Tobramycin, Dexamethasone Ophthalmic Drops

Tobramycin Dexamethasone

Tobramycin Dexamethasone

A combination of a potent eye antibiotic, Tobramycin, and an anti-inflammatory component.

Product Name

Tobramycin Dexamethasone

Formulation

Each mL of Ophthalmic Suspension contains

Tobramycin…3mg

Dexamethasone… 1mg

Description

 Tobramycin/Dexamethasone Opthalmic Suspension is sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use.

Clinical Pharmacology

Corticoids suppress the inflammatory response to a variety of agents, and they probably delay or slow healing. Since corticoids may inhibits the body’s defense mechanism against, infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant.

Dexamethason is a potent corticoid.

The antibiotic component in the combination Tobramycin is included to provide action against susceptible organisms. In vitro studies have demonstrated that Tobramycin, the particular anti-infective drug in the products, is active against susceptible strains of the following microorganisms: Staphyloccoci, including S. aureus and S. epidermis (coagulase-negative), including penicillin-resistant strains, Streptococci, including some of the Group A beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumonia.

Pseudomonae aeruginosa, Escherichia coli, Klebsiella pneumonia, enterobacter arerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata and Acinetobacter calcoacaticus (Horella vaginacola) and some Neisseria species.

Bacterial susceptibility studies demonstrate that in some cases microorganisms resistant to gentamicin remain susceptible to Tobramycin. A significant bacterial population resistant to Tobramycin has not yet emerged, however, bacterial resistance may develop upon prolonged use.

No data are available on the extent of systematic absorption from Tobramycin/Dexamethason Ophthalmic Suspension or Ointment, however it is known that some systematic absorption can occur with ocularly applied drugs. If the maximum dose of Tobramycin/Dexamethason Ophthalmic Suspension is given for the first 48 hours (2 drops in each eye every 2 hours) and complete systemic absorption occurs, which is highly unlikely, the daily dose of dexamethasone would be 2.4 mg. The usual physiologic replacement dose is 0.75 mg daily. If Tobramycin/Dexamethason Ophthalmic  Suspension is given after the first 48 hours as two drops in each eye every 4 hours, the administered dose of dexamethason would be 1.2 mg daily. The administered dose for Tobramycin/Dexamethason Ophthalmic  Ointment in both eyes four times daily would be 0.4 mg of dexamethasone daily.

Indications and Usage

Tobramycin/Dexamethasone Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroid are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the glove where the inherent risk of steroid use in certain infective conjunctivitises, is accepted to obtain a diminution in ederma and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

The use of a combination drug with anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

Contraindications

Epithelial Herpes simplex keratitis (dendritic keratitis), vaccinia, and many other viral diseases of the cornea and conjunctiva. Microbacterial infection of the eyes. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

The use of this combination is always contraindicated after uncomplicated removal of a corneal foreign body.

Dosage and Administration

Suspension: One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely or as prescribed by physician.

Availability

Sterile ophthalmic suspension in 5 mL.

Storage

Store at temperatures not exceeding 30 °C. Shake well before using.

Caution

Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription.

Address

SENSOMED PHILIPPINES, INC.
Unit 1508, 1404 Orient Square Bldg., F. Ortigas Jr. Rd., Ortigas Center, Pasig City, Philippines

Telephone
(+632) 635-4917/ 635-5169

Telefax
(+632) 635-5170