Tobracin-D Eye Ointment

Dexamethasone + Tobramycin Eye prep

(100 mg + 300 mg)/100 gm

OSL Pharma Limited.

Pack size	3 gm tube
Dispensing mode
Source
Agent
Retail Price	90.27 AED

Available as:

(100 mg + 300 mg)/100 ml - Eye Drops

Indications

Tobracin-D Eye Ointment is used for: Bacterial eye infections, Ocular inflammation, Pink eye

Adult Dose

Ophthalmic Ocular inflammation with suspected or confirmed bacterial infection Adult: As Eye Drops: 1-2 drops instilled into the conjunctival sac(s) 4-6 hourly. Dosage may be increased to every 2 hours during the initial 24-48 hr, decrease the frequency gradually as improvement is seen. As Ointment: Apply about ½ inch of ointment into the conjunctival sac(s) up to 3-4 times daily.

Child Dose

Ophthalmic Ocular inflammation with suspected or confirmed bacterial infection <2 years Safety and efficacy not established >2 years As Eye Drops: 1-2 drops instilled into the conjunctival sac(s) 4-6 hrly. Dosage may be increased to every 2 hrly during the initial 24-48 hr, decrease frequency gradually as improvement seen. As Ointment: Apply about ½ inch of ointment into the conjunctival sac(s) up to 3-4 times daily.

Renal Dose

Administration

Contra Indications

Viral infections of corneal and conjunctiva (e.g. epithelial herpes simplex keratitis, vaccinia, varicella). Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva Mycobacterial infection of the eye Fungal diseases of ocular structures Hypersensitivity to a component of the medication

Precautions

Vision may be temporarily blurred following dosing with this medication exercise care when operating machinery or driving a motor vehicle Do not touch dropper tip of bottle to any surface, as this may contaminate the contents The drug contains benzalkonium chloride, an antimicrobial preservative, soft contact lenses may absorb; contact lenses should not be worn during the use of this drug Sensitivity to topically administered aminoglycosides may occur; severity may vary from local effects to generalized reactions; discontinue use if sensitivity reactions occur Bacterial keratitis reported from inadvertent contamination of multiple-dose ophthalmic solution Immunosuppression resulting from prolonged use of steroid use may result in secondary bacterial and fungal infections; steroids may also mask symptoms of infections and enhance existing ocular infections Ocular hypertension and/or glaucoma reported with prolonged corticosteroid use Discontinue use if sensitivity reaction to tobramycin develops Corticosteroid use following cataract surgery may delay healing

Pregnancy-Lactation

Pregnancy There are no adequate and well-controlled studies in pregnant women; however, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation; treatment should be used during pregnancy only if potential benefit justifies potential risk to fetus; infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism Animal data Corticosteroids found to be teratogenic in animal studies; ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits; fetal growth retardation and increased mortality rates observed in rats with chronic dexamethasone therapy; reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus Lactation Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects; not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk; because many drugs are excreted in human milk, caution should be exercised when therapy is administered to a nursing woman

Interactions

Antagonistic effect w/ neostigmine and pyridostigmine. May potentiate the effect of warfarin and phenindione. Contraindicated (0) Serious (21) amphotericin B deoxycholate atracurium bacitracin BCG vaccine live bumetanide cholera vaccine cidofovir cisatracurium ethacrynic acid furosemide mannitol microbiota oral neomycin PO pancuronium quinidine rapacuronium rocuronium succinylcholine torsemide typhoid vaccine live vecuronium

Adverse Effects

Side effects of Dexamethasone + Tobramycin Eye prep : Frequency Not Defined Ocular lid itching and swelling Conjunctival erythema Elevation of intraocular pressure (IOP) with possible development of glaucoma Infrequent optic nerve damage Cataract formation Posterior subcapsular cataract formation Delayed wound healing Secondary infections Keratitis

Mechanism of Action

Tobramycin, an aminoglycoside antibiotic, has actions similar to that of gentamicin and is active against Staphylococci, Streptococci, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Dexamethasone, a synthetic fluorinated corticosteroid, has mainly glucocorticoid activity and suppresses inflammatory response.

Note

Tobracin-D (100 mg + 300 mg)/100 gm Eye Ointment manufactured by OSL Pharma Limited.. Its generic name is Dexamethasone + Tobramycin Eye prep. Tobracin-D is availble in Bangladesh. Farmaco BD drug index information on Tobracin-D Eye Ointment is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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