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Ocupol D Drops and Ointment PDF

OCUPOL-D is an eye/ear drop and ointment combination containing polymyxin B sulfate, chloramphenicol, and dexamethasone. It is indicated for treating surface ocular infections, external ear infections, and steroid-responsive inflammatory eye conditions where risk of infection exists. The antibiotics are active against common pathogens while dexamethasone suppresses inflammation. Prolonged use may cause elevated pressure or cataracts, so monitoring is advised. Adverse effects include irritation, dryness, and secondary infections.

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211 views3 pages

Ocupol D Drops and Ointment PDF

OCUPOL-D is an eye/ear drop and ointment combination containing polymyxin B sulfate, chloramphenicol, and dexamethasone. It is indicated for treating surface ocular infections, external ear infections, and steroid-responsive inflammatory eye conditions where risk of infection exists. The antibiotics are active against common pathogens while dexamethasone suppresses inflammation. Prolonged use may cause elevated pressure or cataracts, so monitoring is advised. Adverse effects include irritation, dryness, and secondary infections.

Uploaded by

Anushka Shrestha
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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OCUPOL-D EYE/EAR

DROPS & OINTMENTS

Composition

Each ml of OCUPOL-D Eye/Ear Drops contains:


Polymyxin-B sulfate 5000 IU
Chloramphenicol 4 mg
Dexamethasone sodium phosphate 1 mg

Each gm of OCUPOL-D Ointment contains:


Polymyxin-B sulfate 10000 IU
Chloranphenicol 10 mg
Dexamethasone sodium phosphate 1 mg
In a sterile base

Pharmacology
The anti-infective components of OCUPOL- D are intended to provide
action against specific organisms susceptible to them. Polymyxin-B, a
cyclic lipopeptide antibiotic, is bactericidal for a variety of Gram-negative
organisms, especially Pseudomonas aeruginosa. It increases the
permeability of the bacterial cell membrane by interacting with the
phospholipid components.

Chloramphenicol is a broad-spectrum antibiotic originally isolated from


Streptomyces venezuelae. It is primarily bacteriostatic and acts by
inhibition of protein synthesis. It has been noted that chloramphenicol is
found in measurable amounts in the aqueous humor following local
application to the eye. Development of resistance to chloramphenicol can
be regarded as minimal for Staphylococci and many other species of
bacteria.

Corticosteroids suppress the inflammatory response to a variety of agents.


Since they may inhibit the body's defense mechanism against infection, a
concomitant antimicrobial drug may be warranted

The combination of OCUPOL-D is rarely irritating, and its absorption


from the intact skin or mucous membrane is insignificant. The incidence
of skin sensitization to this combination has been shown to be low on
normal skin.

Polymyxin-B sulfate and chloramphenicol together are considered active


against Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae,
Enterobacter aerogenes, Haemophilus influenzae, Staphylococcus aureus,
Streptococcus species, Moraxella lacunate and Neisseria species.

The combination of OCUPOL-D has the advantage of greater patient


compliance in terms of both the dosage and convenience.
Indications
OCUPOL-D is indicated for,
· The treatment of, surface ocular infections involving the conjunctiva
and/or cornea caused by susceptible organisms.

· For the treatment of superficial bacterial infections of the external


auditory canal caused by organisms susceptible to the action of the
antibiotics, and for the treatment of infections of mastoidectomy and
fenestration cavities caused by organisms susceptible to the antibiotics.

· For steroid-responsive inflammatory ocular conditions for which a


corticosteroid is indicated and where bacterial infection or a risk of
bacterial ocular infection exists. Ocular steroids are indicated in
inflammatory conditions of the palpebral and bulbar conjunctiva, cornea
and anterior segment of the globe where the inherent risk of steroid use
uncertain infective conjunctivitis’s is accepted to obtain a diminution in
edema and inflammation. They are also indicated in chronic anterior
uveitis and corneal injury from chemical, radiation or thermal burns, or
penetration of foreign bodies.

Contraindications
The use of OCUPOL-D is contraindicated in patients with hypersensitivity to
any ingredient of the formulations.

The use of OCUPOL-D is also contraindicated in epithelial herpes


keratitis (dendritic keratitis), vaccinia, varicella other viral diseases of the
cornea and conjunctiva, mycobacterial infections of the eye and fungal
diseases of ocular structures.

Precautions
The prolonged use of antibiotics may occasionally result in
overgrowth of nonsusceptible organisms, including fungi. If new
infections appear the drug should be discontinued and appropriate
measures instituted.

In all serious infections the topical use of OCUPOL-D should be


supplemented by appropriate systemic medication.

OCUPOL -D should be used with care in cases of perforated eardrum


and in longstanding cases of chronic otitis media due to the possibility of
ototoxicity.

Prolonged use of OCUPOL-D may result in glaucoma and posterior


subcapsular cataract formation. If these products are used for 10 days or
longer, intra-ocular pressure should be routinely monitored even though
it may be difficult in children and uncooperative patients.

Pregnancy & Lactation


There are no adequate and well-controlled studies in pregnant women.
Corticosteroids should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus. Steroids appear in human
milk following oral administration of the drug. Since systemic absorption
may occur on topical application, caution should be exercised when
OCUPOL-D is used by a nursing woman.

Adverse Reactions
The adverse reactions reported with topical corticosteroids especially
under occlusive dressings include burning sensation, itching, irritation,
dryness, folliculitis, hypertrichosis, acneiform eruptions,
hypopigmentation, perioral dermatitis, allergic contact dermatitis,
maceration of the skin, secondary infection, skin atrophy, striae and
miliaria. Blood dyscrasias have been reported in association with the use
of chloramphenicol.

Dosage & Administration


The usual recommended dose of OCUPOL-D Eye Drops is 2 drops to be
instilled in the affected eye every 3 hours. Administration should be
continued day and night for the first 48 hours, after which the interval
between applications may be increased. Treatment should be continued
for at least 48 hours after the eye appears normal.

The usual recommended dose of OCUPOL-D Ear Drops in adults is 4


drops of the suspension to be instilled into the affected ear tid or qid. The
dose in infants and children is 3 drops to be instilled into the affected ear
tid or qid.

The usual recommended dose of OCUPOL-D Ointment is half an inch


ribbon, bid to tid.

Presentation
OCUPOL-D Eye/Ear Drops is available in 5 ml lupolen vial
OCUPOL-D Ointment is available in a tube of 5 g.

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