Product Details
GEMTESA 75 MG TAB 90
Manufacturer: SUNOVION PHARMA
MFG#: 73336-0075-90
NDC: 73336-0075-90
PID: 332511
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Product Properties:
| Description | - |
|---|---|
| Description | - |
| DESI Drug Ind | - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | NR |
| DESI2 Drug Ind | - |
| Drug Category | S |
| Drug Category | - |
| Drug Type Code | S |
| Drug Type Code | 1 |
| FDA Approval Date | 12/23/2020 |
| FDA Approval Date | 04/05/2021 |
| FDA Therap Equiv | TAB |
| FDA Therap Equiv | NR |
| HCPCS | - |
| HCPCS | - |
| Market Entry Date | - |
| Market Entry Date | 04/05/2021 |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | 1 |
| Termination Date | - |
| Unit | TAB |
| Unit | 90 |
| Units Per Pkg | 12/23/2020 |
| Units Per Pkg | 90 |
| Active Ingredients | 18600 vibegron |
| Active Ingredients | 18600 vibegron |
| AHFS Class | 86120812 SELECTIVE BETA-3-ADRENERGIC AGONISTS |
| AHFS Class | 86120812 SELECTIVE BETA-3-ADRENERGIC AGONISTS |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | TABLET |
| Dose Form | TABLET |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 81787 vibegron ORAL TABLET 75 MG |
| Gen Code and Des | 81787 vibegron ORAL TABLET 75 MG |
| Inactive Ingredients | 10138 blue dye; 2272 mannitol 69658; 2432 lactose 64044515 |
| Inactive Ingredients | 10138 blue dye; 2272 mannitol 69658; 2432 lactose 64044515 |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 75MG |
| Strength | 75MG |
| Common Brand Name | COMMON BRAND NAME(S): Gemtesa |
| Common Brand Name | COMMON BRAND NAME(S): Gemtesa |
| 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. |
| 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 | 24 |
| Case Quantity | 24 |
| Drug Form Pack Size | 90 |
| Drug Form Pack Size | 90 |
| Form | TABLET |
| Form | TABLET |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| NIOSH Code | - |
| NIOSH Code | - |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| 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 | 90 |
| Unit Size | 90 |
| How to Use | HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking vibegron and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow this medication whole with a glass of water. If you have trouble swallowing the tablet, you may crush the tablet and mix with 1 tablespoonful (15 milliliters) of applesauce. Take the mixture right away with a glass of water. Do not save the mixture for future use. The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Tell your doctor if your condition does not get better or if it gets worse. |
| How to Use | HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking vibegron and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow this medication whole with a glass of water. If you have trouble swallowing the tablet, you may crush the tablet and mix with 1 tablespoonful (15 milliliters) of applesauce. Take the mixture right away with a glass of water. Do not save the mixture for future use. The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Tell your doctor if your condition does not get better or if it 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. |
| 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. |
| Notes | NOTES: Do not share this medication with others. |
| 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. |
| 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. |
| Phonetic Pronunciation | (vye-BEG-ron) |
| Phonetic Pronunciation | (vye-BEG-ron) |
| Precautions | PRECAUTIONS: Before taking vibegron, 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: other bladder problems (such as blockage), kidney problems, liver problems. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. |
| Precautions | PRECAUTIONS: Before taking vibegron, 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: other bladder problems (such as blockage), kidney problems, liver problems. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. |
| Side Effects | SIDE EFFECTS: Headache, nausea, or diarrhea may occur. 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, including: being unable to empty your bladder (urinary retention). 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 | SIDE EFFECTS: Headache, nausea, or diarrhea may occur. 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, including: being unable to empty your bladder (urinary retention). 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. |
| 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. |
| 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: This medication is used to treat overactive bladder. Overactive bladder is a problem with how your bladder stores urine that causes a sudden urge to urinate. The urge may be hard to control, and overactive bladder symptoms may include frequent urination, strong sudden urges to urinate, or involuntary loss of urine (incontinence). Vibegron works by relaxing a certain bladder muscle (detrusor), which helps the bladder hold more urine and lessens symptoms of overactive bladder. |
| Uses | USES: This medication is used to treat overactive bladder. Overactive bladder is a problem with how your bladder stores urine that causes a sudden urge to urinate. The urge may be hard to control, and overactive bladder symptoms may include frequent urination, strong sudden urges to urinate, or involuntary loss of urine (incontinence). Vibegron works by relaxing a certain bladder muscle (detrusor), which helps the bladder hold more urine and lessens symptoms of overactive bladder. |
Frequently Asked Questions (FAQs)
The cost of GEMTESA 75 MG TAB 90 is $available for registerd members only
GEMTESA 75 MG TAB 90 is manufactured by SUNOVION PHARMA.
You can purchase GEMTESA 75 MG TAB 90 on our website at https://supplies.pipelinemedical.com/product/detail/gemtesa-75-mg-tab-90-332511