Tetrabenazine 25 mg tablets
AOP Orphan Pharmaceuticals AG
1. Name of the medicinal product
Tetrabenazine 25 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 25 mg Tetrabenazine.
Excipient with known effects:
Each tablet contains 60.8 mg lactose (see section 4.4)
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Yellow, round, with a break line on one-side and `TE25` engraved on the reverse side.
The tablet can be divided into equal halves.
4. Clinical particulars
4.1 Therapeutic indications
Tetrabenazine is indicated for hyperkinetic motor disorders with Huntington's chorea.
4.2 Posology and method of administration
The tablets are for oral use. The therapy should be supervised by a doctor experienced in treating hyperkinetic disorders.
Posology
Adults
Huntington's chorea
Dosage and administration are individual in each patient and therefore only a guide is given.
An initial starting dose of 12.5 mg one to three times a day is recommended. This can be increased every three or four days by 12.5 mg until the optimal effect is observed or up to the occurence of intolerance effects (sedation, Parkinsonism, depression).
The maximum daily dose is 200 mg a day.
If there is no improvement at the maximum dose in seven days, it is unlikely that the compound will be of benefit to the patient, either by increasing the dose or by extending the duration of treatment.
Elderly population
No specific studies have been performed in the elderly, but tetrabenazine has been administered to elderly patients in standard dosage without apparent ill effect. Parkinson-like adverse reactions are quite common in these patients and could be dose-limiting.
Paediatric population
The safety and efficacy in children have not yet been established. The treatment is not recommended in children.
Patients with hepatic impairment
In patients with mild and moderate hepatic impairment half the initial dose and a slower up-titration of the dose is recommended. Patients with severe hepatic impairment have not been studied, therefore additional caution is advised in these patients (see also section 4.4 and 5.2).
Patients with renal impairment
No studies have been performed in patients with renal impairment. Caution is advised in the treatment of these patients.
4.3 Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Tetrabenazine can block the action of reserpine. Thus these substances should not be taken concomitantly.
- Use of monoamine oxidase inhibitors
- Presence of a hypokinetic-rigid-syndrome (Parkinsonism)
- Untreated or inadequately treated depression. Patients who are actively suicidal.
- Breast feeding
- Pheochromocytoma
- Pro-lactin-dependent tumours, e.g. pituitary or breast cancer
4.4 Special warnings and precautions for use
The dose of tetrabenazine should be titrated to determine the most appropriate dose for each patient.
In vitro and in vivo studies indicate that the tetrabenazine metabolites α-HTBZ and β-HTBZ are substrates for CYP2D6 (see section 5.2). Therefore dosing requirements may be influenced by a patient's CYP2D6 metaboliser status and concomitant medications which are strong CYP2D6 inhibitors (see section 4.5).
When first prescribed, tetrabenazine therapy should be titrated slowly over several weeks to allow the identification of a dose th |
