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

tripoint therapeutics, llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - elepsia xr is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older. elepsia xr 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 elepsia xr, during pregnancy. encourage women who are taking elepsia xr 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 prolonged experience with levetiracetam in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see human data] . in animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see animal 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. clinical considerations levetiracetam levels may decrease during pregnancy [see warnings and precautions (5.9)] . physiological changes during pregnancy may affect levetiracetam concentration. decrease in levetiracetam plasma concentrations has been observed during pregnancy. this decrease is more pronounced during the third trimester. dose adjustments may be necessary to maintain clinical response. data human data while available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage. animal data when levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rats (1200 mg/kg/day) is approximately 4 times the maximum recommended human dose (mrhd) of 3000 mg on a body surface area (mg/m2 ) basis. oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the mrhd on a mg/m2 basis. oral administration of levetiracetam (0, 70, 350, or 1800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on pre- and postnatal development in rats (70 mg/kg/day) is less than the mrhd on a mg/m2 basis. oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the mrhd on a mg/m2 basis). risk summary levetiracetam is excreted in human milk. there are no data on the effects of elepsia xr on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for elepsia xr and any potential adverse effects on the breastfed infant from elepsia xr or from the underlying maternal condition. safety and effectiveness of elepsia xr in pediatric patients 12 years of age and older has been established based on pharmacokinetic data in adults and adolescents using levetiracetam extended-release tablets and efficacy and safety data in controlled pediatric studies using immediate-release levetiracetam tablets [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1)]. safety and effectiveness in pediatric patients below the age of 12 years have not been established. a 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of immediate-release levetiracetam tablets as adjunctive therapy in 98 pediatric patients with inadequately controlled partial seizures, ages 4 to 16 years (levetiracetam n=64; placebo n=34). the target dose of immediate-release levetiracetam tablets was 60 mg/kg/day. neurocognitive effects were measured by the leiter-r attention and memory (am) battery, which assesses various aspects of a child's memory and attention. although no substantive differences were observed between the placebo-and levetiracetam-treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority between the drug and placebo. the achenbach child behavior checklist (cbcl/6-18), a standardized validated tool used to assess a child's competencies and behavioral/emotional problems, was also assessed in this study. an analysis of the cbcl/6-18 indicated a worsening in aggressive behavior, one of the eight syndrome scores, in patients treated with levetiracetam [see warnings and precautions (5.1)]. juvenile animal toxicity data studies of levetiracetam in juvenile rats (dosing from day 4 through day 52 of age) and dogs (dosing from week 3 through week 7 of age) at doses of up to 1,800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m2 basis) did not indicate a potential for age-specific toxicity. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam extended-release tablets in these patients. it is expected that the safety of elepsia xr in elderly patients 65 and over would be comparable to the safety observed in clinical studies of immediate-release levetiracetam tablets. there were 347 subjects in clinical studies of immediate-release levetiracetam that were 65 and over. no overall differences in safety were observed between these subjects and younger subjects. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of immediate-release levetiracetam tablets in these patients. levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse 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 [see clinical pharmacology (12.3)]. clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance [see clinical pharmacology (12.3)] . dose adjustment is recommended for patients with mild renal impairment [see dosage and administration (2.2)] . elepsia xr is not recommended in patients with moderate or severe renal impairment. in patients with moderate or severe renal impairment, it is recommended that lower strength levetiracetam tablets be used instead of elepsia xr. in patients with end stage renal disease on dialysis, it is recommended that immediate-release levetiracetam tablets be used instead of elepsia xr.

Canada - English - Health Canada

viva pharmaceutical inc. - vitamin b1; vitamin b2; vitamin b6; vitamin b12; nicotinamide; calcium d-pantothenate; biotin; folic acid - tablet (extended-release) - 100mg; 100mg; 100mg; 100mcg; 100mg; 100mg; 100mcg; 0.1mg - vitamin b1 100mg; vitamin b2 100mg; vitamin b6 100mg; vitamin b12 100mcg; nicotinamide 100mg; calcium d-pantothenate 100mg; biotin 100mcg; folic acid 0.1mg - vitamin b complex

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

sweat cosmetics, inc. - zinc oxide 16% - sunscreen helps prevent sunburn

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

otsuka australia pharmaceutical pty ltd - decitabine, quantity: 35 mg; cedazuridine, quantity: 100 mg - tablet, film coated - excipient ingredients: lactose monohydrate; colloidal anhydrous silica; magnesium stearate; croscarmellose sodium; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - inqovi 35/100 is indicated for the treatment of adult patients with myelodysplastic syndromes (mds) intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups, and patients with chronic myelomonocytic leukaemia (cmml).

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

otsuka australia pharmaceutical pty ltd - decitabine, quantity: 35 mg; cedazuridine, quantity: 100 mg - tablet, film coated - excipient ingredients: lactose monohydrate; colloidal anhydrous silica; magnesium stearate; croscarmellose sodium; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - inqovi 35/100 is indicated for the treatment of adult patients with myelodysplastic syndromes (mds) intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups, and patients with chronic myelomonocytic leukaemia (cmml).

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

sanofi-aventis australia pty ltd - atovaquone, quantity: 250 mg; proguanil hydrochloride, quantity: 100 mg - tablet - excipient ingredients: povidone; microcrystalline cellulose; poloxamer; sodium starch glycollate type a; hyprolose; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 8000; iron oxide red; macrogol 400 - promozio (250mg atovaquone/100mg proguanil hydrochloride) is indicated for:,? prophylaxis of plasmodium falciparum malaria in adults.,? treatment of plasmodium falciparum malaria in adults.

Philippines - English - FDA (Food And Drug Administration)

total nutrition corporation dba general nutrition center (gnc) natural health pharmacy; distributor: total nutrition corporation dba general nutrition center (gnc) natural health pharmacy - big 100 - tablet - 100 mg/100 mg/100 mg/100 mg/400 mcg/100 mcg/100 mcg/100 mg/100 mg/100 mcg/30 mg

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

jazz pharmaceuticals, inc. - cannabidiol (unii: 19gbj60sn5) (cannabidiol - unii:19gbj60sn5) - epidiolex is indicated for the treatment of seizures associated with lennox-gastaut syndrome (lgs), dravet syndrome (ds), or tuberous sclerosis complex (tsc) in patients 1 year of age and older. epidiolex is contraindicated in patients with a history of hypersensitivity to cannabidiol or any of the ingredients in the product [see description (11) and warnings and precautions (5.4)].   pregnancy surveillance program and pregnancy exposure registry there are two programs, an epidiolex pregnancy surveillance program and an antiepileptic drug (aed) pregnancy exposure registry, that monitor pregnancy outcomes.  encourage women who are taking epidiolex during pregnancy to enroll in both, by calling the toll free numbers or visiting the websites below: risk summary there are no adequate data on the developmental risks associated with the use of epidiolex in pregnant women.  administration of cannabidiol to pregnant animals produced evidence of developmental toxicity (increased embryofetal mortality in rats and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, long-term neurobehavioral changes, and adverse effects on the reproductive system in rat offspring) at maternal plasma exposures similar to (rabbit) or greater than (rat) that in humans at therapeutic doses (see animal 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 risks of major birth defects and miscarriage for the indicated populations are unknown. data animal data oral administration of cannabidiol (0, 75, 150, or 250 mg/kg/day) to pregnant rats throughout the period of organogenesis resulted in embryofetal mortality at the highest dose tested.  there were no other drug-related maternal or developmental effects.  the highest no-effect dose for embryofetal toxicity in rats was associated with maternal plasma cannabidiol exposures (auc) approximately 16 and 9 times that in humans at the recommended human doses (rhd) of 20 and 25 mg/kg/day, respectively. oral administration of cannabidiol (0, 50, 80, or 125 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in decreased fetal body weights and increased fetal structural variations at the highest dose tested, which was also associated with maternal toxicity.  maternal plasma cannabidiol exposures at the no-effect level for embryofetal developmental toxicity in rabbits were less than that in humans at the rhds. when cannabidiol (75, 150, or 250 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, decreased growth, delayed sexual maturation, neurobehavioral changes (decreased activity), and adverse effects on male reproductive organ development (small testes in adult offspring) and fertility were observed in the offspring at the mid and high dose.  these effects occurred in the absence of maternal toxicity.  the no-effect dose for pre- and post-natal developmental toxicity in rats was associated with maternal plasma cannabidiol exposures approximately 9 and 5 times that in humans at the rhds of 20 and 25 mg/kg/day, respectively. risk summary there are no data on the presence of cannabidiol or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for epidiolex and any potential adverse effects on the breastfed infant from epidiolex or from the underlying maternal condition. safety and effectiveness of epidiolex for the treatment of seizures associated with lgs, ds, or tsc have been established in patients 1 year of age and older.  the use of epidiolex in these indications is supported by adequate and well-controlled studies in patients 2 years of age and older with lgs and ds and in patients 1 year of age and older with tsc [see clinical studies (14.1, 14.2, 14.3)]. safety and effectiveness of epidiolex in pediatric patients below 1 year of age have not been established. juvenile animal data administration of cannabidiol (subcutaneous doses of 0 or 15 mg/kg on postnatal days (pnds) 4-6 followed by oral administration of 0, 100, 150, or 250 mg/kg on pnds 7-77) to juvenile rats for 10 weeks resulted in increased body weight, delayed male sexual maturation, neurobehavioral effects (decreased locomotor activity and auditory startle habituation), increased bone mineral density, and liver hepatocyte vacuolation.  a no-effect dose was not established.  the lowest dose causing developmental toxicity in juvenile rats (15 sc/100 po mg/kg) was associated with cannabidiol exposures (auc) approximately 15 and 8 times that in humans at the rhds of 20 and 25 mg/kg/day, respectively. clinical trials of epidiolex in the treatment of lgs, ds, and tsc did not include a sufficient number of patients aged above 55 years to determine whether or not they respond differently from younger patients.  in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see dosage and administration (2.6), warnings and precautions (5.1), and clinical pharmacology (12.3)] . because of an increase in exposure to epidiolex, dosage adjustments are necessary in patients with moderate or severe hepatic impairment [see dosage and administration (2.6), warnings and precautions (5.1), and clinical pharmacology (12.3)] .  epidiolex does not require dosage adjustments in patients with mild hepatic impairment. epidiolex is not a controlled substance. animal abuse-related studies show that cannabidiol does not produce cannabinoid-like behavioral responses, including generalization to delta-9-tetrahydrocannabinol (thc) in a drug discrimination study. cannabidiol also does not produce animal self-administration, suggesting it does not produce rewarding effects.  in a human abuse potential study, acute administration of cannabidiol to non-dependent adult recreational drug users at therapeutic and supratherapeutic doses of 750, 1500, and 4500 mg in the fasted state (equivalent respectively to 10, 20, and 60 mg/kg in a 75 kg adult) produced responses on positive subjective measures such as drug liking and take drug again that were within the acceptable placebo range.  in contrast, 10 and 30 mg of dronabinol (synthetic thc) and 2 mg alprazolam produced large increases on positive subjective measures compared to placebo that were statistically significantly greater than those produced by cannabidiol.  in other phase 1 clinical studies conducted with cannabidiol, there were no reports of abuse-related adverse events. in a human physical dependence study, administration of cannabidiol 1500 mg/day (750 mg twice daily) to adults for 28 days did not produce signs or symptoms of withdrawal over a 6-week assessment period  beginning three days after drug discontinuation.  this suggests that cannabidiol likely does not produce physical dependence. instructions for use epidiolex® (eh-peh-dye-oh-lex) (cannabidiol) oral solution 100 mg/ml be sure that you read, understand and follow these instructions carefully to ensure proper dosing of the oral solution. important: each package contains: child-resistant cap 2 bottle adapters 1 bottle of epidiolex oral solution (100 mg/ml) 2  reusable 1 ml oral syringes and 2 reusable 5 ml oral syringes: if your dose of epidiolex is 1 ml or less , use the 1 ml syringes to take your medicine. for each syringe size:                            note: if you lose or damage an oral syringe, or cannot read the markings, use the spare syringe. prepare the bottle- to use epidiolex for the first time              note: do not remove the bottle adapter from the bottle after it is inserted. prepare the dose your healthcare provider will tell you how much epidiolex to take or give.               dose                                                                     how to measure                1 ml or less                                                           use the 1 ml oral syringe 1 time                more than 1 ml and less than 5 ml                        use the 5 ml oral syringe 1 time                more than 5 ml                                                     use the 5 ml oral syringe more than 1 time              line up the end of the plunger with the marking for your dose of epidiolex.                if there are air bubbles in the oral syringe, keep the bottle upside down and push the plunger so that all of the                liquid flows back into the bottle. repeat step 5 until the air bubbles are gone. give epidiolex              do not forcefully push on the plunger.              do not direct the medicine to the back of the mouth or throat. this may cause choking.              if the dose of epidiolex prescribed by the healthcare provider is more than 5 ml, repeat steps 4 through 8  to complete the dose.                 for example:                 if your dose of epidiolex is 8 ml, withdraw 5 ml of medicine into the syringe and give the medicine.                 insert the tip of the oral syringe back into the bottle adapter and withdraw 3 ml of medicine. give the                 medicine to receive a total dose of 8 ml. clean up                do not remove the bottle adapter. the cap will fit over it.                do not wash the oral syringe in the dishwasher.           do not throw away the oral syringe. how should i store epidiolex? helpline details for additional assistance, call the toll-free helpline at 1-833-426-4243. hours: monday-friday                                       08:00am – 08:00pm est frequently asked questions q:  what if there are air bubbles in the oral syringe? a:   push the liquid back into the bottle and repeat step 5 until the air bubbles are gone. q:  what should i do if the liquid in the bottle has turned cloudy? a:  the liquid in the bottle may turn cloudy if water gets in the bottle. this does not change the safety or how well the medicine works. continue to use the cloudy liquid as prescribed by your healthcare provider. always make sure the oral syringes are completely dry before each use. q:  what should i do if the oral syringe is not completely dry before use? a:  if the oral syringe is not completely dry, use the spare syringe provided in the pack.  distributed by: jazz pharmaceuticals, inc. palo alto, ca 94304 epidiolex® is a registered trademark of jazz pharmaceuticals plc or its subsidiaries. © 2023 jazz pharmaceuticals, inc. this instructions for use has been approved by the u.s. food and drug administration. revised: 01/2023

Canada - English - Health Canada

bioforce canada inc. - vitamin b1; vitamin b2; vitamin b6; nicotinamide; d-pantothenic acid (calcium d-pantothenate); vitamin b12; biotin; folic acid; choline bitartrate; inositol - tablet - 100mg; 100mg; 100mg; 100mg; 100mg; 100mcg; 100mcg; .4mg; 100mg; 100mg - vitamin b1 100mg; vitamin b2 100mg; vitamin b6 100mg; nicotinamide 100mg; d-pantothenic acid (calcium d-pantothenate) 100mg; vitamin b12 100mcg; biotin 100mcg; folic acid .4mg; choline bitartrate 100mg; inositol 100mg - vitamin b complex

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

macleods pharmaceuticals limited - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)]. quetiapine tablets are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies (14.2)]. quetiapine tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult patients with bipolar i a