OFLOCIN-L EAR DROPS
COMPOSITION
Ofloxacin
0.3% w/v
Clotrimazole
IP 1% w/v
Beclomethasone
Dipropionate IP 0.025 % w/v
Lignocaine
Hydrochloride IP 2% w/v
Propylene
Glycol IP & Glycerine IP [Base]
Excipients
PHARMACOLOGY
Ø Oflocin-L Ear Drops provides an
antibacterial and antifungal along with an anti-inflammatory agent. It may be
used to prevent or treat ear infections.
Ø Oflocin-L Ear Drops has been
specially formulated to maintain the natural environment of the external ear
canal.
Ø Ofloxacin is a
fluoroquinolone that has a broad spectrum of activity against otic pathogens
but lacks the capacity for ototoxicity. Hence ofloxacin is preferred to aminoglycosides
for any application within the middle ear space. Ofloxacin exerts its
antibacterial activity by inhibiting DNA gyrase, a bacterial enzyme that is
essential in DNA replication, repair, deactivation and transcription.
Ø Clotrimazole is a synthetic imidazole
derivative. Clotrimazole is a broad-spectrum antifungal agent that has
fungicidal activity against fungi responsible for superficial mycotic
infections affecting the outer or middle ear including Candida, Microsporum,
Trichophyton. Clotrimazole inhibits fungal cytochrome P-450 synthesis of
ergosterol, which decreases fungal cell wall integrity. By inhibitingthe
biosynthesis of ergosterol for fungal cytoplasmic membrane, clotrimazole
inhibits fungal growth. Resistance to clotrimazole is very rare among the fungi
that cause superficial mycoses.
Ø Beclomethasone like other topical corticosteroids, has anti-inflammatory,
antipruritic, and vasoconstrictive properties. Corticosteroids like
Beclomethasone are thought to act by the induction of phospholipase A2
inhibitory proteins, collectively called lipocortins. It is postulated that
these proteins control the biosynthesis of potent mediators of inflammation such
as prostaglandins and leukotrienes by inhibiting their release from the common
precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids
by phospholipase Beclomethasone Dipropionate 0.025 % is a potent steroid as
compared with other topical corticosteroids. Beclomethasone Dipropionate is
often used in conjunction with acetic acid to reduce inflammation when infection
is present.
Ø Lignocaine Hydrochloride is a topical anaesthetic with a low index of
sensitization and toxicity. It helps reduce pain and stinging in the ear.
Oflocin-L
Ear Drops by virtue of its three active ingredients, ofloxacin, clotrimazole, and
beclometasone, has antibacterial, antifungal an
d
anti-inflammatory activity.
Oflocin-L
Ear Drops is ideally suited to control bacterial and/or fungal infections of the
ear.
Glycerin in Oflocin-L Ear Drops acts as a carrier for the
other ingredients. It soothes and moisturizes the skin. Glycerin also softens
cerumen due to its water-retaining and emollient properties.
The Propylene glycol is an inert,
non-irritant and viscous vehicle. It softens the cerumen and ensures prolonged
contact of the active ingredients with the surface of the ear canal.
Ø
INDICATIONS
Oflocin-L Ear Drops is recommended for the
treatment of superficial bacterial and fungal infections of the external
auditory canal and middle ear, caused by organisms susceptible to the action of
Ofloxacin and Clotrimazole.
Ø DOSAGE & ADMINISTRATION
ü Adults & Children: Apply 3-5
drops of Oflocin-L Ear Drops into the affected ear.
To apply,
tilt head to one side so that the ear is facing up. Then gently pull the ear
lobe backward and upward in case of adults and children older than 3 years
ü For children younger than 3
years, gently pull the ear lobe backward and down ♦ Apply 3-5 drops of Oflocin-L
Ear Drops into the ear. ♦ Keep head tilted for about 5 minutes to allow the drops
to penetrate lower into the ear canal. ♦ Gently pat excess material dripping
out of the ear using a clean cotton ball. ♦ Follow these instructions 3-4 times
a day for 7 to 14 days. If the ear canal is swollen consider inserting a wick
to allow topical treatment to travel along the length of the ear canal. The
wick should be saturated with the ear drops. The wick should be moistened for
the first 24 hours by occasionally adding a few drops on the wick. Remove the
wick after the first 24 hours and continue to instill 5 drops for Adults, and 3
drops for Children, of Oflocin-L Ear Drops 3 or 4 times daily thereafter. To
prevent infection of the other ear during treatment, Oflocin-L Ear Drops may be
used in the unaffected ear 3 times daily.
CONTRAINDICATIONS
♦ Patients
sensitive to Ofloxacin or other quinolones , or to any of the components of this medication
♦ Viral
infections of the ear
♦ This
preparation is not for ophthalmic use
PRECAUTIONS
♦ If a
favorable response does not occur in one week, discontinue the use of this preparation
and obtain cultures to guide further treatment.
♦ As with
other anti-infective preparations, prolonged use may result in over-
growth of
nonsusceptible organisms.
♦ Although
systemic side effects are not common with ototopical medications,
their
possible occurrence must be kept in mind.
♦ If
local irritation or sensitization occurs, discontinue this preparation and
institute
appropriate therapy.
♦ If
otorrhea persists after a full course of therapy, or if two or more episodes of
otorrhea occur within six months, further evaluation is recommended to
exclude
an underlying condition such as cholesteatoma, foreign body, or a
tumor
♦ Use of
corticosteroids, depending on dose and duration may result in
endogenous
steroid production inhibition following drug withdrawal. In patients
presently
receiving or recently withdrawn from corticosteroid treatments,
therapy
with a rapidly acting corticosteroid should be considered in especially
stressful
situations.
WARNINGS
NOT FOR
OPHTHALMIC USE.
NOT FOR
INJECTION.
Serious
and occasionally fatal hypersensitivity reactions, some following the first dose,
have been reported in patients receiving systemic quinolones, including ofloxacin.
If an allergic reaction to Oflocin-L Ear Drops is suspected, stop the medication.
Serious acute hypersensitivity reactions may require immediate emergency
treatment.
ADVERSE EFFECTS
The
following adverse reactions may be observed when using this product: itching, burning,
irritation, dryness, earache, headache, vertigo, dizziness, redness, folliculitis,
hypertrichosis, acneform eruptions and hypopigmentation.
PRESENTATION
Oflocin-L
Ear Drops is available in plastic dropper bottles of 5ml.
For more Detail Click Below Link
