Tetmodis Tablet
Tetrabenazine
25mg
AOP ORPHAN PHARMACEUTICALS AG
| Pack size | 112's HDPE Container |
|---|---|
| Dispensing mode | SCD |
| Source | AUSTRIA |
| Agent | PHARMA STORES |
| Retail Price | 417.50 AED |
Indications
Tetmodis Tablet is used for:
Movement disorders, Moderate to severe tardive dyskinesia
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
Renal Dose
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity. Lactation. Hepatic impairment. Patients who are actively suicidal, or who have untreated or inadequately treated depression.
Precautions
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.
Pregnancy-Lactation
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
Interactions
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.
Adverse Effects
Side effects of Tetrabenazine :
>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).
Mechanism of Action
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
Note
Tetmodis 25mg Tablet manufactured by AOP ORPHAN PHARMACEUTICALS AG. Its generic name is Tetrabenazine. Tetmodis is availble in United Arab Emirates.
Farmaco UAE drug index information on Tetmodis Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.