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Ciprofloxacin HCl + Dexamethasone
|NAME||STRENGTH||PACK SIZE||DOSAGE FORM|
|Bactin-D||0.3% w/v + 0.1% w/v||5 ml||Eye + Ear drops|
Bactin-D is a combination of Ciprofloxacin and Dexamethasone. Ciprofloxacin is a synthetic fluoroquinolones antibacterial agent and Dexamethasone is a potent corticosteroid. The combination effectively resolves inflammation and infection in severe eye and ear condition.
Sterile Eye & Ear drops: Each ml contains Ciprofloxacin USP 3 mg as Ciprofloxacin hydrochloride and Dexamethasone BP 1 mg.
Indications And Uses
Eye: It is indicated for the treatment of steroid responsive inflammatory ocular conditions where bacterial infections or risk of bacterial infections co-exist. The combination can also be used for postoperative inflammation and any other ocular inflammation associated with infection. Ear: Bactin-D is also indicated in the treatment of ear infections accompanied by inflammation such as otitis external, acute and chronic otitis media etc. The combination may also be postoperatively in the ear.
Dosage And Administration
Eye: I or 2 drops instilled into the conjunctival sac every four to six hours. During the initial 24 to 48 hours the dosage may be safely increased to I to 2 drops every two hours. Care should be taken not to discontinue therapy prematurely. Ear: Instil 2-4 drops 3-4 times daily.
Eye: The most frequently reported drug-related adverse reactions seen with Ciprofloxacin are transient ocular burning or discomfort. Other reported reactions include: stinging, redness, itching, facial edema, photophobia, blurred vision, tearing, dryness and eye pain. Rare reports of dizziness have been received. Reactions due to steroid components are elevation of intraocular pressure with possible development of glaucoma, visual acuity or field defects, posterior subcapsular cataract formation and delayed wound healing. Ear: the most common adverse effects are: discomforts and eye pain. Other reported reactions are irritability, dizziness, erythema etc.
Topical corticosteroid therapy frequently induces intraocular hypertension in normal eyes and increases pressure in eyes with initially elevated pressure. Glaucoma has not always been reversible on cessation of corticosteroids treatment. The local administration of corticosteroids to the eyes of patients with bacterial, viral and fungal conjunctivitis, may mask evidence of progression of infection untill sight is lost. Corticosteroids may cause progression of the dendritic keratitis (Herpes simplex infection), resulting in irreversible clouding of the cornea. If the sign of hypersensitivity occur it should be discontinued.
Use In Pregnancy Lactation
Pregnancy: It should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. Nursing mothers: It is not known whether topical administration of Ciprofloxacin or Dexamethasone could result in sufficient systemic absorption to produce detectable quantities in milk. Because of the potential for unwanted effects 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.
Specific drug interaction studies have not been conducted with this combination.
Store between 15-30°C. Keep out of the reach of children.
Sterile Eye & Ear drops: Each plastic dropper bottle contains 5 ml sterile solution.