INDICATION:

Endocrine disorders: Primary or secondary adrenoscortical insufficiency (hydrocortisone or cortisone is the drug of choicel synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoids supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoids supplimentation may be necessary, particularly when synthetic analogs are used); preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical insufficiency exists or suspected, 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: post-traumatic osteoarthritis; synovitis of osteoarthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); acute and subacute bursitis, epicondylitis; acute non-specific tenosynovitis; acute gouty arthritis; psolartic arthritis; ankylosing spondylitis.

Collagen diseases: During an exacerbation or as maintenance theraphy in selected cases of systemic lupus erythematosus, acute rheumatic carditis.

Dermatologic diseases: Pemphigus, severe erythema multiforme (Steven-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, mycosis fungoides.

Allergic states: Control of severe or incapacitating allergic conditions intratable to adequate trials of conventional treatment in: bronchial asthma, contact dermatitis, atopic dermatits, serum sickness, seasonal or perennial allergic rhinitis, drug hypersensitivity reactions, acute non infectious laryngeal edema (epinephrine is the drug of first choice).

Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster opthalmicus, iritis and iridocyclitis, chrioretinitis, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic opthalmia, anterior segment inflamation, allergic conjunctivitis, allergic corneal marginal ulcers, keratitis.

Gastrointestinal diseases: To tide the patient over a critical period of disease in: ulcerative colitis (systemic therapy), regional enteritis-(systemic therapy).

Respiratory diseases: Symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, Loeffler’s syndrome not manageable by other means, aspiration pneumonitis.

Hematologic disorders: Acquired (autoimmune) hemolytic anemia, secondary thrombocytopenia in adults, erthoblastopenia, (RBC anemia), congenital (erthyroid) hypoplastic anemia.

Neoplastic diseases: For polliative management of leukemias and lymphomas in adults, acute leukemia of childhood.

Edematous states: To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, at the idiopathic type or that due to lupus erythematosus.

[catlist name=”Cordex” orderby=rand excerpt_strip=no excerpt_size=15 excerpt=yes thumbnail=yes thumbnail_size=50,25 numberposts=10]

FORMULATION:

Each mL contains:
Dexamethasone Sodium Phosphate BP ………………….. 5 mg

DOSAGE AND ADMINISTRATION:

For parental administration in the intensive therapy or emergencies, the sodium phosphate ester may be given intravenously by injection of infusion or intramuscularly by injection; doses are sometimes expressed in terms of the free alcohol, the phosphate, or the sodium phosphate. Initial doses used expressed in terms of dexamethasone phosphate range from about 0.5 to 20 mg daily. Intravenous doses of the equivalent of 2 to 6mg of dexamethasone phosphate per kg body-weight given slowly over a minimum period of several minutes have been suggested for the treatment of severe shock in an attempt to promote rapid vasodilation. These high doses may be repeated within 2 to 6 hours and this treatment should be continued only until the patient’s condition is stable and usually for no longer than 48 to 72 hours. Alternatively, the initial intravenous injection may be followed immediately by the same dose administered by intravenous infusion. Dexamethasone sodium phosphate is also used in the treatment of cerebral oedema caused by malignancy. An initial intravenous dose of the equivalent of 10 mg of the phosphate is usually given followed by 4mg intramuscularly every 6 hours; a response is usually obtained after 12 to 24 hours and dosage may be reduced after 2 to 4 days, and gradually discontinued over 5 to 7 days. A much higher dosage schedule has also been suggested for use in cerebral oedema in patients with inoperable brain tumors; initial doses of 50 mg intravenously have been given on the first day together with 8 mg intravenously every 12 hours reduced gradually over several days to a maintenance dose of 2mg twice or three times daily.

CONTRAINDICATION:

1. Patients with systemic mycosis, infectious disease, unless specific anti-infective therapy is employed.
2. Patients with hypersensitivity of this drug.
3. Patients with infection in articular cavity, synovia or around tendon
4. Patients with an unstability in articular cavity of joint

PRECAUTION:

1. Patients with peptic ulcer, psychosis, tuberculous disease, simple herpetic keratitis, posterior subcapsular cataract, glaucoma, hypersentivity, electrolyte disorders, thrombosis, an injury by visceral operation.
2. Patients with infections, diabetes mellitus, osteoporosis, renal failure, cirrhosis, hypothyroidism, fat metabolism, myasthenia gravis.
3. Patients with ucular infections due to fungi or viruses.
4. Patients with acute cardiac infarction.
5. Patients with hypersensitivity of sodium bisulfite.

Pregnancy and Lactation:

1. Animal studies have shown evidence of teratogenic effects. The drug may be used in pregnant women when in the judgment of the physician, the expected benefits outweigh the potential risk to the fetus.
2. Administration of the drug should not be administered to patients who are pregnant or to mothers who are breast feeding.

Children:

1. As growth delay in relate to dosage may occur irreversibly in children and the youth, if corticosteroid is administered to children, a minimum dosage should be used and cautious monitoring about growth is required.
2. If this drug use for long term, increased intraranial pressure symptom may occur.
3. As tissue atrophy of administered region may occur in children, if this drug is administered by IM, IV, hypodermic injection, it should be used very cautiously.

Precautions during application:

It should be administered slowly and cautiously according to region and method for injection to prevent vascular pain, phlebitis due to IV injection.

ADVERSE EFFECT:

1. Infection: new infections or inducted infection may appear during use.
2. Endocrine: acute chronic adrenal failure, diabetes mellitus, menstrual irregularities, suppression of growth in children.
3. Gastrointestinal: peptic ulcer, pancreatitis, diarrhea, nousea vomiting, gastralgia, peptoralgia, abdominal distention, dipsia, hyperorexia.
4. Neurologic: depression, euphorbia, insomia, headache, vertigo, convulsion.
5. Musculoskeletal: osteoporosis, aseptic necrosis of femoral and humeral heads, myalgia, anthralgia.
6. Metabolic: moon face, buffalo hump, negative nitrogen balance due to protein catabolism.
7. Fluid and electrolyte disturbances: edema, increased blood pressure, hypokalemic alkalosis, sodium retention, fluid retention, etc.
8. Opthalmic: posterior subcabsular cataracts, increased intraocular pressure, glaucoma, exophthalmos, secondary ocular infection due to fungi or viruses.
9. Blood: leucocytosis, thrombosis, etc.
10. Dermatologic: impaired would healing, thin fragile skin, petchiae and echymosis, facial erythema, increased sweating, pimple, pilosus, epilate, etc.
11. When hypersensitivity may occur, the drug should be discontinued.
12. Others: pyrosis fatigue, steroidal nephropathy, cardiac failure, hypertension, etc.
13. Intra articular injection of a corticosteroid may produce instable joint systemic as well as local effects (swelling, pain, tenderness, etc.)
14. Instramuscular, skin or subcutaneous injection may cause an impression due to atrophy of local tissue.

DRUG INTERACTION:

1. Rifampin, rifabutin, ephedrine, carbamazepine, phenylbutazone, phenobarbitone, phenytoin, primidone, and aminoglutethimide enhance the metabolism of corticosteroid and it’s therapeutic effects may be reduced.
2. The desired effects of hypoglycemic agents (including insulin), anti-hypertensives, cardiac glycosides and diuretics are antagonized by corticosteroid therapy and close monitoring of the INR or prothromin times is required to avoid spontaneous bleeding.
3. The renal clearance salicylated is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication. There may be interaction with salicylated in patients with hypoprothrombinaemia.

STORAGE:

Store at temperatures not exceeding 30 degree Celsius, Protect from light. Do not freeze.

CAUTION:

Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

AVAILABILITY:

10 ampoules / box.