Product Details: Nitoman (Tetrabenazine)

PLEASE NOTE NITOMAN IS ALSO MARKETED INTERNATIONALLY UNDER THE NAME XENAZINE.

Brand Name Options - Manufacturer: Roche

Generic Options - Manufacturer: Generic

What are Generics? A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, how it is taken, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name and works the same way in the body in the same amount of time.

The only differences between generics and their brand-name counterparts is the generics are less expensive and may look slightly different (e.g. different shape or color), as trademark laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to invent a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name drug and sell it at substantial discounts.

Description

Used in the treatment of hyperkinetic movement disorders such as Huntington's chorea, Hemiballismus, Senile Chorea, Tic and Gille's de la Tourette Syndrome and Tardive Dyskinesia.

Directions

General: The initial dose should be low, and dosage should be titrated slowly according to the tolerance and responsiveness of the individual patient.
Adults: An initial starting dose of 12.5 mg 2 to 3 times a day is recommended. This can be increased by 12.5 mg a day every 3 to 5 days until the maximal tolerated and effective dose is reached for the individual, and may have to be up/down titrated depending on individual tolerance. In most cases the maximal tolerated dose will be 25 mg t.i.d. In very rare cases, a 200 mg dose has been reached (the maximum recommended dose in some publications).
If there is no improvement at the maximal tolerated dose in 7 days, it is unlikely that tetrabenazine will be of benefit to the patient, either by increasing the dose or by extending the duration of treatment.
Geriatrics and Debilitated Patients: No adequately controlled clinical studies have been performed in the elderly and/or debilitated patients. Clinical experience suggests that a reduced initial and maintenance dose should be used. Parkinsonian-like adverse reactions are relatively common in these patients and may be dose-limiting.
Children: No adequately controlled clinical studies have been performed in children. Limited clinical experience suggests that treatment should be started at approximately half the adult dose, and titrated slowly and carefully according to tolerance and individual response.

Cautions

General: Occupational Hazards: Tetrabenazine may cause drowsiness and orthostatic hypotension. Therefore caution is recommended when driving, operating machinery, or performing other skilled tasks until the effect of tetrabenazine is known.
Pregnancy: Animal reproductive studies have not been performed with tetrabenazine. There is no information on the safety of the drug in human pregnancy. However, tetrabenazine has been used for many years and no cases of malformation have been reported.
Lactation: Limited information indicates that tetrabenazine is excreted in milk, therefore it should be avoided in breast-feeding mothers.

Side Effects

SIDE EFFECTS, that may occur while taking this medicine include depression, drowsiness, disturbances of the gut such as diarrhea, constipation, nausea, vomiting or abdominal pain, low blood pressure (hypotension), high temperature combined with falling levels of consciousness, paleness, sweating and a fast heart beat (neuroleptic malignant syndrome) this requires stopping the medicine and immediate medical treatment. The side effects listed above may not include all of the side effects reported by the drug's manufacturer. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Active Ingredients

Tetrabenazine