Adult: Adjunctive treatment for short term administration: As betamethasone Na phosphate and betamethasone acetate: 3-12 mg (0.5-2 mL) depending on the size of the affected joint.
Intramuscular Allergic and inflammatory disorders
Adult: As betamethasone Na phosphate and betamethasone acetate: Usual dose: 0.25-9 mg daily. Dosage is individualised according to the disease being treated and patient response. Refer to the disease-specific product guidelines for detailed dosage recommendations. Child: As betamethasone Na phosphate and betamethasone acetate: Usual dose: 0.02-0.3 mg/kg daily in 3 or 4 divided doses. Dosage is individualised according to the disease being treated and patient response. Refer to the disease-specific product guidelines for detailed dosage recommendations.
Nasal Allergic and inflammatory disorders
Adult: For non-infected cases of the nose: As 0.1% betamethasone Na phosphate drops: Instil 2-3 drops into each nostril bid or tid as required. Use the lowest effective dose for the shortest possible time. Discontinue if there is no clinical response within 7 days of treatment. Child: Same as adult dose.
Ophthalmic Allergic and inflammatory conditions of the eye
Adult: For short-term treatment of steroid-responsive cases: As 0.1% betamethasone Na phosphate drops: Initially, instil 1-2 drops into the affected eye(s) every 1-2 hours, then reduce frequency once the condition is under control. As 0.1% betamethasone Na phosphate ointment: Apply 2-4 times daily; alternatively, doses may be applied at night. Use the lowest effective dose for the shortest possible time. Discontinue if there is no clinical response within 7 days of treatment. Child: Same as adult dose.
Oral Allergic and inflammatory disorders
Adult: Dosage is individualised and adjusted according to the disease being treated, its severity and patient response. As betamethasone Na phosphate: Usual dose: 0.5-5 mg daily in divided doses. Recommended regimens: Short-term treatment: 2-3 mg daily for the 1st few days, then decrease by 0.25 mg or 0.5 mg every 2-5 days. Rheumatoid arthritis: 0.5-2 mg daily. Other conditions: 1.5-5 mg daily for 1-3 weeks, then reduce gradually. Use the lowest effective dose. Refer to the disease-specific product guidelines for detailed dosage recommendations.
Otic/Aural Allergic and inflammatory conditions of the ear
Adult: For non-infected cases: As 0.1% betamethasone Na phosphate drops: Initially, instil 2-3 drops into the affected ear(s) 2-3 hourly or 3-4 hourly, then reduce frequency once the condition is under control. Use the lowest effective dose for the shortest possible time. Discontinue if there is no clinical response within 7 days of treatment. Child: Same as adult dose.
Parenteral Allergic and inflammatory disorders
Adult: As betamethasone Na phosphate: 4-20 mg via slow IV inj over 0.5-1 minute, IV infusion or deep IM inj; may be repeated 3-4 times in 24 hours as necessary depending on the condition being treated and patient response. Use the minimum effective dose. Refer to the disease-specific product guidelines for detailed dosage recommendations. Child: As betamethasone Na phosphate: <1 year 1 mg; 1-5 years 2 mg; 6-12 years 4 mg. Doses to be given via slow IV inj or infusion, may be repeated 3-4 times in 24 hours as necessary depending on the condition being treated and patient response.
Parenteral Soft tissue inflammation
Adult: As betamethasone Na phosphate: 4-8 mg as local inj into soft tissue lesions; may be repeated on 2 or 3 occasions according to patient response.
Topical/Cutaneous Mild to moderate plaque psoriasis
Adult: As 0.05% betamethasone dipropionate spray: Apply to affected area bid for up to 4 weeks.
Adult: As 0.1% betamethasone valerate cream, ointment, lotion: Apply thinly onto the affected area 1-3 times daily for up to 4 weeks or until improvement occurs. Re-evaluate treatment if condition worsens or does not improve within 2-4 weeks. As 0.05% betamethasone dipropionate cream, ointment, gel, lotion or solution: Apply thinly onto affected area 1-2 times daily for up to 2 weeks. As 0.1% or 0.12% betamethasone valerate foam: Massage small amounts into affected areas of the scalp bid. Dosage and treatment duration may vary according to the severity of the condition and patient response. Child: As 0.1% betamethasone valerate cream, ointment, lotion: 1-<12 years Use the minimum effective dose and limit treatment courses to 5 days without occlusion.
Administration
Should be taken with food.
Contraindications
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.
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.
IM/Intrabursal/Intradermal/Intralesional/Parenteral/Periarticular/Topical: C
Patient Counseling Information
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.
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). Potentially Fatal: May diminish the therapeutic effect of vaccines (live or inactivated).
Lab Interference
May suppress reactions (e.g. wheal, flare) to skin tests.
Action
Description: Mechanism of Action: Betamethasone is a corticosteroid with primarily glucocorticoid activity. It induces phospholipase A2 inhibitory proteins (lipocortins) and sequentially inhibits the release of arachidonic acid, thereby depressing the formation, release, and activity of prostaglandins, histamines, and other endogenous inflammatory chemical mediators. Pharmacokinetics: Absorption: Readily absorbed from the gastrointestinal tract (oral); absorbed percutaneously (topical). Time to peak plasma concentration: 10-36 minutes (IV). Distribution: Crosses the placenta and enters breast milk. Plasma protein binding: 64%. Metabolism: Metabolised primarily in the liver. Excretion: Via urine (<5% as unchanged drug). Elimination half-life: 6.5 hours.
Chemical Structure
Betamethasone Source: National Center for Biotechnology Information. PubChem Database. Betamethasone, CID=9782, https://pubchem.ncbi.nlm.nih.gov/compound/Betamethasone (accessed on Jan. 21, 2020)
Storage
Tab: Store below 30°C. Protect from light and moisture. Parenteral/ophthalmic ointment/topical cream, ointment, lotion, solution: Store between 15-30°C. Protect from light. Ophthalmic/otic/nasal drops: Store below 25°C. Do not freeze. Protect from light. Topical foam: Store between 20-25°C. Protect from extreme heat exposure.
S01BA06 - betamethasone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye. 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. R01AD06 - betamethasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis. D07AC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases. H02AB01 - betamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
References
Anon. Betamethasone (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/06/2020.Anon. Betamethasone (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/06/2020.Beprogel Topical Solution (HOE Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 05/06/2020.Betaloan Suik Injection, Suspension (Asclemed USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/06/2020.Betamethasone 0.1% w/w Eye Ointment (RPH Pharmaceuticals AB). MHRA. https://products.mhra.gov.uk/. Accessed 05/06/2020.Betamethasone 500 micrograms Soluble Tablets (Roma Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 05/06/2020.Betamethasone Dipropionate Cream (Actavis Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/06/2020.Betamethasone Dipropionate Gel (Taro Pharmaceuticals USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/06/2020.Betamethasone Dipropionate Lotion (Cosette Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/06/2020.Betamethasone Dipropionate Ointment (Prasco Laboratories). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/06/2020.Betamethasone Tablet (Y.S.P. Industries [M] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 05/06/2020.Betamethasone Valerate 0.1% w/w Cream (Manx Healthcare Limited). MHRA. https://products.mhra.gov.uk/. Accessed 05/06/2020.Betamethasone Valerate Aerosol, Foam (Mylan Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/06/2020.Betamethasone Valerate Cream, Ointment (Cosette Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/06/2020.Betasone Cream (Royce Pharma Manufacturing Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 05/06/2020.Betnesol 4 mg/mL Solution for Injection (RPH Pharmaceuticals AB). MHRA. https://products.mhra.gov.uk/. Accessed 05/06/2020.Betnesol Eye, Ear and Nose Drops Solution 0.1% w/v (RPH Pharmaceuticals AB). MHRA. https://products.mhra.gov.uk/. Accessed 12/10/2020.Betnovate Lotion (Glaxo Wellcome UK Ltd.). MHRA. https://products.mhra.gov.uk/. Accessed 05/06/2020.Betnovate Ointment (Glaxo Wellcome UK Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 05/06/2020.Bettamousse 1mg/g Cutaneous Foam (RPH Pharmaceuticals AB). MHRA. https://products.mhra.gov.uk/. Accessed 05/06/2020.Buckingham R (ed). Betamethasone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/06/2020.Diprocel Ointment (Merck Sharp & Dohme [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 05/06/2020.Diprosone 0.05 % w/w Cream (Merck Sharp & Dohme Limited). MHRA. https://products.mhra.gov.uk/. Accessed 12/10/2020.Joint Formulary Committee. Betamethasone. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/06/2020.Mylan New Zealand Ltd. Beta 0.1% w/w Cream or Ointment data sheet 16 January 2019. Medsafe. http://www.medsafe.govt.nz/. Accessed 05/06/2020.Sernivo Spray (Promius Pharma, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/06/2020.Vistamethasone 0.1% w/v Drops (Martindale Pharmaceuticals Limited). MHRA. https://products.mhra.gov.uk/. Accessed 05/06/2020.
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