Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - zolmitriptan (unii: 2fs66th3yw) (zolmitriptan - unii:2fs66th3yw) - zolmitriptan 2.5 mg - zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults. limitations of use - only use zolmitriptan if a clear diagnosis of migraine has been established. if a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. - zolmitriptan orally disintegrating tablets are not indicated for the prevention of migraine attacks. - safety and effectiveness of zolmitriptan have not been established for cluster headache. zolmitriptan orally disintegrating tablets are contraindicated in patients with: -   ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or c oronary artery vasospasm including prinzmetal's angina [seewarnings and precautions (5.1) ]. -   wolff-parkinson-white syndrome or arrhythmias associa

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

vistapharm, inc. - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. lacosamide oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. 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 there are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. developmental neurotoxicity was observed in rats followin

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

gland pharma limited - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide injection is 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) injection. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric  information. lacosamide injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. 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 to 4% and 15 to 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 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. primary generalized tonic-clonic seizures safety and effectiveness of lacosamide as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients with idiopathic generalized epilepsy 4 years of age and older was established in a 24-week double-blind, randomized, placebo-controlled, parallel-group, multi-center study (study 5), which included 37 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1) and clinical studies (14.3)].   safety and effectiveness in pediatric patients below the age of 4 years 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) injection. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric  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 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 (clcr ≥30 ml/min). in patients with severe renal impairment (clcr <30 ml/min as estimated by the cockcroft-gault equation for adults; clcr <30 ml/min/1.73m2 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 injection 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 to 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.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - prochlorperazine edisylate (unii: pg20w5vqzs) (prochlorperazine - unii:yhp6ylt61t) - to control severe nausea and vomiting. for the treatment of schizophrenia. prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation. do not use in patients with known hypersensitivity to phenothiazines. do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.). do not use in pediatric surgery. do not use in pediatric patients under 2 years of age or under 20 lbs. do not use in children for conditions for which dosage has not been established. caution: certain glass syringes may malfunction, break or clog when connected to some needleless luer access devices (nlads) and needles. this syringe has a larger internal syringe tip and an external collar (luer collar). the external collar must remain attached to the syringe (see figure 1). spontaneous disconnection of this glass syringe from needles and nlads with leakage of drug product may occur. assure that the needle or nlad is securely attached before beginning the injection. visually inspect the glass syringe-needle or glass syringe –nlad connection before and during drug administration. figure 1 prochlorperazine edisylate injection is for deep intramuscular or intravenous use only. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. 1. inspect the outer packaging (plastic tube) and the syringe label by verifying: - plastic tube integrity - drug name - drug strength - fill volume - route of administration - expiration date to be sure that the drug has not expired - sterile field applicability do not use if package has been damaged. 2. open the outer packaging and remove the syringe from the tube. 3. perform visual inspection on the syringe by verifying: - absence of syringe damage - absence of external particles - absence of internal particles - proper drug color 4. push plunger rod slightly to break the stopper loose while tip cap is still on. 5. remove tip cap by twisting it off. (see figure 2) figure 2 6. discard the tip cap. 7. expel air bubble. 8. adjust dose into sterile material (if applicable). 9. connect the syringe to an appropriate injection connection depending on the route of administration. - before injection, ensure that the syringe is securely attached to the needle or needleless luer access device (nlad). 10. depress plunger rod to deliver medication. ensure that pressure is maintained on the plunger rod during the entire administration. 11. remove syringe from nlad (if applicable) and discard into appropriate receptacle. when a needle is connected to the syringe, to prevent needle-stick injuries, needles must not be recapped. notes: - all steps must be done sequentially - do not autoclave syringe - do not use this product on a sterile field - do not introduce any other fluid into the syringe at any time - this product is for single dose only; discard unused portion

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

e.r. squibb & sons, l.l.c. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir 150 mg - reyataz® is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. limitations of use: reyataz is contraindicated: table 6 displays drugs that are contraindicated with reyataz. drug class drugs within class that are contraindicated with reyataz alpha 1-adrenoreceptor antagonist alfuzosin anticonvulsants carbamazepine, phenobarbital, phenytoin antiarrhythmics amiodarone (with ritonavir), quinidine (with ritonavir) antimycobacterials rifampin antineoplastics apalutamide, encorafenib, irinotecan, ivosidenib antipsychotics lurasidone (with ritonavir), pimozide benzodiazepines orally administered midazolama , triazolam ergot derivatives dihydroergotamine, ergonovine, ergotamine, methylergonovine gi motility agent cisapride hepatitis c direct-acting antivirals elbasvir/grazoprevir; glecaprevir/pibrentasvir herbal products st. john’s wort (hypericum perforatum) lipid-modifying agents: lomitapide, l

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

sandoz inc - trifluoperazine hydrochloride (unii: 6p1y2snf5v) (trifluoperazine - unii:214izi85k3) - trifluoperazine hydrochloride 1 mg - for the management of schizophrenia. trifluoperazine hcl is effective for the short-term treatment of generalized non-psychotic anxiety. however, trifluoperazine hcl is not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines). when used in the treatment of non-psychotic anxiety, trifluoperazine hcl should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine hcl at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see warnings ). the effectiveness of trifluoperazine hcl as a treatment for non-psychotic anxiety was established in a four-week clinical multicenter study of outpatients with generalized anxiety disorder (dsm-iii). this evidence does not predict that trifluoperazine hcl will be useful in patients with other non-psychotic conditions in w

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

jubilant cadista pharmaceuticals inc. - prochlorperazine maleate (unii: i1t8o1jtl6) (prochlorperazine - unii:yhp6ylt61t) - prochlorperazine 5 mg - for control of severe nausea and vomiting. for the treatment of schizophrenia. prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. however, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). when used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see warnings ). the effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. this evidence does not predict that prochlorperazine will be useful in patients with other non-psychoti

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

upsher-smith laboratories, inc. - chlorpromazine hydrochloride (unii: 9wp59609j6) (chlorpromazine - unii:u42b7vya4p) - chlorpromazine hydrochloride 10 mg - for the management of manifestations of psychotic disorders. for the treatment of schizophrenia. to control nausea and vomiting. for relief of restlessness and apprehension before surgery. for acute intermittent porphyria. as an adjunct in the treatment of tetanus. to control the manifestations of the manic type of manic-depressive illness. for relief of intractable hiccups. for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance. do not use in patients with known hypersensitivity to phenothiazines. do not use in comatose states or in the presence of large amounts of central nervo

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - prochlorperazine maleate (unii: i1t8o1jtl6) (prochlorperazine - unii:yhp6ylt61t) - prochlorperazine 5 mg - prochlorperazine maleate tablets are indicated for the control of severe nausea and vomiting. prochlorperazine maleate tablets are also indicated for the treatment of schizophrenia. prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. however, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). when used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see warnings). the effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime anhydrous 400 mg - suprax is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . suprax is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes. (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator [see clinical studies (14)]. suprax is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections. suprax is generally effective in the eradication of streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of suprax in the subsequent prevention of rheumatic fever is not available.) suprax is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae and haemophilus influenzae. suprax is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates). to reduce the development of drug resistant bacteria and maintain the effectiveness of suprax and other antibacterial drugs, suprax should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. suprax  (cefixime) is contraindicated in patients with known allergy to cefixime or other cephalosporins. pregnancy category b reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. cefixime has not been studied for use during labor and delivery. treatment should only be given if clearly needed. it is not known whether cefixime is excreted in human milk. consideration should be given to discontinuing nursing temporarily during treatment with this drug. safety and effectiveness of cefixime in children aged less than six months old have not been established. the incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets. clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. a pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see clinical pharmacology (12.3)] . these differences were small and do not indicate a need for dosage adjustment of the drug in the elderly. the dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (capd) and hemodialysis (hd). patients on dialysis should be monitored carefully [see dosage and administration (2.3)] .