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TIMOLOL 0.5% OPTH GEL 5 ML

  • Manufacturer Name : ALEMBIC PHARMAC
  • MFG # : 62332054605
  • NDC : 62332054605
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description N
Description -
DESI Drug Ind -; -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Category USES: This medication is used to treat high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases (such as ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. This medication works by decreasing the amount of fluid within the eye. Timolol belongs to a class of drugs known as beta-blockers.
Drug Type Code COMMON BRAND NAME(S): Timoptic-XE
Drug Type Code 1
FDA Approval Date 10/22/2020
FDA Therap Equiv AB
HCPCS -
HCPCS 1
Market Entry Date 11/25/2020
Medical Coverage -
Medical Coverage -
Termination Date (TIE-moh-lohl)
Termination Date -
Unit ML
Units Per Pkg 5
Active Ingredients 1856 timolol maleate 26921175
Active Ingredients 1856 timolol maleate 26921175
AHFS Class 52400800 BETA-ADRENERGIC BLOCKING AGENTS (EENT)
AHFS Class 52400800 BETA-ADRENERGIC BLOCKING AGENTS (EENT)
DEA Class NC
DEA Class NC
Dose Form GEL-FORMING SOLUTION
Dose Form GEL-FORMING SOLUTION
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 21401 timolol maleate OPHTHALMIC SOL-GEL 0.5 %
Gen Code and Des 21401 timolol maleate OPHTHALMIC SOL-GEL 0.5 %
Inactive Ingredients 2272 mannitol 69658
Inactive Ingredients 2272 mannitol 69658
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 0.5%
Strength 0.5%
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Timoptic-XE
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. Some products that may interact with this drug include: oral beta-blockers (such as propranolol), clonidine, certain antidepressants (including SSRIs such as fluoxetine), digoxin, epinephrine, methyldopa, quinidine.
Allocation Period -
Allocation Period -
Case Quantity 200
Case Quantity 200
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: Read the Patient Information Leaflet provided by your pharmacist before you start using timolol and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. This medication is for use in the eye(s), usually one drop in the affected eye(s) once a day, or as directed by your doctor. Apply other eye medications at least 10 minutes before timolol gel solution. To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface. If you wear contact lenses, remove them before using the eye drops. Ask your doctor how long you should wait after using this medication before putting in your contact lenses. With the cap on tightly, turn the eye drop bottle upside down and shake once before each use. You do not need to shake the container more than once. Tilt your head back, look upward and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop in your eye. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. Try not to blink and do not rub your eye. This will prevent the medication from draining out. Repeat these steps for your other eye if so directed. Do not rinse the dropper. Replace the dropper cap after each use. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Keep using this medication even if you feel well. Most people with glaucoma or high pressure in the eyes do not feel sick.
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 NOTES: Do not share this medication with others. Lab and/or medical tests (such as eye exams) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes ML
Overdose AB
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. Symptoms of overdose may include: trouble breathing or slow/irregular heartbeat.
Phonetic Pronunciation (TIE-moh-lohl)
Phonetic Pronunciation -
Precautions -
Precautions PRECAUTIONS: Before using timolol, 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: lung disease (such as current or past history of asthma, severe chronic obstructive pulmonary disease), certain types of irregular heartbeats (such as sinus bradycardia, second or third degree AV block), certain types of heart disease (such as severe heart failure), kidney disease, liver disease, diabetes, low blood flow to the brain (cerebrovascular insufficiency), overactive thyroid disease, muscle weakness disorders, severe allergies. If you develop an eye infection or injury, or have eye surgery, check with your doctor about whether you should continue to use your current bottle of timolol. You may be advised to start using a new bottle. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). The risk is higher if you have diabetes, or are vomiting, fasting, or not eating regularly. Other symptoms of low blood sugar level, such as dizziness and sweating, are not affected by this drug. If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet. 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. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Temporary blurred vision, temporary burning/stinging/itching/redness of the eye, watery eyes, dry eyes, feeling as if something is in the eye, or headache may occur. If any of these effects last or get worse, notify 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. Tell your doctor right away if you have any serious side effects, including: dizziness, eye pain/swelling/discharge, slow/irregular heartbeat, muscle weakness, mental/mood changes, coldness/numbness/pain in the hands or feet, vision changes, unusual tiredness/weakness. Get medical help right away if you have any very serious side effects, including: dizziness that doesn't stop, trouble breathing, sudden unexplained weight gain, chest pain, weakness on one side of the body, trouble speaking, confusion, fainting. 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 10/22/2020
Storage STORAGE: Store at room temperature away from light and moisture. Avoid freezing. Do not store in the bathroom. Keep all medications away from children and pets. This product is normally colorless. Discard the solution if it changes color, becomes cloudy, or develops particles. 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 high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases (such as ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. This medication works by decreasing the amount of fluid within the eye. Timolol belongs to a class of drugs known as beta-blockers.

Frequently Asked Questions(FAQs)

The cost of TIMOLOL 0.5% OPTH GEL 5 ML is available for registerd members only .
TIMOLOL 0.5% OPTH GEL 5 ML is manufactured by ALEMBIC PHARMAC.
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