Adult: Dose is individualised according to the disease being treated and patient response. As betamethasone sodium phosphate and betamethasone acetate: 3-12 mg as a single dose, depending on the size of the affected joint. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Intramuscular Allergic and inflammatory disorders
Adult: Dose is individualised according to the disease being treated and patient response. As betamethasone sodium phosphate: 4-20 mg via IM inj; may be repeated 3 or 4 times in 24 hours. As betamethasone sodium phosphate and betamethasone acetate: Initially, 0.25-9 mg daily. As betamethasone dipropionate and betamethasone disodium phosphate: Initially, 7-14 mg according to disease severity; may repeat dose based on patient response. Use the lowest effective dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines). Child: As betamethasone sodium phosphate and betamethasone acetate: Initially, 0.02-0.3 mg/kg daily in 3 or 4 divided doses. Dose is individualised according to the disease being treated and patient response. Use the lowest effective dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Intravenous Allergic and inflammatory disorders
Adult: Dose is individualised according to the disease being treated and patient response. As betamethasone sodium phosphate: 4-20 mg via slow IV inj over 30 seconds to 1 minute or IV infusion; may be repeated 3 or 4 times in 24 hours. Use the lowest effective dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines). Child: As betamethasone sodium phosphate: Infants up to 1 year 1 mg; Children 1-5 years 2 mg; 6-12 years 4 mg. All doses are given via IV inj or infusion; may be repeated 3 or 4 times in 24 hours according to the disease being treated and patient response.
Nasal Nasal inflammation
Adult: As 0.1% betamethasone sodium phosphate drops: For non-infected cases: Instil 2-3 drops into each nostril bid or tid. Use the lowest effective dose for the shortest possible duration. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Ophthalmic Ophthalmic inflammation
Adult: As 0.1% betamethasone sodium phosphate drops: For short-term treatment of steroid-responsive cases: Instil 1-2 drops into the affected eye(s) 1-2 hourly, then reduce frequency once the condition is controlled. Use the lowest effective dose for the shortest possible duration. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Oral Allergic and inflammatory disorders
Adult: Dose is individualised according to the disease being treated and patient response. Usual dose: 0.5-5 mg daily. Use the lowest effective dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Otic/Aural Otic inflammation
Adult: As 0.1% betamethasone sodium phosphate drops: For non-infected cases: Instil 2-3 drops into the affected ear(s) 2-3 hourly, then reduce frequency once the condition is controlled. Use the lowest effective dose for the shortest possible duration. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Parenteral Soft tissue inflammation
Adult: As betamethasone sodium phosphate: 4-8 mg via local inj into soft tissue lesions; may be repeated on 2 or 3 occasions according to patient response. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Adult: Dose is individualised according to the disease being treated and patient response. As betamethasone valerate 0.1% cream or ointment: Apply thinly onto the affected area 1-3 times daily; once daily or bid dosing frequencies are usually effective. As betamethasone valerate 0.025% cream or ointment: For maintenance treatment after effective treatment with betamethasone valerate 0.1%: Apply thinly onto the affected area once daily or bid. As betamethasone dipropionate 0.05% cream, ointment or gel: Apply thinly onto the affected area once daily or bid. Use the lowest effective dose for the shortest possible duration. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines). Child: As betamethasone valerate 0.025% or 0.1% cream or ointment: >1 year Same as adult dose. As betamethasone dipropionate 0.05% cream or ointment: ≥13 years Same as adult dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Topical/Cutaneous Corticosteroid-responsive dermatoses of the scalp
Adult: As betamethasone valerate 0.1% or 0.12% foam: Apply a small amount onto the affected area of the scalp bid until improvement occurs. As betamethasone dipropionate 0.05% lotion: Apply a few drops to the affected area bid and massage thoroughly and gently. Use the lowest effective dose for the shortest possible duration. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
What are the brands available for Betamethasone in Malaysia?
Oral/Parenteral: Untreated systemic infections; immune thrombocytopenia or idiopathic thrombocytopenic purpura (IM). Concomitant use with live vaccines (in patients receiving immunosuppressive doses). Otic: Perforated tympanic membrane. Ophthalmic: Bacterial, fungal, viral, tuberculous or purulent eye infections; glaucoma. Topical: Untreated fungal, tubercular or bacterial skin infections; viral skin infections (e.g. herpes simplex, varicella, vaccinia), acne vulgaris, rosacea, perianal and genital pruritus, perioral dermatitis, widespread plaque psoriasis, pruritus without inflammation.
Special Precautions
Patient with recent MI, hypertension, CHF; osteoporosis or its risk factors (e.g. postmenopausal women); existing or history of severe affective disorders (particularly steroid-induced psychosis); diabetes mellitus; cataracts, history of TB; 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), phaeochromocytoma, thyroid disease; thromboembolic disorder, history of allergic reactions to corticosteroids. Avoid abrupt withdrawal (particularly during prolonged therapy). Avoid exposure to chickenpox and measles. Nasal betamethasone must be avoided in patients with untreated nasal infection or recent nasal surgery until healing has occurred. Renal and hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Hypercortisolism or suppression of HPA axis (particularly in younger children or use of high doses for prolonged periods); blurred vision or other visual disturbances, increased IOP, glaucoma, posterior subcapsular cataract; growth retardation in children; immunosuppression, increased risk of infection; Kaposi's sarcoma (prolonged use); acute myopathy (high doses); psychiatric reactions (e.g. depression, euphoria, insomnia, mood swings, personality changes); electrolyte disturbances, fluid retention, hypertension; left ventricular free wall rupture (following recent MI); osteoporosis, transient worsening of myasthenia gravis. Rarely, anaphylactoid reactions, central serous chorioretinopathy. Topical: Allergic contact dermatitis; systemic effects may produce reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycaemia or glucosuria; topical steroid withdrawal reactions (particularly after discontinuation of ≥6 months long-term use), may be manifested as severe redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itching, skin peeling and oozing pustules. 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: Nausea, abdominal distension, oesophageal ulceration, dyspepsia, peptic ulceration and haemorrhage, acute pancreatitis; taste disturbance (nasal). General disorders and administration site conditions: Malaise. Investigations: Weight gain. Metabolism and nutrition disorders: Hypokalaemic alkalosis, decreased glucose and carbohydrate tolerance, negative nitrogen balance. Musculoskeletal and connective tissue disorders: Tendon rupture, vertebral and long bone fractures, osteonecrosis. Nervous system disorders: Convulsions, headache. Reproductive system and breast disorders: Menstrual irregularity. Respiratory, thoracic and mediastinal disorders: Hiccups; nasal irritation and dryness, epistaxis, rebound nasal congestion, bronchial asthma, perforation or ulceration of nasal septum, anosmia, parosmia, sneezing (nasal). Skin and subcutaneous tissue disorders: Atrophy, bruising, acne, telangiectasis, striae, Stevens-Johnson syndrome, hypertrichosis; pruritus, local pain and burning, dryness, irritation, folliculitis, hypopigmentation, perioral dermatitis, miliaria (topical). Vascular disorders: Thromboembolism. Potentially Fatal: Phaeochromocytoma crisis.
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 administration of eye drops and wait for 15 minutes before reinsertion. Topical (long-term use of ≥6 months): Inform the doctor immediately if severe redness (which can spread beyond the initial affected area), itching, burning or stinging sensation and skin peeling occur after treatment discontinuation.
Monitoring Parameters
Screen for hepatitis B infection prior to starting immunosuppressive treatment. Monitor blood pressure, serum potassium, glucose, and growth (in children). Assess for signs and symptoms of infection, inj site reactions, HPA axis suppression and adrenal insufficiency. Perform periodic ophthalmic examination in chronic users. Ophthalmic: Monitor IOP and cataract formation.
Drug Interactions
Concomitant use with live or inactivated vaccines may result in diminished therapeutic effects of the vaccines. May reduce the effects of anticholinesterases in patients with myasthenia gravis. Enhanced metabolism and reduced therapeutic effect with rifampicin, carbamazepine, phenobarbital, phenytoin, aminoglutethimide and ephedrine. May diminish the effects of hypoglycaemic agents (e.g. insulin) and somatropin. May increase or decrease the effect of coumarin anticoagulants. May increase the renal clearance of salicylates. Increased risk of hypokalaemia with amphotericin B, loop diuretics and thiazide diuretics. Reduced therapeutic effect with mifepristone (for 3-4 days). Increased risk of gastrointestinal bleeding or ulceration with NSAIDs. Increased risk of tendon rupture with fluoroquinolones. May increase serum concentration with CYP3A4 inhibitors (e.g. ritonavir, itraconazole, cobicistat-containing agents) and oral contraceptives. May antagonise the effects of neuromuscular blocking drugs (e.g. vecuronium). Increases metabolism of quetiapine and tretinoin.
Food Interaction
May enhance gastric mucosal irritation with alcohol.
Lab Interference
May suppress reactions (e.g. wheal, flare) to skin tests.
Action
Description: Mechanism of Action: Betamethasone is a corticosteroid with anti-inflammatory, antipruritic and vasoconstrictive properties. It induces phospholipase A2 inhibitory proteins (lipocortins) and sequentially inhibits arachidonic acid release, thereby suppressing the formation, release, and activity of endogenous inflammatory chemical mediators (e.g. kinins, histamine, liposomal enzymes, prostaglandins). Potency of betamethasone may vary from moderately to very potent depending on the dosage form. Pharmacokinetics: Absorption: 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 Compound Summary for CID 9782, Betamethasone. https://pubchem.ncbi.nlm.nih.gov/compound/Betamethasone. Accessed Sept. 24, 2024.
Storage
Tab/Parenteral inj: Store below 30°C. Ophthalmic, otic, and nasal drops: Store below 25°C. Do not freeze. Protect from light. Cream/Ointment/Lotion: Store between 15-30°C. Foam: Store below 25°C. Store upright. Do not expose to heat or store at temperatures >49°C.
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. 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
Axcel Betamethasone Cream (Kotra Pharma [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/03/2025.Beprogel Topical Solution (HOE Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/03/2025.Beprosone Cream and Ointment 0.064% w/w (HOE Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/03/2025.Betamethasone (Nasal). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/03/2025.Betamethasone (Ophthalmic). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/03/2025.Betamethasone (Otic). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/03/2025.Betamethasone (Systemic). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/03/2025.Betamethasone (Topical). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/03/2025.Betamethasone 0.1% w/v Ear/Eye/Nasal Drops, Solution (Morningside Healthcare Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Betamethasone 500 microgram Soluble Tablets (Manx Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Betamethasone Dipropionate Cream (Golden State Medical Supply, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/03/2025.Betamethasone Dipropionate Gel (Taro Pharmaceuticals U.S.A., Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/03/2025.Betamethasone Dipropionate Ointment, Augmented (Aurobindo Pharma Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/03/2025.Betamethasone Valerate 0.025% w/w Cream (Accord Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Betamethasone Valerate 0.025% w/w Ointment (Accord Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Betamethasone Valerate 0.1% w/w Cream (Manx Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Betamethasone Valerate 0.1% w/w Ointment (Manx Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Betamethasone Valerate Aerosol, Foam (Alembic Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/03/2025.Betnesol 4 mg/mL Solution for Injection (RPH Pharmaceuticals AB). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Betnesol Eye, Ear and Nose Drops Solution 0.1% w/v (RPH Pharmaceuticals AB). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Bettamousse 1 mg/g (0.1%) Cutaneous Foam (RPH Pharmaceuticals AB). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Brayfield A, Cadart C (eds). Betamethasone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/03/2025.Bufencon Injection (Y.S.P. Industries [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/03/2025.Celestone Soluspan Injection, Suspension (Organon LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/03/2025.Diprocel Ointment (Organon Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/03/2025.Diprosone 0.05% w/w Cream (Organon Pharma [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Diprosone 0.05% w/w Lotion (Organon Pharma [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Diprosone 0.05% w/w Ointment (Organon Pharma [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2025.Joint Formulary Committee. Betamethasone. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/03/2025.Topical Corticosteroids: Information on the Risk of Topical Steroid Withdrawal Reactions. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 10/03/2025.Topical Steroids: Introduction of New Labelling and a Reminder of the Possibility of Severe Side Effects, Including Topical Steroid Withdrawal Reactions. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 10/03/2025.Xorsoint 0.1% w/w Ointment (Xorix Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/03/2025.Xorsone 1:4 Cream (Xorix Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/03/2025.YSP Betamethasone Tablet 0.5 mg (Y.S.P. Industries [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/03/2025.
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