Lotemax

DRUG DESCRIPTION

LOTEMAX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder.

Loteprednol etabonate is represented by the following structural formula:

LOTEMAX® (loteprednol etabonate)  Structural Formula Illustration

Chemical Name: chloromethyl 17?-[(ethoxycarbonyl)oxy]-11?-hydroxy-3-oxoandrosta-1,4-diene-17?-carboxylate

Each mL contains

ACTIVE: Loteprednol Etabonate 5 mg (0.5%);

INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg.
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.

What are the possible side effects of loteprednol ophthalmic (Alrex, Lotemax)?

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

Stop using loteprednol and call your doctor at once if you have any of these serious side effects:

  • signs of a new eye infection such as swelling, redness, irritation, or drainage;
  • problems with your vision; or
  • severe pain, burning or stinging when using the eye drops.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Lotemax »

What are the precautions when taking loteprednol etabonate ophthalmic suspension (Lotemax)?

Before using loteprednol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye infections, cataracts, glaucoma (open-angle type), severe nearsightedness (myopia), diabetes.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs,...

Read All Potential Precautions of Lotemax »


Lotemax Consumer (continued)

SIDE EFFECTS: Stinging/burning of the eyes for 1 to 2 minutes and temporary blurred vision may occur when you apply this medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged periods or in high doses may cause serious eye problems (such as high pressure inside the eyes and cataracts). Tell your doctor immediately if any of these unlikely but serious side effects occur: vision problems, eye pain.

This medication may mask the signs of an eye infection. It may also put you at greater risk of developing an eye infection, especially with prolonged use. Report any new or worsening symptoms such as eye discharge/swelling/redness, vision problems, or no improvement of your current eye condition. Your doctor will need to adjust your treatment.

Tell your doctor immediately if any of these unlikely but serious side effects occur: headache, dizziness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using loteprednol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye infections, cataracts, glaucoma (open-angle type), severe nearsightedness (myopia), diabetes.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of loteprednol eye drops or start a new bottle.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if the medication in this product passes into breast milk. Consult your doctor before breast-feeding.


Lotemax Patient Information Including Side Effects

Brand Names: Alrex, Lotemax

Generic Name: loteprednol ophthalmic (Pronunciation: lo te PRED nol off THAL mik)

  • What is loteprednol ophthalmic (Lotemax)?
  • What are the possible side effects of loteprednol ophthalmic (Lotemax)?
  • What is the most important information I should know about loteprednol ophthalmic (Lotemax)?
  • What should I discuss with my healthcare provider before using loteprednol ophthalmic (Lotemax)?
  • How should I use loteprednol ophthalmic (Lotemax)?
  • What happens if I miss a dose (Lotemax)?
  • What happens if I overdose (Lotemax)?
  • What should I avoid while using loteprednol ophthalmic (Lotemax)?
  • What other drugs will affect loteprednol ophthalmic (Lotemax)?
  • Where can I get more information?

What is loteprednol ophthalmic (Lotemax)?

Loteprednol is in a group of drugs called corticosteroids. It prevents the release of substances in the body that cause inflammation.

Loteprednol ophthalmic (for the eye) is used to treat eye swelling caused by surgery, infection, allergies, and other conditions.

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

What are the possible side effects of loteprednol ophthalmic (Lotemax)?

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

Stop using loteprednol and call your doctor at once if you have any of these serious side effects:

  • signs of a new eye infection such as swelling, redness, irritation, or drainage;
  • problems with your vision; or
  • severe pain, burning or stinging when using the eye drops.

Less serious 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.

What is the most important information I should know about loteprednol ophthalmic (Lotemax)?

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using loteprednol before putting your contact lenses in.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

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.

Call your doctor if your symptoms do not improve after 2 days of treatment.

Related Drug Centers
  • Lotemax
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