Loteprednol etabonate and Tobramycin 5 mg/mL
Loteprednol etabonate and Tobramycin · SUSPENSION/ DROPS · Alembic Pharmaceuticals Inc.
Loteprednol etabonate and Tobramycin is a suspension/ drops containing loteprednol etabonate and tobramycin at 5 mg/mL, taken ophthalmic. Manufactured by Alembic Pharmaceuticals Inc..
Key Facts
- Brand Name
- Loteprednol etabonate and Tobramycin
- Generic Name
- Loteprednol etabonate and Tobramycin
- NDC Code (Product)
62332-801- Manufacturer
- Alembic Pharmaceuticals Inc.
- Strength
- 5 mg/mL
- Dosage Form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA217597
- Drug Class
- Aminoglycoside Antibacterial [EPC]
- Marketing Start
- 12/10/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product (tobramycin) is…
Dosage & Administration
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 )].
Contraindications
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. ( 4.1 ) 4.1 Nonbacterial Etiology 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.
Adverse Reactions
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. 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 reactions reported in approximately 14% of subjects was headache; all other non-ocular reactions had an incidence of less than 5%. Loteprednol etabonate ophthalmic suspen…
Frequently Asked Questions
What is Loteprednol etabonate and Tobramycin used for?
Loteprednol etabonate and Tobramycin contains Loteprednol etabonate and Tobramycin. It is a suspension/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Loteprednol etabonate and Tobramycin a controlled substance?
Loteprednol etabonate and Tobramycin is not classified as a controlled substance by the DEA.
What is the generic name for Loteprednol etabonate and Tobramycin?
The generic name for Loteprednol etabonate and Tobramycin is Loteprednol etabonate and Tobramycin. There are 2 other brand versions of Loteprednol etabonate and Tobramycin.
What is the NDC code for Loteprednol etabonate and Tobramycin 5 mg/mL?
The NDC (National Drug Code) for Loteprednol etabonate and Tobramycin 5 mg/mL is 62332-801, listed by Alembic Pharmaceuticals Inc..