Flazacor
(6 mg & 30 mg Tablets)
  • Flazacor 6mg tablets
  • Deflazacort belongs to a group of medicines called corticosteroids. It is sometimes referred to simply as an oral steroid.
  • Composition:
    Each tablet contains:
    Active ingredients:
    Deflazacort (micronized)........6 mg or 30 mg

  • Inactive ingredients:
    Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K25, sodium lauryl sulfate & magnesium stearate.

Indications:
Flazacor is indicated for the treatment of :
Endocrine disorders: primary or secondary adrenal insufficiency (flazacor therapy may be associated with hydrocortisone or cortisone, to finish mineralocorticoid meet the needs of the patient), congenital adrenal hyperplasia and non-supportive thyroiditis.

Rheumatic diseases: psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis and epicondylitis.

Collagen diseases: Systemic lupus erythematosus, acute rheumatic carditis, polymyalgia rheumatica, polyarteritis nodosa, systemic dermatomyositis (polymyositis), temporal arteritis and Wagener's granulomatosis.

Dermatologic diseases: pemphigus, bullous dermatitis herpetiformis, erythema multiforme major (Stevens-Johnson disease), exfoliative dermatitis, mycosis fungoides, severe psoriasis and severe seborrheic dermatitis.

Allergic diseases: Control of severe or incapacitating allergic reactions unresponsive to non-steroidal drugs, seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.

Respiratory diseases: systemic sarcoidosis, Loeffler's syndrome, allergic pneumonitis, idiopathic pulmonary fibrosis and aspiration pneumonia.

Ophthalmic diseases: Inflammation of the cornea, diffuse posterior uveitis and choroiditis, keratitis, chorioretinitis, iritis and iridocyclitis, optic neuritis, sympathetic ophthalmia, ophthalmic zoster and allergic conjunctivitis.

Hematologic disorders: idiopathic thrombocytopenic purpura, secondary thrombocytopenia, acquired hemolytic anemia (autoimmune) PRCA and congenital hypoplastic anemia (erythroid). - Neoplastic diseases: leukemia, lymphoma and multiple myeloma. - Renal diseases: nephrotic syndrome.

Gastrointestinal diseases: ulcerative colitis, regional enteritis and chronic hepatitis.

Neurological disorders: multiple sclerosis exacerbation.

Because of its property to cause less bone loss than other corticosteroids, deflazacort may be the drug of choice for people with increased risk of osteoporosis.
Similarly, its reduced
diabetogenic effect makes the flazacor is the systemic oral glucocorticoid of choice for patients with diabetes or prediabetes.

Clinical pharmacology:
  • Deflazacort, the active ingredient of flazacor, is an oral corticosteroid (glucocorticoid) with anti-inflammatory and immunosuppressive effects of which are used to treat a variety of diseases, and are comparable to those of other anti-inflammatory steroids.
  • Compared with equivalent anti-inflammatory dose prednisone, deflazacort causes less inhibition of intestinal calcium absorption and a smaller increase urinary excretion of calcium with the consequent reduction in normal trabecular bone volume and bone mineral content.
  • Moreover its diabetogenic effect is reduced in normal subjects and in persons with a family history of diabetes and diabetic patients.
  • Deflazacort is well-absorbed when given orally, and is immediately converted into the pharmacologically active metabolite (D21-0H) by plasma esterases. This metabolite reaches peak plasma concentrations in 1.5 to 2 hours, is bound to plasma proteins about 40% and has no affinity for binding globulin, which binds corticosteroids (transcortin).
  • Its plasma elimination half-life is 1.1 to 1.9 hours. Its elimination is mainly via the kidney in the first 8 hours, 70% of the administered drug is excreted in urine and 30% in the feces.
  • Deflazacort metabolism is extensive, the active metabolite (D21-0H) represents only 18% of urinary excretion, while deflazacort metabolites of 6-beta-OH represents one third of urinary elimination.
Contraindications:
  • Hypersensitivity to deflazacort or to any component of the formula.
  • Patients receiving live virus immunizations.

Use during pregnancy and lactation:
There have been no human reproductive studies with glucocorticoids, but it is known that glucocorticoids are teratogenic in animals, so their use during pregnancy should be considered only when the expected benefits outweigh the potential risks.

Infants whose mothers received corticosteroids during pregnancy should be carefully monitored in order to detect possible signs of hypoadrenalism.
Glucocorticoids are excreted in breast milk and may cause growth retardation and hypoadrenalism in infants, so mothers taking corticosteroids should be advised not to breastfeed.

Dosage and route of administration:
Flazacor is a glucocorticoid derivative of prednisolone and 6 mg of deflazacort have approximately the same anti-inflammatory potency as 5 mg of prednisone or prednisolone, The dose varies widely, depending on the disease and the patients.
In severe cases or that represent danger to life, high doses of deflazacort may be needed to be given.
When deflazacort is used in prolonged treatment, the maintenance dose should be as low as possible and titrated individually to achieve the minimum effective dose.
The adjustment should be made according to diagnosis, disease severity and response and patient tolerance.
 The dose may need to be increased during periods of stress or disease exacerbation.
To avoid adrenal insufficiency syndrome after prolonged therapy, dosage should be gradually reduced.

Adults:
In acute and acute exacerbations of chronic conditions:
A starting dose up to  120 mg / day may be needed to be given initially, the usual maintenance dose for most conditions are within the range 3 -18 mg/day.

Children:
Doses of Flazacor usually lies in the range 0.25 - 1.5 mg/kg/day.

Over dosage:
Manifestations and management of overdose or accidental ingestion: Flazacor overdose have been reported rarely. These reports were associated with exaggerated pharmacological effects of the drug and did not result in death. In acute overdose, symptomatic treatment is recommended. In laboratory animals, LD 50 oral dose is greater than 4000 mg/kg.

Storage:
  • Keep at temperature not exceeding 30°C.
  • Keep in dry place.
  • Keep out of reach and sight of children.

Presentation:
Flazacor 30 mg (one, two Al/PVC strips each of 10 tablets in a carton box with pamphlet).
Flazacor 6 mg (one Al/PVC strip of 10 tablets in a carton box with pamphlet).