Loteprednol Etabonate And Tobramycin
Generic Name: loteprednol etabonate and tobramycin
Brand Names:
Loteprednol Etabonate And Tobramycin
11 DESCRIPTION Loteprednol Etabonate and Tobramycin Ophthalmic Suspension is a sterile, multiple dose topical anti-inflammatory corticosteroid and anti-infective combination for ophthalmic use. Both loteprednol etabonate and tobramycin are white to off-white powders. The chemical structures of loteprednol etabonate and tobramycin are shown below.
Overview
11 DESCRIPTION Loteprednol Etabonate and Tobramycin Ophthalmic Suspension is a sterile, multiple dose topical anti-inflammatory corticosteroid and anti-infective combination for ophthalmic use. Both loteprednol etabonate and tobramycin are white to off-white powders. The chemical structures of loteprednol etabonate and tobramycin are shown below.
Uses
1 INDICATIONS AND USAGE Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% is a topical anti-infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.
Dosage
2 DOSAGE AND ADMINISTRATION Apply one or two drops of Loteprednol Etabonate and Tobramycin Ophthalmic Suspension into the conjunctival sac of the affected eye every four to six hours. ( 2.1 ) 2.1 Recommended Dosing Apply one or two drops of Loteprednol Etabonate and Tobramycin Ophthalmic Suspension into the conjunctival sac of the affected eye every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. 2.2 Prescription Guideline Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation [see Warnings and Precautions ( 5.3 )].
Side Effects
6 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. Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% In a 42-day safety study comparing Loteprednol Etabonate and Tobramycin Ophthalmic Suspension to placebo, ocular adverse reactions included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension) and 4% (placebo) of subjects. Nine percent (9%) of Loteprednol Etabonate and Tobramycin Ophthalmic Suspension subjects reported burning and stinging upon instillation.
Warnings
5 WARNINGS AND PRECAUTIONS Intraocular Pressure (IOP) Increase : Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored. ( 5.1 ) Cataracts : Use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 ) Delayed Healing : The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. 4 CONTRAINDICATIONS Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, as with other steroid anti-infective ophthalmic combination drugs, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures...
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with loteprednol etabonate or tobramycin in pregnant women. Loteprednol etabonate produced teratogenicity at clinically relevant doses in the rabbit and rat when administered orally during pregnancy. Loteprednol etabonate produced malformations when administered orally to pregnant rabbits at doses ≥ 0.54 times the recommended human ophthalmic dose (RHOD) and to pregnant rats at doses ≥ 13 times the RHOD.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% is supplied in a white low density polyethylene plastic bottle with a white controlled drop tip and a white polypropylene cap in the following sizes: NDC 82260-358-05 5 mL fill in a 7.5 mL bottle NDC 82260-358-10 10 mL fill in a 10 mL bottle USE ONLY IF IMPRINTED NECKBAND IS INTACT.
Frequently Asked Questions
What is Loteprednol Etabonate And Tobramycin used for?▼
1 INDICATIONS AND USAGE Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% is a topical anti-infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.
What are the side effects of Loteprednol Etabonate And Tobramycin?▼
6 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. Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% In a 42-day safety study comparing Loteprednol Etabonate and Tobramycin Ophthalmic Suspension to placebo, ocular adverse reactions included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension) and 4% (placebo) of subjects. Nine percent (9%) of Loteprednol Etabonate and Tobramycin Ophthalmic Suspension subjects reported burning and stinging upon instillation.
Can I take Loteprednol Etabonate And Tobramycin during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with loteprednol etabonate or tobramycin in pregnant women. Loteprednol etabonate produced teratogenicity at clinically relevant doses in the rabbit and rat when administered orally during pregnancy. Loteprednol etabonate produced malformations when administered orally to pregnant rabbits at doses ≥ 0.54 times the recommended human ophthalmic dose (RHOD) and to pregnant rats at doses ≥ 13 times the RHOD.
What are the important warnings for Loteprednol Etabonate And Tobramycin?▼
5 WARNINGS AND PRECAUTIONS Intraocular Pressure (IOP) Increase : Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored. ( 5.1 ) Cataracts : Use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 ) Delayed Healing : The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. 4 CONTRAINDICATIONS Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, as with other steroid anti-infective ophthalmic combination drugs, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.