Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam 15 mg - temazepam is indicated for the short-term treatment of insomnia (generally 7 - 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 - 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. benzodiazepines may cause fetal harm when administered to a pregnant woman. 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. reproduction studies in animals with temazepam were performed in rats and rabbits. in a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nurs

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see clinical studies (14)] . the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients zolpidem tartrate tablets are contraindicated in patients - who have experienced complex sleep behaviors after taking zolpidem tartrate tablets [see warnings and precautions ( 5.1)]. who have experienced complex sleep behaviors after taking zolpidem tartrate tablets [see warnings and precautions ( 5.1)]. - with known hypersensiti

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam 15 mg - temazepam capsules, usp are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. benzodiazepines may cause fetal harm when administered to a pregnant woman. 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. reproduction studies in animals with temazepam were performed in rats and rabbits. in a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality. teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher. in rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. at doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls. temazepam is contraindicated in women who are or may become pregnant. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. patients should be instructed to discontinue the drug prior to becoming pregnant. the possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. controlled substance temazepam is a controlled substance in schedule iv. abuse temazepam 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 healthcare 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, abuse, misuse, and addiction). 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). dependence physical dependence temazepam 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, dependence and withdrawal reactions). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage (see dosage and administration, discontinuation or dosage reduction of temazepam and warnings, dependence and withdrawal reactions). acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance tolerance to temazepam 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 temazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 10 mg - zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)] . the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . there are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other cns depressants. children b

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see  clinical studies (14) ]. the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . teratogenic effects: pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially whe

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

proficient rx lp - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate tablets usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets usp have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14) ]. the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate is contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . teratogenic effects pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate in pregnant women. studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

proficient rx lp - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. benzodiazepines may cause fetal harm when administered to a pregnant woman. 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. reproduction studies in animals with temazepam were performed in rats and rabbits. in a perinatal- postnatal study in rats, oral doses of 60 mg/kg/day resul

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)] . the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . risk summary neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see clinical   considerations and data] . published data on the use of zolpidem during pregnancy have not  reported a clear association with zolpidem and major birth defects [see data]. oral administ

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

proficient rx lp - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)]. the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . teratogenic effects: pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially wh

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

au pharma pty ltd - buprenorphine, quantity: 15 mg - drug delivery system, transdermal - excipient ingredients: povidone; levulinic acid; oleyl oleate; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; glycidyl methacrylate; 2-hydroxyethyl acrylate - b-patch patches are indicated for the management of severe pain where: - other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and - the pain is opioid-responsive, and - requires daily, continuous, long-term treatment,b-patch patches are not indicated for use in chronic non-cancer pain other than in exception circumstances. b-patch patches are not indicated as an as-needed (prn) analgesia.