New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - celecoxib 200mg;  ;   - capsule - 200 mg - active: celecoxib 200mg     excipient: croscarmellose sodium gelatin lactose monohydrate magnesium stearate povidone sodium laurilsulfate - symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. for the management of acute pain and treatment of primary dysmenorrhoea in adults. the decision to prescribe a selective cox-2 inhibitor should only be made: · if non-pharmacological interventions and simple analgesic therapies have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient, and · after assessment of the individual patient's overall risks. as the cardiovascular risks of the selective cox-2 inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. patients on long-term treatment should be reviewed regularly, such as every three months, with regards to efficacy, risk factors and ongoing need for treatment.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - celecoxib 400mg;   - capsule - 400 mg - active: celecoxib 400mg   excipient: croscarmellose sodium gelatin lactose monohydrate magnesium stearate povidone sodium laurilsulfate tekprint green sb-4027 titanium dioxide - symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. for the management of acute pain and treatment of primary dysmenorrhoea in adults. the decision to prescribe a selective cox-2 inhibitor should only be made: · if non-pharmacological interventions and simple analgesic therapies have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient, and · after assessment of the individual patient's overall risks. as the cardiovascular risks of the selective cox-2 inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. patients on long-term treatment should be reviewed regularly, such as every three months, with regards to efficacy, risk factors and ongoing need for treatment.

United States - English - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - cephalexin (unii: obn7uds42y) (cephalexin anhydrous - unii:5sff1w6677) - cephalexin anhydrous 500 mg - cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by streptococcus pneumoniae and streptococcus pyogenes (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) otitis media due to streptococcus pneumoniae, haemophilus influenzae, staphylococcus aureus, streptococcus pyogenes, and moraxella catarrhalis skin and skin structure infections caused by staphylococcus aureus and/or streptococcus pyogenes bone infections caused by staphylococcus aureus and/or proteus mirabilis genitourinary tract infections, including acute prostatitis, caused by escherichia c

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 2 mg - warfarin sodium tablets are indicated for: - •prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - •prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - •reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. warfarin sodium is contraindicated in: - •pregnancy warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 1 mg - warfarin sodium tablets are indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. warfarin sodium is contraindicated in: - pregnancy warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see warnings and precautions (5.7) and use in specific populations (8.1)] . warfarin sodium can cause fetal harm when administered to a pregnant woman. warfarin sodium exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. if warfarin sodium is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see use in specific populations (8.1)] .  warfarin sodium is contraindicated in patients with: - hemorrhagic tendencies or blood dyscrasias - recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces [see warnings and precautions (5.8)] - bleeding tendencies associated with: − active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract − central nervous system hemorrhage − cerebral aneurysms, dissecting aorta − pericarditis and pericardial effusions − bacterial endocarditis − active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract − central nervous system hemorrhage − cerebral aneurysms, dissecting aorta − pericarditis and pericardial effusions − bacterial endocarditis - threatened abortion, eclampsia, and preeclampsia - unsupervised patients with conditions associated with potential high level of non-compliance - spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding - hypersensitivity to warfarin or to any other components of this product (e.g., anaphylaxis) [see adverse reactions (6)] - major regional or lumbar block anesthesia - malignant hypertension risk summary warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism, and for whom the benefits of warfarin sodium may outweigh the risks [see warnings and precautions (5.7)] . warfarin sodium can cause fetal harm. exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring. because these data were not collected in adequate and well-controlled studies, this incidence of major birth defects is not an adequate basis for comparison to the estimated incidences in the control group or the u.s. general population and may not reflect the incidences observed in practice. consider the benefits and risks of warfarin sodium and possible risks to the fetus when prescribing warfarin sodium to a pregnant woman. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. clinical considerations fetal/neonatal adverse reactions in humans, warfarin crosses the placenta, and concentrations in fetal plasma approach the maternal values. exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring. warfarin embryopathy is characterized by nasal hypoplasia with or without stippled epiphyses (chondrodysplasia punctata) and growth retardation (including low birth weight). central nervous system and eye abnormalities have also been reported, including dorsal midline dysplasia characterized by agenesis of the corpus callosum, dandy-walker malformation, midline cerebellar atrophy, and ventral midline dysplasia characterized by optic atrophy. mental retardation, blindness, schizencephaly, microcephaly, hydrocephalus, and other adverse pregnancy outcomes have been reported following warfarin exposure during the second and third trimesters of pregnancy [see contraindications (4)]. risk summary warfarin was not present in human milk from mothers treated with warfarin from a limited published study. because of the potential for serious adverse reactions, including bleeding in a breastfed infant, consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for warfarin sodium and any potential adverse effects on the breastfed infant from warfarin sodium or from the underlying maternal condition before prescribing warfarin sodium to a lactating woman. clinical considerations monitor breastfeeding infants for bruising or bleeding. data human data based on published data in 15 nursing mothers, warfarin was not detected in human milk. among the 15 full-term newborns, 6 nursing infants had documented prothrombin times within the expected range. prothrombin times were not obtained for the other 9 nursing infants. effects in premature infants have not been evaluated. pregnancy testing warfarin sodium can cause fetal harm [see use in specific populations (8.1)]. verify the pregnancy status of females of reproductive potential prior to initiating warfarin sodium therapy. contraception females advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the final dose of warfarin sodium.  adequate and well-controlled studies with warfarin sodium have not been conducted in any pediatric population, and the optimum dosing, safety, and efficacy in pediatric patients is unknown. pediatric use of warfarin sodium is based on adult data and recommendations, and available limited pediatric data from observational studies and patient registries. pediatric patients administered warfarin sodium should avoid any activity or sport that may result in traumatic injury. the developing hemostatic system in infants and children results in a changing physiology of thrombosis and response to anticoagulants. dosing of warfarin in the pediatric population varies by patient age, with infants generally having the highest, and adolescents having the lowest milligram per kilogram dose requirements to maintain target inrs. because of changing warfarin requirements due to age, concomitant medications, diet, and existing medical condition, target inr ranges may be difficult to achieve and maintain in pediatric patients, and more frequent inr determinations are recommended. bleeding rates varied by patient population and clinical care center in pediatric observational studies and patient registries. infants and children receiving vitamin k-supplemented nutrition, including infant formulas, may be resistant to warfarin therapy, while human milk-fed infants may be sensitive to warfarin therapy. of the total number of patients receiving warfarin sodium in controlled clinical trials for which data were available for analysis, 1885 patients (24.4%) were 65 years and older, while 185 patients (2.4%) were 75 years and older. no overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. patients 60 years or older appear to exhibit greater than expected inr response to the anticoagulant effects of warfarin [see clinical pharmacology (12.3)] . warfarin sodium is contraindicated in any unsupervised patient with senility. conduct more frequent monitoring for bleeding with administration of warfarin sodium to elderly patients in any situation or with any physical condition where added risk of hemorrhage is present. consider lower initiation and maintenance doses of warfarin sodium in elderly patients [see dosage and administration (2.2, 2.3)] . renal clearance is considered to be a minor determinant of anticoagulant response to warfarin. no dosage adjustment is necessary for patients with renal impairment. instruct patients with renal impairment taking warfarin to monitor their inr more frequently [see warnings and precautions (5.4)] . hepatic impairment can potentiate the response to warfarin through impaired synthesis of clotting factors and decreased metabolism of warfarin. conduct more frequent monitoring for bleeding when using warfarin sodium in these patients.

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 3 mg - warfarin sodium tablets are indicated for: - •prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - •prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - •reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. warfarin sodium is contraindicated in: - •pregnancy warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - bupropion hydrochloride extended-release tablets usp, (sr) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . the efficacy of bupropion hydrochloride extended-release tablet (sr) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see clinical studies (14)] . - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a seizure disorder. - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-releas

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 750 mg - levofloxacin are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin susceptible staphylococcus  aureus , pseudomonas  aeruginosa , serratia  marcescens , escherichia  coli , klebsiella  pneumoniae , haemophilus  influenzae , or streptococcus  pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas  aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see  clinical  studies  (14.1)] . levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus  aureus , streptococcus  pneumoniae (including multi-drug-resistant streptococcus  pneumoniae [mdrsp]), haemophilus  influenzae , haemophilus  parainfluenzae , klebsie

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 500 mg - levofloxacin tablets, usp are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. levofloxacin tablets, usp are indicated for the treatment of nosocomial pneumonia due to methicillinsusceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae. adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an antipseudomonal β-lactam is recommended [see clinical studies (14.1) ]. levofloxacin tablets, usp are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus , streptococcus pneumoniae (including multidrug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, haemophilus parainflue

United States - English - NLM (National Library of Medicine)

lundbeck pharmaceuticals llc - vigabatrin (unii: gr120krt6k) (vigabatrin - unii:gr120krt6k) - vigabatrin 50 mg in 1 ml - sabril is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see warnings and precautions (5.1)] . sabril is not indicated as a first line agent for complex partial seizures. sabril is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see warnings and precautions (5.1) ]. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, including sabril, during pregnancy. encourage women who are taking sabril during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/ . this must be done by the patient herself. risk summary there are no adequate data on the developmental risk associated with the use of sabril in pregnant women. limited available data from case reports and cohort studies pertaining to sabril use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, based on animal data, sabril use in pregnant women may result in fetal harm. when administered to pregnant animals, vigabatrin produced developmental toxicity, including an increase in fetal malformations and offspring neurobehavioral and neurohistopathological effects, at clinically relevant doses. in addition, developmental neurotoxicity was observed in rats treated with vigabatrin during a period of postnatal development corresponding to the third trimester of human pregnancy (see data) . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data administration of vigabatrin (oral doses of 50 to 200 mg/kg/day) to pregnant rabbits throughout the period of organogenesis was associated with an increased incidence of malformations (cleft palate) and embryofetal death; these findings were observed in two separate studies. the no-effect dose for adverse effects on embryofetal development in rabbits (100 mg/kg/day) is approximately 1/2 the maximum recommended human dose (mrhd) of 3 g/day on a body surface area (mg/m2 ) basis. in rats, oral administration of vigabatrin (50, 100, or 150 mg/kg/day) throughout organogenesis resulted in decreased fetal body weights and increased incidences of fetal anatomic variations. the no-effect dose for adverse effects on embryo-fetal development in rats (50 mg/kg/day) is approximately 1/5 the mrhd on a mg/m2 basis. oral administration of vigabatrin (50, 100, 150 mg/kg/day) to rats from the latter part of pregnancy through weaning produced long-term neurohistopathological (hippocampal vacuolation) and neurobehavioral (convulsions) abnormalities in the offspring. a no-effect dose for developmental neurotoxicity in rats was not established; the low-effect dose (50 mg/kg/day) is approximately 1/5 the mrhd on a mg/m2 basis. in a published study, vigabatrin (300 or 450 mg/kg) was administered by intraperitoneal injection to a mutant mouse strain on a single day during organogenesis (day 7, 8, 9, 10, 11, or 12). an increase in fetal malformations (including cleft palate) was observed at both doses. oral administration of vigabatrin (5, 15, or 50 mg/kg/day) to young rats during the neonatal and juvenile periods of development (postnatal days 4-65) produced neurobehavioral (convulsions, neuromotor impairment, learning deficits) and neurohistopathological (brain vacuolation, decreased myelination, and retinal dysplasia) abnormalities in treated animals. the early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. the no-effect dose for developmental neurotoxicity in juvenile rats (5 mg/kg/day) was associated with plasma vigabatrin exposures (auc) less than 1/30 of those measured in pediatric patients receiving an oral dose of 50 mg/kg. risk summary vigabatrin is excreted in human milk. the effects of sabril on the breastfed infant and on milk production are unknown. because of the potential for serious adverse reactions from vigabatrin in nursing infants, breastfeeding is not recommended. if exposing a breastfed infant to sabril, observe for any potential adverse effects [see warnings and precautions (5.1, 5.3, 5.4, 5.8)] . the safety and effectiveness of sabril as adjunctive treatment of refractory complex partial seizures in pediatric patients 2 to 16 years of age have been established and is supported by three double-blind, placebo-controlled studies in patients 3 to 16 years of age, adequate and well-controlled studies in adult patients, pharmacokinetic data from patients 2 years of age and older, and additional safety information in patients 2 years of age [see clinical pharmacology (12.3) and clinical studies (14.1)]. the dosing recommendation in this population varies according to age group and is weight-based [see dosage and administration (2.2)]. adverse reactions in this pediatric population are similar to those observed in the adult population [see adverse reactions (6.1)] . the safety and effectiveness of sabril as monotherapy for pediatric patients with infantile spasms (1 month to 2 years of age) have been established [see dosage and administration (2.3) and clinical studies (14.2)] . safety and effectiveness as adjunctive treatment of refractory complex partial seizures in pediatric patients below the age of 2 and as monotherapy for the treatment of infantile spasms in pediatric patients below the age of 1 month have not been established. duration of therapy for infantile spasms was evaluated in a post hoc analysis of a canadian pediatric epilepsy network (cpen) study of developmental outcomes in infantile spasms patients. this analysis suggests that a total duration of 6 months of vigabatrin therapy is adequate for the treatment of infantile spasms. however, prescribers must use their clinical judgment as to the most appropriate duration of use [see clinical studies (14.2)].   abnormal mri signal changes and intramyelinic edema (ime) in infants and young children being treated with sabril have been observed [see warnings and precautions (5.3, 5.4)] . juvenile animal toxicity data oral administration of vigabatrin (5, 15, or 50 mg/kg/day) to young rats during the neonatal and juvenile periods of development (postnatal days 4-65) produced neurobehavioral (convulsions, neuromotor impairment, learning deficits) and neurohistopathological (brain gray matter vacuolation, decreased myelination, and retinal dysplasia) abnormalities. the no-effect dose for developmental neurotoxicity in juvenile rats (the lowest dose tested) was associated with plasma vigabatrin exposures (auc) substantially less than those measured in pediatric patients at recommended doses. in dogs, oral administration of vigabatrin (30 or 100 mg/kg/day) during selected periods of juvenile development (postnatal days 22-112) produced neurohistopathological abnormalities (brain gray matter vacuolation). neurobehavioral effects of vigabatrin were not assessed in the juvenile dog. a no-effect dose for neurohistopathology was not established in juvenile dogs; the lowest effect dose (30 mg/kg/day) was associated with plasma vigabatrin exposures lower than those measured in pediatric patients at recommended doses [see warnings and precautions (5.4)]. clinical studies of vigabatrin did not include sufficient numbers of patients aged 65 and over to determine whether they responded differently from younger patients. vigabatrin is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. oral administration of a single dose of 1.5 g of vigabatrin  to elderly (≥65 years) patients with reduced creatinine clearance (<50 ml/min) was associated with moderate to severe sedation and confusion in 4 of 5 patients, lasting up to 5 days. the renal clearance of vigabatrin was 36% lower in healthy elderly subjects (≥65 years) than in young healthy males. adjustment of dose or frequency of administration should be considered. such patients may respond to a lower maintenance dose [see dosage and administration (2.4) and clinical pharmacology (12.3 )] . other reported clinical experience has not identified differences in responses between the elderly and younger patients. dose adjustment, including initiating treatment with a lower dose, is necessary in pediatric patients 2 years of age and older and adults with mild (creatinine clearance >50 to 80 ml/min), moderate (creatinine clearance >30 to 50 ml/min) and severe (creatinine clearance >10 to 30 ml/min) renal impairment [see dosage and administration (2.4) and clinical pharmacology (12.3)] . vigabatrin is not a controlled substance. vigabatrin did not produce adverse events or overt behaviors associated with abuse when administered to humans or animals. it is not possible to predict the extent to which a cns active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of vigabatrin (e.g., incrementation of dose, drug-seeking behavior). following chronic administration of vigabatrin to animals, there were no apparent withdrawal signs upon drug discontinuation.  however, as with all aeds, vigabatrin should be withdrawn gradually to minimize increased seizure frequency [see warnings and precautions (5.6)] .