deflazacort

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1 hr	unknown

CV: hypertension, peripheral edema, THROMBOEMBOLIC EVENTS

Derm: acne, hirsutism, erythema, rash, skin striae, TOXIC EPIDERMAL NECROLYSIS (TEN)

EENT: cataracts, epistaxis, glaucoma, rhinorrhea

Endo: Cushingoid appearance, ↓bone density, ↓growth (children), adrenal suppression, hyperglycemia

GI: abdominal pain, constipation, nausea, PEPTIC ULCERATION

Metab: ↑appetite, weight gain

MS: avascular necrosis of joints, back pain, myopathy

Neuro: headache, depression, euphoria, insomnia, irritability, mood swings

Resp: cough

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), INFECTION, KAPOSI SARCOMA

Interactions ⬆ ⬇

Drug-drug:

May ↑ requirement for insulins or oral hypoglycemic agents.
May ↓ antibody response to and ↑ the risk of adverse reactions from live-virus vaccines.
Neuromuscular blocking agents may ↑ risk of acute myopathy.
Moderate CYP3A4 inhibitors and strong CYP3A4 inhibitors, including clarithromycin, fluconazole, diltiazem, or verapamil may ↑ levels of active metabolite and risk of toxicity; ↓ deflazacort dose.
Moderate CYP3A4 inducers and strong CYP3A4 inducers, including rifampin, efavirenz, carbamazepine, or phenytoin, may ↓ levels of active metabolite and therapeutic effect; avoid concurrent use.

Drug-Food:

Grapefruit juice may ↑ levels of active metabolite and risk of toxicity; ↓ deflazacort dose.

Route/Dosage ⬆ ⬇

PO (Adults and Children ≥2 yr): 0.9 mg/kg once daily. Concurrent use of moderate or strong CYP3A4 inhibitors: Give ⅓ the recommended dose.

Availability ⬆ ⬇

(Generic available)

Oral suspension: 22.75 mg/mL
Tablets: 6 mg; 18 mg; 30 mg; 36 mg

Assessment ⬆ ⬇

Monitor for signs/symptoms of corticosteroid withdrawal syndrome (anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss) following therapy. May occur months after discontinuation of therapy. May need to reinstate corticosteroids.
Monitor for signs/symptoms of adrenal insufficiency (fatigue, weakness, nausea and vomiting, low BP); should be tapered more slowly.
Monitor for signs/symptoms of Cushing syndrome (hypertension; truncal obesity and thinning of the limbs; purple striae; facial rounding; facial plethora; muscle weakness; easy, frequent bruising with thin, fragile skin; posterior neck fat deposition; osteopenia; acne; amenorrhea; hirsutism; psychiatric abnormalities). May occur with prolonged use of corticosteroids.
Monitor for signs/symptoms of infection (fever, chills, sore throat, painful urination), including ocular infections (eyelid swelling, erythema, chemosis, drainage, crusting, blurry vision), during therapy. May require dose ↓ or discontinuation of deflazacort. If exposed to chickenpox, consider prophylaxis with varicella zoster immune globulin. If exposed to measles, prophylaxis with immunoglobulin may be indicated. If chickenpox develops, consider treatment with antiviral agents. If fungal infections occur, may require dose ↓ or discontinuation of deflazacort. May activate latent amebiasis; rule out amebiasis in patient with unexplained diarrhea or who has spent time in the tropics before starting therapy. If Strongyloides (threadworm) infestation occurs,↓ dose or discontinue deflazacort.
Monitor BP and assess for signs/symptoms of fluid overload (dyspnea, edema) periodically during therapy. Treat symptoms as needed.
Monitor for signs/symptoms of peptic ulceration (abdominal pain; black, tarry stools) periodically during therapy. Symptoms may be masked by deflazacort.
Assess for signs/symptoms of behavioral and mood disturbances (euphoria, insomnia, mood swings) during therapy. May require dose ↓ or discontinuation.
Monitor intraocular pressure periodically during therapy if treatment lasts >6 wk.
Assess for signs/symptoms of TEN (rash, itching, skin blistering) during therapy; usually begins within 8 wk of starting therapy. If rash occurs, discontinue deflazacort.
Monitor for signs/symptoms of Kaposi sarcoma (slightly elevated purple, pink, brown, or red blotches or bumps anywhere on the skin or in the mouth and/or throat; lymphedema; unexplained cough or chest pain; unexplained stomach or intestinal pain) periodically during therapy. May improve clinically with discontinuation of deflazacort.
Pedi: Evaluate growth of children periodically during therapy. Monitor linear growth and weight gain. Adjust doses accordingly.

Lab Test Considerations:

Monitor blood glucose periodically during therapy. May cause hyperglycemia. Treat or adjust treatment as needed.
- May cause changes in thyroid levels. If levothyroxine and corticosteroids are required, initiate corticosteroids 1st to ↓ risk of adrenal crisis.
- If pheochromocytoma is suspected, deflazacort may cause crisis.
- May cause reactivation of hepatitis B virus.
- Monitor potassium during therapy; may cause hypokalemia, which may require supplementation.
- Monitor bone mineral density in patients on long-term therapy.
- Reactivation of tuberculosis (TB) may occur when used to treat patients who have latent TB or tuberculin reactivity. Monitoring recommended.

Implementation ⬆ ⬇

Following immunization guidelines, administer live-attenuated or live vaccines ≥4–6 wk prior to starting therapy. Do not administer live vaccines during therapy.
PO: Administer without regard to food. Tablets may be taken whole or crushed and mixed with applesauce.
Shake suspension well prior to administration. Use disperser provided for accurate dose. Add suspension slowly to 3–4 ounces of juice or milk; mix well. Administer immediately. Do not administer with grapefruit juice. Discard bottle 1 mo after first opened. Pedi: Serious and fatal adverse reactions, including gasping syndrome, may occur in neonates and low-birth-weight infants due to benzyl alcohol preservative contained in oral suspension. When administering, consider combined daily metabolic load of benzyl alcohol from all sources. Avoid use in patients < 2 yr of age.

Patient/Family Teaching ⬆ ⬇

Educate patient on reason for deflazacort and side effects. Instruct patient and parents to take as directed. Do not stop taking without consulting health care professional; must be discontinued gradually. Take missed doses as soon as remembered unless almost time for next dose. Do not double doses. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Stopping the medication suddenly may result in adrenal insufficiency, which can be life-threatening. If these signs/symptoms appear, notify health care professional immediately.
Caution patient to avoid vaccinations without 1st consulting health care professional.
Instruct patient to notify health care professional if signs/symptoms of infection, ↑ BP or fluid retention, behavioral or mood disturbances (manic or depressive symptoms), or rash occur. Instruct patient to notify health care professional immediately if exposed to chickenpox or measles.
Corticosteroids cause immunosuppression and may mask symptoms of infection; may worsen existing TB; fungal, bacterial, viral, or parasitic infections or ocular herpes simplex.
Advise patient to notify health care professional of signs and symptoms of hypercorticism , adrenal suppression , worsening of allergies , or infection .
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to avoid grapefruit juice during therapy.
Inform patient of need for periodic bone mineral density and ophthalmologic exams.
Pedi: Advise parents that use may cause shortened stature.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Adverse developmental outcomes (including cleft lip, with or without cleft palate; intrauterine growth restriction) and ↓ birth weight have occurred with maternal use of corticosteroids (including this drug) during pregnancy. Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. Observe infant for signs/symptoms of hypoadrenalism (poor feeding, irritability, weakness, vomiting).

Evaluation/Desired Outcomes ⬆ ⬇

Improved muscle strength.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0832- Upsher-Smith Laboratories, LLC
- 0832-0814- Deflazacort
  - 0832-0814-11- 1 BOTTLE in 1 CARTON (0832-0814-11) / 100 TABLET in 1 BOTTLE

0832- Upsher-Smith Laboratories, LLC
- 0832-0815- Deflazacort
  - 0832-0815-30- 1 BOTTLE in 1 CARTON (0832-0815-30) / 30 TABLET in 1 BOTTLE

0832- Upsher-Smith Laboratories, LLC
- 0832-0816- Deflazacort
  - 0832-0816-30- 1 BOTTLE in 1 CARTON (0832-0816-30) / 30 TABLET in 1 BOTTLE

0832- Upsher-Smith Laboratories, LLC
- 0832-0817- Deflazacort
  - 0832-0817-30- 1 BOTTLE in 1 CARTON (0832-0817-30) / 30 TABLET in 1 BOTTLE

22552- Symbiotec Pharmalab Private Limited
- 22552-0027-
  - 22552-0027-1- 1 BAG in 1 CONTAINER (22552-0027-1) / 25000 g in 1 BAG

24002- NEWCHEM SPA
- 24002-0036-
  - 24002-0036-0- 1 BAG in 1 BAG (24002-0036-0) / 1 BAG in 1 BAG / 5 kg in 1 BAG

52128- Symbiotica Speciality Ingredients Sdn. Bhd.
- 52128-135-
  - 52128-135-01- 1 kg in 1 CONTAINER (52128-135-01)

52856- PTC Therapeutics, Inc.
- 52856-501- EMFLAZA
  52856-501-01- 100 TABLET in 1 BOTTLE (52856-501-01)

52856- PTC Therapeutics, Inc.
- 52856-502- EMFLAZA
  - 52856-502-03- 30 TABLET in 1 BOTTLE (52856-502-03)

52856- PTC Therapeutics, Inc.
- 52856-503- EMFLAZA
  - 52856-503-03- 30 TABLET in 1 BOTTLE (52856-503-03)

52856- PTC Therapeutics, Inc.
- 52856-504- EMFLAZA
  - 52856-504-03- 30 TABLET in 1 BOTTLE (52856-504-03)

52856- PTC Therapeutics, Inc.
- 52856-505- EMFLAZA
  - 52856-505-22- 13 mL in 1 BOTTLE (52856-505-22)

57582- Tianjin Tianyao Pharmaceuticals Co., Ltd.
- 57582-040-
  - 57582-040-01- 1 kg in 1 BAG (57582-040-01)

59651- Aurobindo Pharma Limited
- 59651-599- Deflazacort
  59651-599-01- 100 TABLET in 1 BOTTLE (59651-599-01)

59651- Aurobindo Pharma Limited
- 59651-600- Deflazacort
  - 59651-600-30- 30 TABLET in 1 BOTTLE (59651-600-30)

59651- Aurobindo Pharma Limited
- 59651-601- Deflazacort
  - 59651-601-30- 30 TABLET in 1 BOTTLE (59651-601-30)

59651- Aurobindo Pharma Limited
- 59651-602- Deflazacort
  - 59651-602-30- 30 TABLET in 1 BOTTLE (59651-602-30)

64918- Sterling S.p.A.
- 64918-1111-
  - 64918-1111-0- 20 kg in 1 DRUM (64918-1111-0)

64918- Sterling S.p.A.
- 64918-1901-
  64918-1901-0- 20 kg in 1 DRUM (64918-1901-0)

70095- Sun Pharmaceutical Industries Limited
- 70095-040- Deflazacort
  70095-040-01- 1 BOTTLE in 1 CARTON (70095-040-01) / 100 TABLET in 1 BOTTLE

70095- Sun Pharmaceutical Industries Limited
- 70095-041- Deflazacort
  - 70095-041-30- 1 BOTTLE in 1 CARTON (70095-041-30) / 30 TABLET in 1 BOTTLE

70095- Sun Pharmaceutical Industries Limited
- 70095-042- Deflazacort
  - 70095-042-30- 1 BOTTLE in 1 CARTON (70095-042-30) / 30 TABLET in 1 BOTTLE

70095- Sun Pharmaceutical Industries Limited
- 70095-043- Deflazacort
  - 70095-043-30- 1 BOTTLE in 1 CARTON (70095-043-30) / 30 TABLET in 1 BOTTLE

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1749- JAYTHARI
  - 70710-1749-1- 1 BOTTLE in 1 CARTON (70710-1749-1) / 100 TABLET in 1 BOTTLE

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1750- JAYTHARI
  - 70710-1750-3- 1 BOTTLE in 1 CARTON (70710-1750-3) / 30 TABLET in 1 BOTTLE

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1751- JAYTHARI
  - 70710-1751-3- 1 BOTTLE in 1 CARTON (70710-1751-3) / 30 TABLET in 1 BOTTLE

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1752- JAYTHARI
  - 70710-1752-3- 1 BOTTLE in 1 CARTON (70710-1752-3) / 30 TABLET in 1 BOTTLE

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-2051- Deflazacort
  - 70710-2051-1- 1 BOTTLE in 1 CARTON (70710-2051-1) / 100 TABLET in 1 BOTTLE

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-2052- Deflazacort
  - 70710-2052-3- 1 BOTTLE in 1 CARTON (70710-2052-3) / 30 TABLET in 1 BOTTLE

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-2053- Deflazacort
  - 70710-2053-3- 1 BOTTLE in 1 CARTON (70710-2053-3) / 30 TABLET in 1 BOTTLE

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-2054- Deflazacort
  - 70710-2054-3- 1 BOTTLE in 1 CARTON (70710-2054-3) / 30 TABLET in 1 BOTTLE

73289- Aucta Pharmaceuticals, Inc.
- 73289-0089- PYQUVI
  - 73289-0089-1- 13 mL in 1 BOTTLE (73289-0089-1)

84241- ALMON HEALTHCARE PRIVATE LIMITED
- 84241-108-
  - 84241-108-01- 50 g in 1 BAG (84241-108-01)

84241- ALMON HEALTHCARE PRIVATE LIMITED
- 84241-108-
  84241-108-02- 100 g in 1 BAG (84241-108-02)

84241- ALMON HEALTHCARE PRIVATE LIMITED
- 84241-108-
  84241-108-03- 500 g in 1 BAG (84241-108-03)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇