Hydrocortisone/ Polymyxin B Sulphate/ Neomycin

Registered South African indications:

• Otitis externa

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Hypersensitivity to framycetin, kanamycin, gentamicin and other related antibiotics
• Perforation of the tympanic membrane
• Large quantities or large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur
• Untreated viral, fungal and tubercular infections
• Children < 3 years

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Elderly
• Prolonged use
• High doses
• Immediate pre- and post-operative period 

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

Otitis externa
- Due to, or complicated by, bacterial infection

Hydrocortisone/ Polymyxin B Sulphate/ Neomycin
10mg/10000 IU/3400 IU (per ml)

• Otic (dro): Apply 3-4 drops into affected ear(s), 6-8hrly

This is best accomplished with the patient lying down with the affected ear turned upwards, remaining in this position for a few minutes

An alternative method of administration consists of introducing a gauze or cotton wick into the external auditory canal; this should be kept constantly saturated with the solution, and may be left in place for 24 to 48 hours

Paed. forms avail. in SA and covered in this monograph: dro

Otitis externa
- Due to, or complicated by, bacterial infection

Hydrocortisone/ Polymyxin B Sulphate/ Neomycin
10mg/10000 IU/ 3400 IU (per ml)

• Younger 3 years: Not established for use
• Older than 3 years: Otic (dro): Apply 2-3 drops into affected ear(s), 6-8hrly

This is best accomplished with the patient lying down with the affected ear turned upwards, remaining in this position for a few minutes

An alternative method of administration consists of introducing a gauze or cotton wick into the external auditory canal; this should be kept constantly saturated with the solution, and may be left in place for 24 to 48 hours

Pregnancy

• FDA Pregnancy Category C

Breastfeeding

• Caution; not recommended

Renal Impairment

• Caution; dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Headache

Skin and Subcutaneous Tissue Disorders

• Hypersensitivity at the application site
• Application site reaction
• Local exfoliative dermatitis
• Skin atrophy
• Telangiectasia
• Striae
• Exacerbation of underlying skin conditions

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reaction

Sensory Disorders

• Otic stinging
• Otic burning

Neuromuscular blocking agents

None routine

Hydrocortisone
Hydrocortisone inhibits the release of arachadonic acid from the cell membrane and thus interferes with the initiation of the inflammatory response. It may depress the formation, release and activity of endogenous chemical mediators of inflammation. It has anti-inflammatory, antipruritic, antiallergic and vasoconstrictive effects. 

Polymyxin B Sulphate
Polymyxin B has a bactericidal action against almost all gram-negative bacilli, it interacts with the lipopolysaccharide of the cytoplasmic outer membrane of Gram-negative bacteria, altering membrane permeability and causing cell death. 

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. This results in the production of non-functional peptide chains. 

COMBINATION PREPARATIONS

Hydrocortisone/Polymyxin B Sulphate/Neomycin

Drops (per ml) 10mg/10000 IU/3400 IU

• Otosporin (GSK)