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

sumitomo pharma america, inc. - eslicarbazepine acetate (unii: bea68zvb2k) (eslicarbazepine - unii:s5vxa428r4) - eslicarbazepine acetate 200 mg - aptiom is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. aptiom is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see warnings and precautions (5.2, 5.3, and 5.4)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as aptiom, during pregnancy. encourage women who are taking aptiom during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary limited available data with aptiom use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in oral studies conducted in pregnant mice, rats, and rabbits, eslicarbazepine acetate demonstrated developmental toxicity, including increased incidence of malformations (mice), embryolethality (rats), and fetal growth retardation (all species), at clinically relevant doses (see data). advise a pregnant woman of the potential risk to a fetus. 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 when eslicarbazepine acetate was orally administered (150, 350, 650 mg/kg/day) to pregnant mice throughout organogenesis, increased incidences of fetal malformations was observed at all doses and fetal growth retardation was observed at the mid and high doses. a no-effect dose for adverse developmental effects was not identified. at the lowest dose tested, plasma eslicarbazepine exposure (cmax , auc) is less than that in humans at the maximum recommended human dose (mrhd, 1600 mg/day). oral administration of eslicarbazepine acetate (40, 160, 320 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in fetal growth retardation and increased incidences of skeletal variations at the mid and high doses. the no-effect dose (40 mg/kg/day) is less than the mrhd on a mg/m2 basis. oral administration to pregnant rats (65, 125, 250 mg/kg/day) throughout organogenesis resulted in embryolethality at all doses, increased incidences of skeletal variations at the mid and high doses, and fetal growth retardation at the high dose. the lowest dose tested (65 mg/kg/day) is less than the mrhd on a mg/m2 basis. when eslicarbazepine acetate was orally administered to female mice during pregnancy and lactation (150, 350, 650 mg/kg/day), the gestation period was prolonged at the highest dose tested. in offspring, a persistent reduction in offspring body weight and delayed physical development and sexual maturation were observed at the mid and high doses. the lowest dose tested (150 mg/kg/day) is less than the mrhd on a mg/m2 basis. when eslicarbazepine acetate was orally administered (65, 125, 250 mg/kg/day) to rats during pregnancy and lactation, reduced offspring body weight was seen at the mid and high doses. delayed sexual maturation and a neurological deficit (decreased motor coordination) were observed at the highest dose tested. the no-effect dose for adverse developmental effects (65 mg/kg/day) is less than the mrhd on a mg/m2 basis. the rat data are of uncertain relevance to humans because of differences in metabolic profile between species. eslicarbazepine is present in human milk. the effects of aptiom on the breastfed infant or on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for aptiom and any potential adverse effects on the breastfed infant from aptiom or from the underlying maternal condition. contraception use of aptiom with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with lower plasma levels of these hormones. advise women of reproductive potential taking aptiom who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control [see drug interactions (7.4)] . infertility eslicarbazepine acetate was evaluated in rats and mice for potential adverse impact on fertility of the parental and first generation [see nonclinical toxicology (13.1)] . in a fertility study in male and female mice, adverse developmental outcomes were observed in embryos. in a fertility study in male and female rats, impairment of female fertility by eslicarbazepine acetate was shown. safety and effectiveness of aptiom have been established in the age groups 4 to 17 years. use of aptiom in these age groups is supported by evidence from adequate and well-controlled studies of aptiom in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data from clinical studies in 393 pediatric patients 4 to 17 years of age [see adverse reactions (6.1) and clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients below the age of 4 years have not been established. animal data in a juvenile animal study in which eslicarbazepine acetate (40, 80, 160 mg/kg/day) was orally administered to young dogs for 10 months starting on postnatal day 21, adverse effects on bone growth (decreased bone mineral content and density) were seen in females at all doses at the end of the dosing period, but not at the end of a 2-month recovery period. convulsions were seen at the highest dose tested. a no-effect dose for adverse effects in juvenile dogs was not identified. the lowest dose tested is less than the maximum recommended pediatric dose (1200 mg/day) on a body surface area (mg/m2 ) basis. a separate juvenile animal study was conducted to assess possible adverse effects on the immune system. eslicarbazepine acetate (10, 40, 80 mg/kg/day) was orally administered to young dogs for 17 weeks starting on postnatal day 21. no effects on the immune system were observed. there were insufficient numbers of patients ≥65 years old enrolled in the controlled adjunctive epilepsy trials (n=15) to determine the efficacy of aptiom in this patient population. the pharmacokinetics of aptiom were evaluated in elderly healthy subjects (n=12) (figure 1). although the pharmacokinetics of eslicarbazepine are not affected by age independently, dose selection should take in consideration the greater frequency of renal impairment and other concomitant medical conditions and drug therapies in the elderly patient. dose adjustment is necessary if crcl is <50 ml/min [see clinical pharmacology (12.3)]. clearance of eslicarbazepine is decreased in patients with impaired renal function and is correlated with creatinine clearance. dosage adjustment is necessary in patients with crcl<50 ml/min (figure 1) [see dosage and administration (2.4) and clinical pharmacology (12.3)]. dose adjustments are not required in patients with mild to moderate hepatic impairment (figure 1). use of aptiom in patients with severe hepatic impairment has not been evaluated, and use in these patients is not recommended [see clinical pharmacology (12.3)]. aptiom is not a controlled substance. prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. drug abuse and drug addiction are separate and distinct from physical dependence (for example, abuse may not be accompanied by physical dependence) [see drug abuse and dependence (9.3)]. in a human abuse study in recreational sedative abusers aptiom showed no evidence of abuse. in phase 1, 1.5% of the healthy volunteers taking aptiom reported euphoria compared to 0.4% taking placebo. physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. there was some evidence of physical dependence or a withdrawal syndrome with aptiom in a physical dependence study conducted in healthy volunteers who were maintained at a daily dose of 800 mg aptiom for 4 weeks prior to discontinuation. the primary endpoint was the maximum change from steady-state baseline in the total score of the physician's withdrawal checklist (pwc-34) during the 21-day discontinuation period. aptiom and placebo were shown to be equivalent on the primary endpoint. two out of 8 secondary endpoints (visual analog scales for anxiety and nausea) showed some increase in these symptoms for subjects who were maintained on aptiom and discontinued, versus subjects who were maintained on placebo. in general, aeds should not be abruptly discontinued in patients with epilepsy because of the risk of increased seizure frequency and status epilepticus.

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takeda pharmaceuticals america, inc. - teduglutide (unii: 7m19191ikg) (teduglutide - unii:7m19191ikg) - teduglutide 5 mg in 0.5 ml - gattex® is indicated for the treatment of adults and pediatric patients 1 year of age and older with short bowel syndrome (sbs) who are dependent on parenteral support. none. risk summary available data from case reports with gattex use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. pregnant women with short bowel syndrome are at risk for malnutrition, which is associated with adverse maternal and fetal outcomes (see clinical considerations) . in animal reproduction studies, no effects on embryo-fetal development were observed with the subcutaneous administration of teduglutide to pregnant rats and rabbits during organogenesis at exposures up to 686 and 657 times, respectively, the clinical exposure at the recommended human dose (based on auc) (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 disease-associated maternal and/or embryo/fetal risk pregnant women with short bowel syndrome are at risk for malnutrition. severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. data animal data reproduction studies have been performed in pregnant rats at subcutaneous doses of teduglutide up to 25 mg/kg twice daily (50 mg/kg/day) (about 686 times the clinical exposure (auc) at the recommended daily human dose of 0.05 mg/kg) and in pregnant rabbits at subcutaneous doses up to 25 mg/kg twice daily (50 mg/kg/day) (about 657 times the clinical exposure (auc) at the recommended daily human dose of 0.05 mg/kg) during the period of organogenesis. these studies did not reveal any evidence of impaired fertility or harm to the fetus due to teduglutide. in a pre- and postnatal development study in rats (gestation day 7 to lactation day 20), teduglutide did not show any significant adverse effects on pre- and postnatal development at doses up to 25 mg/kg twice daily (50 mg/kg/day) (about 343 times the clinical exposure (auc) at the recommended daily human dose of 0.05 mg/kg). risk summary there is no information regarding the presence of gattex in human milk, the effects of gattex on the breastfed infant, or the effects of gattex on milk production. teduglutide is present in the milk of lactating rats (see data ). systemic exposure of teduglutide to a breastfed infant is expected to be low. however, because of the potential for serious adverse reactions in a breastfed infant, including tumorigenicity [see nonclinical toxicology (13.1)] , advise patients that breastfeeding is not recommended during treatment with gattex. data in a milk excretion study in the rat, a single subcutaneous dose of 25 mg/kg of teduglutide (81 times the recommended daily human dose of 0.05 mg/kg based on body surface area) was administered to lactating female rats at day 12 postpartum. the maximum concentration of teduglutide in the milk corresponded to 0.9% and 2.9% of the plasma concentration at 1.5 and 4 hours after dosing, respectively. the safety and effectiveness in pediatric patients less than 1 year of age have not been established. the safety and effectiveness of gattex have been established in pediatric patients 1 year to less than 17 years of age who are dependent on parenteral support for the treatment of sbs. use of gattex in this population is supported by evidence from adequate and well-controlled studies in adults, with additional efficacy, safety, pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age [see dosage and administration (2), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.2)] . these data were derived from two studies of 24-week (study 5) and 12-week (nct01952080) duration in which 41 pediatric patients were treated with gattex in the following groups: 1 infant (1 year to less than 2 years), 37 children (2 years to less than 12 years) and 3 adolescents (12 years to less than 17 years). in these 2 studies and the corresponding extension studies (study 6 and nct02949362), 29 pediatric patients were administered gattex prospectively for up to 94 weeks [see clinical studies (14.2)] . adverse reactions in pediatric patients were similar to those seen in adults [see adverse reactions (6.1)] . juvenile animal toxicity data in a juvenile toxicity study, teduglutide was administered to juvenile minipigs at subcutaneous doses of 0.5, 2.5 and 12.5 mg/kg twice daily (1, 5, and 25 mg/kg/day) from post-natal day 7 and continuing for 90 days). exposures (auc) at these doses were at least 12-, 25-, and 170-fold the pediatric clinical exposure for ages 1 year to 11 years at 0.05 mg/kg, respectively, and 10-, 21-, and 141-fold the pediatric clinical exposure for ages 12 years to 17 years at 0.05 mg/kg, respectively. in juvenile minipigs, subcutaneous teduglutide caused intestinotrophic effects, gall bladder mucosal hyperplasia, bile duct mucosal hyperplasia, and injection site reactions, similar to those observed in adult animals. of the 134 patients with sbs that were treated with gattex at the recommended dosage of 0.05 mg/kg/day in the clinical studies, 19 patients were 65 years or older while 5 patients were 75 years of age or older. no overall differences in safety or efficacy were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see clinical pharmacology (12.3)] . in adult subjects with moderate to severe renal impairment or end-stage renal disease (esrd) (creatinine clearance <60 ml/min), the exposure to teduglutide increased with the degree of renal impairment [see clinical pharmacology (12.3)] . reduce the dosage of gattex by half in both pediatric and adult patients with egfr less than 60 ml/min/1.73 m2  [see dosage and administration (2.3)] . gattex has not been studied in patients with severe hepatic impairment (child-pugh grade c). no dosage adjustment is recommended for patients with mild and moderate hepatic impairment (child-pugh grade a and b) [see clinical pharmacology (12.3)] . read this instructions for use before you start using gattex and each time you get a refill. there may be new information. your healthcare provider or nurse should show you how to prepare, measure your dose, and give your injection of gattex the right way. if you cannot give yourself the injection: - ask your healthcare provider or nurse to help you, or - ask someone who has been trained by a healthcare provider or nurse to give your injections self-administration is not recommended in pediatric patients. in pediatric patients, gattex should be injected by: - a healthcare provider or nurse, or - a parent or adult caregiver who has been trained by a healthcare provider or nurse to give injections of gattex to pediatric patients important information: - use of the gattex 5 mg kit is not recommended in pediatric patients weighing less than 22 pounds (10 kg). - before you start, check the "use by" date on your gattex kit. make sure that the "use by" date has not passed. do not use anything in the gattex kit after the "use by" date on the kit. - give gattex within 3 hours after you mix the powder with the diluent (sterile water for injection). - use the syringes and needles provided in the gattex kit. - do not use a gattex vial more than 1 time, even if there is medicine left in the vial. - throw away (dispose of) any unused gattex after you give your injection. - safely throw away gattex vials after use. - do not re-use syringes or needles. see "step 7: dispose of syringes and needles" for information about how to safely throw away needles and syringes. - to help avoid needle-stick injuries, do not recap needles. gather the supplies you will need to prepare gattex and to give your injection (see figure a). figure a - 5-mg vial of gattex with green cap. your healthcare provider will tell you how many vials of gattex you will need for your injection. - 2 alcohol swab pads - diluent syringe with a white snap-off cap - needle for reconstitution (23g, 1½ inch) - plastic dosing syringe (1 ml) with needle attached (27g, 1/2 inch) - a sharps disposal container (not included in the gattex kit). see "step 7: dispose of needles and syringes." step 1: prepare the injection. - choose a well-lit, clean, flat work surface. - wash your hands with soap and water. step 2: preparing the diluent syringe. - put the diluent syringe (see figure b1) and the 23g, 1½ inch needle in front of you on your work surface. - hold the diluent syringe by the barrel. snap off the white cap (bend the cap sideways until the cap comes off). only the top portion of the white cap should be snapped off. the lower portion of the cap will remain in place (see figure b2) . throw the cap away. - remove the 23g, 1½ inch needle from the package. use the fold in the package to peel back the plastic cover (see figure c) . leave the plastic cap on the needle. - push the open end of the needle onto the end of the diluent syringe (see figure d) . twist the needle clockwise (to the right) until it stops turning. - when the needle is tightly in place, put the diluent syringe and needle on your work surface. step 3: mix gattex powder with diluent. - remove the green cap from the gattex vial. throw away the green cap. - find the gray rubber seal on top of the gattex vial (see figure e) . - use an alcohol swab pad to clean the gray rubber seal (see figure f) . - do not touch the gray rubber seal after you clean it. - pick up the diluent syringe with the needle attached. - remove the plastic cap that covers the needle (see figure g) . throw the cap away. - hold the gattex vial between your thumb and index (pointer) finger (see figure h) . be careful not to touch the gray rubber seal. - push the needle down through the center of the gray rubber seal. - slowly push down on the plunger of the diluent syringe. empty all the diluent into the gattex vial. - leave the needle and diluent syringe in place. - gently tap the barrel of the diluent syringe with a finger (see figure i) . - make sure all the diluent has gone into the gattex vial. - remove the diluent syringe and needle from the gattex vial. let the vial sit for about 30 seconds. - do not put the needle cap back on the needle. - throw away (dispose of) the diluent syringe and needle in your sharps disposal container. - after 30 seconds, place the gattex vial between the palms of your hands. gently roll the vial for about 15 seconds (see figure j) . - do not shake the gattex vial. - do not touch the gray rubber seal. if you do, clean it again with a new alcohol pad. - let the gattex vial stand on your work surface for about 2 minutes. step 4: check the mixed gattex. - after 2 minutes, look at the vial of gattex. the liquid in the vial should be clear and colorless to pale yellow, and should not have any particles in it. - if there is any powder in the gattex vial that did not dissolve, gently roll the vial between your hands for 15 seconds more. - do not shake the gattex vial. - check the gattex vial again for anything that did not dissolve. - do not use the gattex vial if there is anything in it that did not dissolve. start from the beginning of this instructions for use to prepare a new vial. use a new gattex vial, new diluent syringe, and a new needle. step 5: draw up your dose of gattex. - remove the plastic dosing syringe from the package. use the fold in the package to peel back the plastic cover (see figure k) . - remove the needle cap from the plastic dosing syringe (see figure l ). - throw the needle cap away. do not touch the needle or allow it to touch anything. - carefully pull back on the plunger to the line that matches the dose prescribed by your healthcare provider. - use 1 hand to hold the gattex vial steady. use your other hand to insert the needle straight down into the middle of the gray rubber seal on the gattex vial (see figure m) . you may feel some resistance as the needle passes through the rubber seal. - gently push down the plunger until all of the air has gone from the plastic dosing syringe into the gattex vial. - turn the gattex vial and plastic dosing syringe upside down (see figure n) . - hold the gattex vial with 1 hand. - slowly pull back the plunger of the plastic dosing syringe with your other hand. - fill the plastic dosing syringe until the black tip of the plunger lines up with the mark that matches your prescribed dose (see figure o) . - keep the plastic dosing syringe and needle in the gattex vial. - you may see some bubbles inside the gattex vial when the plastic dosing syringe is filled. this is normal. with the needle still in the vial, gently tap the side of the plastic dosing syringe with a finger to make any air bubbles rise to the top (see figure p) . - slowly push the plunger up until all air bubbles are out of the plastic dosing syringe. make sure the tip of the needle is in the fluid. slowly pull back the plunger to draw up the right dose of gattex into the plastic dosing syringe. - remove the plastic dosing syringe and needle from the gattex vial (see figure q) . do not touch the needle or allow it to touch anything. step 6: inject gattex. - choose an injection site on the stomach area (abdomen), thighs, or upper arms. - choose a different site to give the injection each day. do not inject into areas where the skin is tender, bruised, red, or hard. (see figure r and figure s) figure s - clean the skin where you plan to give the injection with a new alcohol swab pad. do not touch this area again before giving the injection. - use 1 hand to gently pinch up a fold of skin around the injection site (see figure t) . - use your other hand to hold the plastic dosing syringe. insert the full length of the needle into the skin at a 45-degree angle with a quick, "dart-like" motion (see figure u) . - let go of the skin. hold the syringe barrel with 1 hand while you slowly push down the plunger until the plastic dosing syringe is empty (see figure v) . - when the plastic dosing syringe is empty, quickly pull the needle out of your skin. there may be a little bleeding at the injection site. apply an adhesive bandage to the injection site if needed. step 7: dispose of syringes and needles. - do not re-use a syringe or needle. - to help avoid needle-stick injuries, do not recap a needle. - put your needles and syringes in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharp items being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharp items being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be local or state laws about how to throw away syringes and needles. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal . - do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your sharps disposal container. - throw away the gattex vial into the container where you put the syringes and needles. - if you have any questions, talk to your healthcare provider or pharmacist. how should i store gattex? - store gattex powder at room temperature up to 77°f (25°c). - do not freeze gattex. - use the gattex powder by the expiration date on the "use by" sticker on the kit. - use gattex within 3 hours after mixing it. - throw away any unused gattex that has been mixed, even if there is medicine left in the vial. - do not store any gattex you have mixed. keep gattex and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. distributed by: takeda pharmaceuticals america, inc. lexington, ma 02421 usa 1-877-825-3327 gattex® and the gattex® logo are registered trademarks of takeda pharmaceuticals u.s.a., inc. ©2024 takeda pharmaceuticals u.s.a., inc. all rights reserved. revised: 02/2024

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denton pharma, inc. dba northwind pharmaceuticals - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin is indicated for: •adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofeta

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

denton pharma, inc. dba northwind pharmaceuticals - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin is indicated for: • management of postherpetic neuralgia in adults •adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fet

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

denton pharma, inc. dba northwind pharmaceuticals - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam tablets usp are indicated for treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam tablets usp are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets usp are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions ( 5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam during pregnancy to enroll in the north american antiepileptic drug (na

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

denton pharma, inc. dba northwind pharmaceuticals - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-free number 1-888-233-2334. information about the north american drug pregnancy

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

denton pharma, inc. dba northwind pharmaceuticals - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-free number 1-888-233-2334. information about the north american drug pregnancy

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

denton pharma, inc. dba northwind pharmaceuticals - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topiramate tablets and topiramate capsules are indicated as adjunctive therapy for  for the treatment of partial-onset seizures,  primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-f

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

denton pharma, inc. dba northwind pharmaceuticals - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin capsules are indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin capsules during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/ . risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin

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

denton pharma, inc. dba northwind pharmaceuticals - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin tablets are indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/ . risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabape