Loteprednol and tobramycin Ophthalmic

In the U.S.

• Zylet

Available Dosage Forms:

• Suspension

Therapeutic Class: Aminoglycoside/Corticosteroid Combination

Pharmacologic Class: Loteprednol

Chemical Class: Aminoglycoside

Loteprednol is a steroid. It prevents the release of substances in the body that cause inflammation.

Tobramycin ophthalmic is an antibiotic that fights bacteria.

Loteprednol and tobramycin ophthalmic (for the eyes) is a combination medicine used to treat eye inflammation caused by surgery, infection, allergies, and other conditions.

Loteprednol and tobramycin ophthalmic may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to loteprednol or tobramycin, or other steroids. You should not use if you have any type of fungal, viral, or bacterial infection in your eye (including herpes or chickenpox).

To make sure this medicine is safe for you, tell your doctor if you have:

• glaucoma;

• cataracts (or if you have recently had cataract surgery); or

• herpes infection of your eye.

FDA pregnancy category C. It is not known whether loteprednol and tobramycin ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether loteprednol and tobramycin ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 6 years old without medical advice.

Usual Adult Dose for Uveitis:

Apply 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4 to 6 hours; during the initial 24 to 48 hours, may increase frequency to every 1 to 2 hours

Comments:
-The frequency should be gradually decreased as warranted by improvement of clinical signs.
-Care should be taken as to not discontinue therapy prematurely.
-A maximum of 20 mL should be prescribed initially and not refilled without further evaluation.

Use: For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or risk of bacterial ocular infection exists; the anti-infective component of this drug is active against the following common bacterial eye pathogens: Staphylococcus aureus, S epidermidis (coagulase positive and negative), some Group A beta-hemolytic and some nonhemolytic streptococci, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, H aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, Klebsiella pneumoniae, and some Neisseria species

Usual Adult Dose for Iritis:

Apply 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4 to 6 hours; during the initial 24 to 48 hours, may increase frequency to every 1 to 2 hours

Comments:
-The frequency should be gradually decreased as warranted by improvement of clinical signs.
-Care should be taken as to not discontinue therapy prematurely.
-A maximum of 20 mL should be prescribed initially and not refilled without further evaluation.

Use: For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or risk of bacterial ocular infection exists; the anti-infective component of this drug is active against the following common bacterial eye pathogens: Staphylococcus aureus, S epidermidis (coagulase positive and negative), some Group A beta-hemolytic and some nonhemolytic streptococci, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, H aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, Klebsiella pneumoniae, and some Neisseria species

Usual Adult Dose for Ocular Infection:

Apply 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4 to 6 hours; during the initial 24 to 48 hours, may increase frequency to every 1 to 2 hours

Comments:
-The frequency should be gradually decreased as warranted by improvement of clinical signs.
-Care should be taken as to not discontinue therapy prematurely.
-A maximum of 20 mL should be prescribed initially and not refilled without further evaluation.

Use: For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or risk of bacterial ocular infection exists; the anti-infective component of this drug is active against the following common bacterial eye pathogens: Staphylococcus aureus, S epidermidis (coagulase positive and negative), some Group A beta-hemolytic and some nonhemolytic streptococci, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, H aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, Klebsiella pneumoniae, and some Neisseria species

Usual Adult Dose for Allergic Conjunctivitis:

Apply 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4 to 6 hours; during the initial 24 to 48 hours, may increase frequency to every 1 to 2 hours

Comments:
-The frequency should be gradually decreased as warranted by improvement of clinical signs.
-Care should be taken as to not discontinue therapy prematurely.
-A maximum of 20 mL should be prescribed initially and not refilled without further evaluation.

Use: For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or risk of bacterial ocular infection exists; the anti-infective component of this drug is active against the following common bacterial eye pathogens: Staphylococcus aureus, S epidermidis (coagulase positive and negative), some Group A beta-hemolytic and some nonhemolytic streptococci, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, H aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, Klebsiella pneumoniae, and some Neisseria species

Usual Adult Dose for Bacterial Conjunctivitis:

Apply 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4 to 6 hours; during the initial 24 to 48 hours, may increase frequency to every 1 to 2 hours

Comments:
-The frequency should be gradually decreased as warranted by improvement of clinical signs.
-Care should be taken as to not discontinue therapy prematurely.
-A maximum of 20 mL should be prescribed initially and not refilled without further evaluation.

Use: For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or risk of bacterial ocular infection exists; the anti-infective component of this drug is active against the following common bacterial eye pathogens: Staphylococcus aureus, S epidermidis (coagulase positive and negative), some Group A beta-hemolytic and some nonhemolytic streptococci, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, H aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, Klebsiella pneumoniae, and some Neisseria species

Usual Adult Dose for Keratitis:

Apply 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4 to 6 hours; during the initial 24 to 48 hours, may increase frequency to every 1 to 2 hours

Comments:
-The frequency should be gradually decreased as warranted by improvement of clinical signs.
-Care should be taken as to not discontinue therapy prematurely.
-A maximum of 20 mL should be prescribed initially and not refilled without further evaluation.

Use: For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or risk of bacterial ocular infection exists; the anti-infective component of this drug is active against the following common bacterial eye pathogens: Staphylococcus aureus, S epidermidis (coagulase positive and negative), some Group A beta-hemolytic and some nonhemolytic streptococci, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, H aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, Klebsiella pneumoniae, and some Neisseria species

Usual Adult Dose for Cyclitis:

Apply 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4 to 6 hours; during the initial 24 to 48 hours, may increase frequency to every 1 to 2 hours

Comments:
-The frequency should be gradually decreased as warranted by improvement of clinical signs.
-Care should be taken as to not discontinue therapy prematurely.
-A maximum of 20 mL should be prescribed initially and not refilled without further evaluation.

Use: For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or risk of bacterial ocular infection exists; the anti-infective component of this drug is active against the following common bacterial eye pathogens: Staphylococcus aureus, S epidermidis (coagulase positive and negative), some Group A beta-hemolytic and some nonhemolytic streptococci, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, H aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, Klebsiella pneumoniae, and some Neisseria species

Applies to loteprednol / tobramycin ophthalmic: ophthalmic suspension

Ocular

Very common (10% or more): Injection (20%), superficial punctuate keratitis (15%), intraocular pressure increased (10%)
Frequency not reported: Vision disorder, discharge, itching, lacrimation disorder, photophobia, corneal deposit, ocular discomfort, eyelid disorder, unspecified eye disorder

Loteprednol etabonate:
Frequency not reported: Intraocular pressure increased, visual acuity defect, field defect, posterior subcapsular cataract formation, delayed wound healing, secondary ocular infection

Tobramycin:
Frequency not reported: Lid itching, conjunctival erythema, lid swelling[Ref]

Nervous system

Very common (10% or more): Headache (14%)[Ref]

Hypersensitivity

Tobramycin:
Frequency not reported: Hypersensitivity[Ref]

General

The most frequently reported side effects were injections and superficial punctate keratitis, increased intraocular pressure, and burning and stinging upon instillation.[Ref]

Local

Common (1% to 10%): Burning, stinging

Tobramycin:
Frequency not reported: Localized ocular toxicity[Ref]

Some side effects of loteprednol / tobramycin ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Apply 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4 to 6 hours; during the initial 24 to 48 hours, may increase frequency to every 1 to 2 hours

Comments:
-The frequency should be gradually decreased as warranted by improvement of clinical signs.
-Care should be taken as to not discontinue therapy prematurely.
-A maximum of 20 mL should be prescribed initially and not refilled without further evaluation.

Use: For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or risk of bacterial ocular infection exists; the anti-infective component of this drug is active against the following common bacterial eye pathogens: Staphylococcus aureus, S epidermidis (coagulase positive and negative), some Group A beta-hemolytic and some nonhemolytic streptococci, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, H aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, Klebsiella pneumoniae, and some Neisseria species

Consult WARNINGS section for additional precautions.

Data not available

Animal studies have revealed evidence of embryotoxicity (delayed ossification) and teratogenicity (increased incidence of meningocele, abnormal left common carotid artery, and limb fixtures) when loteprednol was administered orally at 35 times the maximum daily clinical dose. Reproductive studies in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally revealed no evidence of impaired fertility or fetal harm. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use only if the potential benefit justifies the potential risk to the fetus. US FDA pregnancy category: C