pms-Dexamethasone

pms-Dexamethasone

dexamethasone

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Concise Prescribing Info
Contents
Dexamethasone
Indications/Uses
Cerebral oedema (only w/ symptoms of intracranial pressure evidenced by computerised tomography) caused by a brain tumour, neuro-surgical intervention, cerebral abscess. Acute asthma exacerbations when use of an oral corticosteroid is appropriate; croup. Initial treatment of extensive, severe, acute, skin diseases responding to glucocorticoids eg, erythroderma, pemphigus vulgaris. Initial treatment of autoimmune disorders eg, SLE. Active phases of systemic vasculitides like panarteritis nodosa (treatment duration should be limited to 2 wk in cases of concomitant positive hepatitis B serology). Severe progressive course of active RA eg, fast proceeding destructive forms &/or extraarticular manifestations. Severe systemic course of juvenile idiopathic arthritis (Still's disease). Idiopathic thrombocytopenic purpura in adults. Tuberculous meningitis only in conjunction w/ anti-infective therapy. Palliative treatment of neoplastic diseases. Prophylaxis & treatment of emesis induced by cytostatics, emetogenic chemotherapy w/in antiemetic treatment. Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease & non-Hodgkin's lymphoma in combination w/ other medicinal products. Prevention & treatment of post-op vomiting, w/in antiemetic treatment.
Dosage/Direction for Use
Usual doses: 0.5-10 mg daily. More severe disease conditions: >10 mg/day may be required. Childn Usual dose: 0.01-0.1 mg/kg daily. Cerebral oedema 6-16 mg/day (up to 24 mg), divided into 3-4 individual doses. Acute asthma Adult 16 mg/day for 2 days. Childn 0.6 mg/kg for 1-2 days. Croup Childn 0.15-0.6 mg/kg in a single dose. Acute skin diseases 8-40 mg daily doses depending on the nature & extent of the disease, in some cases up to 100 mg. Followed by down titration according to clinical need. SLE 6-16 mg/day. Active RA w/ severe progressive course form 12-16 mg/day if running at fast destructive forms; 6-12 mg/day if w/ extra-articular manifestations. Idiopathic thrombocytopenic purpura 40 mg for 4 days in cycles. Tuberculous meningitis Patient w/ grade II or III disease IV treatment for 4 wk then oral treatment for 4 wk. Oral: Initially 4 mg/day, decreasing by 1 mg each wk. Patient w/ grade I disease IV treatment for 2 wk then oral treatment for 4 wk. Oral: 0.1 mg/kg/day for 1st wk of oral therapy, then a total of 3 mg/day, decreasing by 1 mg each wk. Palliative treatment of neoplastic diseases 3-20 mg/day. Doses up to 96 mg may also be used for palliative treatment. Prophylaxis & treatment of emesis induced by cytostatics, emetogenic chemotherapy w/in antiemetic treatment 8-20 mg prior to chemotherapy treatment, then 4-16 mg/day on day 2 & 3. Prevention & treatment of post-op vomiting, w/in antiemetic treatment 8 mg single dose before surgery. Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease & non-Hodgkin's lymphoma in combination w/ other medicinal products 20 or 40 mg once daily.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Systemic infection unless specific anti-infective therapy is employed. Stomach ulcer or duodenal ulcer. Avoid live vaccines in patients receiving immunosuppressive doses.
Special Precautions
Serious anaphylactic reactions. Risk of tumour lysis syndrome. Adrenocortical insufficiency after discontinuation of treatment. Increased risk of tendinitis & tendon rupture in patients concomitantly treated w/ fluoroquinolones. Pre-existing myasthenia gravis may initially deteriorate in the beginning of dexamethasone treatment. Can induce chorioretinopathy which may result in impaired vision including loss of vision. May cause posterior subcapsular cataracts, glaucoma w/ possible damage to the optic nerve & can increase risk of secondary ocular infections due to fungi or viruses. Risk of intestinal perforation. Signs of peritoneal irritation after GI perforation may be absent in patients receiving high doses of glucocorticoids. A higher need for insulin or oral antidiabetics must be taken into consideration when administering dexamethasone to diabetics. Regularly monitor BP during treatment, particularly during administration of higher doses & in patients w/ difficult to regulate high BP. Bradycardia may occur in patients treated w/ high doses of dexamethasone. Can conceal symptoms of an existing or developing infection. Prolonged use may increase risk of opportunistic infections. Negative influence on Ca metabolism. Psychological changes eg, euphoria, depression, psychotic reactions, suicidal tendencies. Glucocorticoid doses should be gradually reduced. Use cautiously in patients w/ ocular herpes simplex; patients who have recently suffered MI; patients w/ migraine. Should not be used in conjunction w/ a head injury. Pheochromocytoma crisis. Vaccination w/ inactivated vaccine. Can suppress skin reaction to allergy testing. False negative results w/ nitroblue tetrazolium test for bacterial infections. False positive results w/ doping tests. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive & use machines. Patients undergoing hemodialysis. Patients w/ severe liver impairment. Decreases testosterone biosynthesis & endogenous ACTH secretion which influences spermatogenesis & ovarian cycle. Pregnancy & lactation. May increase the risk of intra-uterine growth retardation. Dose-dependent inhibition of growth in infancy, childhood & adolescence. Elderly.
Adverse Reactions
Short-term treatment: Wt gain, psychological disorders, glucose intolerance, transitory adrenocortical insufficiency. Long-term treatment: Central obesity, skin fragility, muscle atrophy, osteoporosis, growth retardation, long-term suprarenal insufficiency.
Drug Interactions
Increased incidence &/or severity of gastric ulcers w/ NSAIDs. Increased renal clearance of salicylates. Reduced effect of antidiabetic agents eg, insulin, sulfonylurea, metformin. Increased hypokalemic effect of acetazolamide, loop diuretics, thiazide diuretics, kaliuretics, amphotericin B inj, tetracosactide, laxatives. Risk of hypokalemia w/ carbenoxolone. Increased risk of myopathies & cardiomyopathies w/ chloroquine, hydroxychloroquine, mefloquine. Increased risk of blood disorders w/ ACE inhibitors. Altered BP-lowering effects of antihypertensive drugs. Cases of toxic epidermal necrolysis w/ thalidomide. Reduced effect of vaccinations. Possibility of viral infection w/ live vaccines. Risk of serious muscle weakness in patients w/ myasthenia gravis w/ cholinesterase inhibitors. Increased risk of tendinitis & tendon rupture w/ fluoroquinolones. Increased plasma conc & systemic side effects w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, erythromycin, cobicistat-containing products). Decreased plasma conc w/ CYP3A4 inducers (eg, ephedrine, barbiturates, rifabutin, rifampicin, phenytoin, carbamazepine). Accelerated reduction thereby reduced efficacy w/ aminoglutethimide. Decreased absorption w/ bile acid resins eg, cholestyramine. Decreased resorption w/ topically applied GI drugs, antacids, activated charcoal. Suppression of adrenal corticosteroid synthesis w/ ketoconazole. Potential inhibited metabolism & enhanced effect w/ estrogens, including OCs. Increased or decreased plasma conc of CYP3A4 substrates. Reduced plasma conc of isoniazid. Concomitant administration of cyclosporine & corticosteroids may lead to an increased effect of both substances. Reduced plasma conc of praziquantel. Altered effect of oral anticoagulants (coumarin). Increased IOP w/ atropine & other anticholinergics. Longer muscle-relaxing effect of non-depolarizing muscle relaxants. Reduced effect of somatotropin. Reduced increased in TSH w/ protirelin.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB02 - dexamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Form
pms-Dexamethasone tab 4 mg
Packing/Price
100's
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