B-Cort

Approved Indications:

• Endocrine Disorders:
• Primary or secondary adrenocortical insufficiency (as part of corticosteroid replacement)
• Congenital adrenal hyperplasia
• Rheumatic Disorders:
• Rheumatoid arthritis
• Ankylosing spondylitis
• Acute gouty arthritis
• Psoriatic arthritis
• Juvenile idiopathic arthritis
• Collagen Diseases:
• Systemic lupus erythematosus
• Systemic dermatomyositis (polymyositis)
• Dermatologic Conditions:
• Severe psoriasis
• Severe seborrheic dermatitis
• Severe contact dermatitis
• Allergic Conditions:
• Severe allergic rhinitis
• Bronchial asthma
• Drug hypersensitivity reactions
• Anaphylaxis (adjunctive treatment with epinephrine)
• Ophthalmic Diseases (Systemic use):
• Severe inflammatory and allergic eye disorders (e.g., uveitis, allergic conjunctivitis)
• Hematologic Disorders:
• Idiopathic thrombocytopenic purpura in adults
• Hemolytic anemia
• Neoplastic Diseases:
• Palliative treatment of leukemias and lymphomas in adults
• Acute lymphoblastic leukemia in children
• Gastrointestinal Diseases:
• Ulcerative colitis
• Crohn's disease (short-term use in flare-ups)
• Respiratory Diseases:
• Aspiration pneumonitis
• Status asthmaticus (emergency adjunct)
• Other:
• Cerebral edema (adjunctive therapy)
• Shock (as adjunct to standard therapy)

Route: Intravenous (IV), Intramuscular (IM), Intra-articular, Soft-tissue injection, Local infiltration.

Adults:

• IV/IM (systemic use):
• Initial dose: 4 to 20 mg/day
• Maintenance: Adjusted based on response; taper when appropriate.
• In emergency conditions (e.g., status asthmaticus or anaphylaxis): up to 20–40 mg may be given IV as a single bolus.
• Intra-articular/Soft Tissue Injection:
• Small joints: 0.25 to 2 mg
• Medium joints: 2 to 4 mg
• Large joints: 4 to 6 mg
• May be repeated every 1–3 weeks depending on clinical response.

Pediatrics:

• Systemic IV/IM use: 0.02 to 0.3 mg/kg/day in divided doses or as a single dose depending on condition.
• For leukemia or other severe pediatric conditions, higher doses may be used under supervision.

Elderly:

• Use the lowest effective dose. Monitor closely for adverse effects, especially osteoporosis, fluid retention, and glucose intolerance.

Renal/Hepatic Impairment:

• No formal dosage adjustment guidelines, but use with caution. Monitor for fluid retention, electrolyte imbalance, and altered drug clearance.

Duration:

• Should be kept to the shortest duration possible.
• Tapering is essential if used longer than a few days.

Betamethasone Sodium Phosphate is a synthetic glucocorticoid that binds to intracellular glucocorticoid receptors, forming a receptor-steroid complex. This complex translocates into the nucleus, where it regulates the transcription of anti-inflammatory proteins and suppresses the transcription of pro-inflammatory cytokines and mediators such as prostaglandins and leukotrienes. Its phosphoric ester form allows for high solubility, leading to rapid onset when administered parenterally. The anti-inflammatory and immunosuppressive effects are due to inhibition of leukocyte infiltration, suppression of humoral immune responses, and stabilization of cell membranes and lysosomal membranes.

• Absorption: Rapidly absorbed after IM or IV administration due to its water-soluble phosphate ester form.
• Distribution: Widely distributed; crosses the blood-brain barrier and placenta; protein binding ~60–70%.
• Metabolism: Primarily hepatic via cytochrome enzymes to inactive metabolites.
• Elimination: Renal excretion of metabolites.
• Half-life: Biological half-life is approximately 36–54 hours; plasma half-life around 5–6 hours.
• Onset of Action: Within minutes to 1 hour IV; several hours IM.
• Duration of Action: 1 to 3 days depending on the dose and route.

• Pregnancy: Category C (USA).
• Animal studies have shown adverse effects on the fetus; no well-controlled studies in pregnant women. Use only if clearly needed.
• May be associated with fetal growth restriction or orofacial clefts if used in the first trimester.
• Lactation:
• Betamethasone is excreted in small amounts into breast milk.
• Short-term or low-dose use is generally considered compatible with breastfeeding.
• High doses or prolonged use may interfere with infant growth or adrenal function; caution advised.

• Primary Class: Systemic Corticosteroid
• Subclass: Glucocorticoid, Intermediate-acting

• Known hypersensitivity to betamethasone or other corticosteroids
• Systemic fungal infections
• Intrathecal administration
• Recent administration of live or live-attenuated vaccines in immunocompromised patients
• Severe uncontrolled hypertension or diabetes (relative contraindication)

• Use cautiously in patients with:
• Active or latent infections (e.g., tuberculosis, herpes simplex)
• Peptic ulcer disease
• Hypertension
• Diabetes mellitus
• Osteoporosis
• Psychiatric conditions (may exacerbate mood disorders)
• May mask signs of infection or delay wound healing.
• Prolonged use may lead to adrenal suppression; taper gradually.
• Monitor blood glucose, electrolytes, BP, and intraocular pressure.
• Increased risk of gastrointestinal bleeding, especially with NSAIDs.

Common:

• Gastrointestinal: Nausea, increased appetite, indigestion
• Endocrine/Metabolic: Cushingoid features, weight gain, hyperglycemia
• Musculoskeletal: Muscle weakness, osteoporosis with prolonged use
• Neuropsychiatric: Insomnia, mood swings, euphoria, anxiety
• Dermatologic: Skin thinning, delayed wound healing

Serious/Rare:

• Adrenal suppression
• Avascular necrosis of bone
• Severe infections due to immunosuppression
• Anaphylaxis (rare but serious)
• Increased intraocular pressure or glaucoma

• CYP3A4 inducers (e.g., rifampin, phenytoin): ↓ betamethasone levels
• CYP3A4 inhibitors (e.g., ketoconazole): ↑ betamethasone levels/toxicity
• NSAIDs: ↑ risk of GI bleeding
• Antidiabetics: Reduced efficacy of hypoglycemic agents
• Live vaccines: Risk of disseminated infection
• Diuretics: ↑ risk of hypokalemia when combined

• Latest WHO and FDA corticosteroid guidelines emphasize cautious use in viral infections and suggest short-term corticosteroids in severe COVID-19 pneumonia, but Betamethasone Sodium Phosphate is not first-line in that setting.
• EMA updates reinforce warnings regarding adrenal suppression and stress the need for tapering after prolonged use.

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from light and excessive moisture
• Do not freeze
• Once opened, use within the recommended in-use period (usually 28 days if multidose vial)
• Shake well before use if suspension form is used