Betamethasone/ Gentamicin

Registered South African indications:

Corticosteroid-responsive dermatoses with secondary infection caused by:

• Most Gram-negative aerobic bacilli 
• Methicillin-sensitive Staphylococcus aureus

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Gentamicin
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product

Cautions

• Pregnancy
• Breastfeeding
• Prolonged use

Betamethasone
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Herpes simplex, vaccinia, varicella or tuberculosis of skin
• Rosacea
• Acne vulgaris
• Pruritis without inflammation
• Perianal and genital pruritis
• Perioral dermatitis
• Widespread plaque psoriasis
• Prolonged use in diabetic patients
• Untreated cutaneous infections
• Long term use in patients with tuberculosis

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Occlusive dressings
• Application to face and eyes
• Psoriasis
• Skin crease areas
• Chronic leg ulcers

Forms avail. in SA and covered in this monograph: cre, oin

Corticosteroid-responsive dermatoses with secondary infection caused by most Gram-negative aerobic bacilli; Methicillin-sensitive Staphylococcus aureus

Betamethasone/ Gentamicin
0.5/1.7 (mg/g)

• Topical (cre, oin): Apply to affected area, 12hrly

No information available

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• FDA Pregnancy Category Not Rated (NR) (Gentamicin)

Breastfeeding

• Caution; not recommended (Betamethasone)

Renal Impairment

• Caution; no dose adjustment recommended (Betamethasone)

Hepatic Impairment

• Caution; no dose adjustment recommended (Betamethasone)

Elderly

• Caution; no dose adjustment recommended (Betamethasone)

Drugs in Sport

• Permitted - No warning

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Gentamicin
Skin and Subcutaneous Tissue Disorders

• Erythema 
• Pruritus

Betamethasone
Central Nervous System Disorders

• Benign intracranial hypertension

Cardiovascular Disorders

• Hypertension

Endocrine and Metabolic Disorders

• Hypothalamic-pituitary-adrenal axis suppression
• Cushingoid features 
• Growth retardation in children
• Cushing's syndrome
• Delayed weight gain
• Osteoporosis
• Hyperglycaemia
• Glucosuria
• Decreased endogenous cortisol levels

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Skin thinning
• Dilation of superficial blood vessels
• Loss of elasticity
• Ecchymoses
• Purpura
• Trichorrhexis
• Pruritus
• Local skin burning
• Allergic contact dermatitis 
• Erythema
• Rash
• Urticaria
• Pustular psoriasis
• Skin dryness
• Striae
• Pigmentation changes
• Hypertrichosis

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Opportunistic infection

Sensory Disorders

• Raised intraocular pressure
• Corneal ulcers
• Visual impairment
• Cataract
• Glaucoma

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Gentamicin

• No information available

Betamethasone

• CYP3A4 inhibitors

None routine

Gentamicin
Gentamicin interferes with bacterial protein synthesis by binding to 30S ribosomal subunit resulting in a defective bacterial cell membrane.

Betamethasone
Betamethasone is a glucocorticoid receptor agonist, which acts as an anti-inflammatory agent via multiple mechanisms to inhibit late phase allergic reactions. The anti-inflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition of arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes.

COMBINATION PREPARATIONS

Betamethasone/ Gentamicin

Cream (per g) 0.5mg/1mg

• Diprogenta (MSD) originator

Ointment (per g) 0.5mg/1mg

• Diprogenta (MSD) originator