Glaxosmithkline Pakistan Limited

Otosporin Ear Drop 5Ml

Otosporin Ear Drop 5Ml

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SPECIFICATION

Requires Prescription (YES/NO)

Yes

Generics

Polymyxin B , Neomycin , Hydrocortisone

Used For

Ear Infection

How it works

It is a bactericidal preparation active against all the pathogens commonly found in bacterial infections of the ear. Polymixin B is bactericidal against a wide range of gram negative bacilli including Pseudomonas Spp., Escherichia coli, Enterobacter Spp., Klebsiella Spp., and Haemophilus influenzae. It exerts a bactericidal effect by binding to acid phospholipids in the cell wall and membranes of the bacterium, thereby rendering ineffective the osmotic barrier normally provided by the cell membrane. This leads to escape of the cell contents and the death of the organism.Neomycin sulphate is bactericidal against a wide range of gram positive and negative bacterial pathogens including Staphylococci, Streptococci, Escherichia, Enterobacter, Klebsiella, Haemophilus, Proteus, Salmonella and Shigella species. It is also active against some strains of the Pseudomonas aeruginosa and against Mycobacterium tuberculosis and Neisseria gonorrhoea. Neomycin exerts its bactericidal effect by interfering with the protein synthesis of susceptible organisms.

USAGE AND SAFETY

Dosage

Polymyxin B , Neomycin , Hydrocortisone

Side Effects

Stinging and burning .

Drug Interactions

Following significant systemic absorption, both neomycin sulphate and polymyxin b sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.

Indication

They are indicated for the treatment of otitis externa due to, or complicated by, bacterial infection .

When not to Use

Contra-indicated in patients in whom perforation of the tympanic membrane is known or suspected. Due to the known ototoxic and nephrotoxic potential of neomycin sulphate, use of these Ear Drops in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur. Contra-indicated in patients who have demonstrated allergic hypersensitivity to any of the components of the preparation or to crosssensitising substances such as framycetin, kanamycin, gentamicin and other related antibiotics. Contra-indicated in the presence of untreated viral, fungal and tubercular infections. A possibility of increased absorption exists in very young children, thus these Ear Drops are not recommended for use in neonates and infants (up to 3years). In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature .

PRECAUTIONS

Precaution

Prolonged, unsupervised, use should be avoided as it may lead to irreversible partial or total deafness, especially in the elderly and in patients with impaired renal function .

WARNINGS

Warning 1

Occasionally, delayed hypersensitivity to corticosteriods may occur. Treatment with topical steroid antibiotic combinations should not be continued for more than seven days in the absence of any clinical improvement, since prolonged use may lead to extension of infection due to the masking effect of the steroid. Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.

Warning 2

Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity; neomycin and polymyxin B sulphate have nephrotoxic potential and polymyxin B sulphate has neurotoxic potential .

Warning 3

All topically active corticosteroids possess the potential to suppress the pituitary-adrenal axis following systemic absorption. Development of adverse systemic effects due to the hydrocortisone component of these Ear Drops is considered to be unlikely, although the recommended dosage should not be exceeded, particularly in infants.

ADDITIONAL INFORMATION

Pregnancy category

Always consult your physician before using any medicine.

Storage (YES/NO)

Store this medicine at room temperature, away from direct light and heat.

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