Registered Kenya · PPB

FLAZART SYRUP

DEFLAZACORT

H2022/CTD6336/7503ER 6MG/5ML NEW/INNOVATOR systemic hormonal preparations, excl. sex hormones and insulins INN generic

What it does

Deflazacort is a corticosteroid used to reduce inflammation and suppress the immune system.

Commonly used for: inflammatory conditions, allergic reactions, muscle disorders

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2022/CTD6336/7503ER
Registration date
2022-09-01 14:41:09
Expiry date
-
Status
Registered
Active ingredient
DEFLAZACORT
Dosage form
6MG/5ML
Strength
-
Pack size
N/A
Therapeutic class
NEW/INNOVATOR
ATC class (WHO)
H02AB - Glucocorticoids
RxNorm RxCUI
22396
Manufacturer / MAH
Win-pharma
Applicant / LTR
WIN-PHARMA LTD
Country of origin
FOREIGN
Manufacturer location
PR5C+PJQ, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-02-08 02:09:36 · updated 2026-08-03 02:12:01

Drug Interactions

42
Check interactions

Pharmacodynamic Warnings

Deflazacort appears in TABLE 17: Drugs that reduce serum potassium

Severe (1)

Mifamurtide - decreases efficacy

Corticosteroidsarepredictedtodecreasetheefficacyof mifamurtide.Avoid.rTheoretical

Severe Theoretical

Moderate (20)

Corticosteroids - increases exposure

Dronedarone is predicted to increase the exposure to corticosteroids (methylprednisolone). Monitor and adjust dose.

Moderate Study

Corticosteroids - increases concentration

Miconazole is predicted to increase the concentration of corticosteroids (methylprednisolone). Monitor and adjust dose.

Moderate Theoretical

Corticosteroids - increases exposure

Antifungals, azoles (fluconazole, isavuconazole, posaconazole) are predicted to increase the exposure to corticosteroids (methylprednisolone). Monitor and adjust dose.

Moderate Study

Corticosteroids - decreases exposure

Cenobamate is predicted to decrease the exposure to corticosteroids (fluticasone). Adjust dose.

Moderate Theoretical

Corticosteroids - decreases efficacy

Mifepristone is predicted to decrease the efficacy of corticosteroids. Use with caution and adjust dose.

Moderate Theoretical

Unknown (21)

Aspirin - decreases concentration

Corticosteroids are predicted to decrease the concentration of aspirin (high-dose) and aspirin (high-dose) increases the risk of gastrointestinal bleeding when given with corticosteroids.

Unknown Study

Choline Salicylate - decreases concentration

Corticosteroids are predicted to decrease the concentration of cholinesalicylate. Ciclesonide → see corticosteroids Ciclosporin → see TABLE 2 p. 1517 (nephrotoxicity), TABLE 16 p. 1521 (increased seru

Unknown Study

Corticosteroids - increases exposure

Cobicistat is predicted to increase the exposure to corticosteroids (beclometasone) (risk with beclometasone is likely to be lower than with other corticosteroids).

Unknown Theoretical

Corticosteroids - increases risk of gastrointestinal perforation

Erlotinib is predicted to increase the risk of gastrointestinal perforation when given with corticosteroids.

Unknown Theoretical

Corticosteroids - increases exposure

Idelalisib is predicted to increase the exposure to corticosteroids (betamethasone, budesonide, ciclesonide, deflazacort, dexamethasone, fludrocortisone, fluticasone, hydrocortisone, methylprednisolon

Unknown Study

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: class

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Deflazacort is a corticosteroid used to reduce inflammation and suppress the immune system.

What it treats

  • inflammatory conditions
  • allergic reactions
  • muscle disorders

How it works

It works by decreasing inflammation and the immune response in the body.

Who it's for

This medicine is for individuals with certain inflammatory or autoimmune conditions.

Drug class

Corticosteroids

Cautions

  • • Be cautious if you're taking medications that lower potassium levels.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Deflazacort

BNF-referenced

Deflazacort is a synthetic corticosteroid prodrug derived from prednisolone, primarily exerting glucocorticoid activity. It is used to suppress inflammatory and allergic disorders and is especially noted for its application in managing conditions such as Duchenne muscular dystrophy (DMD) and various palliative care scenarios. Deflazacort is recognized for its favorable side effect profile compared to other corticosteroids, making it a preferred choice in long-term treatment regimens.

Indications

  • Suppression of inflammatory disorders
  • Management of allergic disorders
  • Adjunctive treatment in suspected bacterial meningitis
  • Palliative care for dyspnea due to bronchospasm
  • Headaches due to raised intracranial pressure
  • Pain due to nerve compression
  • Duchenne muscular dystrophy

Dosage

Children: For children aged

Adults: The typical adult dosage for deflazacort is 4 to 8 mg daily, with an initial maximum dosage of 120 mg daily in acute situations. Dosage may be adjusted based on clinical response.

Mechanism of action

Deflazacort is converted into its active metabolite, 21-deflazacort, which binds to the glucocorticoid receptor, resulting in anti-inflammatory and immunosuppressive effects. The exact mechanism of action in conditions such as DMD is not fully understood but is believed to involve modulation of inflammatory pathways, thereby alleviating symptoms and delaying disease progression.

Pharmacodynamics

Deflazacort demonstrates significant anti-inflammatory activity, particularly beneficial in conditions like DMD. Clinical studies indicate that long-term treatment with deflazacort results in improved muscle strength, ambulation, and quality of life. Patients treated with deflazacort show better preservation of muscle mass and a delayed onset of complications compared to untreated controls.

Pharmacokinetics

Deflazacort is well absorbed following oral administration, with a bioavailability that depends on food intake. It is metabolized primarily in the liver, with its metabolites being excreted via the urine. The drug's half-life is variable, typically ranging from 2 to 6 hours, and it is recommended to take it early in the day to minimize potential insomnia. Dose adjustments may be necessary in hepatic impairment.

Adverse effects

  • Oedema
  • Hypotension

Interactions

  • mitotane (moderate, decreases exposure)
  • rifampicin (moderate, decreases exposure)
  • oral antacids (unknown, decreases absorption)
  • cobicistat (unknown, increases exposure)
  • idelalisib (unknown, increases exposure)
  • clarithromycin (unknown, increases exposure)

Pregnancy

Deflazacort should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is advised.

Breast-feeding

Deflazacort is excreted in breast milk; caution is advised when administering to nursing mothers.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Calcort 6 mg tablets
BNF 85 (British National Formulary) p.772 BNF for Children 2019-2020 p.476 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Deflazacort

PubChem CID 189821

Molecular formula: C25H31NO6

Mechanism of action

Deflazacort is a corticosteroid prodrug with an active metabolite, 21-deflazacort, which binds to the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects on the body. The exact mechanism by which deflazacort exerts its therapeutic effects in patients with DMD is unknown but likely occurs via its anti-inflammatory activities.

Pharmacodynamics

Deflazacort exerts anti-inflammatory activity in DMD, likely improving various symptoms, including muscle weakness and cardiorespiratory symptoms in addition to delaying their onset. This allows for an increased quality of life and prevents the necessity for surgical procedures, such as those for scoliosis, which is associated with DMD. Studies showed significant preservation of muscle mass in patients generally treated with 0.9 mg/kg/day of deflazacort compared to a control group. The following findings are based on clinical studies using deflazacort on a long term basis: **Effects on muscle strength** At age 16, individuals treated with long-term deflazacort had 63 ± 4% score in muscle strength compared to a mean muscle strength score of 31 ± 3% for control patients. Significant improvements in climbing stairs and rising from a supine position were also seen in patients taking deflazacort. **Effects on ambulation** Ambulation was significantly higher by 12 years of age and 18 years of age in patients taking deflazacort when compared with the control group. The control group showed a mean loss of ambulation of 2 years sooner than with deflazacort treatment. **Effects on cardiac function** Mean left ventricular ejection fraction (a measure of cardiac function) was higher in patients treated with deflazacort over the long term. Preservation of cardiac function was demonstrated by a mean difference in ejection fraction of about 7%, favoring study groups taking deflazacort over control groups. **Effects on spinal alignment** Children treated with deflazacort also significantly lowered the rate and severity of scoliosis and eliminated the need for scoliosis surgery after long-term treatment.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.