Tobramycin + dexamethasone


Full Generic Medicine Info
Dosage/Direction for Use

Ophthalmic
Ocular inflammation with suspected or confirmed bacterial infection
Adult: Available preparations: Tobramycin 3 mg and dexamethasone 1 mg per mL of eye drop susp Tobramycin 3 mg and dexamethasone 0.5 mg per mL of eye drop susp Tobramycin 3 mg and dexamethasone 1 mg per gram of eye ointment As eye drop susp: Instil 1-2 drops into the conjunctival sac(s) of the affected eye(s) 4-6 hourly; may increase to 1-2 drops 2 hourly during the initial 24-48 hours then gradually decrease the frequency as signs and symptoms improve. As eye ointment: Apply a small amount (approx half an inch ribbon) into the conjunctival sac(s) of the affected eye(s) up to 3-4 times daily.
Child: ≥2 years Same as adult dose. Dosage recommendations may vary among countries or individual products. Refer to specific product guidelines.
Contraindications
Hypersensitivity to tobramycin or dexamethasone. Viral infections of cornea and conjunctiva (e.g. epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella), mycobacterial eye infection, fungal diseases of ocular structure, untreated parasitic eye infection, untreated purulent eye infection, post-uncomplicated removal of foreign body.
Special Precautions
Patients with hypersensitivity to other aminoglycoside antibiotics, known or suspected neuromuscular disorder (e.g. myasthenia gravis, Parkinson's disease), glaucoma, history of ocular herpes simplex, diabetes. Children. Pregnancy and lactation. Patient Counselling Wearing of contact lenses during treatment of eye infection or inflammation is not recommended. If the use of contact lenses is allowed by the physician, remove contact lenses before administration and reinsert after 15 minutes. This drug may cause temporary blurring of vision, if affected, do not drive or operate machinery. Monitoring Parameters Monitor intraocular pressure especially if used for >10 days and in patients with glaucoma; signs and symptoms of secondary infection. Examine the patient with the aid of magnification such as slit lamp biomicroscopy or fluorescein staining (if appropriate) before initial prescription and renewal of medication.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. erythema, pruritus, urticaria, skin rash, anaphylaxis, anaphylactoid or bullous reactions); secondary ocular infection (e.g. fungal infection), ocular hypertension or glaucoma, optic nerve injury, visual defects in acuity and field of vision, posterior subcapsular cataracts formation (prolonged use); central serous chorioretinopathy; overgrowth of non-susceptible organisms including fungi (prolonged use); slow corneal wound healing; cornea or scleral perforations (in diseases which thin the cornea or sclera). Eye disorders: Eye pain, eye pruritus, ocular discomfort, conjunctival oedema, eye irritation, eye allergy, blurred vision, dry eye, ocular hyperaemia, mydriasis, increased lacrimation, foreign body sensation. Gastrointestinal disorders: Dysgeusia. Investigations: Increased intraocular pressure. Nervous system disorders: Headache, dizziness. Respiratory, thoracic and mediastinal disorders: Rhinorrhoea, laryngospasm.
Drug Interactions
May increase risk for toxicity with systemic aminoglycosides. Tobramycin: May be inactivated if used concomitantly with topical β-lactam antibiotic. Dexamethasone: May increase the potential for corneal healing problems with topical NSAIDs. May increase risk of adrenal suppression or Cushing's syndrome with CYP3A4 inhibitors (e.g. ritonavir and cobicistat).
Action
Tobramycin, an aminoglycoside antibiotic, inhibits bacterial protein synthesis by irreversibly binding to 30S ribosomal subunit resulting in abnormal bacterial cell membrane. Dexamethasone inhibits the inflammatory response by suppressing the migration of neutrophil, decreasing the production of inflammatory mediators and reversing the increased capillary permeability. Additionally, it inhibits the normal immune response.
Absorption: Tobramycin: Poorly absorbed across the cornea and conjunctiva. Time to reach peak concentration in the aqueous humour: 2 hours. Dexamethasone: Absorbed into the eye. Time to reach maximum concentration in the cornea and aqueous humour: Within 1-2 hours.
Storage
Ophthalmic: Ophthalmic susp: Store below 30°C. Discard 4 weeks after opening. Ophthalmic ointment: Store below 25°C. Discard 4 weeks after opening. Storage recommendation may vary among countries or individual products or preparations. Refer to country- or product-specific recommendation.
CIMS Class
Eye Antiseptics with Corticosteroids
ATC Classification
C05AA09 - dexamethasone ; Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids and anal fissures.
H02AB02 - dexamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
D10AA03 - dexamethasone ; Belongs to the class of topical corticosteroids used in the treatment of acne.
S01BA01 - dexamethasone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
S02BA06 - dexamethasone ; Belongs to the class of corticosteroids used in the treatment of inflammation of the ear.
A01AC02 - dexamethasone ; Belongs to the class of local corticosteroid preparations. Used in the treatment of diseases of the mouth.
D07XB05 - dexamethasone ; Belongs to the class of moderately potent (group II) corticosteroids in other combinations. Used in the treatment of dermatological diseases.
S01AA12 - tobramycin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
S03BA01 - dexamethasone ; Belongs to the class of corticosteroids used in ophthalmologic and otologic preparations.
D07AB19 - dexamethasone ; Belongs to the class of moderately potent (group II) corticosteroids. Used in the treatment of dermatological diseases.
S01CB01 - dexamethasone ; Belongs to the class of corticosteroids/antiinfectives/mydriatics combinations. Used in the treatment of eye diseases.
J01GB01 - tobramycin ; Belongs to the class of other aminoglycosides. Used in the systemic treatment of infections.
R01AD03 - dexamethasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Disclaimer: This information is independently developed by CIMS based on tobramycin + dexamethasone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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