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Zylet (Loteprednol Etabonate / Tobramycin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS:

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination.

Zylet:

In a 42 day safety study comparing Zylet to placebo, the incidence of ocular adverse events reported in greater than 10% of subjects included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% (Zylet) and 4% (placebo) of subjects. Nine percent (9%) of Zylet subjects reported burning and stinging upon instillation. Ocular reactions reported with an incidence less than 4% include vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders.

The incidence of non-ocular adverse events reported in approximately 14% of subjects was headache; all other non-ocular events had an incidence of less than 5%.

Loteprednol etabonate ophthalmic suspension 0.2% - 0.5%:

Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥ 10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.

Tobramycin ophthalmic solution 0.3%:

The most frequent adverse reactions to topical tobramycin are hypersensitivity and localized ocular toxicity, including lid itching and swelling and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.



REPORTS OF SUSPECTED ZYLET SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Zylet. The information is not vetted and should not be considered as verified clinical evidence.

Possible Zylet side effects / adverse reactions in 54 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-07

Patient: 54 year old female weighing 123.4 kg (271.4 pounds)

Reactions: Throat Tightness

Adverse event resulted in: life threatening event

Suspect drug(s):
Zylet



Possible Zylet side effects / adverse reactions in 74 year old female

Reported by a consumer/non-health professional from United States on 2012-01-27

Patient: 74 year old female

Reactions: Headache, DRY Eye, Eye Pain

Suspect drug(s):
Zylet
    Indication: Ocular Hyperaemia
    Start date: 2011-02-01
    End date: 2011-03-01

Zylet
    Start date: 2011-02-01
    End date: 2011-03-01

Zylet
    Indication: Eye Infection
    Start date: 2011-02-01
    End date: 2011-03-01

Zylet
    Start date: 2011-02-01
    End date: 2011-03-01

Other drugs received by patient: Soothe XP; Xalatan /swe/



Possible Zylet side effects / adverse reactions in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-01-27

Patient: 49 year old female

Reactions: Hypersensitivity, Eye Irritation, Drug Ineffective, Condition Aggravated

Suspect drug(s):
Zylet
    Indication: Eye Allergy
    Start date: 2011-07-23
    End date: 2011-07-24

Zylet
    Indication: Conjunctivitis Infective
    Start date: 2011-07-23
    End date: 2011-07-24



See index of all Zylet side effect reports >>

Drug label data at the top of this Page last updated: 2011-01-13

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