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Rx Item-Tetrabenazine 25Mg Tab 112 By Tagi Pharma

NDC 68682-0422-25 UPC/GTIN No.3-68682-42225-2 Mfg.Part No.42225BRAND: TETRABENAZINE NDC: 51224-0425-10,51224042510 UPC: 3-51224-42510-1,351224425101 Tetrabenazine 25mg Tab 112 by TAGI PharmaOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Tetrabenazine 25Mg Tab 112 By Tagi Pharma

$3516.00$3917.82

Item No.: RX430266/m NDC No.51224042510 UPC No.:351224425101 NDC No. 51224-0425-10 51224-425-10 UPC/GTIN No. 3-51224-42510-1 MPN 42225 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx619569 Tetrabenazine 25mg Tab 112 by Tagi Pharm Item No. 619569 NDC No. 51224042510 UPC No. 351224-425101 35122442

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XENAZINE- tetrabenazine tablet
Lundbeck Inc.
708
tablet , tan , scored , cylindrical other
biplanar (flat on both sides)Beveled edgeDebossed

WARNING: DEPRESSION AND SUICIDALITY

XENAZINE can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease. Anyone considering the use of XENAZINE must balance the risks of depression and suicidality with the clinical need for control of chorea. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician.



Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington's disease. XENAZINE is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression [see Contraindications (4), Warnings and Precautions (5.2)].

1 INDICATIONS AND USAGE

XENAZINE is indicated for the treatment of chorea associated with Huntington's disease.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Considerations
The chronic daily dose of XENAZINE used to treat chorea associated with Huntington's disease (HD) is determined individually for each patient. When first prescribed, XENAZINE therapy should be titrated slowly over several weeks to identify a dose of XENAZINE that reduces chorea and is tolerated. XENAZINE can be administered without regard to food [see Clinical Pharmacology (12.3)].

2.2 Individualization of Dose
The dose of XENAZINE should be individualized.

Dosing Recommendations Up to 50 mg per day

The starting dose should be 12.5 mg per day given once in the morning. After one week, the dose should be increased to 25 mg per day given as 12.5 mg twice a day. XENAZINE should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. If a dose of 37.5 to 50 mg per day is needed, it should be given in a three times a day regimen. The maximum recommended single dose is 25 mg. If adverse reactions such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing XENAZINE treatment or initiating other specific treatment (e.g., antidepressants) [see Adverse Reactions (6.1)].

Dosing Recommendations Above 50 mg per day

Patients who require doses of XENAZINE greater than 50 mg per day should be first tested and genotyped to determine if they are poor metabolizers (PMs) or extensive metabolizers (EMs) by their ability to express the drug metabolizing enzyme, CYP2D6. The dose of XENAZINE should then be individualized accordingly to their status as PMs or EMs [see Warnings and Precautions (5.3), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

Extensive and Intermediate CYP2D6 Metabolizers

Genotyped patients who are identified as extensive (EMs) or intermediate metabolizers (IMs) of CYP2D6, who need doses of XENAZINE above 50 mg per day, should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. Doses above 50 mg per day should be given in a three times a day regimen. The maximum recommended daily dose is 100 mg and the maximum recommended single dose is 37.5 mg. If adverse reactions such as akathisia, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing XENAZINE treatment or initiating other specific treatment (e.g., antidepressants) [see Warnings and Precautions (5.3), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

Poor CYP2D6 Metabolizers

In PMs, the initial dose and titration is similar to EMs except that the recommended maximum single dose is 25 mg, and the recommended daily dose should not exceed a maximum of 50 mg [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

2.3 Dosage Adjustments with CYP2D6 Inhibitors
Strong CYP2D6 Inhibitors

Medications that are strong CYP2D6 inhibitors such as quinidine or antidepressants (e.g., fluoxetine, paroxetine) significantly increase the exposure to ?-HTBZ and ?-HTBZ, therefore, the total dose of XENAZINE should not exceed a maximum of 50 mg and the maximum single dose should not exceed 25 mg [see Warnings and Precautions (5.3), Drug Interactions (7.1), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

2.4 Discontinuation of Treatment
Treatment with XENAZINE can be discontinued without tapering. Re-emergence of chorea may occur within 12 to 18 hours after the last dose of XENAZINE [see Drug Abuse and Dependence (9.2)].

2.5 Resumption of Treatment
Following treatment interruption of greater than five (5) days, XENAZINE therapy should be re-titrated when resumed. For short-term treatment interruption of less than five (5) days, treatment can be resumed at the previous maintenance dose without titration.

3 DOSAGE FORMS AND STRENGTHS

XENAZINE tablets are available in the following strengths and packages:

The 12.5 mg XENAZINE tablets are white, cylindrical biplanar tablets with beveled edges, non-scored, embossed on one side with "CL" and "12.5."

The 25 mg XENAZINE tablets are yellowish-buff, cylindrical biplanar tablets with beveled edges, scored, embossed on one side with "CL" and "25."

4 CONTRAINDICATIONS

XENAZINE is contraindicated in patients:


Who are actively suicidal, or in patients with untreated or inadequately treated depression [see Warnings and Precautions (5.2)].

With hepatic impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Taking monoamine oxidase inhibitors (MAOIs). XENAZINE should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI [see Drug Interactions (7.3)].

Taking reserpine. At least 20 days should elapse after stopping reserpine before starting XENAZINE [see Drug Interactions (7.2)].
ADVERSE REACTIONS

The following serious adverse reactions are described below and elsewhere in the labeling:


Depression and suicidality [see Warnings and Precautions (5.2)]

Akathisia, restlessness, and agitation [see Warnings and Precautions (5.5)]

Parkinsonism [see Warnings and Precautions (5.6)]

Dysphagia [see Warnings and Precautions (5.7)]

Sedation and somnolence [see Warnings and Precautions (5.8)]
DESCRIPTION

XENAZINE (tetrabenazine) is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6.51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac �1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one.

The empirical formula C19 H27 NO3
Tetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.

Each XENAZINE (tetrabenazine) Tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient.

XENAZINE (tetrabenazine) Tablets contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose, magnesium stearate, maize starch, and talc. The 25 mg strength tablet also contains yellow iron oxide as an inactive ingredient.

XENAZINE (tetrabenazine) is supplied as a yellowish-buff scored tablet containing 25 mg of XENAZINE or as a white non-scored tablet containing 12.5 mg of XENAZINE.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
The precise mechanism by which XENAZINE (tetrabenazine) 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. Tetrabenazine reversibly inhibits the human vesicular monoamine transporter type 2 (VMAT2) (Ki ? 100 nM), resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores. Human VMAT2 is also inhibited by dihydrotetrabenazine (HTBZ), a mixture of ?-HTBZ and ?-HTBZ. ?- and ?-HTBZ, major circulating metabolites in humans, exhibit high in vitro binding affinity to bovine VMAT2. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (Ki = 2100 nM).

NDC 68682-0422-25 UPC/GTIN No.3-68682-42225-2 Mfg.Part No.42225
RX ITEM-Tetrabenazine 25Mg Tab 112 By Ta
NDC 68682-0422-25 UPC/GTIN No.3-68682-42225-2 Mfg.Part No.42225

BRAND: TETRABENAZINE NDC: 51224-0425-10,51224042510 UPC: 3-51224-42510-1,351224425101 Tetrabenazine 25mg Tab 112 by TAGI Pharma
Tetrabenazine 25Mg Tab 112 By Tagi Pharm
BRAND: TETRABENAZINE NDC: 51224-0425-10,51224042510 UPC: 3-51224-42510-1,351224425101 Tetrabenazine 25mg Tab 112 by TAGI Pharma

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
Click above for TETRABENAZINE
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.