Fluocinolone/ Clioquinol

Registered South African indications:

• Inflammatory dermatoses, including eczema, dermatitis, seborrhoea and intertrigo, where secondary bacterial and/or fungal infection is present or likely to occur

Contraindications

• Hypersensitivity to the active ingredient and any of its excipients
• Primary infections of the skin caused by bacteria, fungi or viruses (e.g Herpes, vaccinia or varicella) and in rosacea, acne, perioral dermatitis, napkin rash and anogenital pruritis

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment 
• Hepatic impairment 
• Elderly 
• Sensitive skin
• Prolonged use
• Application to face
• Application near eyes
• Plaque psoriasis
• Skin crease areas

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

Inflammatory dermatoses, including eczema, dermatitis, seborrhoea and intertrigo, where secondary bacterial and/or fungal infection is present or likely to occur

Fluocinolone/ Clioquinol
0.25/30 (mg/g)

• Topical (cre, oin): Apply small quantity sparingly to affected area(s), 2-3 times dly, massaged gently and thoroughly into the skin 

When an occlusive dressing is required, the affected area is first thoroughly cleansed, the preparation is then applied and covered with suitable plastic dressing. In some cases the application of hot, moist compresses may be an advantage

The preparation with rare exceptions should not be applied to the face. If applied this should not be for prolonged periods

The creams are particularly suitable for very inflamed or weeping surfaces. The ointments are suitable for dry scaly lesions

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

Inflammatory dermatoses, including eczema, dermatitis, seborrhoea and intertrigo, where secondary bacterial and/or fungal infection is present or likely to occur

Fluocinolone/ Clioquinol
0.25/30 (mg/g)

• Younger than 1 year: Use is not advised
• Older than 1 year: See adult dosage

Treatment of children should not normally extend over 5 days

Occlusion should not be used on children

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

Pregnancy

• FDA Pregnancy Category C (Fluocinolone, Clioquinol)

Breastfeeding

• Caution; no information available (Clioquinol)

Renal Impairment

• Caution; no information available (Clioquinol)

Hepatic Impairment

• Caution; no information available (Clioquinol)

Elderly

• Caution; no information available (Clioquinol)

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

Fluocinolone
Central Nervous System Disorders

• Benign intracranial hypertension

Endocrine and Metabolic Disorders

• Depressed hypothalamic-pituitary-adrenal axis
• Growth retardation
• Cushingoid state

Skin and Subcutaneous Tissue Disorders

• Atrophic skin changes
• Striae
• Skin thinning
• Loss of elasticity
• Dilatation of superficial blood vessels
• Telangiectasia
• Ecchymosis

Clioquinol
Endocrine and Metabolic Disorders

• Abnormal thyroid function tests  

Skin and Subcutaneous Tissue Disorders

• Rash
• Local irritation
• Discolouration of hair and nails 
• Staining of skin 

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity

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

Fluocinolone

• No information available

Clioquinol 

• Other hydroxyquinolines
• Quinoline derivatives 
• Iodides 

None routine 

Fluocinolone
Fluocinolone acetonide is a synthetic anti-inflammatory corticosteroid. It acts by causing vasoconstriction and suppression of cell membrane permeability, mitotic activity and by decreasing the immune response and the release of inflammatory mediators.

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

COMBINATION PREPARATIONS

Clioquinol/ Fluocinolone

Cream 30mg/0.25mg

• Synalar C (Glenmark) originator

Ointment 30mg/0.25mg

• Synalar C (Glenmark) originator