Ajuben 6 Tablet
Deutetrabenazine
6 mg
Incepta Pharmaceuticals Ltd.
| Pack size | 10's |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 70 AED |
Available as:
Indications
Ajuben 6 Tablet is used for:
Indicated for chorea associated with Huntington disease, Tardive Dyskinesia
Adult Dose
Chorea
Oral
Indicated for chorea associated with Huntington disease
Dose is determined individually for each patient based on reduction of chorea and tolerability
Initial dose when not being switched from tetrabenazine: 6 mg once daily
May increased dose at weekly intervals in increments of 6 mg/day; not to exceed 48 mg/day
Administer doses >12 mg/day in 2 divided doses
Tardive Dyskinesia
Indicated for treatment of tardive dyskinesia (TD)
Dose is determined individually for each patient based on reduction of TD and tolerability
Initial dose when not being switched from tetrabenazine: 6 mg PO BID
May increased dose at weekly intervals in increments of 6 mg/day; not to exceed 48 mg/day
Child Dose
Renal Dose
Administration
Administer with food
Swallow tablet whole; do not chew, crush, or break
Contra Indications
Patients with Huntington disease who are suicidal, or in patients with untreated or inadequately treated depression
Hepatic impairment
Coadministration with MAOIs; deutetrabenazine should not be used in combination with an MAOI or within 14 days of discontinuing an MAOI
Coadministration with reserpine; at least 20 days should elapse after stopping reserpine before initiating deutetrabenazine
Coadministration with tetrabenazine or valbenazine
Precautions
Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease
Balance risks of depression and suicidality with the clinical need for treatment of chorea when considering the use of Deutetrabenazine
Inform patients, caregivers and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician
Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation
Deutetrabenazine is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression
QT Prolongation: May cause an increase in QT interval. Avoid use in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval
Neuroleptic Malignant Syndrome (NMS): Discontinue if this occurs
Akathisia, agitation, restlessness, and parkinsonism: Reduce dose or discontinue if this occurs
Sedation/somnolence: May impair the patient’s ability to drive or operate complex machinery
Monitoring Parameters
Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior
Monitor for manifestations of NMS (eg, hyperpyrexia, muscle rigidity, altered mental status, autonomic instability, increased creatinine phosphokinase, myoglobinuria, rhabdomyolysis, acute renal failure)
Pregnancy-Lactation
Pregnancy
There are no adequate data on the developmental risk in pregnant women
Animal studies
Administration of deutetrabenazine to rats during organogenesis produced no clear adverse effect on embryofetal development
However, administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality
Lactation
Unknown if distributed in human breast milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
Coadministration with dopamine antagonists or antipsychotics may increase risk for parkinsonism, NMS, and akathisia
Coadministration with alcohol and other sedating drugs may worsen somnolence associated with deutetrabenazine
Contraindicated (12)
isocarboxazid
linezolid
mavorixafor
methylene blue
phenelzine
rasagiline
safinamide
selegiline
selegiline transdermal
tetrabenazine
tranylcypromine
valbenazine
Serious (20)
acrivastine
adagrasib
benzhydrocodone/acetaminophen
buprenorphine buccal
buprenorphine subdermal implant
buprenorphine transdermal
buprenorphine, long-acting injection
givosiran
iobenguane I 131
metoclopramide intranasal
oliceridine
olopatadine intranasal
opicapone
reserpine
ropeginterferon alfa 2b
safinamide
sodium oxybate
thalidomide
tolcapone
zuranolone
Adverse Effects
Side effects of Deutetrabenazine :
>10%
Somnolence (11%)
1-10%
Diarrhea (9%)
Dry mouth (9%)
Fatigue (9%)
Urinary tract infection (7%)
Insomnia (7%)
Anxiety (4%)
Constipation (4%)
Contusion (4%)
Dizziness (4%)
Akathisia, agitation, or restlessness (4%)
Depression in patients with Huntington’s disease (4%)
Suicidal ideation in patients with Huntington’s disease (2%)
Parkinsonism in patients with Huntington’s disease
Mechanism of Action
Oral vesicular monoamine transporter-2 (VMAT-2) inhibitor; decreases uptake of monoamines (eg, dopamine, serotonin, norepinephrine, histamine) into synaptic vesicles and depletes monoamine stores from nerve terminals
The precise mechanism by which deutetrabenazine exerts its antichorea effects is unknown, but is believed to be related to its effect on reversible depletion of monoamines from nerve terminals
Note
Ajuben 6 6 mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Deutetrabenazine. Ajuben 6 is availble in Bangladesh.
Farmaco BD drug index information on Ajuben 6 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.