Ajuben

Ajuben6 mg

Tablet

Deutetrabenazine

Incepta Pharmaceuticals Ltd.

Product Code : 19936
MRP 70.00
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Medicine overview

Indications of Ajuben 6 mg

Ajuben 6 mg is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of Chorea associated with Huntington’s disease & Tardive dyskinesia in adults.

Dosage of Ajuben 6 mg

Patients not presently receiving Tetrabenazine: Titrate up at weekly intervals by 6 mg per day to a tolerated dose that reduces chorea, up to a maximum recommended daily dosage of 48 mg (24 mg twice daily). Administer total daily dosages of 12 mg or above in two divided doses and administer with foods.Patients receiving Tetrabenazine: If switching patients from tetrabenazine, discontinue tetrabenazine and initiate Ajuben 6 mg the following day. After patients are switched to Ajuben 6 mg, the dose may be adjusted at weekly intervals.Patients with Hepatic & Renal Impairment: No clinical studies have been conducted to assess the effect of renal & hepatic impairment on the pharmacokinetics of Ajuben 6 mg.Patients with poor CYP2D6 metabolizers: Maximum recommended dosage of Ajuben 6 mg in poor CYP2D6 metabolizers is 36 mg per day (i.e., 18 mThe precise mechanism by which Ajuben 6 mg exerts its anti-chorea effects is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (α-dihydrotetrabenazine and βdihydrotetrabenazine) of Ajuben 6 mg, are reversible inhibitors of vesicular monoamine transporter 2 (VMAT2), resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.g twice daily).Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Interaction of Ajuben 6 mg

Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of Ajuben 6 mg is 36 mg per day (18 mg twice daily).Alcohol or other sedating drugs: May have additive sedation and somnolence.

Contraindications

Ajuben 6 mg is contraindicated in patients: Who are suicidal, or in patients with untreated or inadequately treated depression. With hepatic impairment. Taking monoamine oxidase inhibitors (MAOIs). Ajuben 6 mg should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI. Taking reserpine. At least 20 days should elapse after stopping reserpine before starting AUSTEDO. Taking tetrabenazine

Side Effects of Ajuben 6 mg

The most common side effects of Ajuben 6 mg include: sleepiness (sedation) tiredness diarrhea dry mouth

Precautions & Warnings

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 Ajuben 6 mg Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior 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 Ajuben 6 mg is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression

Overdose Effects of Ajuben 6 mg

Overdoses ranging from 100 mg to 1 g have been reported in the literature with tetrabenazine, a closely related VMAT2 inhibitor. The following adverse reactions occurred with overdosing: acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor. Treatment should consist of those general measures employed in the management of overdosage with any central nervous system-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Mode Of Action

The precise mechanism by which Ajuben 6 mg exerts its anti-chorea effects is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (α-dihydrotetrabenazine [HTBZ] and β-HTBZ) of Ajuben 6 mg, are reversible inhibitors of VMAT2, resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores

Pregnancy

Pregnancy: There are no adequate data on the developmental risk associated with the use of Ajuben 6 mg in pregnant women. Administration of Ajuben 6 mg 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: There are no data on the presence of Ajuben 6 mg or its metabolites in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ajuben 6 mg and any potential adverse effects on the breastfed infant from Ajuben 6 mg or from the underlying maternal condition.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.