Lotemax

Do not use other eye medications unless your doctor tells you to.

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

Call your doctor if your symptoms do not improve after 2 days of treatment. Stop using loteprednol and call your doctor at once if you have signs of a new eye infection such as swelling, redness, irritation, or drainage, or if you have problems with your vision, or severe pain, burning, or stinging when you use the eye drops.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use other eye medications unless your doctor tells you to.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using loteprednol and call your doctor at once if you have:

• signs of a new eye infection such as swelling, redness, irritation, or drainage;

• blurred vision, eye pain, or seeing halos around lights;

• problems with your vision; or

• severe pain, burning or stinging when using the eye drops.

Common side effects may include:

• minor burning when using the eye drops;

• dry, red, itchy, or watery eyes;

• feeling that something is in your eye;

• being more sensitive to light;

• headache; or

• runny nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of loteprednol in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of loteprednol in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bemiparin
• Nadroparin
• Pixantrone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataract surgery—Use with caution. May cause delayed healing.

• Certain eye diseases that cause the cornea to get thin—Use could cause a hole to form (perforation).

• Eye infection caused by fungus, mycobacteria or
• Eye infection caused by virus (e.g., herpes simplex)—Should not be used in patients with these conditions.

• Glaucoma—Use with caution. May make this condition worse.

Lotemax, as with other ophthalmic corticosteroids, 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. Lotemax is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma.

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

SHAKE VIGOROUSLY BEFORE USING.

Steroid Responsive Disease Treatment: Apply one to two drops of Lotemax into the conjunctival sac of the affected eye four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).

Post-Operative Inflammation: Apply one to two drops of Lotemax into the conjunctival sac of the operated eye four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

Applies to loteprednol ophthalmic: ophthalmic gel, ophthalmic ointment, ophthalmic suspension

General

The most common reported side effects were anterior chamber inflammation, eye pain, and foreign body sensation.[Ref]

Ocular

Common (1% to 10%): Corneal defect, eye discharge, ocular discomfort, dry eye, epiphora, foreign body sensation in eyes, conjunctival hyperemia, ocular itching, burning on instillation
Uncommon (0.1% to 1%): Abnormal vision, blurring of vision, chemosis, conjunctivitis, conjunctival hyperemia, iritis, eye irritation, eye pain, conjunctival papillae, photophobia, uveitis, keratoconjunctivitis
Frequency not reported: Elevated intraocular pressure, optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation[Ref]

Dermatologic

Rare (less than 0.1%): Urticaria, rash, dry skin, eczema[Ref]

Gastrointestinal

Rare (less than 0.1%): Diarrhea, nausea, vomiting[Ref]

Genitourinary

Rare (less than 0.1%): Urinary tract infection, urethritis[Ref]

Metabolic

Rare (less than 0.1%): Weight gain[Ref]

Nervous system

Rare (less than 0.1%): Migraine, taste perversion, dizziness, paresthesia, tinnitus[Ref]

Oncologic

Rare (less than 0.1%): Breast neoplasm[Ref]

Other

Uncommon (0.1% to 1%): Asthenia
Rare (less than 0.1%): Chills, fever, pain, face edema
Frequency not reported: Delayed wound healing[Ref]

Psychiatric

Rare (less than 0.1%): Nervousness[Ref]

Respiratory

Uncommon (0.1% to 1%): Rhinitis, pharyngitis
Rare (less than 0.1%): Chest pain, cough[Ref]

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

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on: 

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

What are you taking this medication for?

Brand: Lotemax

• Lotemax drops:
  • The typical dose is one or two drops in the affected eye, four times per day.
  • During the first week of treatment, the dose may be increased by one drop every hour, if needed.
• Lotemax gel and ointment are not used for nonallergic eye inflammation. 

It has not been confirmed that Lotemax is safe and effective for use in people younger than 18 years of age.

Brand: Lotemax

• Lotemax drops:
  • The typical dose is one or two drops in the affected eye, four times per day.
  • You should start using the drops 24 hours after surgery and continue using them for 2 weeks.
• Lotemax gel:
  • The typical dose is one or two drops in the affected eye, four times per day.
  • You should start drops 24 hours after surgery and continue using them for 2 weeks.
• Lotemax ointment:
  • The typical dose is about a ½-inch ribbon in the affected eye.
  • You should start the drug 24 hours after surgery and continue using it for 2 weeks.

It has not been confirmed that Lotemax is safe and effective for use in people younger than 18 years of age.

Take this drug at the time(s) recommended by your doctor

Store this drug carefully

A prescription for this medication is not refillable

Travel

Self-management

Clinical monitoring

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead

Insurance

Are there any alternatives?