Xalcort 6 mg

Description

Indications Xalcort is prescribed for the treatment of various inflammatory and autoimmune conditions, including:

• Anaphylaxis, asthma, and severe hypersensitivity reactions
• Rheumatoid arthritis, juvenile chronic arthritis, and polymyalgia rheumatica
• Systemic lupus erythematosus, dermatomyositis, and mixed connective tissue disease (excluding systemic sclerosis)
• Polyarteritis nodosa and sarcoidosis
• Pemphigus, bullous pemphigoid, and pyoderma gangrenosum
• Minimal change nephrotic syndrome and acute interstitial nephritis
• Rheumatic carditis
• Ulcerative colitis and Crohn’s disease
• Uveitis and optic neuritis
• Autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura
• Acute and lymphatic leukemia, malignant lymphoma, and multiple myeloma
• Immune suppression following transplantation procedures

Use only as directed by a registered physician.

Pharmacology Deflazacort exerts anti-inflammatory effects by inhibiting the Phospholipase A2 enzyme, thereby reducing prostaglandin synthesis. Additionally, it suppresses immune responses by limiting the release of key immune system chemicals, making it effective as an immunosuppressive agent.

Dosage & Administration

Adults:

• Acute disorders: Initial doses of up to 120 mg per day may be required. Maintenance therapy usually ranges from 3-18 mg per day.
• Rheumatoid arthritis: Maintenance doses typically range between 3-18 mg per day, with the lowest effective dose preferred.
• Bronchial asthma: In acute attacks, high doses (48-72 mg per day) may be needed initially, followed by gradual reduction. For chronic asthma management, the dose should be adjusted to the minimum level needed for symptom control.
• Other conditions: Dosage is individualized and titrated to the lowest effective maintenance dose. The starting dose is generally determined based on an equivalent ratio of 5 mg prednisone or prednisolone to 6 mg Deflazacort.

Children: Due to limited clinical trial data, pediatric dosage follows adult indications but must be kept at the lowest effective level. Alternate-day administration may be considered. Typical dosages include:

• Juvenile chronic arthritis: 0.25-1.0 mg/kg per day
• Nephrotic syndrome: Initial dose of 1.5 mg/kg per day, gradually reduced as needed
• Bronchial asthma: Initial dose ranging from 0.25-1.0 mg/kg on alternate days

Deflazacort Withdrawal: Patients who have been on systemic corticosteroids exceeding physiological doses (approximately 9 mg per day or more) for over three weeks should not stop treatment abruptly. The tapering schedule depends on the likelihood of disease recurrence upon dose reduction.

Use only as directed by a registered physician.

Drug Interactions Deflazacort is metabolized in the liver. Dosage adjustments may be necessary when taken with:

• Liver enzyme inducers (e.g., rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, aminoglutethimide) – may require an increased dose.
• Liver enzyme inhibitors (e.g., ketoconazole) – may require a reduced dose.

Contraindications

• Known hypersensitivity to Deflazacort or any of its components
• Patients receiving live virus vaccines

Side Effects Possible side effects include:

• Gastrointestinal issues (nausea, indigestion, ulceration)
• Musculoskeletal effects (osteoporosis, muscle weakness)
• Endocrine disturbances (adrenal suppression, glucose intolerance)
• Neuropsychiatric symptoms (mood changes, insomnia, anxiety)
• Ophthalmic conditions (cataracts, glaucoma)
• Fluid and electrolyte imbalances
• Increased susceptibility to infections, delayed wound healing
• Skin changes (atrophy, striae, acne, telangiectasia)
• Cardiovascular risks (myocardial rupture, thromboembolism)

Pregnancy & Lactation

• Pregnancy: Deflazacort crosses the placenta. Long-term or repeated use during pregnancy may lead to intrauterine growth retardation. It should only be prescribed if the benefits outweigh the risks.
• Lactation: Corticosteroids are excreted in breast milk, though specific data for Deflazacort are unavailable. Doses up to 50 mg daily are unlikely to cause harm to the infant. Higher doses may result in some adrenal suppression in infants, though breastfeeding is generally still considered beneficial.

Precautions & Warnings Frequent monitoring is recommended for patients with the following conditions:

• Cardiovascular disease (heart failure, hypertension, thromboembolism)
• Gastrointestinal disorders (gastritis, peptic ulcer, ulcerative colitis, diverticulitis)
• Diabetes mellitus (including a family history)
• Osteoporosis, myasthenia gravis, or renal impairment
• Psychiatric conditions (emotional instability, epilepsy, psychosis)
• Liver failure, hypothyroidism, or cirrhosis
• Ocular herpes simplex (risk of corneal perforation)

Use in Special Populations

• Hepatic Impairment: May lead to increased drug levels, requiring careful dose adjustment.
• Renal Impairment: No specific precautions beyond standard glucocorticoid therapy considerations.
• Elderly: Common corticosteroid side effects may have more severe consequences in older adults, necessitating careful monitoring.

Therapeutic Class Glucocorticoids

Storage Conditions Store below 25°C in a cool, dry place, away from light and moisture. Keep out of reach of children