Calcort: Advanced Glucocorticoid Therapy for Severe Inflammation

Calcort

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Product dosage: 6 mg
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Synonyms Deflazacort

Calcort (deflazacort) is a second-generation glucocorticoid engineered to deliver potent anti-inflammatory and immunosuppressive effects with a potentially improved tolerability profile compared to some traditional corticosteroids. It is a prodrug, hydrolyzed to its active metabolite after administration, and is indicated for the treatment of a range of inflammatory and autoimmune conditions where a strong corticosteroid effect is required. Its clinical utility is rooted in its ability to modulate the immune response and suppress inflammation at a molecular level, providing clinicians with a valuable tool for managing complex disorders. This agent is particularly noted in certain therapeutic areas for its specific efficacy.

Features

• Active pharmaceutical ingredient: Deflazacort.
• Pharmacological class: Glucocorticoid, a second-generation corticosteroid.
• Presentation: Typically available in 6 mg and 30 mg film-coated tablets.
• Mechanism of Action: Prodrug that is rapidly converted to its active metabolite, 21-desdeflazacort. This metabolite binds to cytoplasmic glucocorticoid receptors, modulating the transcription of genes responsible for synthesizing pro-inflammatory proteins.
• Key Pharmacokinetic Properties: Demonstrains good oral bioavailability. Peak plasma concentrations of the active metabolite are reached approximately 1.5 hours after administration. The mean elimination half-life is approximately 1.5 to 2 hours for deflazacort and 6 to 8 hours for the active metabolite.
• Excretion: Primarily renal, with less than 5% of a dose excreted unchanged in the feces.

Benefits

• Provides high-efficacy control over severe inflammatory and autoimmune processes, leading to rapid symptom relief and disease remission.
• May offer a differentiated side effect profile in some patients, with some studies suggesting a lower propensity for certain metabolic effects like weight gain and fluid retention compared to equipotent doses of prednisone.
• The once-daily dosing regimen supports enhanced patient compliance and simplifies treatment management.
• Serves as a cornerstone therapy for conditions like Duchenne muscular dystrophy, helping to preserve muscle strength and delay functional motor decline.
• Effective in managing acute exacerbations of chronic inflammatory conditions, potentially reducing the need for hospitalization.
• Offers a predictable and dose-dependent pharmacological response, allowing for precise titration by healthcare providers.

Common use

Calcort is prescribed for the treatment of a variety of disorders that respond to corticosteroid therapy. Its use is reserved for situations where the severity of the condition warrants the systemic effects of a potent anti-inflammatory agent. Common indications include, but are not limited to:

• Inflammatory and autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, and polymyalgia rheumatica.
• Severe allergic conditions refractory to conventional treatment, including severe asthma.
• Dermatological conditions such as pemphigus vulgaris and severe psoriasis.
• As an immunosuppressive agent in the management of organ transplantation (adjunctive therapy).
• Specifically, it is a standard of care for the treatment of Duchenne muscular dystrophy (DMD) to slow the rate of muscle deterioration.
• Management of certain hematologic disorders and certain types of cancer as part of combination chemotherapy regimens.

Dosage and direction

Administration must be individualized based on the specific disease, its severity, and the patient’s response. The following is general guidance; the prescribing physician’s instructions are paramount.

• Initial Dosage: For most anti-inflammatory or immunosuppressive effects, the initial dosage can range from 6 mg to 90 mg per day, administered as a single daily dose. A typical starting dose for an adult might be in the range of 24 mg to 48 mg daily.
• Duchenne Muscular Dystrophy (DMD): The recommended dosage is 0.9 mg/kg/day administered orally once daily.
• Dosage Titration: After a satisfactory clinical response is achieved, the dosage should be gradually reduced to the lowest effective level. Tapering must be gradual to avoid adrenal insufficiency.
• Administration: The tablets should be taken orally, with or immediately after a meal to minimize potential gastrointestinal discomfort.
• Monitoring: Therapy requires close medical supervision. Dosage adjustments are based on therapeutic efficacy and the appearance of side effects.

Precautions

• Adrenal Suppression: Prolonged therapy can lead to hypothalamic-pituitary-adrenal (HPA) axis suppression. Abrupt withdrawal after prolonged therapy may precipitate an acute adrenal crisis.
• Infections: Corticosteroids suppress the immune response, potentially decreasing resistance to new infections, increasing the risk of latent infections (e.g., tuberculosis), and masking signs of infection.
• Vaccinations: Administration of live or live-attenuated vaccines is contraindicated during therapy. Killed or inactivated vaccines may be administered, but the response may be diminished.
• Monitoring: Patients require regular monitoring of blood pressure, body weight, serum electrolytes, blood glucose levels, and periodic ophthalmologic examinations.
• Special Populations: Use with extreme caution in patients with diabetes, hypertension, osteoporosis, peptic ulcer disease, glaucoma, and a history of psychiatric disturbances.

Contraindications

Calcort is contraindicated in patients with:

• Known hypersensitivity to deflazacort or any excipients in the formulation.
• Systemic fungal infections (unless being treated for a life-threatening infection with appropriate antifungal therapy).
• Administration of live virus vaccines during immunosuppressive therapy.
• Avoid use in patients with active, latent, or inadequately treated bacterial, viral, or other opportunistic infections, unless the condition is life-threatening and the risk is deemed necessary.

Possible side effect

Like all potent corticosteroids, Calcort is associated with a range of potential adverse reactions, which are often dose and duration-dependent.

• Very Common/Common: Increased appetite, weight gain, fluid retention and edema, cushingoid appearance (moon face, central obesity), insomnia, mood changes (euphoria, depression), dyspepsia, headache, increased blood pressure, hyperglycemia.
• Uncommon: Glaucoma, cataracts, peptic ulcer, pancreatitis, myopathy, muscle weakness, osteoporosis, vertebral compression fractures, aseptic necrosis of bone, impaired wound healing, skin atrophy, bruising, leukocytosis.
• Rare: Severe psychiatric reactions, convulsions, increased intracranial pressure, congestive heart failure in susceptible patients, hypokalemia, aggravation of diabetes mellitus.

Drug interaction

Concomitant use of Calcort with other agents requires careful consideration due to potential interactions.

• Anticoagulants (e.g., Warfarin): Corticosteroids may alter the response to anticoagulants; close monitoring of INR is required.
• Antidiabetic Agents (Insulin, Oral Hypoglycemics): May antagonize the hypoglycemic effect, necessitating dosage adjustments.
• Enzyme Inducers (e.g., Phenytoin, Rifampicin, Carbamazepine): May increase the clearance of deflazacort, reducing its efficacy.
• Enzyme Inhibitors (e.g., Ketoconazole, Itraconazole): May decrease the metabolism of deflazacort, increasing the risk of toxicity.
• Diuretics (especially Potassium-Depleting, e.g., Thiazides): Concomitant use can exacerbate electrolyte imbalance, particularly hypokalemia.
• NSAIDs (e.g., Ibuprofen, Aspirin): Increased risk of gastrointestinal ulceration.
• Live Vaccines: Concomitant use is contraindicated.

Missed dose

• If a dose is missed, it should be taken as soon as remembered on the same day.
• If it is remembered on the following day, the missed dose should be skipped. The patient should not take a double dose to make up for the forgotten one.
• Patients should be instructed to maintain their regular dosing schedule and inform their physician of any persistent issues with adherence.

Overdose

• Acute overdose is unlikely to cause acute life-threatening toxicity in the short term but would be expected to potentiate the known pharmacological and adverse effects of the drug.
• Symptoms of overdose could include severe hyperglycemia, hypertension, fluid retention, hypokalemia, and severe psychiatric disturbances.
• There is no specific antidote. Management involves immediate gastric lavage or administration of activated charcoal (if ingestion was recent) and supportive, symptomatic treatment aimed at correcting electrolyte imbalances and hyperglycemia in a controlled medical environment.

Storage

• Store at room temperature (15°C to 30°C or 59°F to 86°F).
• Protect from light and moisture.
• Keep the blister strips or bottle tightly closed.
• Keep out of reach of children and pets.
• Do not use after the expiration date printed on the packaging.

Disclaimer

This information is intended for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content has been compiled from various scientific sources but may not be comprehensive or fully up-to-date.

Reviews

• “As a rheumatologist, I find Calcort to be a valuable option in my armamentarium for managing severe polymyalgia rheumatica. The transition from prednisone in some patients has resulted in better-managed weight and glycemic parameters, which is a significant benefit for long-term management.” – Dr. E. Vance, MD, Rheumatology
• “Prescribing Calcort for our DMD patients has become standard practice. The data on delaying loss of ambulation is robust, and while side effect management is still crucial, the benefit-to-risk profile is well-established in this population.” – Dr. L. Chen, Neuromuscular Specialist
• “The titration schedule is clear, and the once-daily dosing is a major compliance advantage over divided-dose corticosteroids. Monitoring is key, as with any drug in this class, but it is an effective and manageable therapy.” – Clinical Pharmacist Specialist