Betamethasone/ Gentamicin/ Tolnaftate/ Clioquinol

Registered South African indications:

• Variety of eczemas and other allergic and inflammatory steroid-responsive dermatoses, including pruritus

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Pregnancy
• Tuberculosis
• Viral lesions of the skin, particularly herpes simplex, vaccinia or varicella

Cautions

• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Children
• Long-term continuous treatment
• Use on face
• Use with occlusive dressings
• Use of large quantities
• Application to wide areas of the body or to damaged skin
• Secondary microbial skin infection
• Facial dermatoses
• Use near the eyes
• Use in nappy area in infants for flexural eruptions
• Psoriasis
• Contact with clothing

For additional pharmacological effects not accounted for by the action of the combination product 

Refer to the single agent monograph for Betamethasone
Refer to the single agent monograph for Gentamicin
Refer to the single agent monograph for Tolnaftate
Refer to the single agent monograph for Clioquinol

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

Variety of eczemas and other allergic and inflammatory steroid-responsive dermatoses, including pruritus 
- Where secondary bacterial and/or fungal infection is present or threatens

Betamethasone/ Gentamicin/ Tolnaftate/ Clioquinol
0.5/1/10/10 (mg/g)

• Topical (cre): Apply sufficient quantity to affected area, 8-12hrly; Treatment duration: According to patient response

Longer therapy of 2-4 weeks may be necessary in cases of tinea pedis 

No information available

These corticosteroid preparations should not be used in the nappy areas in infants for flexural eruptions, and ideally they should not be applied to infants and young children at all

No specific dosage recommendations for paediatric patients are provided in South African manufacturer recommendations

Pregnancy

• Contraindicated
• Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore, betamethasone/ gentamicin/ tolnaftate/ clioquinol should not be used during pregnancy

Breastfeeding

• Caution; no information available 

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available 

Elderly

• Caution; no information available 

Drugs in Sport

• Permitted - No warnings

For additional recommendations based on the individual active ingredients

Refer to the single agent monograph for Betamethasone
Refer to the single agent monograph for Gentamicin
Refer to the single agent monograph for Tolnaftate
Refer to the single agent monograph for Clioquinol

Central Nervous System Disorders

• Benign intracranial hypertension

Endocrine and Metabolic Disorders

• Depression of the hypothalamic-pituitary adrenal axis
• Growth retardation
• Cushingoid state

Skin and Subcutaneous Tissue Disorders

• Atrophic changes to the skin (long-term continuous use)
  - Thinning
  - Loss of elasticity
  - Dilatation of superficial blood vessels
  - Telangiectasiae
  - Ecchymoses
• Rosacea-like facies
• Pustular form of psoriasis

For additional pharmacological effects not accounted for by the action of the combination product 

Refer to the single agent monograph for Betamethasone
Refer to the single agent monograph for Gentamicin
Refer to the single agent monograph for Tolnaftate
Refer to the single agent monograph for Clioquinol

No information available

For additional pharmacological effects not accounted for by the action of the combination product 

Refer to the single agent monograph for Betamethasone
Refer to the single agent monograph for Gentamicin
Refer to the single agent monograph for Tolnaftate
Refer to the single agent monograph for Clioquinol

None routine 

For additional monitoring parameters not accounted for the combination product 

Refer to the single agent monograph for Betamethasone
Refer to the single agent monograph for Gentamicin
Refer to the single agent monograph for Tolnaftate
Refer to the single agent monograph for Clioquinol

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.

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

Tolnaftate
The exact mechanism of action of tolnaftate is unknown. It is thought to distort hyphae and stunt mycelial growth in susceptible fungi.

Clioquinol
Clioquinol is a hydroxyquinolone with broad-spectrum antifungal and anti-bacterial actions. The precise mechanism of clioquinol is not known.

Spectrum of activity: Candida albicans and some gram-positive organisms

COMBINATION PREPARATIONS

Tolnaftate/ Clioquinol/ Gentamicin/ Betamethasone

Cream (per g) 10mg/10mg/1mg/0.5mg

• Quadriderm (MC Pharma) originator