Uses of Revocon 12.5: - Huntington's disease Movement disorders, Moderate to severe tardive dyskinesia Hypersensitivity. Lactation. Hepatic impairment. Patients who are actively suicidal, or who have untreated or inadequately treated depression.

Atypical neuroleptic drugs

Prolongation of the QTc interval has been observed at doses of 50 mg. In rats, it has been observed that tetrabenazine or its metabolites bind to melanin-containing tissues such as the eyes and skin. After a single oral dose of radiolabeled tetrabenazine, radioactivity was still detected in eye and fur at 21 days post dosing.Tetrabenazine is a reversible human vesicular monoamine transporter type 2 inhibitor (Ki = 100 nM). It acts within the basal ganglia and promotes depletion of monoamine neurotransmitters serotonin, norepinephrine, and dopamine from stores. It also decreases uptake into synaptic vesicles. Dopamine is required for fine motor movement, so the inhibition of its transmission is efficacious for hyperkinetic movement. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (Ki = 2100 nM).

How to use Tetrabenazine: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Tetrabenazine may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Adult Dose: Oral Huntington Disease Indicated for treatment of chorea associated with Huntington’s disease Adult: Individualize and slowly titrate dosage over several weeks to identify a dose that reduces chorea and is well tolerated Total daily dose up to 50 mg/day 12.5 mg PO qDay initially; after 1 week, the dose should be increased to 12.5 mg q12hr Maintenance: Titrate slowly by weekly intervals of 12.5 mg/day to identify dose that reduces chorea and is tolerated If daily dose is 37.5 to 50 mg/day, administer in divided doses q8hr Elderly: Initially 12.5 mg daily, increased gradually. Total Daily dose >50 mg/day If >50 mg/day is required, test and genotype to determine if poor or extensive metabolizers of CYP2D6; not to exceed 100 mg/day or 37.5 mg/dose Moderate to severe tardive dyskinesia Adult: Initially 12.5 mg daily increased gradually according to response. Hepatic impairment Contraindicated; it is not possible to adjust the dose to ensure safe use Child Dose: Safety and efficacy not established

Tetrabenazine should not be given with or within 14 days of discontinuation of MAOI therapy. Blocks action of reserpine. Decreases effects of levodopa and worsen parkinsonism. Increased risk of extrapyramidal side effects when given with amantadine, metoclopramide, antipsychotics.

Hypersensitivity. Lactation. Hepatic impairment. Patients who are actively suicidal, or who have untreated or inadequately treated depression.

Common - Nausea - Insomnia (difficulty in sleeping) - Anxiety - Fatigue - Sleepiness - Akathisia (inability to stay still) - Depression >10% Sedation/somnolence (31%),Fatigue (22%),Insomnia (22%),Depression (19%),Akathisia (19%),Extrapyramidal event (15%),Anxiety (15%),Nausea (13%) 1-10% Irritability (9%),Bruising (6%),Vomiting (6%),Decreased appetite (4%),Dysuria (4%),Obsessive reaction (4%),Imbalance (9%),Parkinsonism/bradykinesia (9%),Dizziness (4%),Dysarthria (4%),Unsteady gait (4%),Headache (4%) Frequency Not Defined QTc prolongation,Neuroleptic malignant syndrome,Orthostatic Hypotension,Restlessness and agitation,Dysphagia,Depression and suicidality Potentially Fatal: Neuroleptic malignant syndrome (NMS).

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tetrabenazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Nursing Mothers: It is not known whether Tetrabenazine or its metabolites are excreted in human milk. Since many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from Tetrabenazine, a decision should be made whether to discontinue nursing or to discontinue Tetrabenazine, taking into account the importance of the drug to the mother.

Precaution: May exacerbate symptoms of parkinsonism. Caution to be exercised when driving or performing skilled tasks. Pregnancy. Increased risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Monitor for emergence or worsening of depression, suicidality, or unusual changes in behavior. Caution in patients with a history of depression or prior suicide attempts or ideation.

Signs and symptoms of overdosage of Tetrabenazine may include drowsiness, sweating and hypothermia.

Store in a cool & dry place. protect from light & moisture. Keep all medicines out of the reach of the children.

Atypical neuroleptic drugs

Reversibly inhibits human vesicular monoamine transporter type 2 (VMAT2), resulting in decreased uptake of monoamines (eg, dopamine, serotonin, norepinephrine, histamine) into synaptic vesicles and depletion of monoamine stores from nerve terminals This effect is similar to reserpine, but with less peripheral activity and is shorter-acting

Pregnancy There are no adequate data on the developmental risk associated with therapy in pregnant women; administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality Lactation There are no data on presence of tetrabenazine or metabolites in human milk, effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and potential adverse effects on breastfed infant or underlying maternal condition