Tetrazin® (tetrabenazine) Tablets

Tetrazin® (tetrabenazine) Tablets are used to treat the involuntary movements (chorea) of Huntington’s disease. Tetrazin® does not cure the cause of the involuntary movements, and it does not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions. It is not known whether tetrabenazine is safe and effective in children.

      For more information, please see MEDICATION GUIDE

      For more information, please see Full Prescribing Information.

Side Effects

Before You Start Tetrazin^® (tetrabenazine)

Before you start taking Tetrazin®, you should tell your doctor about all of the prescription medications as well as non-prescription medicines, vitamins, herbal products or other supplements you are taking. Tetrazin® may interact with some of these medications. Make sure you tell your doctor before you start or stop any new medication, or if you change the dose of any medication or supplements you are taking. Always read the Medication Guide before starting your treatment with Tetrazin®. If you have any questions regarding Tetrazin®, be sure to talk with your doctor.

How to Take Tetrazin®

Tetrazin® (tetrabenazine) is a tablet you swallow. You can take it with or without food. Tetrazin® comes in two different tablet strengths, 12.5 milligrams (mg) and 25 mg.

You should always take Tetrazin® as prescribed by your doctor. Depending on you or your loved one’s condition and previous history with taking Tetrazin®, your doctor will start slowly and may increase the strength and number of tablets (dose) you take over the course of several weeks up to a few months.

The process of slowly increasing your dose is also known as titration. Your doctor may give you a dosing schedule to help you keep track of when and how much Tetrazin® to take.

While taking Tetrazin®, it is important to remain patient since it may take awhile for your physician to find the right dose that works for you. During this time, you may experience some side effects, so be sure to communicate with your doctor about how you are feeling. Your doctor may adjust your dose.

Tell your doctor if you stop taking Tetrazin® for more than 5 days. Do not take another dose until you talk to your doctor. If your doctor thinks you need to take more than

50 mg of Tetrazin® each day, you will need to have a blood test to see if you should be taking Tetrazin®.

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings or worsening depression. This is especially important when Tetrazin® is started or when the dose is changed.

Tetrazin® is Not Suitable for Everyone

Some people should not take Tetrazin®. Tetrazin® can increase the chance of depression, suicidal thoughts, or suicidal actions in some patients.

Do not take Tetrazin® if:

• You are sad (depressed) much of the time. You can become more depressed taking Tetrazin®.
• You take medicine for depression, but it is not well controlled.
• You think or talk about harming yourself or killing yourself (suicide.) You may be more likely to think about ending your life while taking Tetrazin®.
• You have liver problems.
• You take a monoamine oxidase inhibitor (MAOI), reserpine, or a medicine that contains reserpine. If your doctor plans to switch you from taking reserpine to Tetrazin®, you must wait at least 20 days after your last dose of reserpine before you start taking Tetrazin®. Ask your doctor or pharmacist if you are not sure.

When taking Tetrazin®, pay close attention to any changes in how you feel. Let your doctor know if you have sudden changes in your mood, behaviors, or thoughts. These changes may occur when you start Tetrazin® and when your doctor changes your dose.

Possible Tetrazin® Side Effects

TETRAZIN® can cause serious side effects, including:

• Depression, suicidal thoughts, or actions. See "What is the most important information I should know about TETRAZIN®?"
• Neuroleptic Malignant Syndrome (NMS). Call your doctor right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause:
  • high fever
  • stiff muscles
  • problems thinking
  • very fast or uneven heartbeat
  • increased sweating
• Parkinsonism. Symptoms of parkinsonism include: slight shaking, body stiffness, trouble moving or keeping your balance.
• Restlessness. You may get a condition where you feel a strong urge to move. This is called akathisia.
• Trouble swallowing. Tetrazin® may increase the chance that you will have trouble swallowing. Increased coughing may be the first sign that you are having trouble swallowing. Trouble swallowing increases your risk of pneumonia.
• Irregular heartbeat. Tetrazin® increases your chance of having certain changes in the electrical activity in your heart which can be seen on an electrocardiogram (EKG). These changes can lead to a dangerous abnormal heartbeat. Taking Tetrazin® with certain medicines may increase this chance.
• Dizziness due to blood pressure changes when you change position (orthostatic hypotension). Change positions slowly from lying down to sitting up and from sitting up to standing when taking Tetrazin®. Tell your doctor right away if you get dizzy or faint while taking Tetrazin®. Your doctor may need to watch your blood pressure closely.
• Tardive dyskinesia (TD). TD is a condition where there is repeated facial grimacing that cannot be controlled, sticking out of the tongue, smacking of the lips, puckering and pursing of the lips, and rapid eye blinking. Tetrazin® works like other drugs that can cause TD. If you get TD with Tetrazin®, it is possible that the TD will not go away.

Common side effects with Tetrazin® include:

• sleepiness (sedation)
• trouble sleeping
• depression
• tiredness (fatigue)
• anxiety
• restlessness
• agitation
• nausea

Tell your doctor if you have any side effects. Do not stop taking Tetrazin® without talking to your doctor first.

Call your doctor for medical advice about side effects. You may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.

TETRAZIN®^® (tetrabenazine) Tablets

Indications and Usage:

TETRAZIN® is a medicine that is used to treat the involuntary movements (chorea) of Huntington’s disease. TETRAZIN® does not cure the cause of the involuntary movements, and it does not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions.

It is not known whether TETRAZIN® is safe and effective in children.

Important Safety Information:

• TETRAZIN® can cause serious side effects, including:
  • depression
  • suicidal thoughts
  • suicidal actions
• You should not start taking TETRAZIN® if you are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts.
• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings, or worsening depression. This is especially important when TETRAZIN® is started and when the dose is changed.

• Do not take TETRAZIN® if you have liver problems or are taking monoamine oxidase inhibitors or reserpine. Ask your doctor or pharmacist if you are not sure. At least 20 days should pass after stopping reserpine before starting TETRAZIN®.
• Tell your doctor if you are pregnant, breast-feeding or have breast cancer. Do not start any new medicines while taking TETRAZIN® without talking to your doctor first.
• The need for therapy should be evaluated on an ongoing basis with your doctor. The dose of TETRAZIN® should be adjusted slowly over several weeks for a dose that is appropriate for you. Tell your doctor if you stop taking TETRAZIN® for more than 5 days. Do not take another dose until you talk to your doctor. If your doctor thinks you need to take more than 50 mg of TETRAZIN® each day, you will need to have a blood test to see if a higher dose is right for you.
• Neuroleptic Malignant Syndrome (NMS) is a potentially fatal side effect reported with TETRAZIN®. Call your doctor right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, or increased sweating. TETRAZIN® should be stopped immediately if NMS is diagnosed.
• TETRAZIN® can also cause other serious side effects, including: parkinsonism (slight shaking, body stiffness, trouble moving or keeping your balance), restlessness (akathisia), trouble swallowing, irregular heartbeat, and dizziness due to blood pressure changes when you change position (orthostatic hypotension). Trouble swallowing may increase the risk of pneumonia. Uncontrolled movements called tardive dyskinesia (TD) may also develop in patients treated with TETRAZIN®. It is possible that the TD will not go away.
• Side effects such as irregular heartbeat, NMS, and parkinsonism, may be increased when using TETRAZIN® with other drugs (e.g., dopamine antagonists).
• Sleepiness is a common side effect of TETRAZIN®; do not drive a car or operate dangerous machinery until you know how TETRAZIN® affects you. Alcohol and other drugs may increase sleepiness caused by TETRAZIN®.

TETRAZIN® is a registered trademark of Taj Pharma India

      For more information, please see MEDICATION GUIDE

      For more information, please see Full Prescribing Information.

Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited,  medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.

Information for Health Care Professionals

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).



 

Tetrazin® (tetrabenazine) Tablets
Tetrabenazine is the only FDA-approved treatment for chorea associated with Huntington's disease.2 It treats a symptom of Huntington's disease (HD) called chorea (Kor-EE-ya), or involuntary movements.2 These movements can be brief, repetitive, jerky, or uncontrolled and dance-like.2,4 Chorea is the hallmark symptom of HD and affects about 90% of people who have HD at some point in their illness.3,5
 

Introducing new 5 products for Central Nervous System (CNS) disorders .

  Mebrasil® CIV (brand of mephobarbital tablets, USP)
  Rematal® CII Sodium Solution (pentobarbital sodium injection, USP)
  Pegarin® (ethotoin tablets, USP)
  Vegarin® (vigabatrin) Tablets & Oral Solution
  Zepran® CIV (clorazepate dipotassium)
  Tetrazin ® (tetrabenazine) Tablets

Tetrazin® (tetrabenazine) is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6.51. Tetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: cis rac –1,3,4,6,7,11bhexahydro- 9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The empirical formula C19H27NO3 is represented by the following structural formula.

Tetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.

Each Tetrazin® (tetrabenazine) Tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient.

Tetrazin® (tetrabenazine) Tablets contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose, magnesium stearate, maize starch, and talc. The 25 mg strength tablet also contains yellow iron oxide as an inactive ingredient.

Tetrazin® (tetrabenazine) is supplied as a yellowish-buff scored tablet containing 25 mg of Tetrazin® or as a white non-scored tablet containing 12.5 mg of Tetrazin®.
 

Tetrazin® (tetrabenazine) Tablets - used to treat the involuntary movements (chorea) of Huntington’s disease tetrabenazine tablets active ingredient tetrabenazine tetrabenazine tablets 25 mg tablet tetrabenazine tablets tetrabenazine only FDA-approved treatment for chorea associated with Huntington's disease tetrabenazine tablets treats a symptom of Huntington's disease (HD) called chorea (Kor-EE-ya) tetrabenazine tablets chorea) of Huntington’s disease tetrabenazine tablets tetrabenazine tablets India tetrabenazine tablets anti-cancer tetrabenazine tablets reduce chorea tetrabenazine tablets Huntington's chorea tetrabenazine tablets safe and effective tetrabenazine tablets India – Taj Pharma Tetrazin® tetrabenazine tablets tetrabenazine tablets tetrabenazine tablets  tetrabenazine tablets 25 mg tablets tetrabenazine tablets treatment involuntary movements chorea tetrabenazine tablets Huntington’s disease tetrabenazine tablets FDA-approved treatment tetrabenazine tablets chorea associated tetrabenazine tablets Huntington's disease tetrabenazine tablets treats symptom tetrabenazine tablets 25 mg tablet tetrabenazine tablets Huntington's disease (HD) tetrabenazine tablets chorea (or-EE-ya) tetrabenazine tablets chorea tetrabenazine tablets Huntington’s disease tetrabenazine tablets tetrabenazine tablets tetrabenazine tablets India tetrabenazine tablets anti-cancer tetrabenazine tablets reduce chorea tetrabenazine tablets Huntington's chorea tetrabenazine tablets safe tetrabenazine tablets effective tetrabenazine tablets India – Taj Pharma Tetrazin tetrabenazine tablets does not cure cause involuntary movements tetrabenazine tablets does not treat other symptoms tetrabenazine tablets Huntington’s disease tetrabenazine tablets such problems tetrabenazine tablets thinking or emotions








 

Select Language English Russian French German Italian Japanese Korean Portuguese Spanish Greek Dutch Hindi

              
 Print page   Send by mail