Rocipro Eye Drops
Ciprofloxacin 0.3% + Dexamethasone 0.1% E/E prep
(300 mg + 100 mg)/100 ml
Healthcare Pharmaceuticals Ltd.
| Pack size | 5 ml drop |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 45.00 AED |
Available as:
Indications
Rocipro Eye 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.
Adult Dose
For Eye:
1 drop to be instilled into conjunctival sac(s) every four to six hours.
During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.
For Ear:
Acute otitis externa: 4 drops instilled into the affected ear 2 times daily for 7 days.
Frequency should be decreased gradually or warranted in clinical signs. Care should be taken not to discontinue therapy prematurely.
Child Dose
For Eye:
1 drop to be instilled into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.
For Ear:
Acute otitis media in pediatric patients with tympanostomy tube: 4 drops instilled into the affected ear 2 times daily for 7 days.
Frequency should be decreased gradually or warranted in clinical signs.
Care should be taken not to discontinue therapy prematurely.
<6 months: Not recommended
Renal Dose
Administration
Contra Indications
Known hypersensitivity to any ingredient of the product.
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 subcapsular cataract formation.
Patients wearing contact lenses must not use the drops during the time the lenses are worn.
Discontinue if hypersensitivity or superinfection occurs
Reevaluate if no improvement is noted after 1 week
Prolonged use may result in overgrowth of non-susceptible bacteria and fungi
Otorrhea may occur; if it 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
Tendon inflammation and/or rupture reported with systemic fluoroquinolones; exposure resulting from otic administration is substantially lower than systemic therapy; discontinue at first sign of tendon inflammation or pain
Pregnancy-Lactation
Pregnancy
There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; because of minimal systemic absorption of ciprofloxacin and dexamethasone following topical otic administration, product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women
Animal reproduction studies have not been conducted; oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits not reported to cause fetal malformations; these doses were at least 200 times the recommended otic human dose (ROHD in mice, rats, and rabbits, respectively, based on body surface area (BSA); with dexamethasone, malformations have been observed in animal studies after ocular and systemic administration
Lactation
Not known whether ciprofloxacin and dexamethasone are present in human milk following topical otic administration
Published literature reports presence of ciprofloxacin in human milk after oral administration to lactating women; however, because of minimal systemic absorption of ciprofloxacin following topical otic administration, breastfeeding is not expected to result in exposure of infant to ciprofloxacin
Systemically administered corticosteroids appear in human milk; dexamethasone in breast milk could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects; however, not known whether topical otic administration of drug could result in systemic absorption that is sufficient to produce detectable quantities of dexamethasone in human milk
There are no data on effects of ciprofloxacin or dexamethasone on milk production
Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug combination and any potential adverse effects on breast-fed child from therapy
Interactions
May increase plasma concentrations of CYP1A2 substrates (e.g. clozapine, ropinirole, theophylline).
Enhances effect of oral anticoagulants (e.g. warfarin) and glibenclamide. Increased toxicity of methotrexate.
Plasma concentrations may be increased by probenecid.
Reduced absorption w/ oral multivitamins and mineral supplements containing divalent or trivalent cations (e.g. Fe, Zn, Ca) and antacids containing Al, Ca or Mg. Concomitant use w/ class IA antiarrhythmics (e.g. quinidine, procainamide), class III antiarrhythmics (e.g. amiodarone, sotalol), TCAs, macrolides and antipsychotics may result in additive effects on QT interval prolongation.
Concurrent use w/ corticosteroids may increase risk of severe tendon disorders. Increased risk of CNS stimulation w/ NSAIDs. Altered serum concentrations of phenytoin.
Potentially Fatal: Marked elevation in serum levels of tizanidine which is associated w/ potentiated hypotensive and sedative effect.
Adverse Effects
Side effects of Ciprofloxacin 0.3% + Dexamethasone 0.1% 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, conjunctivitis/keratitis, 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.
Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%). Others reported reactions are irritability, dizziness, erythema etc.
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.
Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.
Note
Rocipro (300 mg + 100 mg)/100 ml Eye Drops manufactured by Healthcare Pharmaceuticals Ltd.. Its generic name is Ciprofloxacin 0.3% + Dexamethasone 0.1% E/E prep. Rocipro is availble in Bangladesh.
Farmaco BD drug index information on Rocipro Eye Drops is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.