Penodex

Penodex

dexamethasone

Manufacturer:

Rotexmedica GmbH

Distributor:

Duopharma Trade (Phils)
Concise Prescribing Info
Contents
Dexamethasone Na phosphate
Indications/Uses
Endocrine & non-endocrine disorders responsive to corticosteroids. Systemic administration: Primary or secondary adrenocortical insufficiency. Non-endocrine disorders eg, angioneurotic edema & anaphylaxis; Crohn's disease & ulcerative colitis; miliary TB & endotoxic shock; raised intracranial pressure secondary to cerebral tumors & infantile spasms; bronchial asthma & aspiration pneumonitis; toxic epidermal necrolysis. Adjunctive treatment where high pharmacological doses are needed. Early treatment of shock. Local administration: Intra-articular or soft-tissue inj as adjunctive therapy for short-term administration in soft-tissue disorders eg, carpal tunnel syndrome & tenosynovitis; intra-articular disorders eg, RA & OA w/ an inflammatory component; localized lichen simplex & keloids by intralesion inj.
Dosage/Direction for Use
Initially 0.5-20 mg a day. Shock (hemorrhagic, traumatic or surgical) 2-6 mg/kg as single IV inj, may be repeated 2-6 hr if shock persists. Cerebral edema Initially 10 mg IV followed by 4 mg IM every 6 hr until symptoms subside. Dosage may be reduced after 2-4 days & gradually discontinued over 5-7 days. Suggested high dose schedule in cerebral edema Adult Initially 50 mg IV; 1st-3rd day: 8 mg IV every 2 hr; 4th day: 4 mg IV every 2 hr; 5th-8th day: 4 mg IV every 4 hr, thereafter, decrease by 4 mg daily. Childn ≥35 kg Initially 25 mg IV; 1st-3rd day: 4 mg IV every 2 hr; 4th day: 4 mg IV every 4 hr; 5th-8th day: 4 mg IV every 6 hr, thereafter, decrease by 2 mg daily. <35 kg Initially 20 mg IV; 1st-3rd day: 4 mg IV every 3 hr; 4th day: 4 mg IV every 6 hr; 5th-8th day: 2 mg IV every 6 hr, thereafter, decreased by 1 mg daily. Palliative management of recurrent or inoperable brain tumors 2 mg bid-tid. Intra-synovial, intralesional, & soft tissue inj Large joints (eg, knee): 2-4 mg; small joints (eg, interphalangeal, temporomandibular): 0.8-1 mg; bursae: 2-3 mg; tendon sheaths: 0.4-1 mg; soft tissue infiltration: 2-6 mg; ganglia: 1-2 mg. Frequency of inj: Once every 3-5 day to once every 2-3 wk, depending on response.
Contraindications
Hypersensitivity. Systemic fungal infections. Systemic infection. Live virus vaccine administration.
Special Precautions
May exacerbate systemic fungal infections. Cardiac enlargement & congestive failure. Elevation of BP, retention of salt & water & increased K excretion in large doses. Increased Ca excretion. Left ventricular free wall rupture after recent MI. Restricted in cases of fulminating or disseminated TB. Prolonged coma & an increased incidence of pneumonia & GI bleeding. Chickenpox or herpes zoster. Measles. May produce subcapsular cataracts, glaucoma w/ possible damage to the optic nerves & may enhance secondary ocular infections due to fungi or viruses. May increase or decrease motility & number of spermatozoa. Renal insufficiency; HTN; diabetes or history of diabetes, CHF, osteoporosis, previous steroid myopathy, glaucoma, myasthenia gravis, non-specific ulcerative colitis, intestinal anastomoses, active or latent peptic ulcer, existing or previous history of severe affective disorders, liver failure & epilepsy. Signs of peritoneal irritation following GI perforation. Fat embolism. Enhanced effect in patients w/ hypothyroidism & cirrhosis. Possible corneal perforation in patients w/ ocular herpes simplex. Avoid inj into infected site. Septic arthritis. Should not be injected into unstable joints. Charcot-like arthropathies. Growth retardation in infants, childn & adolescents. Pregnancy & lactation.
Adverse Reactions
Na & fluid retention, CHF, K loss, hypokalemic alkalosis, HTN, increased Ca excretion; muscle weakness, steroid myopathy, loss of muscles mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral & humeral heads, pathological fracture of long bones, tendon rupture & post inj flare (intra-articular); peptic ulcer w/ possible perforation & hemorrhage, small & large bowel perforation, pancreatitis, abdominal distension, ulcerative esophagitis, dyspepsia, esophageal candidiasis; impaired wound healing, thin fragile skin, petechiae & ecchymoses, erythema, striae, telangiectasia, acne, increased sweating, possible suppression of skin tests, burning or tingling in the perineal area (IV), allergic dermatitis, urticaria, angioneurotic edema & hypo- or hyper-pigmentation; convulsions, increased intracranial pressure w/ papilloedema, vertigo, headache, psychic disturbances (eg, euphoria, psychological dependence, depression, insomnia); menstrual irregularities, amenorrhea, development of Cushingoid state, suppression of growth in childn & adolescents, secondary adrenocortical & pituitary unresponsiveness (in times of stress), decreased carbohydrate tolerance, latent DM, increased insulin requirement or oral hypoglycemic agents in diabetes, hirsutism; opportunistic infections, recurrence of dormant TB; posterior subcapsular cataracts, IOP, papilloedema, corneal or scleral thinning, exacerbation of ophth viral disease, glaucoma, exophthalmos. -ve nitrogen balance due to protein catabolism, -ve Ca balance; hypertrophic cardiomyopathy in low birth-wt infants; hypersensitivity (anaphylaxis), leucocytosis, thromboembolism, wt gain, increased appetite, nausea, malaise, hiccups & sterile abscess; acute adrenal insufficiency, hypotension & death.
Drug Interactions
Increased renal clearance of salicylates. Enhanced metabolic clearance & decreased blood levels w/ phenytoin, barbiturates, ephedrine, rifabutin, carbamazepine, rifampicin & aminoglutethimide. False -ve dexamethasone suppression test in patients treated w/ indomethacin. Antagonized effects of hypoglycemic agents eg, insulin. Development of hypokalemia w/ K-depleting diuretics. False -ve nitro blue tetrazolium test for bacterial infection.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB02 - dexamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Form
Penodex soln for inj 4 mg/mL
Packing/Price
2 mL x 10 × 1's
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