Epidexone 0.05%

Dexamethasone 0.05%

Warnings
Contraindications
Systemic fungal infection
Documented hypersensitivity
Cerebral malaria
Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids

Cautions
Use with caution in cirrhosis, diverticulitis, myasthenia gravis, peptic ulcer disease, ulcerative colitis, renal insufficiency, pregnancy
Average and large doses of corticosteroids can cause elevation of blood pressure, sodium and water retention, and increased excretion of potassium; these effects are less likely to occur with synthetic derivatives except when used in large doses; dietary salt restriction and potassium supplementation may be necessary; all corticosteroids increase calcium excretion
Literature reports suggest apparent association between use of corticosteroids and left ventricular free wall rupture after recent myocardial infarction; therapy with corticosteroids should be used with great caution in these patients
Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with potential for glucocorticosteroid insufficiency after withdrawal of treatment; adrenocortical insufficiency may result from too rapid withdrawal; may be minimized by gradual reduction of dosage; relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, reinstitute hormone therapy; if patient is receiving steroids already, may increase dosage
Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients; changes in thyroid status of patient may necessitate adjustment in dosage
Corticosteroids may exacerbate systemic fungal infections; not for use in presence of such infections unless needed to control life-threatening drug reactions; concomitant use of amphotericin B and hydrocortisone followed by cardiac enlargement and congestive heart failure reported
Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, toxoplasma; rule out latent amebiasis or active amebiasis before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea
Corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation; corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia; not for use in cerebral malaria
Close observation necessary if corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity; reactivation of the disease may occur; during prolonged corticosteroid therapy, these patients should receive chemoprophylaxis
Use of oral corticosteroids not recommended in treatment of optic neuritis and may lead to increase in risk of new episodes; corticosteroids should not be used in active ocular herpes simplex
Use lowest possible dose to control condition under treatment; risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used
May lead to inhibition of bone growth in pediatric patients and development of osteoporosis at any age; special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy
Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations; existing emotional instability or psychotic tendencies may also be aggravated by corticosteroids
Minimal mineralocorticoid activity
Thromboembolic disorders
Myopathy has been reported
Delayed wound healing
Withdraw therapy with gradual tapering dose
May have systemic and local effects; examine joint fluid, as necessary to exclude a septic process; avoid injection into infected site; frequent intra-articular injections may result in damage to joint tissue
If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated; if exposed to measles, prophylaxis with immune globulin (IG) may be indicated; if chickenpox develops, treatment with antiviral agents should be considered
Latent tuberculosis may be reactivated (patients with positive tuberculin test should be monitored)
Some suggestion (not fully substantiated) of slightly increased cleft palate risk if corticosteroids are used in pregnancy
Prolonged corticosteroid use may result in elevated intraocular pressure, glaucoma, or cataracts; if steroid therapy is continued for more than 6 weeks, monitor intraocular pressure
Prolonged therapy has been associated with development of Karposi sarcoma
May affect velocity growth in children; monitor routinely
Killed or inactivated vaccines may be administered; however, the response to such vaccines cannot be predicted
Patient may requre higher doses when subject to stress
Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy in physiologic doses (eg, for Addison’s disease)
Epidural injection

  • Serious neurologic events, some resulting in death, have been reported with epidural injection
  • Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke
  • These serious neurologic events have been reported with and without use of fluoroscopy
  • Safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Epidexone 0.05% only for the indication prescribed.