Ciprocort Eye/Ear Drops
Ciprofloxacin 0.3% + Hydrocortisone Acetate 1% E/E prep
0.3%+1%
Drug International Ltd.
| Pack size | 10 ml drop |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 90.30 AED |
Indications
Ciprocort Eye/Ear Drops is used for:
Steroid responsive inflammatory ocular conditions, Otitis media, Otitis externa, Ocular inflammation associated with infection, Post-operative inflammation of ear and eye, Corneal Ulcers, Bacterial Conjunctivitis
Adult Dose
Eye:
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcer is 2 drops into the affected eye every 15 minutes for the first six hours and then 2 drops into the affected eye every 30 minutes for the remainder of the first day.
On the second day, instill 2 drops in the affected eye hourly.
On the third through the fourteenth day, place 2 drops in the affected eye every four hours.
Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis:
The recommended dosage regimen for the treatment of bacterial conjunctivitis:
1 or 2 drops instilled into the conjunctival sac(s) every two hours while awake for two days and 1 or 2 drops every four hours while awake for the next five days.
Ear: Acute Otitis Externa
4 drops instilled into the affected ear twice daily for seven days.
Child Dose
Eye:
Safety and effectiveness of this suspension in pediatric patients for eye application have not been established.
Ear:
Safety and effectiveness of this suspension in pediatric (6 months of age and older) patients for ear application have been established.
Renal Dose
Administration
Ear Drop: The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the suspension should be instilled. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear.
Contra Indications
Known hypersensitivity to any ingredient of the product.
Tympanic membrane perforation (nonsterile preparation)
Viral infections of external canal including varicella & herpes simplex infections
Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.
Precautions
Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation. Patients wearing contact lenses must not use the drops during the time the lenses are worn.
Prolonged use may result in bacterial or fungal overgrowth
Resistance to the product may develop
Pregnancy-Lactation
Pregnancy:
Teratogenic Effects:
Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and IV doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
Animal reproduction studies have not been conducted with Ciprofloxacin + Hydrocortisone. No adequate and well-controlled studies have been performed in pregnant women. Caution should be exercised when Ciprofloxacin + Hydrocortisone is used by a pregnant woman.
Lactation:
Ciprofloxacin is excreted in human milk with systemic use. It is not known whether ciprofloxacin is excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Interactions
Adverse Effects
Side effects of Ciprofloxacin 0.3% + Hydrocortisone Acetate 1% E/E prep :
The most frequently reported drug-related adverse reactions seen with Ciprofloxacin are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness and eye pain. Rare reports of dizziness have been received.
The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior sub-capsular cataract formation and delayed wound healing.
Mechanism of Action
Ciprofloxacin promotes breakage of double-stranded DNA in susceptible organisms and inhibits DNA gyrase, which is essential in reproduction of bacterial DNA.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
Note
Ciprocort 0.3%+1% Eye/Ear Drops manufactured by Drug International Ltd.. Its generic name is Ciprofloxacin 0.3% + Hydrocortisone Acetate 1% E/E prep. Ciprocort is availble in Bangladesh.
Farmaco BD drug index information on Ciprocort Eye/Ear Drops is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.