Betamethason-BP

Betamethasoni

Each ml suspension for injection contains betamethasone 5 mg (as betamethasone dipropionate 6.43 mg) and betamethasone 2 mg (as betamethasone sodium phosphate 2.63 mg). Excipients with known effect: sodium, benzyl alcohol 9 mg/ml, methyl parahydroxybenzoate 1.30 mg/ml, propyl parahydroxybenzoate 0.20 mg/ml.

Indication: Corticosteroid suspension used as adjunctive therapy (not a substitute for conventional treatment) in acute and chronic conditions responsive to corticosteroid therapy: musculoskeletal and soft-tissue disorders (rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, sciatica, lumbago, etc.), allergic conditions (bronchial asthma, hay fever, angioneurotic oedema, contact dermatitis, allergic rhinitis, etc.), skin conditions (atopic dermatitis, psoriasis, lichen planus, pemphigus, etc.), collagen diseases (systemic lupus erythematosus, scleroderma, dermatomyositis) and, as palliative treatment, in certain neoplastic conditions (leukaemias, lymphomas).

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Hypersensitivity to betamethasone, to other corticosteroids, or to any of the excipients listed in section 6.1 All systemic infectious conditions, except in selected cases of infection Certain ongoing viral diseases (hepatitis, herpes, varicella, zoster) Uncontrolled psychotic states not managed with medication Coagulation disorders, ongoing anticoagulant treatment.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Betametason-BP is not intended for intravenous injection. Serious neurological events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, tetraplegia, cortical blindness, and stroke. These serious neurological events have been reported with and without the use of fluoroscopy. The safety and efficacy of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. Phaeochromocytoma crisis, which may be fatal, has been reported following administration of systemic corticosteroids. Corticosteroids should be given only to patients with suspected or identified phaeochromocytoma after appropriate […]