Fluocinolone/ Neomycin

Registered South African indications:

• Inflammatory dermatoses, including eczema, dermatitis, seborrhoea and intertrigo, where secondary bacterial 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
• History of hypersensitivity to neomycin
• Application to the external auditory canal of patients with perforated eardrums

Cautions

• Pregnancy
• Breastfeeding
• Elderly
• Prolonged use
• Application to face
• Application near eyes
• Plaque psoriasis
• Skin crease areas
• Concomitant use of contact lenses

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

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

Fluocinolone/ Neomycin
0.25mg/3500 i.u (per 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 infection is present or likely to occur

Fluocinolone/ Neomycin
0.25mg/3500 i.u (per 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 D (Neomycin)

Breastfeeding

• Caution; no information available (Neomycin)

Renal Impairment

• No dose adjustment recommended (Fluocinolone, Neomycin)

Hepatic Impairment

• No dose adjustment recommended (Fluocinolone, Neomycin)

Elderly

• Caution; no information available (Neomycin)

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

Neomycin
Central Nervous System Disorders

• Headache 

Genitourinary Disorders

• Nephrotoxicity 

Skin and Subcutaneous Tissue Disorders

• Dermatitis 
• Itching 

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity 

Sensory Disorders

• Ocular discomfort
• Keratitis
• Eye irritation
• Ototoxicity 

No information available

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. 

Neomycin
Neomycin is an aminoglycoside antibiotic which acts by binding to a specific protein on the 30S ribosomal subunit of the microbe. This results in faulty alignment or recognition with respect to mRNA and probably tRNA during initiation of microbial peptide chain formation. The mRNA is misread on the recognition region of the ribosome, resulting in the wrong amino acid being inserted into the peptide. This result in production of non-functional peptide chains.

COMBINATION PREPARATIONS

Fluocinolone Acetonide/ Neomycin

Cream (per g) 0.25mg/3500iu

• Synalar N (Glenmark) originator

Ointment (per g) 0.25mg/3500iu

• Synalar N (Glenmark) originator