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

henry schein, inc. - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride injection is indicated in adults and pediatric patients: • as an adjunct to general anesthesia • to facilitate tracheal intubation • to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine chloride is contraindicated: • in patients with skeletal muscle myopathies [see warnings and precautions ( 5.1)] • in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions ( 5.2)] • after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions ( 5.4)] • in patients with known or suspected genetic susceptibility to malignant hyperthermia [see warnings and precautions ( 5.5), clinical pharmacology ( 12.5)] 8.1 pregnancy risk summary available data from published literature from case

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

amring pharmaceuticals inc. - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride injection is indicated in adults and pediatric patients: - as an adjunct to general anesthesia - to facilitate tracheal intubation - to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine chloride injection is contraindicated: - in patients with skeletal muscle myopathies [see warnings and precautions (5.1)] - in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions (5.2)] - after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions (5.4)] - in patients with known or suspected genetic susceptibility to malignant hyperthermia [see warnings and precautions (5.5), clinical pharmacology (12.5)] risk summary available data from published literature from case reports and case s

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

lifestar pharma llc - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride injection is indicated in adults and pediatric patients: - as an adjunct to general anesthesia - to facilitate tracheal intubation - to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine chloride injection is contraindicated: - in patients with skeletal muscle myopathies [see warnings and precautions (5.1)] - in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions (5.2)] - after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions (5.4)] - in patients with known or suspected genetic susceptibility to malignant hyperthermia [see warnings and precautions (5.5), clinical pharmacology (12.5)] risk summary available data from published literature from case reports and case ser

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

somerset therapeutics, llc - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride injection is indicated in adults and pediatric patients: -   as an adjunct to general anesthesia -   to facilitate tracheal intubation -   to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine chloride injection is contraindicated: -   in patients with skeletal muscle myopathies [see warnings and precautions (5.1)] -   in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions (5.2)] -   after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions (5.4)] -   in patients with known or suspected genetic susceptibility to malignant hyperthermia [see warnings and precautions (5.5), clinical pharmacology (12.5)] risk summary available data from published literature from case reports

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

hikma pharmaceuticals usa inc. - succinylcholine chloride dihydrate (unii: 8l0s1g435e) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride injection is indicated in adults and pediatric patients: - as an adjunct to general anesthesia - to facilitate tracheal intubation - to provide skeletal muscle relaxation during surgery or mechanical ventilation succinylcholine chloride injection is contraindicated: - in patients with skeletal muscle myopathies [see warnings and precautions (5.1)] - in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions (5. 2) ] - after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions (5.4)] - in patients with known or suspected genetic susceptibility to malignant hyperthermia [see warnings and precautions (5.5), clinical pharmacology (12.5)] risk summary available data from published literature from case reports and case series over several decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation.  if succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see clinical considerations). animal reproduction studies have not been conducted with succinylcholine chloride. 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 2-4% and 15-20%, respectively. clinical considerations maternal adverse reactions plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of succinylcholine. therefore, some pregnant patients may experience prolonged apnea. fetal/neonatal adverse reactions apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase, in the mother. labor or delivery succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation. risk summary there are no data on the presence of succinylcholine or its metabolite in either human or animal 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 succinylcholine chloride injection and any potential adverse effects on the breastfed infant from succinylcholine chloride injection or from the underlying maternal condition. safety and effectiveness of succinylcholine chloride have been established in pediatric patient age groups, neonate to adolescent. because of a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of succinylcholine chloride injection in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible [see warnings and precautions (5.1)] . intravenous bolus administration of succinylcholine chloride injection in pediatric patients (including infants) may result in profound bradycardia or, rarely, asystole. the incidence and severity of bradycardia is higher in pediatric patients than adults [see warnings and precautions (5.6)] . the effective dose of succinylcholine chloride injection in pediatric patients may be higher than that predicted by body weight dosing alone [see dosage and administration (2.3)] . clinical studies of succinylcholine chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and 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.

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

ranvet pty. limited - nicotinic acid; choline chloride; pantothenol-d = panthenol-d; vitamin b2 phosphate sodium = riboflavin phosphate sodiu; vitamin b1 hydrochloride = thiamine hydrochloride; vitamin b6 hydrochloride = pyridoxine hydrochloride - parenteral liquid/solution/suspension - nicotinic acid alkaloid active 50.0 mg/ml; choline chloride vitamin-b complex active 5.0 mg/ml; pantothenol-d = panthenol-d vitamin-b5 active 20.0 mg/ml; vitamin b2 phosphate sodium = riboflavin phosphate sodiu vitamin-b2 active 2.0 mg/ml; vitamin b1 hydrochloride = thiamine hydrochloride vitamin-b1 active 50.0 mg/ml; vitamin b6 hydrochloride = pyridoxine hydrochloride vitamin-b6 active 10.0 mg/ml - nutrition & metabolism - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - choline deficiency | vitamin b deficiency

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

cantrell drug company - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride 20 mg in 1 ml

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

eli lilly and company - olanzapine pamoate (unii: x7s6q4mhcb) (olanzapine - unii:n7u69t4szr) - olanzapine 210 mg in 1.4 ml - zyprexa relprevv is available only through a restricted distribution program [see warnings and precautions (5.2)] . zyprexa relprevv must not be dispensed directly to a patient. for a patient to receive treatment, the prescriber, healthcare facility, patient, and pharmacy must all be enrolled in the zyprexa relprevv patient care program. to enroll, call 1-877-772-9390. zyprexa relprevv is indicated for the treatment of schizophrenia. efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults [see clinical studies (14.1)] . none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including zyprexa relprevv, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs, including zyprexa relprevv, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see clinical considerations). overall available data from published epidemiologic studies of pregnant women exposed to olanzapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are risks to the mother associated with untreated schizophrenia or bipolar i disorder and with exposure to antipsychotics, including zyprexa relprevv, during pregnancy (see clinical considerations) . olanzapine was not teratogenic when administered orally to pregnant rats and rabbits at doses that are 9- and 30-times the daily oral maximum recommended human dose (mrhd), based on mg/m2 body surface area; some fetal toxicities were observed at these doses (see data ). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defects, 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 embryo/fetal risk there is a risk to the mother from untreated schizophrenia or bipolar i disorder, including increased risk of relapse, hospitalization, and suicide. schizophrenia and bipolar i disorder are associated with increased adverse perinatal outcomes, including preterm birth. it is not known if this is a direct result of the illness or other comorbid factors. fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including zyprexa relprevv, during the third trimester of pregnancy. these symptoms have varied in severity. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. data human data placental passage has been reported in published study reports; however, the placental passage ratio was highly variable ranging between 7% to 167% at birth following exposure during pregnancy. the clinical relevance of this finding is unknown. published data from observational studies, birth registries, case reports and meta-analyses that have evaluated the use of atypical antipsychotics during pregnancy do not establish an increased risk of major birth defects. a retrospective cohort study from a medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. animal data in oral reproduction studies in rats at doses up to 18 mg/kg/day and in rabbits at doses up to 30 mg/kg/day (9 and 30 times the daily oral mrhd based on mg/m2 body surface area, respectively), no evidence of teratogenicity was observed. in an oral rat teratology study, early resorptions and increased numbers of nonviable fetuses were observed at a dose of 18 mg/kg/day (9 times the daily oral mrhd based on mg/m2 body surface area), and gestation was prolonged at 10 mg/kg/day (5 times the daily oral mrhd based on mg/m2 body surface area). in an oral rabbit teratology study, fetal toxicity manifested as increased resorptions and decreased fetal weight, occurred at a maternally toxic dose of 30 mg/kg/day (30 times the daily oral mrhd based on mg/m2 body surface area). no evidence of teratogenicity or embryo-fetal toxicity was observed in rats or rabbits with olanzapine at intramuscular doses up to 75 mg/kg (1 and 2 times the mrhd of 300 mg every 2 weeks, respectively, based on mg/m2 body surface area). risk summary olanzapine pamoate is present in human milk. there are reports of excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to olanzapine pamoate through breast milk (see clinical considerations) . there is no information on the effects of olanzapine pamoate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zyprexa relprevv and any potential adverse effects on the breastfed child from zyprexa relprevv or from the mother’s underlying condition. infants exposed to zyprexa relprevv should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements). infertility females based on the pharmacologic action of olanzapine (d2 receptor antagonism), treatment with zyprexa relprevv may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see warnings and precautions (5.17)] . safety and effectiveness of zyprexa relprevv in children and adolescent patients have not been established [see warnings and precautions (5.7)] . compared to patients from adult clinical trials, adolescents treated with oral zyprexa were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, ldl cholesterol, prolactin and hepatic aminotransferase levels. clinical studies of zyprexa relprevv did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in the premarketing clinical studies with oral olanzapine, there was no indication of any different tolerability of olanzapine in elderly patients compared to younger patients with schizophrenia. oral olanzapine studies in elderly patients with dementia-related psychosis have suggested that there may be a different tolerability profile in this population compared to younger patients with schizophrenia. elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. in placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis, there was a higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) in patients treated with olanzapine compared to patients treated with placebo. in 5 placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis (n=1184), the following adverse reactions were reported in olanzapine-treated patients at an incidence of at least 2% and significantly greater than placebo-treated patients: falls, somnolence, peripheral edema, abnormal gait, urinary incontinence, lethargy, increased weight, asthenia, pyrexia, pneumonia, dry mouth and visual hallucinations. the rate of discontinuation due to adverse reactions was greater with olanzapine than placebo (13% vs 7%). elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. olanzapine is not approved for the treatment of patients with dementia-related psychosis [see boxed warning, warnings and precautions (5.3), and patient counseling information (17)] . olanzapine is not approved for the treatment of patients with dementia-related psychosis. also, the presence of factors that might decrease pharmacokinetic clearance or increase the pharmacodynamic response to olanzapine should lead to consideration of a lower starting dose for any geriatric patient [see boxed warning, dosage and administration (2.1), and warnings and precautions (5.3)] . in studies prospectively designed to assess abuse and dependence potential, olanzapine was shown to have acute depressive cns effects but little or no potential of abuse or physical dependence in rats administered oral doses up to 15 times the daily oral mrhd (20 mg) and rhesus monkeys administered oral doses up to 8 times the daily oral mrhd based on mg/m2 body surface area. olanzapine has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. because zyprexa relprevv is to be administered by healthcare professionals, the potential for misuse or abuse by patients is low. - single-dose vial of zyprexa relprevv powder - 3-ml vial of diluent - one 3-ml syringe with pre-attached 19-gauge, 1.5-inch (38 mm) hypodermic needle-pro® needle with needle protection device - two 19-gauge, 1.5-inch (38 mm) hypodermic needle-pro needles with needle protection device step 2 after insertion of the needle into the muscle, aspirate for several seconds to ensure that no blood appears. if any blood is drawn into the syringe, discard the syringe and the dose and begin with a new convenience kit. the injection should be performed with steady, continuous pressure.

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

par pharmaceutical, inc. - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.375 mg - pramipexole dihydrochloride extended-release tablets are indicated for the treatment of parkinson's disease. none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride extended-release tablets in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [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. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high inciden

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

upsher-smith laboratories, llc - trifluoperazine hydrochloride (unii: 6p1y2snf5v) (trifluoperazine - unii:214izi85k3) - trifluoperazine 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