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Amgy (Ophthalmic Solution)

COMPOSITION

Each ml contains:

Tobramycin U.S.P…………………………………..3.00 mg.
Hydroxypropyl Methylcellulose U.S.P….…5.00 mg.
with: Phenylmercuric nitrate 0.004%, sodium chloride, boric acid, sodium sulphate and purified water.

CLINICAL PHARMACOLOGY

Tobramycin is aminoglycoside antibiotic acts by interfering with bacterial protein synthesis.
In vitro studies have demonstrated 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.

INDICATIONS

AMGY Ophthalmic Solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of AMGY. Clinical studies have shown tobramycin to be safe and effective for use in children.

CONTRAINDCATIONS

Hypersensitivity to any component of the medication.

ADVERSE REACTIONS

The most frequent adverse reactions to topical ocular tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with tobramycin. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from tobramycin therapy ;however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

Pregnancy: Reproduction studies in three types of animals at doses up to thirty three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: Because of the potential for adverse reactions in nursing infants from tobramycin, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.
Overdosage: Clinically apparent signs and symptoms of an overdose of Tobramycin Ophthalmic solution (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

DOSAGE

In mild to moderate infections: one or two drops into the conjunctival sac(s) every four hours.
In severe infections: Two drops into the conjunctival sac(s) hourly until improvement, following which treatment should be reduced prior to discontinuation or as directed by the ophthalmologist.

HOW SUPPLIED

AMGY Ophthalmic solution is available as a sterile solution in 5 ml pilfer proof plastic dropper bottles (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.