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Roweepra 500 Mg Tab 120

  • Manufacturer Name : OWP PHARMACEUTICALS
  • MFG # : 69102010501
  • NDC : 69102010501
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind AB
Drug Category -
Drug Type Code N
FDA Approval Date 01/05/2021
FDA Therap Equiv TAB
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit 1
Units Per Pkg 01/15/2009
Active Ingredients 8058 levetiracetam 102767282
AHFS Class 28129200 ANTICONVULSANTS, MISCELLANEOUS
DEA Class NC
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 44633 levetiracetam ORAL TABLET 500 MG
Inactive Ingredients 2537 povidone 9003398
OMP Family -
Product Category RX Pharmaceuticals
Strength 500MG
Common Brand Name COMMON BRAND NAME(S): Keppra
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. A product that may interact with this drug is: orlistat.
Allocation Period -
Case Quantity 24
Drug Form Pack Size 120
Form TABLET
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 120
How to Use HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking levetiracetam and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take the liquid and regular-release tablets by mouth as directed by your doctor, usually twice daily with or without food. Crushing or chewing the tablet may cause a bitter taste. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If you are using the extended-release tablets, take this medication as directed by your doctor, usually once daily. Swallow the extended-release tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects. The dosage is based on your medical condition and response to treatment. The dosage in children is also based on weight. To reduce your risk of side effects (such as dizziness and drowsiness), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Do not stop taking this medication without consulting your doctor. Your seizures may become worse when the drug is suddenly stopped. Your dose should be gradually decreased. Tell your doctor if your seizures lasts, change, or gets worse.
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take 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 kidney function, complete blood count) may be done while you are taking this medication. In children younger than 4 years, blood pressure may also be monitored. Consult your doctor for more details.
Overdose OVERDOSE: 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 slow/shallow breathing, loss of consciousness.
Phonetic Pronunciation (lev-eh-turr-RASS-ih-tam)
Precautions PRECAUTIONS: Before taking levetiracetam, 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: kidney disease (such as dialysis treatment), mental/mood disorders (such as depression). This drug may make you dizzy or drowsy, especially during the first month of treatment. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, ride a bicycle, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children may be more sensitive to the side effects of the drug, especially mental/mood changes (such as irritability, aggression, agitation, anger, anxiety, depression, thoughts of suicide). Children younger than 4 years may be at greater risk for increased blood pressure while using this drug (see also Notes section). Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness or loss of coordination. These side effects can increase the risk of falling. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Drowsiness, dizziness, unusual tiredness, or weakness may occur. These side effects are more common during the first 4 weeks and usually lessen as your body adjusts to the medication. If any of 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. Tell your doctor right away if you have any serious side effects, such as: loss of coordination (such as difficulty walking and controlling muscles), mental/mood changes (such as irritability, aggression, agitation, anger, anxiety), signs of infection (such as sore throat that doesn't go away, fever, chills), signs of anemia (such as unusual tiredness that doesn't go away, pale skin, fast breathing, fast heartbeat), easy bruising/bleeding. A small number of people who take anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. Levetiracetam can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash. 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, such as: 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.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. 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: Levetiracetam is used to treat seizures (epilepsy). It belongs to a class of drugs known as anticonvulsants. Levetiracetam may decrease the number of seizures you have.

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Roweepra 500 Mg Tab 120 is manufactured by OWP PHARMACEUTICALS.
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