Deflacort 6mg/12mg/18mg/24mg tablets,
List of Related Indications:
- Allergic inflam.diord.,acu/sev
List Of Drugs:
- Deflazacort- Emflaza-@- -Glucocorticosteriid -(2007/2017)
Indication Type Description:
Dosages/ Overdosage Etc
Pregnancy and lactation
ACE inhibitors, anti-hypertensives, and diuretics, antacids, aspirin, barbiturates, ketoconazole, coumarins, rotonavir, and oral contraceptives
Severe Asthma Rheumatoid artheritis Inflammatory skin disorders
Increased susceptibilty to opportunistic infections with suppression of clinical symptoms and signs, gastrointestinal disturbances, osteoporosis, neuropsychaitric events, such as headache, vertigo, psycholgical dependence, hypmania, or depression, skin atrophy, fluid and electrolyte disturbances, glacoma and acne.
Systemic infection, patients receiving live virus immunizatiion and hypersensitivity to deflazacort or any ingriedents in the formulation.
Dosages/ Overdosage Etc:
Severe Asthma Rheumatoid artheritis Inflammatory skin disorders
upto 120mg daily
Maintenance - 3-18mg daily, titrated to lowest effective dose
Children- 0.25 - 1.5mg /kg daily or on alternate days
PATIENT COUNSELING INFORMATION
Advise the patients and/or caregivers to read the FDA-approved patient labeling if EMFLAZA Oral Suspension is prescribed (Instructions for Use). Administration
? Warn patients and/or caregivers to not stop taking EMFLAZA abruptly or without first checking with their healthcare providers as there may be a need for gradual dose reduction to decrease the risk of adrenal insufficiency
? EMFLAZA may be taken with or without food.
? EMFLAZA Tablets may be taken whole or crushed and taken immediately after mixing with applesauce. Oral Suspension
? EMFLAZA Oral Suspension must be shaken well prior to measuring out each dose with the enclosed oral dispenser.
? The EMFLAZA Oral Suspension dose may be placed in 3-4 ounces of juice or milk, mixed thoroughly, and immediately administered. Do not take with grapefruit juice.
? Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle.
Increased Risk of Infection- Tell patients and/or caregivers to inform their healthcare provider if the patient has had recent or ongoing infections or if they have recently received a vaccine.
Medical advice should be sought immediately if the patient develops fever or other signs of infection.
Patients and/or caregivers should be made aware that some infections can potentially be severe and fatal. Warn patients who are on corticosteroids to avoid exposure to chickenpox or measles and to alert their healthcare provider immediately if they are exposed
Alterations in Cardiovascular/Renal Function- Inform patients and/or caregivers that EMFLAZA can cause an increase in blood pressure and water retention. If this occurs, dietary salt restriction and potassium supplementation may be needed
Behavioral and Mood Disturbances- Advise patients and/or caregivers about the potential for severe behavioral and mood changes with EMFLAZA and encourage them to seek medical attention if psychiatric symptoms develop
Decreases in Bone Mineral Density- Advise patients and/or caregivers about the risk of osteoporosis with prolonged use of EMFLAZA, which can predispose the patient to vertebral and long bone fractures
Ophthalmic Effects- Inform patients and/or caregivers that EMFLAZA may cause cataracts or glaucoma and advise monitoring if corticosteroid therapy is continued for more than 6 weeks
Vaccination- Advise patients and/or caregivers that the administration of live or live attenuated vaccines are not recommended. Inform them that killed or inactivated vaccines may be administered, but the responses cannot be predicted
Serious Skin Rashes- Instruct patients and/or caregivers to seek medical attention at the first sign of a rash
Drug Interactions- Certain medications can cause an interaction with EMFLAZA. Advise patients and/or caregivers to inform their healthcare provider of all the medicines the patient is taking, including over-the-counter medicines (such as insulin, aspirin or other NSAIDS), dietary supplements, and herbal products. Inform patients and/or caregivers that alternate therapy, dosage adjustment, and/or special test(s) may be needed during the treatment.
Manufactured for: Marathon Pharmaceuticals, LLC Northbrook, IL, 60062 U.S.A. EMFLAZA Oral Suspension made in Spain PC####X Feb 2017 EMFLAZATM is a trademark of Marathon Pharmaceuticals, LLC.
Deflazacort is a new glucocorticoid with lesser side-effects. It is a synthetic heterocyclic oxazoline derivative of prednisolone both anti-inflammatory and immunosuppressive activities.
Deflacort is well absorbed after oral admin. and immediately gets converted to pharmacogically active alcohol metabolite 21-desacetyl deflazcort ( D- 21 OH ) by plasma esterase It reaches peak plasma concentrations in about 1.5 to 2 hours. The plasma half life is 1.1 to 1.9 hours and the plasma proteins binding is 40%. The drug is extensively metabolised in the liver and eliminatiion takes place primarily through the kidneys. About 70% of the administerd dose is excreted in the urine and remaining 30% is eliminated through the feces.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy Risk Summary- Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
There are no adequate and well-controlled studies with EMFLAZA in pregnant women to inform drug-associated risks. Corticosteroids, including EMFLAZA, readily cross the placenta. Adverse developmental outcomes, including orofacial clefts (cleft lip, with or without cleft palate) and intrauterine growth restriction, and decreased birth weight, have been reported with maternal use of corticosteroids, including EMFLAZA, during pregnancy.
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Animal reproduction studies have not been conducted with deflazacort.
2.Lactation Risk Summary- Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EMFLAZA and any potential adverse effects on the breastfed infant from EMFLAZA. There are no data on the effects on milk production.
3. Pediatric Use- The safety and effectiveness of EMFLAZA for the treatment of DMD have been established in patients 5 years of age and older. Use of EMFLAZA in pediatric patients is supported by a multicenter, randomized, double-blind, placebo- and active-controlled study in 196 males
Safety and effectiveness of EMFLAZA have not been established in pediatric patients less than 5 years of age.
EMFLAZA Oral Suspension contains benzyl alcohol and is not approved for use in pediatric patients less than 5 years of age.
4. Geriatric Use- DMD is largely a disease of children and young adults; therefore, there is no geriatric experience with EMFLAZA.
5. Renal Impairment- No dose adjustment is required in patients with mild, moderate or severe renal impairment [see Clinical Pharmacology (12.3)].
6.Hepatic Impairment- No dose adjustment is required in patients with mild or moderate hepatic impairment.There is no clinical experience in patients with severe hepatic impairment, and a dosing recommendation can not be provided for patients with severe hepatic impairment.
Treatment of acute overdosage is by immediate gastric lavage or emesis followed by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of EMFLAZA may be reduced temporarily, or alternate day treatment may be introduced.