
OTOBIOTIC EAR DROPS
KSh 280.00
Otobiotic ear drops provide an antibacterial and antifungal along with anti-inflammatory agent. It may be used to prevent or treat ear infections.
Description
Composititon
Ciprofloxacin HCL B.P 0.3% w/v
Beclomethasone B.P 0.025% w.v
Clotrimazole B.P 1% w.v
Lignocaine Hydrochloride B.P 2%
in Glycerin B.P and Propylene Glycol base
Ciprofloxacin is a fluoroquinolone that has a broad spectrum of activity against otic pathogens but lacks the capacity for ototoxicity. Hence ciprofloxacin is preferred to amino glycosides for any application within the middle ear space. It exerts its antibacterial activity by inhibiting DNA gyrase, a bacteria enzyme that is essential in DNA replication, repair, deactivation and transcription.
Beclomethasone has anti-inflammatory, antipruritic and vasoconstrictive properties.
Clotrimazole is a synthetic imidazole derivative; it is a broad-spectrum antifungal agent responsible for superficial mycotic infections affecting the outer or middle ear including Candida, Microsporum and Trichophyton.
Clotrimazole also has activity against certain gram-positive bacteria such as streptococci and staphylococci.
Lignocaine HCL is a topical anesthetic with a low index of sentitization and toxicity so helps reduce pain and stinging in the ear.
Indications
Otobiotic ear drops by virtue of its three active ingredients has antibacterial, antifungal, and anti-inflammatory activity of the ear. It is recommended for the treatment of superficial bacterial and fungal infections of the external auditory canal caused by organism susceptible to the action of ciprofloxacin and clotrimazole.
Dosage and administration
Adults and Children
- Apply 3-5 drops of OTOBIOTIC 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
- For children younger than 3 years gently pull ear lobe backward and down apply 3-5 drops of otobiotic 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 7-14 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, otobiotic 3 to 4 times daily thereafter.
Contraindications
- Patients sensitive to ciprofloxacin or other quinolones, or to any of the components of this medication.
- Viral infections of the ear.
- This preparation is not for ophthalmic use.
- Patients known or suspected perforation of tympanic membrane or where there is risk of perforation.
Precautions
- If a favorable response doesn’t 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 overgrowth of non-susceptible organisms.
- Although systemic side effects are not common with oto-topical 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 ciprofloxacin. If an allergic reaction to otobiotic drops is suspected stop the treatment. The reaction may require immediate emergency treatment.
Use in special population.
PREGNANCY AND LACTATION
Safety during pregnancy and lactation has not been established. Studies have shown that corticosteroids may induce fetal abnormalities in pregnant animals. The relevance of this finding to human use has not been elucidated. It is not known whether the active substances pass into breast milk when applied topically. Therefore the potential benefit of this product during pregnancy or lactation should be weighed against possible hazard to the fetus or the nursing infant.
PEDIATRICS USE
Safety and efficacy of ciprofloxacin as ear drops have been demonstrated in pediatric patients of the following ages for the listed indications;
- Six months and older: Otitis externa with intact tympanic membranes.
- One year and older: acute otitis media with tympanostomy tubes.
- Twelve years and older: chronic supportive otitis media with perforated tympanic membranes.
Safety and efficacy in pediatric patients below these ages have not been established.
Although no data is available on patients less than 6 months old there is no known safety.
Concerns or differences in the disease process in this population that will preclude use of this product.
No changes in hearing function occured in 30 subjects treated with otic ciprofloxacin and tested for audiometric parameters. Although quinolones, including ciprofloxacin, have been shown to cause arthropathy in immature animals after sytemic administration, young growing guinea pigs dosed in the middle ear with 0.3% ciprofloxacin solution for one month showed no systemic effects.
ADVERSE EFFECTS
The following adverse effects may be observed when using this product.
Itching, burning sensation, irritation, earache, headache, vertigo dizziness, redness, hypertrichosis, acne form eruptions and hypo pigmentation.
Manufactured by: Biopharma LTD, Nairobi Kenya.
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