Generic Medicine Info
Should be taken with food.
Untreated systemic infections (oral, parenteral); idiopathic thrombocytopenic purpura (IM); perforated tympanic membrane (otic). Ophthalmic: Bacterial, fungal, viral, tuberculous or purulent eye infections; glaucoma, herpetic keratitis (e.g. dendritic ulcer), undiagnosed red eye. Topical: Untreated fungal, tubercular or bacterial skin infections; viral skin lesions (e.g. herpes simplex, varicella, vaccinia), acne vulgaris, rosacea, perianal and genital pruritus, perioral dermatitis, pruritus without inflammation; infants <1 year (betamethasone valerate). Concomitant administration with live vaccines (in patients receiving immunosuppressive doses).
Special Precautions
Patient with recent MI, hypertension, CHF; osteoporosis or its risk factors (e.g. post-menopausal women); existing or history of severe affective disorders (particularly steroid psychosis); cirrhosis, diabetes mellitus, active or history of TB, ocular disease (e.g. cataracts, glaucoma); prior corticosteroid-induced myopathy, myasthenia gravis, epilepsy or history of seizure disorder, gastrointestinal diseases (e.g. peptic ulcer, diverticulitis, fresh intestinal anastomoses, nonspecific ulcerative colitis), thromboembolic tendencies, systemic sclerosis, thyroid disease; recent nasal surgery, untreated nasal infection; psoriasis (topical). Patient with history of local hypersensitivity to corticosteroids (betamethasone valerate); subjected to stress conditions (e.g. trauma, intercurrent illness, surgery). Avoid abrupt withdrawal (particularly during prolonged therapy). Renal and hepatic impairment. Children. Pregnancy and lactation. Patient Counselling Ophthalmic: This drug may cause visual disturbances such as transient blurred vision; if affected, do not drive or operate machinery. Remove contact lenses prior to instillation of eye drops and wait at least 15 minutes before reinsertion. Monitoring Parameters Monitor blood pressure, serum K and glucose, growth in children; signs and symptoms of infection, inj site reactions, HPA axis suppression, adrenal insufficiency. Perform ophthalmic examination periodically.
Adverse Reactions
Significant: Adrenal suppression (e.g. suppression of hypothalamic-pituitary-adrenal [HPA] axis, hypercortisolism, adrenal cortical atrophy); visual disturbances (e.g. blurred vision, increased intraocular pressure, glaucoma, posterior subcapsular cataract, central serous chorioretinopathy); growth retardation in children, immunosuppression (prolonged use), Kaposi's sarcoma (prolonged use), acute myopathy, psychiatric disturbances (e.g. depression, euphoria, insomnia, mood swings, personality changes); electrolyte disturbances, fluid retention, hypertension, left ventricular free wall rupture. Rarely, anaphylactoid reactions. Topical: Allergic contact dermatitis, systemic effects (e.g. manifestations of Cushing's syndrome, hyperglycaemia, glucosuria). Blood and lymphatic system disorders: Leucocytosis. Eye disorders: Papilloedema, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases; mydriasis, ptosis, epithelial punctate keratitis (ophthalmic). Gastrointestinal disorders: Abdominal distension, dyspepsia, nausea, oesophageal ulceration, peptic ulcer with perforation and haemorrhage; acute pancreatitis; taste disturbance (nasal). General disorders and administration site conditions: Malaise. Investigations: Weight gain. Metabolism and nutrition disorders: Hypokalaemic alkalosis, impaired carbohydrate tolerance. Musculoskeletal and connective tissue disorders: Osteoporosis, tendon rupture, vertebral and long bone fractures, avascular osteonecrosis. Nervous system disorders: Headache. Psychiatric disorders: Irritability, mania, delusions, hallucinations, behavioural disturbances, anxiety, sleep disturbances, confusion. Reproductive system and breast disorders: Menstrual irregularity, amenorrhoea. Respiratory, thoracic and mediastinal disorders: Nasal irritation and dryness, epistaxis, rebound congestion, bronchial asthma, perforation or ulceration of nasal septum, anosmia, parosmia, sneezing. Skin and subcutaneous tissue disorders: Atrophy, bruising, acne, telangiectasia, striae, hypertrichosis, Stevens-Johnson syndrome; pruritus, burning or stinging sensation, pain (topical). Vascular disorders: Thromboembolism.
Drug Interactions
May reduce effects of anticholinesterases in patients with myasthenia gravis. Enhanced metabolism and decreased therapeutic effect with rifampicin, carbamazepine, phenobarbitone, phenytoin, primidone, aminoglutethimide, ephedrine. May antagonise the effects of hypoglycaemic agents (e.g. insulin), antihypertensives, diuretics, neuromuscular blocking drugs (e.g. vecuronium). May enhance the effect of coumarin anticoagulants. Increased renal clearance of salicylates. Increased risk of hypokalaemia with theophylline, carbenoxolone, antifungals (e.g. amphotericin B), and diuretics. May reduce effect with mifepristone. May inhibit the growth promoting effects of somatropin. May increase risk of gastrointestinal bleeding with NSAIDs. May increase the risk of tendon rupture with fluoroquinolones. May increase serum concentration with CYP3A4 inhibitors (e.g. ritonavir, itraconazole) and oral contraceptives. May increase the risk of systemic side effects with cobicistat-containing agents (ophthalmic/nasal/otic).
CIMS Class
Antiasthmatic & COPD Preparations / Corticosteroid Hormones / Ear Corticosteroids / Eye Corticosteroids / Topical Corticosteroids
ATC Classification
S01BA06 - betamethasone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
C05AA05 - betamethasone ; Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids and anal fissures.
H02AB01 - betamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
S01CB04 - betamethasone ; Belongs to the class of corticosteroids/antiinfectives/mydriatics combinations. Used in the treatment of eye diseases.
D07XC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids in other combinations. Used in the treatment of dermatological diseases.
D07AC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
R03BA04 - betamethasone ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
A07EA04 - betamethasone ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
R01AD06 - betamethasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
S02BA07 - betamethasone ; Belongs to the class of corticosteroids used in the treatment of inflammation of the ear.
S03BA03 - betamethasone ; Belongs to the class of corticosteroids used in ophthalmologic and otologic preparations.
Disclaimer: This information is independently developed by CIMS based on betamethasone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 CIMS. All rights reserved. Powered by
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