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Nitoman Tetrabenazine Product monograph

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  • Nitoman Tetrabenazine Product monograph

    • NITOMAN?
      Roche
      Tetrabenazine
      Monoamine Depleting Agent


    Action And Clinical Pharmacology: The central effects of tetrabenazine closely resemble those of reserpine, but it differs from the latter in having less peripheral activity and in being much shorter acting. In laboratory animals, tetrabenazine interferes with vesicular storage of biogenic amines, including dopamine as well as serotonin and norepinephrine; this effect is mainly limited to the brain.

    Hydroxytetrabenazine is believed to be the principle active moiety, and it is thought that its clinical activity in movement disorders results from its action on monoamine storage in the brain. The duration of action of tetrabenazine ranges from 16 to 24 hours.

    Tetrabenazine also has dopamine antagonistic effects, such as displacing -spiperone from striatal binding sites in vitro, and blocking dopaminergic inhibition of prolactin release in vitro and in vivo.

    Pharmacokinetics: Tetrabenazine has a low and erratic bioavailability. It is extensively metabolised by first-pass metabolism. Little to no unchanged tetrabenazine can be detected in the urine. The major metabolite, hydroxytetrabenazine, is formed by reduction. Following i.v. administration of radiolabelled tetrabenazine to humans, the radioactivity decreased to minimal levels within 10 hours and could not be detected 3 days later. Forty percent of total activity was found in the urine within 24 hours and 2.5% in the feces. Fifty four percent of the total activity was excreted after 48 hours.

    Indications And Clinical Uses: In the treatment of hyperkinetic movement disorders such as Huntington's chorea, Hemiballismus, Senile Chorea, Tic and Gille's de la Tourette Syndrome and Tardive Dyskinesia.

    Tetrabenazine is not indicated for the treatment of levodopa-induced dyskinetic/choreiform movements (see Warnings).

    Tetrabenazine should only be used by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders.

    Contra-Indications: Patients with a known hypersensitivity to the drug or to any of the components of the formulation.

    Tetrabenazine is contraindicated in patients with a current episode or a history of clinical depression (see Warnings).

    Tetrabenazine should not be administered together with a MAO inhibitor. At least 14 days should elapse between the discontinuation of an MAO inhibitor and initiation of treatment with tetrabenazine, as well as between the discontinuation of tetrabenazine and the initiation of treatment with an MAO inhibitor (see Precautions, Drug Interactions).

    Manufacturers' Warnings In Clinical States: Depression: Tetrabenazine may cause depression. Recognition of depression may be difficult because this condition may often be disguised by somatic complaints. The drug should be stopped immediately at the first signs or symptoms of depression. The depression can be profound, and the possibility of suicide should be kept in mind until the depression clears. There is no information on the safety or efficacy of antidepressant drug treatment in tetrabenazine-induced depression.

    Parkinsonism: Tetrabenazine can induce symptoms of parkinsonism, which are seen more frequently in the elderly and at relatively low doses. Tetrabenazine dosage should be adjusted as tolerated and needed. Levodopa-induced dyskinetic/choreiform movements should be treated by reducing the dose of levodopa, and not by giving tetrabenazine, since the latter exacerbates parkinsonian symptoms.

    Precautions: General: Occupational Hazards: Tetrabenazine may cause drowsiness and orthostatic hypotension. Therefore caution is recommended when driving, operating machinery, or performing other skilled tasks until the effect of tetrabenazine is known.

    Pregnancy: Animal reproductive studies have not been performed with tetrabenazine. There is no information on the safety of the drug in human pregnancy. However, tetrabenazine has been used for many years and no cases of malformation have been reported.

    Lactation: Limited information indicates that tetrabenazine is excreted in milk, therefore it should be avoided in breast-feeding mothers.

    Drug Interactions: Levodopa: Tetrabenazine exacerbates Parkinsonian symptoms, and thereby attenuates the effect of levodopa (see Warnings).

    Antidepressants and MAO Inhibitors: Central excitation and possibly hypertension have occurred when tetrabenazine was added to existing therapy with desipramine or MAO inhibitors.

    There is no information on the safety and efficacy of antidepressant drugs, including MAO inhibitors, in the treatment of tetrabenazine-induced depression (see Contraindications).

    Neuroleptic Agents: There is a potential for severe manifestations of dopamine deficiency, when administering tetrabenazine concomitantly with neuroleptic agents (e.g., haloperidol, chlorpromazine, metoclopramide, etc.).

    Adverse Reactions: The most commonly observed adverse reactions with tetrabenazine include, in decreasing order of frequency and observed during clinical use of the drug: signs and symptoms of Parkinsonism; drowsiness, fatigue, weakness; depression; anxiety, nervousness; insomnia; restlessness, akathisia; drooling; irritability, agitation; nausea, vomiting, epigastric pain; confusion, disorientation; hypotension; dizziness.

    Although tetrabenazine has been in clinical use for a number of years, controlled clinical trials with the drug are limited.

    Symptoms And Treatment Of Overdose: Symptoms Signs and symptoms of overdosage may include drowsiness, sweating, hypotension and hypothermia. tag_Treatment

    Treatment: Treatment is symptomatic.

    Dosage And Administration: General: The initial dose should be low, and dosage should be titrated slowly according to the tolerance and responsiveness of the individual patient.

    Adults: An initial starting dose of 12.5 mg 2 to 3 times a day is recommended. This can be increased by 12.5 mg a day every 3 to 5 days until the maximal tolerated and effective dose is reached for the individual, and may have to be up/down titrated depending on individual tolerance. In most cases the maximal tolerated dose will be 25 mg t.i.d. In very rare cases, a 200 mg dose has been reached (the maximum recommended dose in some publications).

    If there is no improvement at the maximal tolerated dose in 7 days, it is unlikely that tetrabenazine will be of benefit to the patient, either by increasing the dose or by extending the duration of treatment.

    Geriatrics and Debilitated Patients: No adequately controlled clinical studies have been performed in the elderly and/or debilitated patients. Clinical experience suggests that a reduced initial and maintenance dose should be used. Parkinsonian-like adverse reactions are relatively common in these patients and may be dose-limiting.

    Children: No adequately controlled clinical studies have been performed in children. Limited clinical experience suggests that treatment should be started at approximately half the adult dose, and titrated slowly and carefully according to tolerance and individual response.

    Availability And Storage: Each round, yellowish-buff tablet, with ROCHE imprinted across one face and a single break bar on the other, contains: tetrabenazine 25 mg. Nonmedicinal ingredients: iron oxide, lactose, magnesium stearate, starch maize white and talc. Bottles of 120. Store in well-closed containers. Store at 15 to 30?C.
    Steve
    TouretteLinks Forum

  • #2
    Nitoman Tetrabenazine Product monograph

    My son was on this drug for 2 weeks only and then I took him off myself without my Dr's permission because he would not get back to me when I told him it wasn't working. He was only on 2 mg a day but even then we had our reservations. This is when my son started seeing this neurologist and it was the first med recommended for his TS that he wasn't even officially diagnosed for. We do not see this Dr anymore.
    Rose

    Comment


    • #3
      Nitoman Tetrabenazine Product monograph

      Hello Rose,

      Have you found another physician with whom you feel more comfortable to treat your son?
      Steve
      TouretteLinks Forum

      Comment


      • #4
        Nitoman Tetrabenazine Product monograph

        Yes Steve we have. We went to another neurologist for a second opinion and she was the one who got us on the right track for diagnosis and medication. It was her referral to the Tourettes Clinic that got us in to see Dr Sandor. I have to admit that I did the right thing taking him off this drug as the four psychiatrists that we saw all agreed to TS and possible OCD, with no psychosis (because of the voices). They also gave a strange look when I told them he was on this drug. When I researched it not too many people had heard of this drug, especially giving it to a 15 yr old.
        Rose

        Comment


        • #5
          Nitoman Tetrabenazine Product monograph

          Rose,

          Glad to hear you found your way to the Tourette Clinic and Dr. Sandor.

          Thank you for providing the benefit of your experience.
          Steve
          TouretteLinks Forum

          Comment


          • #6
            Nitoman Tetrabenazine Product monograph

            Good evening folks!

            Firstly, I took the time to read a lot about Nitoman, side effects and what it does and how it does it. I will try this drug soon and let you know if it works on me!

            Who can be better placed than someone using it and talking about it on a forum?

            Comment


            • #7
              Nitoman Tetrabenazine Product monograph

              Hi Mathieu,

              I am really happy to hear that you looked up the risks and benefits of medications.

              Being an active part of your health care is vital especially with Tourette Syndrome because it is not widely know.

              Please don't take this medication just to let us know how it works!

              What other medications have you tried and how have they helped or hurt you?

              Keep us posted. Steph

              Comment


              • #8
                Nitoman Tetrabenazine Product monograph

                It works both ways.

                First, I want to try it in order to see if it can really help me in my fight vs TS. (Yeah, i'm at war with Tourette .

                2nd, most of us here know what it is to live with TS. If my experience (positive or negative) with this drug can help some people here to make their mind, I'll gladly take that risk.

                I'm 25 years old, quite healthy and willing to try some new things to get rid of TS. Hopefully, it'll work ;)

                Comment


                • #9
                  Nitoman Tetrabenazine Product monograph

                  I'm 25 years old, quite healthy and willing to try some new things to get rid of TS.
                  Hi Mathieu

                  Make sure you have realistic expectations when trying new things. There is nothing out there that gets rid of TS, yet anyway. Keep in mind that 1/3 of the population with TS will see symptoms go away and another 1/3 will see them become better with age and time. Stay informed and continue to partner with your doctor to make the best choices for yourself. The best outcome one can expect with treatment is reducing symptoms and many report increased quality of life when a treatment is found that works for them as an individual.

                  good luck with whatever route you choose and keep us updated because your experiences can add insight for others
                  Janet

                  TSFC Homepage

                  Comment


                  • #10
                    Nitoman Tetrabenazine Product monograph

                    I don't have any doctor ;)
                    I usually don't like to have one around either. Considering nothing can really cure TS yet, I don't see the point of having one following me hehe.
                    From what I have heard (from 2 friends of mine (who also are psychiatris hehe)), the result may vary but they have a strong positive feedback from the people using it.
                    I know that some people been living with TS from most of their life, compared to my little 18 years of experience hehe. But I won't sit back and tell myself that it could be worse. I want it gone! Sooner or later I will succeed hehe

                    Comment


                    • #11
                      Nitoman Tetrabenazine Product monograph

                      Hi Mathieu,

                      There are many good and bad things about medications.

                      Even though TS has no cure, you don't want to make yourself any worse by having an adverse reaction to a medication.

                      There are lots of nice doctors who would love to find out how TS affects you, so please find a doctor that will help you.

                      Keep us posted. Steph

                      Comment


                      • #12
                        nitoman

                        I was interested in the discussion about nitoman. My son was prescribed it in December but I had rarely seen any discussion regarding it. My son is 11 and was diagnosed with TS a year ago. He had been on clondidine with great results in handling the tics and hyperactivity. But in November the tics got much worse and he started yelling "shut up" at the top of his lungs. Needless to say, the school had a problem with that. His doctor put him on nitoman. No pharmacy in our area had it so it had to be ordered in. My son takes 12.5mg morning and evening and 6.25mg at lunch. His tics improved greatly (they are not completely gone but he and his classmates can cope). The shut up tic has disappeared. But if he forgets to take his nitoman we know within a few hours because his tics get worse. Our doctor is planning that my son not be on Nitoman for very much longer. we will see. By the way he is taking clonidine as well. It would be interesting to know how other people find nitoman and how long they have been on it. Thanks.

                        Comment


                        • #13
                          Nitoman Tetrabenazine Product monograph

                          Hi Donna,

                          Welcome to the TSFC forum, we are happy that you have joined us.

                          There are support groups all across Canada for support resources in your community.

                          There is a discussion on coping mechanism in the general discussion area and we have many discussions on various tics thoughout the body in the tic parade.

                          Please jump into any discussion that you want or start a new one.

                          Have you asked your doctor about why he is planning to go off Nitoman soon especially if the medication is working well for your son.

                          Will your son's doctor also stop the clonidine? How do you find these medications work together?

                          Looking forward to hearing from you. Steph

                          Comment


                          • #14
                            Nitoman Tetrabenazine Product monograph

                            Welcome to the Forum, Donna and thanks for sharing your son's experience.

                            Why does your son's doctor feel it necessary to withdraw the Nitoman?

                            Feel free to join in any other ongoing discussion or start one of your own.
                            Steve
                            TouretteLinks Forum

                            Comment


                            • #15
                              Nitoman Tetrabenazine Product monograph

                              Donna:

                              Hello & Welcome!

                              Clondidine was once used for my son that has TS+.

                              He experienced outbursts starting around the age of 11 and was also taking other medications for the + part of his disorders.

                              Has your Doctor not explained his plan of action of changing out medications?

                              You can ask him directly about reactions and concerns about using Clondidine with other med's and removing your son from the med's he is on.
                              You may get a clearer picture by speaking directly to your pharmacist about reactions and concerns about mixing medications. The will have his record in front of them and can offer direction.

                              We always keep our school informed in advance of dosage changes or medication changes so that they can monitor behavior and reactions during the school day. It also helps provide an open line of communication so the teachers and staff know what he is experiencing during that period.

                              Has your son managed well with his TS in school? This is always an open topic for us and any success stories or tips you'd like to share would be greatly appreciated by other members.

                              We also have experiences and tips to share on the same topic that might help.

                              Please keep us posted on your progress and I am glad you found us.
                              PJK

                              Comment

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