Revocon 12.5

✔️ Side Effects

Common and clinically significant adverse reactions include depression, suicidal thoughts or behavior, akathisia, restlessness, agitation, parkinsonism, dysphagia, sedation, and somnolence.

✔️ Dosage & Administration

General Dosing Principles

The daily dose for treating Huntington’s disease–associated chorea must be individualized. Treatment should begin at a low dose and be gradually titrated over several weeks to determine the lowest effective and well-tolerated dose. Tetrabenazine may be taken with or without food.

Dosing Up to 50 mg/day

Initial dose: 12.5 mg once daily in the morning

After one week: Increase to 25 mg/day (12.5 mg twice daily)

Further increases: Incrementally increase by 12.5 mg/day at weekly intervals

Doses of 37.5–50 mg/day should be administered in three divided doses

Maximum single dose: 25 mg

If adverse effects such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety, or sedation occur, dose escalation should be stopped and the dose reduced. Persistent adverse reactions may require treatment discontinuation or additional supportive therapy.

Dosing Above 50 mg/day

Patients requiring doses exceeding 50 mg/day should undergo CYP2D6 genotyping to determine metabolizer status.

Extensive or Intermediate CYP2D6 Metabolizers:

Titrate by 12.5 mg/day at weekly intervals

Doses above 50 mg/day should be given in three divided doses

Maximum daily dose: 100 mg

Maximum single dose: 37.5 mg

Dose adjustments or discontinuation should be considered if intolerable adverse effects develop.

✔️ Drug Interactions

Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation is contraindicated

Interaction with reserpine may reduce therapeutic effectiveness

May diminish the effects of levodopa and exacerbate Parkinsonian symptoms

Concurrent use with antipsychotics, metoclopramide, or amantadine increases the risk of extrapyramidal reactions

✔️ Tetrabenazine is contraindicated in patients with:

Active suicidal ideation or untreated/inadequately treated depression

Hepatic impairment

Concurrent or recent (within 14 days) use of MAOIs

✔️ Pregnancy & Lactation

Pregnancy Category C: No adequate, well-controlled studies are available in pregnant women. Tetrabenazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is unknown whether tetrabenazine or its metabolites are excreted in human breast milk. Due to the potential for serious adverse effects in nursing infants, a decision should be made to either discontinue breastfeeding or discontinue the drug, considering its importance to the mother.

✔️ Precautions & Warnings

Tetrabenazine may worsen symptoms of parkinsonism. Patients should exercise caution when performing tasks requiring mental alertness, such as driving or operating machinery.