the following conditions: Abnormality of adrenocorticoid function, for the treatment of: Primary acute and chronic adrenocortical insufficiency: Hydrocortisone and cortisone are preferred as adjunctive replacement therapy because of their significant mineralocorticoid activities. Replacement of sodium and fluids are also required. In some patients, additional mineralocorticoid replacement may also be necessary.
Secondary adrenocorticoid insufficiency: Glucocorticoid replacement is usually sufficient, a mineralocorticoid is not always required.
Allergic disorders: Drug allergy.
Anaphylactic or anaphylactoid reaction (treatment adjunct): Use of glucocorticoids is generally reserved for prolonged reactions or those not responding to other forms of treatment within 1 hour, or situations in which there is a significant risk of relapse.
Angioedema (treatment adjunct).
Acute non-infectious laryngeal oedema.
Seasonal or perennial allergic rhinitis (chronic oracute).
Serum sickness.
Urticarial transfusion reaction.
Collagen disorders: Indicated during an acute exacerbation or as maintenance therapy: Acute rheumatic (or non-rheumatic) carditis.
Systemic dermatomyocytis (polymyocytis): Glucocorticoids may be the treatment of choice in children with this condition.
Systemic lupus erythematosus.
“Giant cell” arthritis.
Complicated bound tissue disease.
Polyarthritis nodosa.
Polychondritis relapse.
Rheumatoid polymyalgia.
Vasculitis.
Dermatologic disorders: Atopic, contact or exfoliative dermatitis.
Herpetiformic bullous dermatitis.
Severe seborrheic dermatitis.
Severe inflammatory dermatitis.
Severe erythema multiforme (Steven-Johnson syndrome).
Mycosis fungoides.
Pemphigus.
Severe psoriasis.
Pemphigoid.
Localized cutaneous sarcoid.
Gastrointestinal disorders: Treatment of inflammatory bowel disease, including ulcerative colitis.
Regional enteritis (Crohn's disease).
Severe celiac disease.
Oral or parenteral administration indicated when systemic therapy is required during a critical period of the disease, long term use is not recommended.
Haematologic disorders: Acquired haemolytic anemia (autoimmune).
Congenital (erythoid) hypoplastic anemia.
Red blood cell anemia (erythroblastopenia).
Secondary thrombocytopenia (in adults).
Idiophatic thrombocytopenia purpura in adults (orally or i.v. only, i.m. administration is contraindicated).
Haemolysis.
Hepatic disease: Alcoholic hepatitis with encelopathy.
Chronic active hepatitis.
Non-alcoholic hepatitis in women.
Subacute hepatic necrosis.
Hypercalcemia associated with neoplasm (or sarcoidosis).
Non-rheumatoid inflammation: Indicated during an acute episode or exacerbation of the following disorders (local injection is preferred when only a few joints or areas are affected).
Acute and subacute bursitis.
Epicondylitis.
Non-specific acute tenosynovitis.
Neoplastic diseases (treatment adjunct): Indicated in conjuction with appropriate specific antineoplastic disease therapy, for the palliative management of the following neoplastic disease therapy and related problems: Acute or chronic lymphocytic leukemia.
Hodgkin's or non-Hodgkin's lymphomas.
Breast cancer.
Prostatic cancer.
Fever caused by severe cancer.
Multiple myeloma.
Nephrotic syndrome: Indicated to induce diuretics or to reduce proteinuria symptoms in idiophatic necrotic syndrome, long-term therapy may be required to prevent frequent relapses.
Neurologic disease: Tuberculosis meningitis (treatment adjunct). Concurrent administration with appropriate antituberculous chemotherapy in patient with subarachnoid block.
Multiple sclerosis, indicated for acute exacerbation treatment.
Neurotrauma: Spinal cord injury.
Ophthalmic disorders: Treatment of chronic or acute allergic and inflammatory ophthalmic condition: Chorioretinitis.
Choroiditis posterior diffusion.
Allergic conjunctivitis (diffuse posterior choroiditis controlled).
Herpes zoster.
Iridocyclitis.
Keratitis not associated with herpes simplex of fungal infection.
Optic neuritis.
Sympathetic ophthalmia.
Diffuse posterior uveitis.
Pericarditis: Used to eliminate inflammation and fever.
Nasal polyps.
Respiratory diseases: Used for prophylaxis and treatment.
Prophylaxis: Given before or during heart surgery if patient has a pre-existing pulmonary disorder and given before, during and after oral, facial or neck surgery to prevent oedema that may inhibit the airway.
Treatment: Bronchial asthma.
Berylliosis.
Loeffler syndrome (eosinophilic pneumonitis or hyper-eosinophil syndrome).
Aspiration pneumonia.
Symptomatic sarcoidosis.
Fulminanting or disseminated pulmonary tuberculosis (treatment adjunct) when used concurrently with appropriate tuberculosis chemotherapy.
Acute and chronic asthma bronchitis.
Non-cardiogenic pulmonary oedema (caused by protamine sensitivity), treatment should be administered by i.v. or i.m. injection.
Airway obstructing hemangioma (children should be administered by i.v. or i.m. injection).
Pneumonia, Pneumocystis carinii associated with AIDS (treatment adjunct).
Pneumocystis pneumonia in patients infected with HIV virus.
Chronic obstructive pulmonary disease (not controlled with theophylline and β-adrenergic agonist).
Status asthmaticus should be given i.v. or i.m. injection.
Rheumatic disorders: Local injections should be applied only if few joints or areas are involved. Indicated as adjunctive therapy during an acute episode or exacerbation of rheumatic disorders: Ankylosing spondylitis.
Psoriatic arthritis.
Rheumatoid arthritis, including arthritis in children (for patients who cannot be treated with aspirin, steroidal anti-inflammatory agents, rest and physical therapy).
Acute gout arthritis.
Post-traumatic osteoarthritis.
Osteoarthritis synovitis.
Acute calcium pyrophosphate deposition disease (pseudogout, articularis condrocalcinosis, synovitis caused by crystal).
Rheumatica polymyalgia.
Reiter's disease.
Shock therapy caused by adrenocortical insufficiency.
Non-suppurative thyroiditis.
Prophylaxis and treatment of organ transplant rejection: Administration concurrently with other immunosuppressant e.g., azathioprine or cyclosporine.
Trichinosis treatment.

Usual adult and adolescent dose: Intramuscular or intravenous, 10 to 40 mg (base), repeated as needed. For high-dose (“pulse” therapy): intravenous, 30 mg (base) per kg body weight administered over at least 30 minutes. This dose may be repeated every 4 to 6 hours as needed.
For acute exacerbations of multiple sclerosis: intramuscular or intravenous, 160 mg (base) per day for one week, followed by 64 mg every other day for one month.
For treatment of acute spinal cord injury: intravenous, 30 mg (base) per kg of body weight administered over 15 minutes, followed in 45 minutes by continuous infusion of 5.4 mg per kg body weight per hour, for 23 hours.
For adjunctive treatment in AIDS-associated Pneumocystis carinii: intravenous, 30 mg (base) two times a day on days one through five, 30 mg once on days six through ten, and 15 mg once a day on days eleven trough twenty one.
Usual pediatric dose: Adrenocortical insufficiency: intramuscular, 117 mcg (0.117 mg) (base) per kg of body weight or 3.33 mg (base) per square meter of body surface a day (in three divided doses) every third day; or 39 to 58.5 mcg (0.039 to 0.0585 mg) (base) per kg of body weight or 1.11 to 1.66 mg (base) per square meter of body surface once a day.
For treatment of acute spinal cord injury: intravenous, 30 mg (base) per kg of body weight administered over 15 minutes, followed in 45 minutes by a continuous infusion of 5.4 mg per kg of body weight per hour, for 23 hours.
Other indications: intramuscular, 139 to 835 mcg (0.139 to 0.835 mg) (base) per kg of body weight or 4.16 to 25 mg (base) per square meter of body surface every 12 to 24 hours.
For adjunctive treatment in AIDS-associated Pneumocystis carinii: children 13 years of age and younger dosage has not been established). Children over 13 years of age see usual adult and adolescent dose.
Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hours post-prandial blood sugar, determination of blood pressure and body weight, and a chest x-ray should be made at regular intervals during prolonged therapy.
Method of Administration: CAMELON injection may be administered either by intravenous injection or by intramuscular injection.
Direction for reconstitutions: Add 2 mL of solvent into the vial of dry injection, close the vial and shake until the powder is dissolved.
Direct intravenous can be given at least 1 minute or can be given by intravenous infusion in 5% dextrose, NaCl 0.9% or 5% dextrose in 0.9% NaCl for at least 30 minutes.
The solution is stable physically and chemically for 48 hours at temperature 15°- 30°C.

Systemic fungal infections and patients with known hypersensitivity to the Methylprednisolone and its constituents.
Premature infant, because Methylprednisolone contain benzyl alcohol that has been reported to be associated with fatal “Gasping Syndrome”.
Long-term treatment is contra-indicated in duodenal and peptic ulcer, severe osteoporosis, patients with a history of psychosis, herpes.
Recent immunization.

While on corticosteroid therapy, patient should not be vaccinated against small-pox or other immune vaccines especially on high doses, because of possible hazards of neurological complications.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur.
Not recommended to patients with ocular herpes simplex because it may cause corneal perforation.
Administration of this drug may mask some signs of infection and new infections may appear during their use.
Long-term treatment may decrease body's stamina against infectious diseases.
Use in pregnancy and lactation: Not recommended in pregnant women and nursing mothers, except if clearly needed. Methylprednisolone may cause fetal damage when administered to pregnant women. Corticosteroid can diffuse into breast milk and may suppress or cause other side effects in the nursing infant. Infants born of mothers who have received substantial doses of corticosteroid during pregnancy should be carefully observed and evaluated for signs of adrenal insufficiency.
Use in children: Administration of pharmacological dose of glucocorticoids in children should be avoided because the drugs can retard bone growth. If the therapy is necessary, infant growth should be closely monitored. Alternate-day therapy given as single dose in the morning may minimize growth suppression and should be instituted if growth retardation occurs. High dosage of glucocorticoids in children may cause acute pancreatitis followed by pancreatic destruction.
Use in the elderly: Hypertension may occur during adrenocorticoid therapy. Geriatric patients, especially in post-menopausal women, may also be more likely to develop glucocorticoid-induced osteoporosis.

Not recommended in pregnant women and nursing mothers, except if clearly needed. Methylprednisolone may cause fetal damage when administered to pregnant women. Corticosteroid can diffuse into breast milk and may suppress or cause other side effects in the nursing infant. Infants born of mothers who have received substantial doses of corticosteroid during pregnancy should be carefully observed and evaluated for signs of adrenal insufficiency.

Adrenocortical insufficiency: High dose in prolonged periods can decrease endogenous corticosteroid secretion by suppressing pituitary release of corticotropin (secondary adrenocortical insufficiency).
Musculoskeletal effects: Pain or muscle weakness, delayed wound healing and atrophy of the bound protein matrix resulting in bone osteoporosis, vertebral compression fractures, aseptic necrosis in humeral or femoral head, or pathology fractures of long bones.
Fluid and electrolyte disturbances: Sodium retention with resultant oedema, potassium loss, hypokalemic alkalosis and hypertension or congestive heart attack.
Ocular effects: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmus.
Endocrine effect: Irregular menstruation, appearance of Cushingoid state and growth retardation in children, decreased glucose tolerance, hyperglycaemia, aggravation of diabetes mellitus.
Gastrointestinal tract: Nausea, vomiting, anorexia which may result in weight loss, increased appetite which may increase body weight, diarrhea or constipation, abdominal distension, pancreatitis, gastric irritation, ulcerative esophagitis, reactivation, perforation, haemorrhage and delayed healing of peptic ulcers.
Nervous system: Headache, vertigo, insomnia, increased motor activity, ischemic neuropathy, EEG abnormalities, convulsion.
Dermatological effects: Skin atrophy, acne, increased sweating, hirsutism, facial erythema, striae, allergic dermatitis, urticaria and angioedema.
Others: Sudden discontinuation of glucocorticoid treatment will produce nausea, vomiting, loss of appetite, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss and/or hypotension. The following additional adverse reactions related to parenteral corticosteroid therapy: hyperpigmentation or hypopigmentation, subcutaneous and cutaneous atrophy, sterile abscess, anaphylactic reaction with or without circulatory collapse, cardiac arrest, bronchospasm, cardiac arrhythmias.

Hepatic microsomal enzyme inducers: Drug e.g., barbiturates, phenytoin and rifampicin which induce hepatic enzymes may increase glucocorticoid metabolism and may require dosage adjustment or the drugs not given concomitantly.
Non-steroidal anti-inflammatory drugs (NSAIDs): Concomitant administration with ulcerogenic drugs e.g., indomethacin may increase risk of gastrointestinal tract ulceration. Concomitant use with NSAIDs or other anti-rheumatics may result in gastrointestinal risk, gastrointestinal bleeding. Aspirin should be given cautiously to patients with hypoprothrombinaemia. Although concomitant administration with salicylate does not appear to increase the incidence of gastrointestinal ulceration, the possibility of this effect should be considered.
Potassium-depleting drugs: Potassium-depleting diuretics (e.g., thiazides, furosemide, ethacrynic acid) and other drugs that deplete potassium.
Anti-cholinesterase agents: Interaction between glucocorticoid and anti-cholinesterase agents e.g., ambenonium, neostigmine or pyridostigmine can produce weakness in patients with myasthenia gravis. If possible, anticholinesterase treatment should be discontinued at least 24 hours before initiation of glucocorticoid therapy.
Vaccines and toxoids: Because glucocorticoids may inhibit antibody response, this drug may cause reduction responses to toxoids and live or inactivated vaccines. Patients should not receive small-pox vaccination or other immune vaccines especially in large doses while on corticosteroid therapy.

Store below 30°C, away from light.
After reconstituted, store below 30°C and use within 48 hours.

Corticosteroid Hormones

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

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