Xalcort 24 mg

Description

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

• Severe allergic reactions such as anaphylaxis, asthma, and acute hypersensitivity reactions.
• Inflammatory and autoimmune disorders including rheumatoid arthritis, juvenile chronic arthritis, polymyalgia rheumatica, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (excluding systemic sclerosis), polyarteritis nodosa, and sarcoidosis.
• Dermatological conditions such as pemphigus, bullous pemphigoid, and pyoderma gangrenosum.
• Renal diseases including minimal change nephrotic syndrome and acute interstitial nephritis.
• Cardiac conditions such as rheumatic carditis.
• Gastrointestinal disorders like ulcerative colitis and Crohn’s disease.
• Ophthalmic conditions including uveitis and optic neuritis.
• Hematological disorders such as autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
• Oncological uses, including treatment for acute and lymphatic leukemia, malignant lymphoma, and multiple myeloma.
• Immunosuppression in organ transplantation.

Use under the supervision of a registered physician.

Pharmacology Deflazacort exerts its anti-inflammatory effects by inhibiting the enzyme phospholipase A2, which is crucial for prostaglandin synthesis. Additionally, it reduces the release of certain immune system chemicals, leading to immunosuppressive effects.

Dosage & Administration

Adults:

• Acute conditions: Initial doses may reach up to 120 mg/day. Maintenance doses typically range between 3-18 mg/day.
• Rheumatoid arthritis: Maintenance dose ranges from 3-18 mg/day, with the lowest effective dose preferred.
• Bronchial asthma: Acute attacks may require doses of 48-72 mg/day, with gradual reduction once symptoms are controlled. Chronic asthma treatment should involve dose titration to the minimum effective level.
• Other conditions: Doses should be tailored to individual needs. Initial dosages are often determined based on a 5 mg prednisone/prednisolone equivalent to 6 mg Deflazacort.

Children:

• Clinical trials in children are limited, and the lowest effective dose should be used. Alternate-day administration may be considered.
• Juvenile chronic arthritis: Maintenance dose typically falls between 0.25-1.0 mg/kg/day.
• Nephrotic syndrome: Initial dose of 1.5 mg/kg/day with gradual reduction based on clinical response.
• Bronchial asthma: Initial doses typically range from 0.25-1.0 mg/kg on alternate days.
• Withdrawal: If Deflazacort has been administered at doses exceeding physiological levels (~9 mg/day or equivalent) for more than three weeks, discontinuation should be gradual to prevent relapse.

Use under the supervision of a registered physician.

Drug Interactions Xalcort is metabolized in the liver, and its dosage may require adjustment when co-administered 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

• Hypersensitivity to Deflazacort or any of its components.
• Patients receiving live virus vaccines.

Side Effects Potential adverse effects include:

• Gastrointestinal disturbances
• Musculoskeletal, endocrine, and neuropsychiatric disorders
• Ophthalmic complications
• Fluid and electrolyte imbalances
• Increased susceptibility to infections
• Impaired healing
• Hypersensitivity reactions
• Skin-related effects such as atrophy, striae, telangiectasia, and acne
• Risk of myocardial rupture following recent myocardial infarction
• Thromboembolic events

Pregnancy & Lactation

• Pregnancy: Deflazacort crosses the placenta. Prolonged or repeated use may increase the risk of intrauterine growth retardation. Use only if benefits outweigh potential risks.
• Breastfeeding: Although data on Deflazacort excretion in breast milk is lacking, corticosteroids are generally excreted in breast milk. Doses up to 50 mg daily are unlikely to cause significant effects in infants, but higher doses may lead to adrenal suppression. The benefits of breastfeeding should be weighed against any potential risks.

Precautions & Warnings Patients with the following conditions require special monitoring:

• Cardiac conditions: Congestive heart failure, hypertension, thromboembolic disorders (corticosteroids may cause fluid retention and potassium loss; dietary modifications may be necessary).
• Gastrointestinal conditions: Gastritis, esophagitis, ulcerative colitis (especially with risk of perforation), fresh intestinal anastomosis, and active or latent peptic ulcers.
• Endocrine and metabolic disorders: Diabetes mellitus, osteoporosis, myasthenia gravis, renal insufficiency.
• Neurological and psychiatric conditions: Emotional instability, psychotic tendencies, epilepsy.
• Liver impairment: Hypothyroidism and cirrhosis may enhance glucocorticoid effects.
• Ophthalmic conditions: Ocular herpes simplex due to risk of corneal perforation.

Use in Special Populations

• Hepatic Impairment: Patients with liver impairment may have increased drug levels, necessitating dose adjustments.
• Renal Impairment: No special precautions required beyond standard glucocorticoid monitoring.
• Elderly Patients: Standard glucocorticoid precautions apply, with heightened attention to potential adverse effects due to age-related vulnerabilities.

Therapeutic Class Glucocorticoids

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