What happens if I overdose Deflorax?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Deflorax?
Grapefruit and grapefruit juice may interact with Deflorax and lead to unwanted side effects. Avoid the use of grapefruit products while taking Deflorax.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.
Do not receive a "live" vaccine while using Deflorax, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Deflorax warnings
Adrenal suppression and infection, child, adolescents, elderly, history of TB and steroid myopathy, hypertension, recent MI, CHF, liver failure, renal impairment, DM and glaucoma (including family history), osteoporosis, corneal perforation, severe affective disorders, epilepsy, peptic ulcer, hypothyroidism, pregnancy and lactation.
What should I discuss with my healthcare provider before taking Deflorax?
You should not use Deflorax if you are allergic to it.
To make sure Deflorax is safe for you, tell your doctor if you have:
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any type of bacterial, fungal, or viral infection;
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high blood pressure, heart disease, or a history of stroke or blood clot;
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fluid retention;
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diabetes;
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cataracts, glaucoma, or herpes infection of the eyes;
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a nerve-muscle disorder, such as myasthenia gravis;
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liver disease (especially hepatitis B or C);
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a stomach or intestinal disorder;
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a colostomy or ileostomy;
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low bone mineral density; or
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a problem with your thyroid, pituitary gland, or adrenal gland.
Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Deflorax can pass into breast milk and may cause side effects in the nursing baby. Tell your doctor if you are breast-feeding.
Deflorax can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Deflorax is not approved for use by anyone younger than 5 years old.
Deflorax precautions
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully.
• Anaphylaxis: Rare cases of anaphylaxis have occurred in patients receiving corticosteroids.
• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, cause activation of latent infections, mask acute infection (including fungal infections), prolong or exacerbate existing infections, or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided. Vaccinate patients based on current immunization schedules prior to therapy initiation; any live-attenuated or live vaccines should be administered at least 4 to 6 weeks prior to starting Deflorax. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only in conjunction with antituberculosis treatment). Avoid use in patients with active ocular herpes simplex. Hepatitis B reactivation can occur in patients who are hepatitis B carriers. Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred.
• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).
• Myopathy: Acute myopathy has been reported with high dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatinine kinase; recovery may be delayed.
• Ocular effects: Prolonged use may cause posterior subcapsular cataracts, glaucoma (with possible nerve damage), and increased intraocular pressure. Consider routine eye exams in chronic users.
• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.
• Skin reactions: Toxic epidermal necrolysis has been reported within 8 weeks of starting treatment; discontinue at first sign of rash, unless rash is clearly not drug-related.
• Thromboembolic events: Higher cumulative doses of corticosteroids have been associated with an increased risk of thromboembolism. Use caution in patients with a history of or at increased risk for thromboembolic disorders.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with heart failure and/or hypertension; use has been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.
• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.
• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, fresh intestinal anastomoses, ulcerative colitis, active or latent peptic ulcer, abscess or other pyogenic infections) due to perforation risk. Avoid use if there is a probability of impending perforation, abscess, or other pyogenic infection.
• Hepatic impairment: Use with caution in patients with severe hepatic impairment.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.
• Osteoporosis: Use with caution in patients with or who are at risk for osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss, osteoporotic fractures, and avascular necrosis.
• Pheochromocytoma: Use with caution in patients with pheochromocytoma; cases of pheochromocytoma crisis, which can be fatal, have been reported with corticosteroids.
• Renal impairment: Use with caution in renal impairment; fluid retention may occur.
• Seizure disorders: Use with caution in patients with a history of seizure disorder.
• Systemic sclerosis: Use with caution in patients with systemic sclerosis; an increase in scleroderma renal crisis incidence has been observed with corticosteroid use. Monitor BP and renal function in patients with systemic sclerosis treated with corticosteroids (EULAR [Kowal-Bielecka 2017]).
• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Special populations:
• Pediatric: May affect growth velocity; growth should be routinely monitored in pediatric patients.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.
Other warnings/precautions:
• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Complete necessary immunizations ≥4 to 6 weeks prior to initiating therapy; live vaccines should not be given concurrently with Deflorax.
• Stress: Patients may require higher doses when subject to stress (ie, trauma, surgery, severe infection).
What happens if I miss a dose of Deflorax?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "DEFLAZACORT: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "DEFLAZACORT". http://www.drugbank.ca/drugs/DB11921 (accessed September 17, 2018).
- MeSH. "Anti-Inflammatory Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
