Eyebetsol N Betomethosone and Neomycin Eye and Ear Drops

EYEBETSOL-N
Betomethosone and Neomycin Eye/Ear Drops.

For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.

 

COMPOSITION

Betamethasone Sodium Phosphate BP 0.1%w/v

Neomycin Sulphate BP eq. to Neomycin: 0.5% w/v

Thiomersal BP 0.005%w/v

(As Preservative)

 

INDICATIONS

Betamycin-N is indicated in the treatment of a variety of eye infections caused by sensitive organisms. Eye conditions. Non-infected inflammatory conditions such as non-specific keratitis, conjunctival allergies and acute or chronic uveitis.

 

MECHANISM OF ACTION

Betamethasone Sodium Phosphate is a glucocorticoid receptor agonist. The anti-inflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienea. Betamethasone Sodium Phosphate binds to plasma transcortin, and it becomes active when it is not bound to transcortin.

Neomycin actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30 S subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30 S subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.

 

PHARMAKINETICS

Betamycin-N eye/ear drop contain the water-soluble corticosteroid betamethasone sodium phosphate, and have the advantage of containing no steroid particles to cause irritation. This is of particular value in ophthalmic work. Neomycin sulphate is an antibiotic, active against many strains of Gram-positive and Gram-negative bacteria including Staph. aureus, E. coli, Klebsiella spp., H. influenzae, S. typhi, Shigella and Mycobacterium tuberculosis. It is ineffective against fungi and viruses.

Minimum inhibitory concentration ranges from 0.5-10 micrograms per mL.

 

DOSAGE

One or two drops to be instilled into the eye every one or two hours until control is achieved, when the frequency may be reduced.

 

ADVERSE EFFECTS

Eye/ear preparations containing corticosteroids can cause a serious rise in intra-ocular pressure in a small percentage of the population. A milder rise in ocular tension may be experienced by a larger proportion of subjects if treatment is continued for no longer than a few weeks. Neomycin may cause irreversible partial or total deafness.

Hypersensitivity reactions usually of the delayed type may occur. Resistance to Neomycin and other amino-glycosides is acquired.

 

CONTRAINDICATIONS

The use of Betamycin-N is contra-indicated in sensitive persons.

 

SPECIAL PRECAUTION

Do not administer to ‘red eyes’ until a definitive diagnosis is made. Treatment with corticosteroid preparations should not be prolonged without regular review.

 

STORAGE

Store in a cool, dry and dark place.

 

SHELF LIFE

36 Months.

 

PRESENTATION

10mI vial.

 

KEEP OUT OF REACH OF CHILDREN.

NAFDAC REG. No. : A4-8135

 

Marketed by

AL-TINEZ PHARMA Ltd.

18, Jones Street, Ebute Metta,

Lagos, NIGERIA.

 

Manufactured In India by

ALPA LABORATORIES LTD.

33/2, A.B. Road,

Pigdamber-453 446.

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