Tobramycin-Loteprednol Ophthalmic

Tobramycin-Loteprednol Ophthalmic is a prescription medication used for steroid-responsive ocular inflammations with a risk for superficial bacterial infections.

• Tobramycin-Loteprednol Ophthalmic is available under the following different brand names: Zylet

Common side effects of Tobramycin-Loteprednol Ophthalmic include:

• stinging, burning, irritation, itching, discomfort, or redness of the eyes for 1 to 2 minutes at the application site
• headache
• sensitivity of the eyes to light
• blurred vision

Serious side effects of Tobramycin-Loteprednol Ophthalmic include:

• blurred vision
• change in vision
• feeling like something is in the eye
• increased pressure in the eye
• loss of vision
• pain or irritation of the clear front part of the eye
• sensitivity of the eyes to light

Rare side effects of Tobramycin-Loteprednol Ophthalmic include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Ophthalmic suspension

• 0.3%/0.5%

Ocular inflammation

Adult and pediatric dosage

• Shake vigorously before use
• Instill 1-2 drops in the affected eye(s) every 4-6 hours; may use as frequently as every 1-2 hours during the first 24-48 hours
• Decrease the frequency of administration as signs and symptoms improve; if use exceeds 20 mL, evaluate the therapy further

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Tobramycin-Loteprednol Ophthalmic has severe interactions with no other drugs.
• Tobramycin-Loteprednol Ophthalmic has serious interactions with at least 23 other drugs.
• Tobramycin-Loteprednol Ophthalmic has moderate interactions with at least 66 other drugs.
• Tobramycin-Loteprednol Ophthalmic has minor interactions with at least 71 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to any component of the formulation or other corticosteroids
• Viral, mycobacterial and fungal eye infections

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tobramycin-Loteprednol Ophthalmic?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tobramycin-Loteprednol Ophthalmic?”

Cautions

• History of herpes simplex virus infections
• May exacerbate infections by nonsusceptible organisms
• Monitor intraocular pressure, if used for more than 10 days
• Bacterial keratitis was reported from inadvertent contamination of the multiple-dose ophthalmic solution
• Immunosuppression resulting from prolonged use of steroid use may result in secondary bacterial and fungal infections; steroids may also mask symptoms of infections and enhance existing ocular infections
• Ocular hypertension and/or glaucoma reported with prolonged corticosteroid use
• Discontinue use if sensitivity reaction to tobramycin develops
• Corticosteroid use following cataract surgery may delay healing
• Do not allow the dropper tip to touch any surface, as this may contaminate the suspension
• As with all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to wear soft contact lenses while receiving therapy

Pregnancy and Lactation

• There are no adequate and well-controlled studies on the use of etabonate or tobramycin in pregnant women.
• Lactation
  • There are no data on the presence of loteprednol etabonate or tobramycin in human milk, its effects on breastfed infants, or milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from the drug