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

aphena pharma solutions - tennessee, llc - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam 0.25 mg - triazolam is indicated for the short-term treatment of insomnia (generally 7–10 days). use for more than 2–3 weeks requires complete reevaluation of the patient (see warnings). prescriptions for triazolam should be written for short-term use (7–10 days) and it should not be prescribed in quantities exceeding a 1-month supply. triazolam tablets are contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines. benzodiazepines may cause fetal damage when administered during pregnancy. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. triazolam is contraindicated in pregnant women. if there is a likelihood of the patient becoming pregnant while receiving triazolam, she should

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

stat rx usa llc - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam 0.25 mg - triazolam is indicated for the short-term treatment of insomnia (generally 7–10 days). use for more than 2–3 weeks requires complete reevaluation of the patient (see warnings). prescriptions for triazolam should be written for short-term use (7–10 days) and it should not be prescribed in quantities exceeding a 1-month supply. triazolam tablets are contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines. benzodiazepines may cause fetal damage when administered during pregnancy. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. triazolam is contraindicated in pregnant women. if there is a likelihood of the patient becoming pregnant while receiving triazolam, she should

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

greenstone llc - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam 0.125 mg - triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. triazolam is contraindicated in: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including triazolam, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.10) and clinical considerations] . available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see data ). the background risk of major birth defects and miscarriage for the indic

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

pd-rx pharmaceuticals, inc. - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam 0.25 mg - triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. triazolam is contraindicated in: - patients with known hypersensitivity to triazolam, any of component of triazolam, or other benzodiazepines. reactions consistent with angioedema (involving the tongue, glottis, or larynx), dyspnea, and throat closing have been reported and may be fatal. - concomitant administration of strong cytochrome p450 (cyp 3a) enzyme inhibitors (e.g., ketoconazole, itraconazole, nefazodone, lopinavir, ritonavir) [see warnings and precautions (5.8), drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to triazolam during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for other psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-

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

unit dose services - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam 0.25 mg - triazolam is indicated for the short-term treatment of insomnia (generally 7–10 days). use for more than 2–3 weeks requires complete reevaluation of the patient (see warnings). prescriptions for triazolam should be written for short-term use (7–10 days) and it should not be prescribed in quantities exceeding a 1-month supply. triazolam tablets are contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines. benzodiazepines may cause fetal damage when administered during pregnancy. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. triazolam is contraindicated in pregnant women. if there is a likelihood of the patient becoming pregnant while receiving triazolam, she should

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

aphena pharma solutions - tennessee, inc. - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam 0.25 mg - triazolam tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days). use for more than 2 to 3 weeks requires complete reevaluation of the patient (see warnings). prescriptions for triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply. triazolam tablets are contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines. benzodiazepines may cause fetal damage when administered during pregnancy. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. triazolam tablets are contraindicated in pregnant women. if there is a likelihood of the patient becoming pregnant while recei

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

bryant ranch prepack - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam 0.25 mg - triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. triazolam is contraindicated in: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to triazolam during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for other psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/. risk summary infants born to mothers using benzodiazepines during the later stages of pregnancy have been reported to experience symptoms of sedation and neonatal withdrawal (see clinical considerations) [see warnings and precautions ( 5.10 )]. at this time, there is no clear evidence that triazolam exposure in early pregnancy can cause major birth defects (see data). the estimated background risk of major birth defects and miscarriage for the indicated population

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

a-s medication solutions - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam 0.25 mg - triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. triazolam is contraindicated in: - patients with known hypersensitivity to triazolam, any of component of triazolam, or other benzodiazepines. reactions consistent with angioedema (involving the tongue, glottis, or larynx), dyspnea, and throat closing have been reported and may be fatal. - concomitant administration of strong cytochrome p450 (cyp 3a) enzyme inhibitors (e.g., ketoconazole, itraconazole, nefazodone, lopinavir, ritonavir) [see warnings and precautions (5.8), drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to triazolam during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for other psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.

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

rebel distributors corp - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam 0.125 mg - triazolam tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days). use for more than 2 to 3 weeks requires complete reevaluation of the patient (see warnings). prescriptions for triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply. triazolam tablets are contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines. benzodiazepines may cause fetal damage when administered during pregnancy. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. triazolam tablets are contraindicated in pregnant women. if there is a likelihood of the patient becoming pregnant while recei

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

hikma pharmaceuticals usa inc. - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. triazolam is contraindicated in: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including triazolam, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.10) and clinical considerations]. available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (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. clinical considerations fetal/neonatal adverse reactions benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. monitor neonates exposed to triazolam during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. monitor neonates exposed to triazolam during pregnancy for signs of withdrawal. manage these neonates accordingly [see warnings and precautions ( 5.10 )]. data human data published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. in addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings. animal data oral administration of triazolam to pregnant rats and rabbits during the period of organogenesis caused skeletal developmental changes (variations and malformations) at maternally toxic doses in rats and at doses in rats and rabbits which are approximately equal to or greater than 200 times the maximum recommended human dose (mrhd) of 0.5 mg/day based on mg/m2 body surface area. oral administration of triazolam to male and female rats before mating, and continuing during gestation and lactation did not result in embryotoxicity at doses up to approximately 100 times the mrhd based on mg/m2 body surface area, but did cause an increase in the number of stillbirths and postnatal pup mortalities at doses greater than or equal to approximately 40 times the mrhd based mg/m2 body surface area. 14 c-triazolam was administered orally to pregnant mice. drug-related material appeared uniformly distributed in the fetus with 14 c concentrations approximately the same as in the brain of the mother. risk summary there are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. there are no data on the presence of triazolam in human milk or the effects on milk production. triazolam and its metabolites are present in the milk of lactating rats (see data ). when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for triazolam and any potential adverse effects on the breastfed infant from triazolam or from the underlying maternal condition. clinical considerations infants exposed to triazolam through breast milk should be monitored for sedation, poor feeding and poor weight gain. a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 28 hours (approximately 5 elimination half-lives) after triazolam administration in order to minimize drug exposure to a breast fed infant. data both triazolam and triazolam metabolites were detected in milk of rats. lactating rats were orally administered 0.3 mg/kg 14 c-triazolam; drug and metabolite levels were determined in milk collected at 6 and 24 hours after administration. safety and effectiveness of triazolam have not been established in pediatric patients. elderly patients exhibit higher plasma triazolam concentrations due to reduced clearance as compared with younger subjects at the same dose. because elderly patients are especially susceptible to dose related adverse reactions and to minimize oversedation, the smallest effective dose should be used [see dosage and administration (2.2), clinical pharmacology (12.3)]. triazolam tablets contain triazolam, a schedule iv controlled substance. triazolam is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders [see warnings and precautions ( 5.2)] . the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). physical dependence triazolam may produce physical dependence from continued therapy. 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 discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use [see warnings and precautions ( 5.3)] . to reduce the risk of withdrawal reactions, use a gradual taper to discontinue triazolam or reduce the dosage [see dosage and administration ( 2.3), warnings and precautions (5.3)] . tolerance tolerance to triazolam may develop from continued therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of triazolam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.