Product Details
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Product Properties:
| Description | - |
|---|---|
| DESI Drug Ind | - |
| DESI2 Drug Ind | - |
| Drug Category | S |
| Drug Type Code | 1 |
| FDA Approval Date | 04/03/2017 |
| FDA Therap Equiv | NR |
| HCPCS | - |
| Market Entry Date | 04/12/2017 |
| Medical Coverage | - |
| Termination Date | - |
| Unit | TAB |
| Units Per Pkg | 1 |
| Active Ingredients | 17158 deutetrabenazine |
| AHFS Class | 28560000 VESICULAR MONOAMINE TRANSPORT2 INHIBITOR |
| DEA Class | NC |
| Dose Form | TABLET |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 77269 deutetrabenazine ORAL TABLET 6 MG |
| Inactive Ingredients | 10138 blue dye; 10141 red dye; 2272 mannitol 69658; 2537 povidone 9003398 |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Strength | 6MG |
| Common Brand Name | COMMON BRAND NAME(S): Austedo |
| 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: valbenazine. Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Do not take any MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication. Deutetrabenazine is very similar to tetrabenazine. Do not use medications containing tetrabenazine while using deutetrabenazine. |
| Allocation Period | - |
| Case Quantity | 24 |
| Drug Form Pack Size | 60 |
| Form | TABLET |
| Hazard Code | - |
| Listed Chemical | - |
| NIOSH Code | - |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit Size | 60 |
| How to Use | HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using deutetrabenazine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with food as directed by your doctor, usually once or twice a day. The manufacturer directs not to chew, crush or break the tablet before taking it. However, many similar drugs (immediate-release tablets) can be chewed, crushed or split. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. If you stop taking this medication for more than 1 week, do not take another dose until you talk to your doctor. You may need to restart your medication at a lower dose. Tell your doctor if you do not get better or if you get 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. |
| 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: muscle stiffness/pain, fixed upward position of the eyeballs, sweating, dizziness, severe drowsiness. |
| Phonetic Pronunciation | (DU-tet-ra-BEN-a-zeen) |
| Precautions | PRECAUTIONS: See also Warning section. Before taking deutetrabenazine, tell your doctor or pharmacist if you are allergic to it; or to tetrabenazine; 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: breast cancer, liver problems, certain heart problems (fast/slow/irregular heartbeat, QT prolongation in the EKG). This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, 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). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding. |
| Side Effects | SIDE EFFECTS: See also Warning section. Drowsiness, trouble sleeping, tiredness, dizziness, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Your doctor may need to adjust your dose to reduce these side effects. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. 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: agitation/restlessness, Parkinson's disease symptoms (such as shaking/tremors, slowed movement, loss of balance). Sometimes deutetrabenazine can cause side effects that are similar to the symptoms of worsening Huntington's disease. Your doctor may need to adjust your dose to see if these side effects are due to the drug or to the disease. Tell your doctor right away if any of these serious side effects occur: mental/mood changes (such as new/worsening depression, suicidal thoughts/attempts, problems with thinking), trouble swallowing, uncontrolled muscle movements of the face (such as lip smacking, unusual tongue movements), signs of increased prolactin hormone (such as enlarged breasts, abnormal breast milk production, decreased sexual ability, a change in menstrual cycle). This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine). 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. |
| Uses | USES: Deutetrabenazine is used to decrease involuntary movements (chorea) caused by Huntington's disease. It is also used to treat involuntary movements of the face, tongue, or other body parts (tardive dyskinesia). Reducing involuntary movements will help you take part in more of your normal daily activities. This medication is thought to work by decreasing the amount of certain natural substances in the brain that affect how your nerves and muscles work (monoamines such as dopamine, serotonin, and norepinephrine). |
Frequently Asked Questions (FAQs)
The cost of AUSTEDO 6 MG TAB 60 is $available for registerd members only
AUSTEDO 6 MG TAB 60 is manufactured by TEVA USA.
You can purchase AUSTEDO 6 MG TAB 60 on our website at https://supplies.pipelinemedical.com/product/detail/austedo-6-mg-tab-60-316354