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

energique, inc. - american ginseng (unii: 8w75vcv53q) (american ginseng - unii:8w75vcv53q), potassium gluconate (unii: 12h3k5qkn9) (potassium cation - unii:295o53k152), ginkgo (unii: 19fuj2c58t) (ginkgo - unii:19fuj2c58t), magnesium gluconate (unii: t42nad2khc) (magnesium cation - unii:t6v3lhy838), sus scrofa pancreas (unii: 9y3j3362ry) (sus scrofa pancreas - unii:9y3j3362ry), sus scrofa spleen (unii: 92amn5j79y) (sus scrofa spleen - unii:92amn5j79y), sus scrofa stomach (unii: t0920p9z9a) (sus scrofa stomach - unii:t0 - may temporarily relieve stomach discomfort, diarrhea, and fever.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. may temporarily relieve stomach discomfort, diarrhea, and fever.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

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

energique, inc. - american ginseng (unii: 8w75vcv53q) (american ginseng - unii:8w75vcv53q), berberis vulgaris root bark (unii: 1th8q20j0u) (berberis vulgaris root bark - unii:1th8q20j0u), causticum (unii: dd5fo1wkfu) (causticum - unii:dd5fo1wkfu), conium maculatum flowering top (unii: q28r5gf371) (conium maculatum flowering top - unii:q28r5gf371), turnera diffusa leafy twig (unii: rq2cfa7wwj) (turnera diffusa leafy twig - unii:rq2cfa7wwj), graphite (unii: 4qqn74lh4o) (graphite - unii:4qqn74lh4o), lachesis muta venom (u - may temporarily relieve symptoms in women such as decreased sexal desire and feelings of fatigue.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. may temporarily relieve symptoms in women such as decreased sexal desire and feelings of fatigue.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

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

energique, inc. - american ginseng (unii: 8w75vcv53q) (american ginseng - unii:8w75vcv53q), avena sativa flowering top (unii: ma9cqj3f7f) (avena sativa flowering top - unii:ma9cqj3f7f), sus scrofa adrenal gland (unii: 398iyq16yv) (sus scrofa adrenal gland - unii:398iyq16yv), arsenic triiodide (unii: 3029988o2t) (arsenic cation (3+) - unii:c96613f5av), strychnos ignatii seed (unii: 1nm3m2487k) (strychnos ignatii seed - unii:1nm3m2487k), lycopodium clavatum spore (unii: c88x29y479) (lycopodium clavatum spore - unii:c88x2 - may temporarily relieve nervous exhaustion, fatigue and forgetfulness.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. may temporarily relieve nervous exhaustion, fatigue and forgetfulness.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

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

golden state medical supply, inc. - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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 available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. these effects were observed at doses associated with clinically relevant plasma exposures (see data) . the 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 2-4% and 15-20%, respectively. data animal data oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. however, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. these doses were associated with maternal plasma lacosamide exposures (auc) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (mrhd) of 400 mg/day. in two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. the no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide auc similar to that in humans at the mrhd. oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). 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 rats was associated with a plasma lacosamide auc less than that in humans at the mrhd. in vitro data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential adverse effects on cns development related to this activity cannot be ruled out. risk summary data from published literature indicate that lacosamide is present in human milk. there are reports of increased sleepiness in breastfed infants exposed to lacosamide (see clinical considerations) . there is no information on the effects of lacosamide on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition. clinical considerations monitor infants exposed to lacosamide through breastmilk for excess sedation. partial-onset seizures safety and effectiveness of lacosamide tablets for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of age. use of lacosamide in this age group is supported by evidence from adequate and well-controlled studies of lacosamide in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1, 14.2)]. safety and effectiveness in pediatric patients below 1 month of age have not been established. animal data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential related adverse effects on cns development cannot be ruled out. administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (auc) less than that in humans at the maximum recommended human dose of 400 mg/day. additional pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. there were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients. no lacosamide tablets dose adjustment based on age is necessary. in elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy [see dosage and administration (2.1, 2.4, 2.5)and clinical pharmacology (12.3)] . no dose adjustment is necessary in patients with mild to moderate renal impairment (cl cr ≥30 ml/min). in patients with severe renal impairment (cl cr <30 ml/min as estimated by the cockcroft-gault equation for adults; cl cr less than 30 ml/min/1.73m 2 as estimated by the schwartz equation for pediatric patients) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended [see dosage and administration (2.4)and clinical pharmacology (12.3)] . in all patients with renal impairment, dose initiation and titration should be based on clinical response and tolerability. lacosamide is effectively removed from plasma by hemodialysis. dosage supplementation of up to 50% following hemodialysis should be considered. for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. patients with mild to moderate hepatic impairment should be observed closely for adverse reactions, and dose initiation and titration should be based on clinical response and tolerability [see dosage and administration (2.5), clinical pharmacology (12.3)] . the pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment. lacosamide use is not recommended in patients with severe hepatic impairment. lacosamide tablets contains lacosamide, a schedule v controlled substance. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. in a human abuse potential study, single doses of 200 mg (equal to the maximum single dosage) and 800 mg lacosamide (equal to twice the recommended daily maintenance dosage) produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a schedule iv drug. the duration of the euphoria-type responses following lacosamide was less than that following alprazolam. a high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300-800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). however, the rate of euphoria reported as an adverse event in the lacosamide development program at therapeutic doses was less than 1%. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. however, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans. dispense with medication guide available at: www.bpirx.com/products/patientinformation read this medication guide before you start taking lacosamide tablets and each time you get a refill. there may be new information. this medication guide describes important safety information about lacosamide tablets. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. what is the most important information i should know about lacosamide tablets? do not stop taking lacosamide tablets without first talking to your healthcare provider. stopping lacosamide tablets suddenly can cause serious problems. stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). lacosamide tablets can cause serious side effects, including: - like other antiepileptic drugs, lacosamide tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: - thoughts about suicide or dying - attempt to commit suicide - new or worse depression - new or worse anxiety - feeling agitated or restless - panic attacks - trouble sleeping (insomnia) - new or worse irritability - acting aggressive, being angry, or violent - acting on dangerous impulses - an extreme increase in activity and talking (mania) - other unusual changes in behavior or mood - pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. - keep all follow-up visits with your healthcare provider as scheduled. - call your healthcare provider between visits as needed, especially if you are worried about symptoms. - suicidal thoughts or actions can be caused by things other than medicines. if you have suicidal thoughts or actions, your healthcare provider may check for other causes. - lacosamide tablets may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide tablets affect you. - lacosamide tablets may cause you to have an irregular heartbeat or may cause you to faint. in rare cases, cardiac arrest has been reported. call your healthcare provider right away if you: - have a fast, slow, or pounding heartbeat or feel your heart skip a beat - have shortness of breath - have chest pain - feel lightheaded - fainted or if you feel like you are going to faint - lacosamide tablets are a federally controlled substance (cv) because it can be abused or lead to drug dependence. keep your lacosamide tablets in a safe place, to protect them from theft. never give your lacosamide tablets to anyone else, because it may harm them. selling or giving away this medicine is against the law. what are lacosamide tablets? lacosamide tablets are a prescription medicine used: - to treat partial-onset seizures in people 4 years of age and older. it is not known if lacosamide tablets are safe and effective for partial-onset seizures in children under 1 month of age. what should i tell my healthcare provider before taking lacosamide tablets? before you take lacosamide tablets, tell your healthcare provider about all of your medical conditions, including if you: - have or have had depression, mood problems or suicidal thoughts or behavior. - have heart problems. - have kidney problems. - have liver problems. - have abused prescription medicines, street drugs or alcohol in the past. - are pregnant or plan to become pregnant. it is not known if lacosamide tablets can harm your unborn baby. tell your healthcare provider right away if you become pregnant while taking lacosamide tablets. you and your healthcare provider will decide if you should take lacosamide tablets while you are pregnant. if you become pregnant while taking lacosamide tablets, talk to your healthcare provider about registering with the north american antiepileptic drug pregnancy registry. you can enroll in this registry by calling 1-888-233-2334. the purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. - if you become pregnant while taking lacosamide tablets, talk to your healthcare provider about registering with the north american antiepileptic drug pregnancy registry. you can enroll in this registry by calling 1-888-233-2334. the purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. - are breastfeeding or plan to breastfeed. lacosamide passes into breast milk. breastfeeding during treatment with lacosamide tablets may cause your baby to have more sleepiness than normal. if this happens, contact your baby's healthcare provider. talk to your healthcare provider about the best way to feed your baby if you take lacosamide tablets. - breastfeeding during treatment with lacosamide tablets may cause your baby to have more sleepiness than normal. if this happens, contact your baby's healthcare provider. - talk to your healthcare provider about the best way to feed your baby if you take lacosamide tablets. tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. taking lacosamide tablets with certain other medicines may cause side effects or affect how well they work. do not start or stop other medicines without talking to your healthcare provider. know the medicines you take. keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine. how should i take lacosamide tablets? - take lacosamide tablets exactly as your healthcare provider tells you. - your healthcare provider will tell you how many lacosamide tablets to take and when to take them. - your healthcare provider may change your dose if needed. - do not stop lacosamide tablets without first talking to a healthcare provider. stopping lacosamide tablets suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). - lacosamide tablets may be taken with or without food. - swallow lacosamide tablets whole with liquid. do not cut lacosamide tablets. - if you take too many lacosamide tablets, call your healthcare provider or local poison control center right away. what should i avoid while taking lacosamide tablets? do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide tablets affect you. lacosamide tablets may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. what are the possible side effects of lacosamide tablets? - see " what is the most important information i should know about lacosamide tablets? " lacosamide tablets may cause other serious side effects including: - a serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells . call your healthcare provider right away if you have: - a skin rash, hives - fever or swollen glands that do not go away - shortness of breath - tiredness (fatigue) - swelling of the legs - yellowing of the skin or whites of the eyes - dark urine the most common side effects of lacosamide tablets include : - double vision - headache - dizziness - nausea - sleepiness these are not all of the possible side effects of lacosamide tablets. for more information ask your healthcare provider or pharmacist. tell your healthcare provider about any side effect that bothers you or that does not go away. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store lacosamide tablets? - store lacosamide tablets at room temperature between 68°f to 77°f (20°c to 25°c). keep lacosamide tablets and all medicines out of the reach of children. general information about the safe and effective use of lacosamide tablets. medicines are sometimes prescribed for purposes other than those listed in a medication guide. do not use lacosamide tablets for a condition for which it was not prescribed. do not give lacosamide tablets to other people, even if they have the same symptoms that you have. it may harm them. this medication guide summarizes the most important information about lacosamide tablets. if you would like more information, talk with your healthcare provider. you can ask your pharmacist or healthcare provider for information about lacosamide tablets that is written for health professionals. for more information, contact breckenridge pharmaceutical, inc. at 1-800-367-3395 or at www.bpirx.com. what are the ingredients in lacosamide tablets? active ingredient : lacosamide tablet inactive ingredients : colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, lecithin, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and additional ingredients listed below: - 50 mg tablets: red iron oxide, black iron oxide, fd&c blue #2 / indigo carmine aluminum lake - 100 mg tablets: yellow iron oxide - 150 mg tablets: yellow iron oxide, red iron oxide, black iron oxide - 200 mg tablets: fd&c blue #2 / indigo carmine aluminum lake additional pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. manufactured by: msn laboratories private limited telangana – 509 228, india distributed by: breckenridge pharmaceutical, inc. berlin, ct 06037, usa this medication guide has been approved by the u.s. food and drug administration trademarks are the property of their respective owners. revised: 11/2023 marketed by: gsms, inc. camarillo, ca 93012 usa

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

redox limited - zinc sulfate heptahydrate - topical solution/suspension - zinc sulfate heptahydrate mineral-zinc active 950.0 g/kg - dermatological preps. - sheep | ewe | hogget | lamb | ovine | ram | weaner | wether - foot rot

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - european house dust mite extract, quantity: 6 sq-hdm; american house dust mite extract, quantity: 6 sq-hdm - tablet - excipient ingredients: gelatin; sodium hydroxide; purified water; mannitol - allergic rhinitis acarizax is indicated for the treatment of house dust mite (hdm) allergic rhinitis not well controlled despite use of symptom relieving medication in adults and adolescents (? 12 years). allergic asthma acarizax is indicated for the treatment of hdm allergic asthma not well controlled by inhaled corticosteroids and associated with hdm allergic rhinitis in adults. patients? asthma status should be carefully evaluated before the initiation of treatment.

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

american regent, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 15 mg in 1 ml - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). acute pain in adult patients ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration, and adverse reactions ). patients should be switche

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

american health packaging - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 100 mg - extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin is contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)]. reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)]. - co-administration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as extended phenytoin sodium, during pregnancy. physicians are advised to recommend that pregnant patients taking extended phenytoin sodium enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/ risk summary in humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. prenatal phenytoin exposure is associated with an increased incidence of major malformations, including orofacial clefts and cardiac defects. in addition, the fetal hydantoin syndrome, a pattern of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits has been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [see data]. there have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy. administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations and other manifestations of developmental toxicity (including embryofetal death, growth impairment, and behavioral abnormalities) in multiple species at clinically relevant doses [see data]. in the u.s. general population, the estimated background risk of major birth defects and of 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. clinical considerations disease-associated maternal risk an increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see dosage and administration (2.3, 2.7)]. however, postpartum restoration of the original dosage will probably be indicated [see clinical pharmacology (12.3)]. fetal/neonatal adverse reactions a potentially life-threatening bleeding disorder related to decreased levels of vitamin k-dependent clotting factors may occur in newborns exposed to phenytoin in utero . this drug-induced condition can be prevented with vitamin k administration to the mother before delivery and to the neonate after birth. data human data meta-analyses using data from published observational studies and registries have estimated an approximately 2.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. an increased risk of heart defects, facial clefts, and digital hypoplasia has been reported. the fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies. animal data administration of phenytoin to pregnant rats, rabbits, and mice during organogenesis resulted in embryofetal death, fetal malformations, and decreased fetal growth. malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low as 100, 75, and 12.5 mg/kg, respectively. risk summary phenytoin is secreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for phenytoin and any potential adverse effects on the breastfed infant from phenytoin or from the underlying maternal condition. initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. a recommended daily maintenance dosage is usually 4 to 8 mg/kg. children over 6 years and adolescents may require the minimum adult dosage (300 mg/day) [see dosage and administration (2.2)]. phenytoin clearance tends to decrease with increasing age [see clinical pharmacology (12.3)]. lower or less frequent dosing may be required [see dosage and administration (2.6)]. the liver is the chief site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity. because the fraction of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients. patients who are intermediate or poor metabolizers of cyp2c9 substrates (e.g., *1/*3, *2/*2, *3/*3) may exhibit increased phenytoin serum concentrations compared to patients who are normal metabolizers (e.g., *1/*1). thus, patients who are known to be intermediate or poor metabolizers may ultimately require lower doses of phenytoin to maintain similar steady-state concentrations compared to normal metabolizers. if early signs of dose-related central nervous system (cns) toxicity develop, serum concentrations should be checked immediately [see clinical pharmacology (12.5)].

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

american health packaging - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 50 mg - phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin chewable tablets are contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)] . - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary in humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. prenatal phenytoin exposure is associated with an increased incidence of major malformations, including orofacial clefts and cardiac defects. in addition, the fetal hydantoin syndrome, a pattern of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits has been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [see data] . there have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy. administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations and other manifestations of developmental toxicity (including embryofetal death, growth impairment, and behavioral abnormalities) in multiple species at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth defects and of 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. clinical considerations disease-associated maternal risk an increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see dosage and administration (2.4, 2.8)] . however, postpartum restoration of the original dosage will probably be indicated [see clinical pharmacology (12.3)] . fetal/neonatal adverse reactions a potentially life-threatening bleeding disorder related to decreased levels of vitamin k-dependent clotting factors may occur in newborns exposed to phenytoin in utero . this drug-induced condition can be prevented with vitamin k administration to the mother before delivery and to the neonate after birth. data human data meta-analyses using data from published observational studies and registries have estimated an approximately 2.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. an increased risk of heart defects, facial clefts, and digital hypoplasia has been reported. the fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies. animal data administration of phenytoin to pregnant rats, rabbits, and mice during organogenesis resulted in embryofetal death, fetal malformations, and decreased fetal growth. malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low as 100 mg/kg, 75 mg/kg, and 12.5 mg/kg, respectively. risk summary phenytoin is secreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for phenytoin and any potential adverse effects on the breastfed infant from phenytoin or from the underlying maternal condition. initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. a recommended daily maintenance dosage is usually 4 mg/kg to 8 mg/kg. children over 6 years and adolescents may require the minimum adult dosage (300 mg/day) [see dosage and administration (2.3)] . phenytoin clearance tends to decrease with increasing age [see clinical pharmacology (12.3)] . lower or less frequent dosing may be required [see dosage and administration (2.7)] . the liver is the chief site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity. because the fraction of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients. patients who are intermediate or poor metabolizers of cyp2c9 substrates (e.g., *1/*3, *2/*2, *3/*3) may exhibit increased phenytoin serum concentrations compared to patients who are normal metabolizers (e.g., *1/*1). thus, patients who are known to be intermediate or poor metabolizers may ultimately require lower doses of phenytoin to maintain similar steady-state concentrations compared to normal metabolizers. if early signs of dose-related central nervous system (cns) toxicity develop, serum concentrations should be checked immediately [see clinical pharmacology (12.5)].

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