IBN SINA PHARMACEUTICALS LTD.
CIPROFLOXACIN + HYDROCORTISONE ACETATE
This is indicated in 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
Aural steroid & antibiotic combined preparations
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.
Eye: Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcer is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred. Eye: Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days. Ear: Four drops instilled into the affected ear twice daily for seven days. 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.
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 with oral multivitamins and mineral supplements containing divalent or trivalent cations (e.g. Fe, Zn, Ca) and antacids containing Al, Ca or Mg. Concomitant use with 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 with corticosteroids may increase risk of severe tendon disorders. Increased risk of CNS stimulation with NSAIDs. Altered serum concentrations of phenytoin. Potentially Fatal: Marked elevation in serum levels of tizanidine which is associated with potentiated hypotensive and sedative effect. Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
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.
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.
Pregnancy Category C+D.Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Lactation: Excretion in breast milk unknown; not recommended.
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.
Should be stored in cool and dry place.