Al-Tinez Dexamethasone Injection
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Tel: 01-4826452; 0802-307-7320, 0803-305-7978
Medipharco 8 Nguyen Truong To St., Hue City, Vietnam.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Injection (NRN: ): Each ampoule of 1 mL contains 4 mg of dexamethasone-21-phosphate in the form of disodium salt.
Pack size: Boxes of 100 ampoules in 1 mL or 25 ampoules.
Dexamethasone is the generic name for 9-alpha-fluoro-16-alpha-methyl-prednisolone.
It exerts a potent antiallergic and anti-inflammatory action.
Severe allergic reactions (anaphylactic shock, post-transfusion reactions, acute bronchial asthma, medicamentous allergies, asthmatic conditions.
Stevens-Johnson syndrome, edema of larynx, acute dermatoses), adrenocortical insufficiency, acute exacerbations in patients treated with oral glucocorticoids, viral hepatitis, thyroid crisis and acute thyroiditis, croup, differential diagnosis of adrenocortical hyperplasia and tumors, rheumatic diseases of joints and diseases of soft tissues.
Absolute active or cured tuberculosis, ophthalmic herpes simplex.
Relative: peptic ulcer, osteoporosis, diabetes hypertension, fresh intestinal anastomases, diverticulitis, thrombophlebitis, inclination to psychoses, pregnancy (especially during the first trimester), renal insufficiency.
Cushing's syndrome, healing wounds, myasthenia gravis, acute and chronic infections (varicella, vaccination).
Perforation of lympanum is a contraindication to the use of solution in ear diseases.
Corticosteroids may conceal symptoms of infections. Due to the risk of adrenocortical insufficiency, the treatment with steroids should not be interrupted suddenly.
Corticosteroids may induce hyperacidity and penticulcus, therefore, in prolonged treatment a corresponding diet and application of antacids are required. In gastric disorders and in prolonged treatment an x-ray control is required.
Latent diabetes mellitus occurs faster. Do not inject into the deltoid muscle because of the danger of tissue atrophy. It should not be injected locally into the infected region or intravertebral space.
During pregnancy, the glucocorticoids may be appned exceptionally only i.e. in extremely severe cases.
Newborns should be controlled carefully.
Relative adrenocortical insufficiency, increased catabolism of proteins with negative nitrogen balance, disorders of electrolytic balance, disorders in metabolism of glucose with aggravaton of diabetes, osteoporosis, spontaneous fractures of bones, aseptic necrosis of the hip, myopathies, activation and aggravation of peptic ulcer, aggravation of infection, hypertension, moon-shaped face, hirsutism, ache,
abdominal striae, convulsions petechia and purpura amenorrhea, insomnia, mental disorders, increased intraocular pressure, pancreatitis angilitis, disorders in children's growth, thrombophlebitis, vertigo, nausea, facial erythema, ulcerous, esophagitis, headache, exophtalamus, leucocytosis, lymphopenia, corneal ulcus, oligospermia and systemic fat emboliy, abnormal ecuphoria, increase in appetite and body weight, tissue atrophy, hypopigmentation of skin, post-injection swelling, reactions similar to shock.
Dosage & Administration
The dosage should be adjusted to individual case. If the drug has been given longer than for a couple of days, the dose should be diminished slowly and the drug should not be discontinued immediately. It may be injected intravenously, intramuscularly, intrasynovially, or by local tissue infiltation.
Initial dose: 1 to 5 of even 20 ampoules daily (i.v. or i.m.), followed by a maintenance dose of ½ to 1 ampoule several times daily.
Intrasynovial: ½ to 1 ampoule every 24 hours
Chronic diseases: Initial treatment at a dose of 0.5 to 1mg daily with a slow increase until clinical effect is observed. Later on the drug is given twice daily.