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Amgydex (Ophthalmic Solution & Ointment)

 

COMPOSITION

Ophthalmic Suspension:
Each ml contains:
Tobramycin U.S.P. ………………………….. 3.00 mg.
Dexamethasone U.S.P. ………………….. 1.00 mg.
with: Benzalkonium chloride 0.01%, sodium chloride, edetate disodium, boric acid, hydroxypropyl methylcellulose 0.5% and purified water.
Ophthalmic Ointment:
Each gm contains:
Tobramycin U.S.P. ………………………….. 3.00 mg.
Dexamethasone U.S.P. ………………….. 1.00 mg.
with: Mineral oil & white petrolatum. (Preservative Free)

CLINICAL PHARMACOLOGY

Tobramycin is aminoglycoside antibiotic acts by interfering with bacterial protein synthesis.
In vitro studies have demonstrated that Tobramycin is active against susceptible strains of the following microorganisms
Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A beta-hemolytic species, some nonhemolytic species and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes. Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, and Acinetobacter calcoaceticus (Herellea vaginacola) and some Neisseria species.
Bacterial susceptibility studies demonstrate that in some cases microorganisms resistant to gentamicin remain susceptible to Tobramycin.
Dexamethasone is a corticosteroid with powerful anti-inflammatory action. It acts by inhibiting the inflammatory response to inciting agents of mechanical, chemical or immunological nature. It exerts its principal effect on the inflammatory conditions of the anterior segment of the eye.

INDICATIONS

Amgydex Ophthalmic Suspension/Ointment is indicated in bacterial ocular infections, inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use 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 or thermal burns or penetration of foreign bodies. Specially indicated in post-operative conditions of eye i.e. cataract, IOL implant surgery and other surgical procedures.

CONTRAINDCATIONS

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to any component of the product.

ADVERSE REACTIONS

The most frequent adverse reactions to topical ocular Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching, swelling and conjunctival erythema.
Steroids may mask, activate or enhance infection. If infections do not respond promptly, discontinue use until the infection has been adequately controlled by other measures.
Prolonged use of topical steroids may result in overgrowth of non – susceptible organisms including fungi.
Extended use of steroids may cause an increase in IOP in certain cases including most of those with family history of glaucoma. This may lead to optic nerve damage.
Topical steroids when used in diseases causing thinning of cornea or sclera, may lead to perforation of the globe.

Pregnancy: There are no adequate and well controlled studies in pregnant women. It should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

Nursing Mothers: 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 when using this product.

Pediatric Use : Safety and effectiveness have not been established.

DOSAGE

Ophthalmic Suspension: 1 to 2 drops into the conjunctival sac(s) every 4 to 6 hours. During the initial 24 to 48 hours, the dosage may be increased to 1 or 2 drops every 2 hours.
Ophthalmic Ointment: Apply a small amount (app. 1/2 inch ribbon) into the conjunctival sac(s) every 6 to 8 hours.
Care should be taken not to discontinue therapy prematurely.

HOW SUPPLIED

Loxiget Eye Drops are available as a sterile solution 5 ml in pilfer proof plastic dropper bottles (Gamma Irradiated).
Loxiget Eye Ointment is available as a sterile ointment 3.5 gm in ophthalmic tube (Gamma Irradiated).

STORAGE

Protect from sunlight. Keep away from children’s reach. Do not freeze. Store between 8°C to 27°C.
After opening the bottle, use within 4 weeks.