Betamethasone/ Neomycin

Registered South African indications:

• Inflammatory conditions of the eye, ear or nose

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

Betamethasone
Contraindications 

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Infections of the eye
• Glaucoma
• Herpetic keratitis

Cautions 

• Breastfeeding
• Undiagnosed red eye
• Prolonged use
• Concomitant use of soft contact lenses
• Infants

Neomycin
Contraindications

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

Cautions

• Breastfeeding 
• Elderly 
• Prolonged use
• Concomitant use of contact lens 

Additional contraindications for this combination product

• Viral, fungal or purulent infections
• Ruptured tympanic membrane
• Neonates

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

Non-infected inflammatory conditions of the eye
-Non-specific keratitis
-Conjunctival allergies
-Acute uveitis
-Chronic uveitis

Betamethasone/ Neomycin
0.1/0.35 (g/100ml)

• Ophthalmic (dro): 1-2 drops, 1-2hrly until control achieved, then reduce frequency

Inflammatory conditions of the ear
-Otitis externa where bacterial infection present or probable

Betamethasone/ Neomycin
0.1/0.35 (g/100ml)

• Otic (dro): 2-3 drops, 2-3hrly until control achieved, then reduce frequency

Hayfever
Vasomotor or unseasonal allergic rhinitis
Steroid responsive inflammatory conditions where infection is suspected or present

Betamethasone/ Neomycin
0.1/0.35 (g/100ml)

• Nasal (dro): 2-3 drops, 8-12hrly

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

Non-infected inflammatory conditions of the eye
-Non-specific keratitis
-Conjunctival allergies
-Acute uveitis
-Chronic uveitis
Inflammatory conditions of the ear
-Otitis externa where bacterial infection present or probable
Hayfever
Vasomotor or unseasonal allergic rhinitis
Steroid responsive inflammatory conditions where infection is suspected or present

Betamethasone/ Neomycin
0.1/0.35 (g/100ml)

• Younger than 1 month: Not established for use
• Older than 1 month: See adult dosage

Reduce frequency in infants

Pregnancy

• Caution; positive evidence of risk
• Safety for use in pregnancy has not been established. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus
• There is a risk of foetal ototoxicity if aminoglycoside antibiotic preparations are administered during pregnancy

Breastfeeding

• Caution
• Safety for use during breastfeeding has not been established

Renal Impairment

• Caution; no dose adjustment recommended 
  Extreme caution is recommended when high dose topical treatment is given to small children or infants (increased risk of ototoxicity)

Hepatic Impairment

• Caution; no dose adjustment recommended
  Extreme caution is recommended when high dose topical treatment is given to small children or infants (increased risk of ototoxicity)

Elderly

• Caution; no information available

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

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

Betamethasone
Immune, Blood and Lymphatic System Disorders

• Hypersensitivity disorders

Sensory Disorders

• Increased intraocular pressure
• Optic nerve damage
• Reduced visual acuity
• Visual field defect
• Posterior subcapsular cataracts
• Globe perforation

Neomycin
Central Nervous System Disorders

• Headache

Genitourinary Disorders

• Nephrotoxicity 

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity 

Sensory Disorders

• Ocular discomfort 
• Keratitis 
• Eye irritation 
• Ototoxicity

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

Betamethasone

• No information available

Neomycin

• Other ophthalmic preparations

None routine

Betamethasone
Betamethasone sodium phosphate is a corticosteroid used topically in the treatment of inflammatory conditions. The anti-inflammatory action of this drug is thought to involve lipocortins, which are phospholipase A2 inhibitory proteins that control the biosynthesis of prostaglandins and leukotrienes.

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

Betamethasone/ Neomycin

Ear/Nose drops (per 100ml) 0.1g/0.35g

• Betnesol-N (Pharmacare) originator