Tobadexa

Tobadexa

tobramycin + dexamethasone

Manufacturer:

Samchundang

Distributor:

AA Medical
Full Prescribing Info
Contents
Tobramycin, dexamethasone.
Description
Each mL contains: Tobramycin 3 mg (potency), dexamethasone 1 mg.
Excipients/Inactive Ingredients: Sodium chloride, benzalkonium chloride, boric acid sodium borate, polysorbate 80, hydrochloric acid, sterile purified water.
Indications/Uses
TOBADEXA Eye drops is indicated for steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where there is superficial bacterial ocular infection.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid in certain infective conjunctivitis is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation of thermal burns or penetration of foreign bodies.
Dosage/Direction for Use
One or two drops instilled into conjunctival sac every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two every two hours. Frequency should be decreased gradually as warranted by improved in clinical signs. Care should be taken not to discontinue therapy prematurely.
Overdosage
Clinically apparent signs and symptoms of an overdose of TOBADEXA eye drop may be similar to adverse reaction effects seen in some patients.
Contraindications
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal disease of ocular structures. Hypersensitivity to a component of the medication. Corneal ulcer.
Special Precautions
General cautions: Prolonged use may result in super infection of nonsusceptible organisms including fungi.
Cross-sensitivity to other aminoglycoside antibiotics may occur.
If re-infected, appropriate measures are instituted.
Cautions on application: Ophthalmic use only.
When using the eye drops the patient should take care not to touch the dropper tip to the eye.
Don't have for common use in order to avoid contaminating the eye drops.
Use In Pregnancy & Lactation
Pregnancy: There are no adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mother: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, a decision should be considered to discontinue nursing temporarily while using TOBADEXA eye drop.
Adverse Reactions
Hypersensitivity and localized adverse reactions such as lid itching and swelling and conjunctival erythema may occur. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity dose occurs, discontinue use.
Use of this drug may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation, ocular perforation, and delayed wound healing.
In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
Fungal infections of the cornea are particularly prone to develop coincidentally with long term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.
Symptoms of an overdosage of TOBADEXA are punctuate keratitis, erythema, increased lacrimation, edema and lid itching.
Inform the doctor in case of any adverse reactions related to drug use.
Drug Interactions
No report so far.
Storage
Store in a tight container at a room.
Shelf-Life: 24 months from manufacturing date. Do not use after 1 month from opening date.
ATC Classification
S01CA01 - dexamethasone and antiinfectives ; Belongs to the class of corticosteroids in combination with antiinfectives. Used in the treatment of eye diseases.
Presentation/Packing
Eye drops (susp) 5 mL x 1's.
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