USA - engelska - NLM (National Library of Medicine)

hunters specialties, inc. - aluminum zirconium trichlorohydrex gly (unii: t27d6t99lh) (aluminum zirconium trichlorohydrex gly - unii:t27d6t99lh) - aluminum zirconium trichlorohydrex gly 200 mg in 1 g - anti-perspirant reduces underarm wetness. extra effective.

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

aop orphan ltd - tetrabenazine - oral tablet - 25mg

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

aop orphan ltd - tetrabenazine - oral tablet - 25mg

USA - engelska - NLM (National Library of Medicine)

bionpharma inc. - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine 12.5 mg - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington’s disease. tetrabenazine is contraindicated in patients: - who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings  and precautions ( 5.1) ] . - with hepatic impairment [see use in specific populations ( 8.6),  clinical pharmacology ( 12.3) ] . - taking monoamine oxidase inhibitors (maois). tetrabenazine 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 tetrabenazine [see drug interactions ( 7.2) ] . - taking deutetrabenazine or valbenazine [see drug interactions ( 7.7)]. risk summary there are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality. administration of a major human metabolite of tetrabenazine to rats during pregnancy or during pregnancy and lactation produced adverse effects on the developing fetus and offspring (increased mortality, decreased growth, and neurobehavioral and reproductive impairment). the adverse developmental effects of tetrabenazine and a major human metabolite of tetrabenazine in rats occurred at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data tetrabenazine had no clear effects on embryofetal development when administered to pregnant rats throughout the period of organogenesis at oral doses up to 30 mg/kg/day (or 3 times the maximum recommended human dose [mrhd] of 100 mg/day on a mg/m 2 basis). tetrabenazine had no effects on embryofetal development when administered to pregnant rabbits during the period of organogenesis at oral doses up to 60 mg/kg/day (or 12 times the mrhd on a mg/m 2 basis). when tetrabenazine (5, 15, and 30 mg/kg/day) was orally administered to pregnant rats from the beginning of organogenesis through the lactation period, an increase in stillbirths and offspring postnatal mortality was observed at 15 and 30 mg/kg/day and delayed pup maturation was observed at all doses. a no-effect dose for pre- and postnatal developmental toxicity in rats was not identified. the lowest dose tested (5 mg/kg/day) was less than the mrhd on a mg/m 2 basis. because rats dosed orally with tetrabenazine do not produce 9-desmethyl-β-dhtbz, a major human metabolite of tetrabenazine, the metabolite was directly administered to pregnant and lactating rats. oral administration of 9-desmethyl-β-dhtbz (8, 15, and 40 mg/kg/day) throughout the period of organogenesis produced increases in embryofetal mortality at 15 and 40 mg/kg/day and reductions in fetal body weights at 40 mg/kg/day, which was also maternally toxic. when 9-desmethyl-β-dhtbz (8, 15, and 40 mg/kg/day) was orally administered to pregnant rats from the beginning of organogenesis through the lactation period, increases in gestation duration, stillbirths, and offspring postnatal mortality (40 mg/kg/day); decreases in pup weights (40 mg/kg/day); and neurobehavioral (increased activity, learning and memory deficits) and reproductive (decreased litter size) impairment (15 and 40 mg/kg/day) were observed. maternal toxicity was seen at the highest dose. the no-effect dose for developmental toxicity in rats (8 mg/kg/day) was associated with plasma exposures (auc) of 9-desmethyl-β-dhtbz in pregnant rats lower than that in humans at the mrhd. risk summary there are no data on the presence of tetrabenazine 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 tetrabenazine and any potential adverse effects on the breastfed infant from tetrabenazine or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. the pharmacokinetics of tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects. because the safety and efficacy of the increased exposure to tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of tetrabenazine in hepatic impairment to ensure safe use. the use of tetrabenazine in patients with hepatic impairment is contraindicated [see contraindications ( 4),  clinical  pharmacology ( 12.3) ] . patients who require doses of tetrabenazine greater than 50 mg per day, should be first tested and genotyped to determine if they are poor (pms) or extensive metabolizers (ems) by their ability to express the drug metabolizing enzyme, cyp2d6. the dose of tetrabenazine should then be individualized accordingly to their status as either poor (pms) or extensive metabolizers (ems)  [see dosage and administration ( 2.2), warnings and precautions ( 5. 3),  clinical pharmacology ( 12.3) ] . poor metabolizers poor cyp2d6 metabolizers (pms) will have substantially higher levels of exposure to the primary metabolites (about 3-fold for α-htbz and 9-fold for β-htbz) compared to ems. the dosage should, therefore, be adjusted according to a patient’s cyp2d6 metabolizer status by limiting a single dose to a maximum of 25 mg and the recommended daily dose to not exceed a maximum of 50 mg/day in patients who are cyp2d6 pms [see dosage and administration ( 2.2), warnings and precautions ( 5.3),  clinical pharmacology ( 12.3) ] . extensive / intermediate metabolizers in extensive (ems) or intermediate metabolizers (ims), the dosage of tetrabenazine can be titrated to a maximum single dose of 37.5 mg and a recommended maximum daily dose of 100 mg [see dosage and administration  ( 2.2 ), drug interactions ( 7.1),  clinical pharmacology ( 12.3) ] . tetrabenazine is not a controlled substance. clinical trials did not reveal patients developed drug seeking behaviors, though these observations were not systematic. abuse has not been reported from the postmarketing experience in countries where tetrabenazine has been marketed. as with any cns-active drug, prescribers should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of tetrabenazine misuse or abuse (such as development of tolerance, increasing dose requirements, drug-seeking behavior). abrupt discontinuation of tetrabenazine from patients did not produce symptoms of withdrawal or a discontinuation syndrome; only symptoms of the original disease were observed to re‑emerge  [see dosage and  administration ( 2.4) ] .

USA - engelska - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington's disease. tetrabenazine is contraindicated in patients: - who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings and precautions (5.1)] . - with hepatic impairment [see use in specific populations (8.6), clinical pharmacology (12.3)] . - taking monoamine oxidase inhibitors (maois). tetrabenazine 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 tetrabenazine [see drug interactions (7.2)] . - taking deutetrabenazine or valbenazine [see drug interactions ( 7.7)]. there are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. administration of tetrabenazine to rats throughout preg

USA - engelska - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington’s disease. tetrabenazine is contraindicated in patients: risk summary there are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality. administration of a major human metabolite of tetrabenazine to rats during pregnancy or during pregnancy and lactation produced adverse effects on the developing fetus and offspring (increased mortality, decreased growth, and neurobehavioral and reproductive impairment). the adverse developmental effects of tetrabenazine and a major human metabolite of tetrabenazine in rats occurred at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectiv

USA - engelska - NLM (National Library of Medicine)

slate run pharmaceuticals, llc - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington’s disease. tetrabenazine tablets are contraindicated in patients: risk summary there are no adequate data on the developmental risk associated with the use of tetrabenazine tablets in pregnant women. administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality. administration of a major human metabolite of tetrabenazine to rats during pregnancy or during pregnancy and lactation produced adverse effects on the developing fetus and offspring (increased mortality, decreased growth, and neurobehavioral and reproductive impairment). the adverse developmental effects of tetrabenazine and a major human metabolite of tetrabenazine in rats occurred at clinically relevant doses [see data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 t

USA - engelska - NLM (National Library of Medicine)

apotex corp. - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington's disease. tetrabenazine tablets are contraindicated in patients: - who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings and precautions (5.1)] . who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings and precautions (5.1)] . - with hepatic impairment [see use in specific populations (8.6), clinical pharmacology (12.3)] . with hepatic impairment [see use in specific populations (8.6), clinical pharmacology (12.3)] . - taking monoamine oxidase inhibitors (maois). tetrabenazine tablets 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 monoamine oxidase inhibitors (maois). tetrabenazine tablets 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 tetrabenazine tablets [see drug interactions (7.2)] . taking reserpine. at least 20 days should elapse after stopping reserpine before starting tetrabenazine tablets [see drug interactions (7.2)] . - taking deutetrabenazine or valbenazine [see drug interactions (7.7)] . taking deutetrabenazine or valbenazine [see drug interactions (7.7)] . risk summary there are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality. administration of a major human metabolite of tetrabenazine to rats during pregnancy or during pregnancy and lactation produced adverse effects on the developing fetus and offspring (increased mortality, decreased growth, and neurobehavioral and reproductive impairment). the adverse developmental effects of tetrabenazine and a major human metabolite of tetrabenazine in rats occurred at clinically relevant doses [see data] .   in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown.   data   animal data tetrabenazine had no clear effects on embryofetal development when administered to pregnant rats throughout the period of organogenesis at oral doses up to 30 mg/kg/day (or 3 times the maximum recommended human dose [mrhd] of 100 mg/day on a mg/m2 basis). tetrabenazine had no effects on embryofetal development when administered to pregnant rabbits during the period of organogenesis at oral doses up to 60 mg/kg/day (or 12 times the mrhd on a mg/m2 basis).   when tetrabenazine (5, 15, and 30 mg/kg/day) was orally administered to pregnant rats from the beginning of organogenesis through the lactation period, an increase in stillbirths and offspring postnatal mortality was observed at 15 and 30 mg/kg/day and delayed pup maturation was observed at all doses. a no-effect dose for pre- and postnatal developmental toxicity in rats was not identified. the lowest dose tested (5 mg/kg/day) was less than the mrhd on a mg/m2 basis.   because  rats dosed orally with tetrabenazine do not produce 9-desmethyl-β-dhtbz, a major human metabolite of tetrabenazine, the metabolite was directly administered to pregnant and lactating rats. oral administration of 9-desmethyl-β-dhtbz (8, 15, and 40 mg/kg/day) throughout the period of organogenesis produced increases in embryofetal mortality at 15 and 40 mg/kg/day and reductions in fetal body weights at 40 mg/kg/day, which was also maternally toxic. when 9-desmethyl-β-dhtbz (8, 15, and 40 mg/kg/day) was orally administered to pregnant rats from the beginning of organogenesis through the lactation period, increases in gestation duration, stillbirths, and offspring postnatal mortality (40 mg/kg/day); decreases in pup weights (40 mg/kg/day); and neurobehavioral (increased activity, learning and memory deficits) and reproductive (decreased litter size) impairment (15 and 40 mg/kg/day) were observed. maternal toxicity was seen at the highest dose. the no-effect dose for developmental toxicity in rats (8 mg/kg/day) was associated with plasma exposures (auc) of 9-desmethyl-β-dhtbz in pregnant rats lower than that in humans at the mrhd. risk summary there are no data on the presence of tetrabenazine 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 tetrabenazine and any potential adverse effects on the breastfed infant from tetrabenazine or from the underlying maternal condition.   safety and effectiveness in pediatric patients have not been established. the pharmacokinetics of tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects. because the safety and efficacy of the increased exposure to tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of tetrabenazine in hepatic impairment to ensure safe use. the use of tetrabenazine in patients with hepatic impairment is contraindicated [see contraindications (4), clinical pharmacology (12.3)] . patients who require doses of tetrabenazine tablets greater than 50 mg per day, should be first tested and genotyped to determine if they are poor (pms) or extensive metabolizers (ems) by their ability to express the drug metabolizing enzyme, cyp2d6. the dose of tetrabenazine should then be individualized accordingly to their status as either poor (pms) or extensive metabolizers (ems) [see dosage and administration (2.2), warnings and precautions (5.3), clinical pharmacology (12.3)] .   poor metabolizers   poor cyp2d6 metabolizers (pms) will have substantially higher levels of exposure to the primary metabolites (about 3-fold for α-htbz and 9-fold for β-htbz) compared to ems. the dosage should, therefore, be adjusted according to a patient’s cyp2d6 metabolizer status by limiting a single dose to a maximum of 25 mg and the recommended daily dose to not exceed a maximum of 50 mg/day in patients who are cyp2d6 pms [see dosage and administration (2.2), warnings and precautions (5.3), clinical pharmacology (12.3)] .   extensive/intermediate metabolizers   in extensive (ems) or intermediate metabolizers (ims), the dosage of tetrabenazine can be titrated to a maximum single dose of 37.5 mg and a recommended maximum daily dose of 100 mg [see dosage and administration (2.2), drug interactions (7.1), clinical pharmacology (12.3)]. tetrabenazine is not a controlled substance. clinical trials did not reveal patients developed drug seeking behaviors, though these observations were not systematic. abuse has not been reported from the postmarketing experience in countries where tetrabenazine has been marketed. as with any cns-active drug, prescribers should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of tetrabenazine misuse or abuse (such as development of tolerance, increasing dose requirements, drug-seeking behavior). abrupt discontinuation of tetrabenazine from patients did not produce symptoms of withdrawal or a discontinuation syndrome; only symptoms of the original disease were observed to re-emerge [see dosage and administration (2.4)].

USA - engelska - NLM (National Library of Medicine)

ajanta pharma usa inc. - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington’s disease. tetrabenazine is contraindicated in patients: - who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings and precautions (5.1)]. - with hepatic impairment [see use in specific populations (8.6), clinical pharmacology (12.3)]. - taking monoamine oxidase inhibitors (maois). tetrabenazine 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 tetrabenazine[see drug interactions (7.2)] . - taking deutetrabenazine or valbenazine [see drug interactions (7.7)]. risk summary there are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in

USA - engelska - NLM (National Library of Medicine)

golden state medical supply, inc. - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington's disease. tetrabenazine tablets are contraindicated in patients: - who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings and precautions ( 5.1)] . who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings and precautions ( 5.1)] . - with hepatic impairment [see use in specific populations ( 8.6), clinical pharmacology ( 12.3)] . with hepatic impairment [see use in specific populations ( 8.6), clinical pharmacology ( 12.3)] . - taking monoamine oxidase inhibitors (maois). tetrabenazine tablets 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 monoamine oxidase inhibitors (maois). tetrabenazine tablets 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 tetrabenazine tablets [see drug interactions ( 7.2)] . taking reserpine. at least 20 days should elapse after stopping reserpine before starting tetrabenazine tablets [see drug interactions ( 7.2)] . - taking deutetrabenazine or valbenazine [see drug interactions ( 7.7)] . taking deutetrabenazine or valbenazine [see drug interactions ( 7.7)] . risk summary there are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality. administration of a major human metabolite of tetrabenazine to rats during pregnancy or during pregnancy and lactation produced adverse effects on the developing fetus and offspring (increased mortality, decreased growth, and neurobehavioral and reproductive impairment). the adverse developmental effects of tetrabenazine and a major human metabolite of tetrabenazine in rats occurred at clinically relevant doses [see data] .   in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown.   data   animal data tetrabenazine had no clear effects on embryofetal development when administered to pregnant rats throughout the period of organogenesis at oral doses up to 30 mg/kg/day (or 3 times the maximum recommended human dose [mrhd] of 100 mg/day on a mg/m 2 basis). tetrabenazine had no effects on embryofetal development when administered to pregnant rabbits during the period of organogenesis at oral doses up to 60 mg/kg/day (or 12 times the mrhd on a mg/m 2 basis).   when tetrabenazine (5, 15, and 30 mg/kg/day) was orally administered to pregnant rats from the beginning of organogenesis through the lactation period, an increase in stillbirths and offspring postnatal mortality was observed at 15 and 30 mg/kg/day and delayed pup maturation was observed at all doses. a no-effect dose for pre- and postnatal developmental toxicity in rats was not identified. the lowest dose tested (5 mg/kg/day) was less than the mrhd on a mg/m 2 basis.   because  rats dosed orally with tetrabenazine do not produce 9-desmethyl-β-dhtbz, a major human metabolite of tetrabenazine, the metabolite was directly administered to pregnant and lactating rats. oral administration of 9-desmethyl-β-dhtbz (8, 15, and 40 mg/kg/day) throughout the period of organogenesis produced increases in embryofetal mortality at 15 and 40 mg/kg/day and reductions in fetal body weights at 40 mg/kg/day, which was also maternally toxic. when 9-desmethyl-β-dhtbz (8, 15, and 40 mg/kg/day) was orally administered to pregnant rats from the beginning of organogenesis through the lactation period, increases in gestation duration, stillbirths, and offspring postnatal mortality (40 mg/kg/day); decreases in pup weights (40 mg/kg/day); and neurobehavioral (increased activity, learning and memory deficits) and reproductive (decreased litter size) impairment (15 and 40 mg/kg/day) were observed. maternal toxicity was seen at the highest dose. the no-effect dose for developmental toxicity in rats (8 mg/kg/day) was associated with plasma exposures (auc) of 9-desmethyl-β-dhtbz in pregnant rats lower than that in humans at the mrhd. risk summary there are no data on the presence of tetrabenazine 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 tetrabenazine and any potential adverse effects on the breastfed infant from tetrabenazine or from the underlying maternal condition.   safety and effectiveness in pediatric patients have not been established. the pharmacokinetics of tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects. because the safety and efficacy of the increased exposure to tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of tetrabenazine in hepatic impairment to ensure safe use. the use of tetrabenazine in patients with hepatic impairment is contraindicated [see contraindications ( 4), clinical pharmacology ( 12.3)] . patients who require doses of tetrabenazine tablets greater than 50 mg per day, should be first tested and genotyped to determine if they are poor (pms) or extensive metabolizers (ems) by their ability to express the drug metabolizing enzyme, cyp2d6. the dose of tetrabenazine should then be individualized accordingly to their status as either poor (pms) or extensive metabolizers (ems) [see dosage and administration ( 2.2), warnings and precautions ( 5.3), clinical pharmacology ( 12.3)] .   poor metabolizers   poor cyp2d6 metabolizers (pms) will have substantially higher levels of exposure to the primary metabolites (about 3-fold for α-htbz and 9-fold for β-htbz) compared to ems. the dosage should, therefore, be adjusted according to a patient’s cyp2d6 metabolizer status by limiting a single dose to a maximum of 25 mg and the recommended daily dose to not exceed a maximum of 50 mg/day in patients who are cyp2d6 pms [see dosage and administration ( 2.2), warnings and precautions ( 5.3), clinical pharmacology ( 12.3)] .   extensive/intermediate metabolizers   in extensive (ems) or intermediate metabolizers (ims), the dosage of tetrabenazine can be titrated to a maximum single dose of 37.5 mg and a recommended maximum daily dose of 100 mg [see dosage and administration ( 2.2), drug interactions ( 7.1), clinical pharmacology ( 12.3)]. tetrabenazine is not a controlled substance. clinical trials did not reveal patients developed drug seeking behaviors, though these observations were not systematic. abuse has not been reported from the postmarketing experience in countries where tetrabenazine has been marketed. as with any cns-active drug, prescribers should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of tetrabenazine misuse or abuse (such as development of tolerance, increasing dose requirements, drug-seeking behavior). abrupt discontinuation of tetrabenazine from patients did not produce symptoms of withdrawal or a discontinuation syndrome; only symptoms of the original disease were observed to re-emerge [see dosage and administration ( 2.4)].