Diflucortolone/ Isoconazole

Registered South African indications:

Corticosteroid-responsive infections caused by:

• Fungi 

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

Diflucortolone
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Hypersensitivity to corticosteroids
• Infants < 1 year
• Viral, bacterial, fungal or parasitic skin infections
• Skin manifestations of tuberculosis or syphilis
• Post-vaccination eruptions
• Rosacea
• Pruritis without inflammation
• Perianal and genital pruritus
• Perioral dermatitis
• Acne vulgaris
• Ophthalmic application

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Children
• Prolonged use
• High doses
• Abrupt withdrawal
• Occlusive dressings
• Psoriasis
• Stasis dermatitis
• Chronic leg ulcers
• Application near eyes, face, groin, or axillae 
• Immunocompromised patients

Isoconazole
Contraindications 

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

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment 
• Hepatic impairment 
• Elderly 

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

Fungal infections accompanied by inflammation or eczematous skin conditions
- Skin, in the region of the hands, the interdigital spaces of the feet, inguinal and genital regions

Diflucortolone/ Isoconazole
1/10 (mg/g)

• Topical (cre): Apply small quantity to affected area, 12hrly; Treatment duration: Until regression of inflammation 

Continue with an isoconazole preparation without additional corticosteroid

See adult dosage

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

Pregnancy

• FDA Pregnancy Category Not Rated (NR) (Diflucortolone, Isoconazole)

Breastfeeding

• Caution (Diflucortolone, Isoconazole)

Renal Impairment

• Caution; no information available (Isoconazole)

Hepatic Impairment

• Caution; no information available (Isoconazole)

Elderly

• Caution; no information available (Isoconazole)

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warning

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

Diflucortolone
Central Nervous System Disorders

• Steroid withdrawal syndrome

Cardiovascular Disorders

• Hypertension

Endocrine and Metabolic Disorders

• Cushingoid appearance
• Decreased plasma cortisol
• Glycosuria
• Hypothalamic-pituitary-adrenal axis suppression
• Hyperglycemia
• Obesity
• Weight gain

Musculoskeletal Disorders

• Decreased linear skeletal growth rate
• Osteoporosis

Skin and Subcutaneous Tissue Disorders

• Application site irritation
• Application site pain
• Acneiform eruption
• Alopecia
• Atrophic striae
• Contact dermatitis
• Dermatitis
• Dyschromia
• Epidermal thinning
• Erythema
• Folliculitis
• Hair breakage
• Hypertrichosis
• Miliaria
• Perioral dermatitis
• Pruritus
• Pustular psoriasis
• Skin atrophy
• Skin pain
• Skin rash
• Telangiectasia
• Urticaria
• Wrinkling of skin
• Xeroderma

Immune, Blood and Lymphatic System Disorders

• Local hypersensitivity reactions
• Immunosuppression

Sensory Disorders

• Cataract
• Glaucoma

Isoconazole
Central Nervous System Disorders

• Headache

Genitourinary Disorders

• Pelvic cramps 
• Vaginal irritation 

Skin and Subcutaneous Tissue Disorders

• Contact dermatitis 
• Burning of skin

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

Diflucortolone

• Aldesleukin
• Hyaluronidase

Isoconazole

• Miconazole
• Econazole
• Tioconazole

None routine. Specific cases may require

• Adrenocorticotropic hormone stimulation test
• Growth (children)

Diflucortolone
Diflucortolone is a topical corticosteroid of intermediate potency. Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties likely as a result of the induction of phospholipase A2 inhibitory proteins, which results in the decreased activity of endogenous chemical mediators of inflammation. 

Isoconazole
Isoconazole has a broad spectrum of activity against dermatophytes, pathogenic yeasts, pathogenic filamentous fungi, gram positive bacteria and trichomonads. It damages the fungal cell membrane by inducing rapid reduction in ATP concentrations. 

COMBINATION PREPARATIONS 

Isoconazole/ Diflucortolone

Cream (per g) 10mg/1mg

• Maxaderm (Cipla)
• Travocort (Bayer) originator