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Lotemax 0.5 % Gel 5 Gm

  • Manufacturer Name : BAUSCH & LOMB
  • MFG # : 24208050307
  • NDC : 24208050307
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description I
Description -
DESI Drug Ind -
DESI Drug Ind -; -
DESI2 Drug Ind -
Drug Category I
Drug Category USES: This medication is used to treat eye inflammation and pain after eye surgery. Loteprednol works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.
Drug Type Code COMMON BRAND NAME(S): Lotemax
Drug Type Code 1
FDA Approval Date 09/28/2012
FDA Therap Equiv NR
HCPCS -
HCPCS 1
Market Entry Date 01/02/2013
Medical Coverage -
Medical Coverage -
Termination Date (LOE-te-PRED-nol)
Termination Date -
Unit GM
Units Per Pkg 5
Active Ingredients 7443 loteprednol etabonate 82034466
Active Ingredients 7443 loteprednol etabonate 82034466
AHFS Class 52080800 CORTICOSTEROIDS (EENT)
AHFS Class 52080800 CORTICOSTEROIDS (EENT)
DEA Class NC
DEA Class NC
Dose Form DROPS, GEL (GRAM)
Dose Form DROPS, GEL (GRAM)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 70083 loteprednol etabonate OPHTHALMIC DROPS GEL 0.5 %
Gen Code and Des 70083 loteprednol etabonate OPHTHALMIC DROPS GEL 0.5 %
Inactive Ingredients 2468 propylene glycol 57556; 3141 benzalkonium chloride 8001545; 3785 edetic acid 60004
Inactive Ingredients 2468 propylene glycol 57556; 3141 benzalkonium chloride 8001545; 3785 edetic acid 60004
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 0.5%
Strength 0.5%
Common Brand Name COMMON BRAND NAME(S): Lotemax
Common Brand Name -
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Allocation Period -
Case Quantity 144
Case Quantity 144
Drug Form Pack Size 5
Drug Form Pack Size 5
Form GELATIN
Form GELATIN
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 5
Unit Size 5
How to Use -
How to Use HOW TO USE: Do not wear contact lenses while you are using this medication. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again. To apply the eye gel, wash your hands first. To avoid contamination, do not touch the bottle tip or let it touch your eye or any other surface. Turn the bottle upside down and shake once to fill the tip with the gel. Gently pull down the lower eyelid to make a pouch. Place the prescribed number of drops into the pouch. Gently close the eye and roll the eyeball in all directions to spread the medication. Try not to blink or rub your eye. Repeat these steps for your other eye if so directed. If you are using another kind of eye medication (for example, drops, ointments, or other gels), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments or gels to allow the drops to enter the eye. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Apply as directed by your doctor, usually 4 times a day. The dosage and length of treatment are based on your medical condition and response to treatment. Do not increase your dose or use this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Continue to use this medication for the full time prescribed. Do not stop using this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased. Do not use this product if it becomes contaminated (for example, the gel turns a dark color or develops particles in it). Using contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Ask your doctor or pharmacist for more information. Tell your doctor if your condition does not improve after a few days or if it worsens.
Missed Dose 5
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes GM
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another eye condition unless your doctor directs you to do so. A different medication may be necessary in that case. Lab and/or medical tests (such as eye exams, measurement of the pressure inside the eyes) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose NR
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation -
Phonetic Pronunciation (LOE-te-PRED-nol)
Precautions -
Precautions 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, 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 can do it 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 gel 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 unknown if the medication in this product passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Temporary blurred vision may occur when you apply this medication. A feeling as if something is in your eye may also occur. If these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor 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. Using this medication for prolonged periods or in high doses may cause serious side effects, including serious eye problems (such as cataracts and high pressure inside the eyes). Tell your doctor right away if you have any serious side effects, including: vision problems/changes, eye pain, headache, dizziness. 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 right away any new or worsening symptoms such as eye discharge/swelling/redness/itching/pain, vision problems/changes, or no improvement of your current eye condition. Your doctor will need to adjust your treatment. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects -
Storage 09/28/2012
Storage STORAGE: Store at room temperature. Keep bottle upright and tightly closed when not in use. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses -
Uses USES: This medication is used to treat eye inflammation and pain after eye surgery. Loteprednol works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.

Frequently Asked Questions(FAQs)

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Lotemax 0.5 % Gel 5 Gm is manufactured by BAUSCH & LOMB.
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