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Austedo (Generic Deutetrabenazine)

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WARNING

In patients with Huntington’s disease, deutetrabenazine may raise the risk of depression or suicidal thoughts (thinking about injuring or killing yourself, preparing to do so, or trying to do so) (an inherited disease that causes the progressive breakdown of nerve cells in the brain). If you suffer from depression now or in the past, as well as if you have ever considered harming or killing yourself, let your doctor know. Your doctor would probably advise against taking deutetrabenazine if you have Huntington’s disease and are depressed or have suicidal thoughts. If you experience any of the following symptoms, you, your family, or caregiver should contact your doctor right away: new or worsening depression, thoughts of harming or killing yourself, plans, or attempts to do so, extreme worry, agitation, difficulty falling asleep or staying asleep, hostile or aggressive behaviour, acting without thinking, severe restlessness, anxiety, changes in body weight, loss of interest in social interactions, difficulty paying a bill. Make sure your family or caregiver constantly checks on you and is aware of any symptoms that might be significant so they can contact the doctor on your behalf if you are unable to call for help.

Keep all of your doctor’s appointments. While you are on this medicine, your doctor will undoubtedly want to discuss with you about your mental health.

The patient information sheet (Medication Guide) from the manufacturer will be provided to you by your doctor or pharmacist when you start taking deutetrabenazine and each time you get a prescription refill. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Why is this medication prescribed?

Deutetrabenazine is used to treat chorea (rapid, uncontrollable movements) brought on by Huntington’s disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). TARD is another condition that it is used to treat (uncontrollable movement of the face, tongue, or other body parts). A group of drugs known as vesicular monoamine transporter 2 (VMAT2) inhibitors includes deutetrabenazine. It operates by altering the behaviour of specific organic compounds in the brain that influence nerves and muscles.

How should this medicine be used?

Deutetrabenazine is available as an oral tablet. It is often given with food once day at initially for people with Huntington’s disease before being increased to twice daily. It is often administered twice day with food to people with tardive dyskinesia. Deutetrabenazine should be taken every day at about the same time(s). Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the deutetrabenazine directions exactly. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole.

Deutetrabenazine dosages are often started at modest levels and then gradually increased, usually no more than once per week, by your doctor.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking deutetrabenazine,

  • If you have an allergy to deutetrabenazine, any other medications, or any of the ingredients in deutetrabenazine tablets, tell your doctor and pharmacist right away. It functions by altering the way that a few organic brain chemicals behave. Request a list of the components from your pharmacist.
  • Tell your doctor if you take reserpine, tetrabenazine (Xenazine), valbenazine (Ingrezza), or a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), Most likely, your doctor will advise against taking deutetrabenazine.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: medications for anxiety, antidepressants like bupropion (Aplenzin, Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem, Selfemra), and paroxetine (Brisdelle, Paxil, Pexeva); antipsychotics like chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), quetiapine (Seroquel), Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • In case you have liver problems, let your doctor know. Most likely, your doctor will advise against taking deutetrabenazine.
  • Inform your doctor if you have long QT syndrome or any other irregular heartbeat or cardiac rhythm issues. Long QT syndrome raises the chance of developing an abnormal heartbeat that could result in fainting or sudden death. Additionally, let your doctor know if you have breast cancer or low blood levels of potassium or magnesium.
  • If you are breastfeeding a child or intend to become pregnant, let your doctor know. Call your doctor if you become pregnant while taking deutetrabenazine.
  • You should be aware that deutetrabenazine may produce fatigue or make you feel sleepy. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • You should be aware that drinking alcohol can make the drowsiness this medicine causes worse. Deutetrabenazine should not be taken with alcohol.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

Consult your doctor before starting deutetrabenazine again if you skip more than a week of taking it. Most likely, you’ll need to start taking it again at a lesser dosage.

What side effects can this medication cause?

Side effects from deutetrabenazine are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Diarrhea
  • Constipation
  • Mouth ache
  • Tiredness
  • Urination may cause burning or pain
  • Bruising
  • A higher respiratory infection

Some adverse effects can be very harmful. Deutetrabenazine should be stopped immediately if you suffer any of the following symptoms or any of those mentioned in the IMPORTANT WARNING section:

  • Fever, perspiration, dizziness, rapid or erratic heartbeat, and extreme muscle stiffness
  • Trembling, stiffness, or trouble balancing or moving
  • Falls
  • Fast or irregular pulse
  • Fainting

Other negative effects of deutetrabenazine could occur. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from light, excessive heat, and moisture at room temperature (not in the bathroom).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Jerking or twisting motions
  • Quickly moving eyes
  • Nausea
  • Vomiting
  • Sweating
  • Sedation
  • Confusion
  • Diarrhea
  • Hallucinations (seeing items or hearing voices that do not exist)
  • Skin rashes
  • Uncontrollable trembling

What other information should I know?

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Austedo®
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