Before using Xenazine, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.
For this medicine, the following should be considered:
Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of tetrabenazine in the pediatric population. Safety and efficacy have not been established.
Geriatric Population: No information is available on the relationship of age to the effects of tetrabenazine in geriatric patients.
Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.
When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur.
The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems: The presence of other medical problems may affect the use of this medicine.
Make sure you tell your doctor if you have any other medical problems, especially:
Suicidal thoughts or behavior, active—Should not be used in patients with these conditions
3 Proper Usage
To use Xenazine properly, you must follow all instructions given by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This medicine may be taken with or without food.
Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label.
The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets):
Adults—At first, 12.5 milligrams (mg) in the morning once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 100 mg per day.
Children—Use and dose must be determined by your doctor.
Missed Dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.
4 Precautions to Take
Before using Xenazine, there are some precautions you must take. It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to allow for changes in the dose.
Tetrabenazine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies, or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.
Do not take this medicine if you are also taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®). If you have questions, check with your doctor.
Do not take this medicine if you are also taking reserpine (Harmonyl®). Wait at least 20 days after stopping reserpine before starting tetrabenazine. If you have questions, check with your doctor.
Check with your doctor right away if you have more than one of these symptoms while taking this medicine:
These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
This medicine may cause drowsiness, trouble with thinking, or trouble with controlling movements. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think well.
Make sure your doctor knows if you are using chlorpromazine (Thorazine®), thioridazine (Mellaril®), ziprasidone (Geodon®), moxifloxacin (Avelox®), quinidine, procainamide (Pronestyl®), amiodarone (Cordarone®), or sotalol (Betapase®). Using any of these medicines together with tetrabenazine may cause serious side effects.
This medicine may cause tardive dyskinesia (a movement disorder). This may not go away after you stop using the medicine.
Check with your doctor right away if you have any of the following symptoms while taking this medicine:
lip smacking or puckering
puffing of the cheeks
rapid or worm-like movements of the tongue
uncontrolled chewing movements
uncontrolled movements of the arms and legs
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert.
Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics.
This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above whiles you are using this medicine.
seeing, hearing, or feeling things that are not there
shakiness in legs, arms, hands, or feet
sticking out of tongue
trembling or shaking of hands or feet
uncontrolled twisting movements of neck, trunk, arms, or legs
unusual facial expressions
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.
Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
large, flat, blue, or purplish patches in the skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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