NEXTOB | Tobramycin Ophthalmic Solution USP
Product Description:
COMPOSITION:
Tobramycin Sulphate IP
Eq. to Tobramycin………………………………………….0.3% w/v
Benzalkonium Chloride Solution IP………………..0.01% v/v
(As preservative)
Sterile Aqueous Base……………………………………..q.s.
DESCRIPTION: NEXTOB (tobramycin ophthalmic solution) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each ml of NEXTOB solution contains: Active: tobramycin 0.3% (3mg).
Tobramycin is a water soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens
CLINICAL PHARMACOLOGY:
In Vitro Data: 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 mirabillis, morganella morganii, most proteus vulgaris, Haemophilus influenzea and H.aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.
INDICATIONS AND USAGE: NEXTOB (tobramycin ophthalmic solution) 0.3% 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 NEXTOB. Clinical studies have shown tobramycin to be safe and effective for use in children.
CONTRAINDICATIONS: NEXTOB (tobramycin ophthalmic solution) 0.3% is contraindicated in patients with known hypersensitivity to any of its components.
WARNINGS: FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to NEXTOB (tobramycin ophthalmic solution) 0.3% occurs, discontinue use.
PRECAUTIONS: General. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy. Patients should be advised not to wear contact lenses if they have signs symptoms of bacterial conjunctivitis.
Information For Patients: Do not touch dropper tip to any surface, as this may contaminate the solution.
Pregnancy Category B: 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 NEXTOB, 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.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of two months has not been established.
Geriatric Drug: No overall clinical differences in safety or effectiveness have been observed between elderly and younger patients.
ADVERSE REACTIONS: The most frequent adverse reactions to NEXTOB Ophthalmic Solution are hypersensitivity and localized ocular toxicity, including lid itching and swelling and conjunctival erythema. These reactions occur in less than three of 100 patients treated with NEXTOB Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from NEXTOB (tobramycin ophthalmic solution) 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotic, care should be taken to monitor the total serum concentration.
DOSAGE AND ADMINISTRATION: In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.
STORAGE: Store at a temperature not exceeding 30°C. Protect from light & Moisture.
Presentation: Nextob eye drops is available in 5ml pack.
