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

preferred pharmaceuticals, inc.. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate extended-release tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).) the clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see clinical studies (14)]. zolpidem tartrate extended-release tablets are contraindicated in patients 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 administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effec

Israel - English - Ministry of Health

neurim pharmaceuticals (1991) ltd, israel - melatonin - tablets prolonged release - melatonin 2 mg - melatonin - short-term treatment for primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

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

spirit pharmaceuticals llc - diphenhydramine hydrochloride (unii: tc2d6jad40) (diphenhydramine - unii:8gts82s83m) - nighttime sleep-aid for the relief of occasional sleeplessness

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

preferred pharmaceuticals inc. - armodafinil (unii: v63xwa605i) (armodafinil - unii:v63xwa605i) - armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (osa), narcolepsy, or shift work disorder (swd). limitations of use in osa, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. if continuous positive airway pressure (cpap) is the treatment of choice for a patient, a maximal effort to treat with cpap for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness. armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . risk summary limited available data on armodafinil use in pregnant women are insufficient to inform a drug associated risk of adverse pregnancy outcomes. intrauterine growth restriction and spontaneous abortion have been reported in association with armodafinil and modafinil. although the pharmacology of armodafinil is not identical to that of the sympathomimetic amines, armodafinil shares some pharmacologic properties with this class [see clinical pharmacology (12.1)] . some sympathomimetics have been associated with intrauterine growth restriction and spontaneous abortions. in animal reproduction studies of armodafinil (r-modafinil) and modafinil (a mixture of r-and s-modafinil) conducted in pregnant rats (armodafinil, modafinil) and rabbits (modafinil) during organogenesis, evidence of developmental toxicity (increased embryofetal and offspring mortality, decreased fetal growth) was observed at clinically relevant plasma exposures. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. 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 armodafinil (60, 200, or 600 mg/kg/day) to pregnant rats throughout organogenesis resulted in decreased fetal body weight and increased incidences of fetal variations indicative of growth delay at the highest dose, which was also maternally toxic. the highest no-effect dose for embryofetal developmental toxicity in rat (200 mg/kg/day) was associated with a plasma armodafinil exposure (auc) less than that in humans at the maximum recommended human dose (mrhd) of armodafinil (250 mg/day). modafinil (50, 100, or 200 mg/kg/day) administered orally to pregnant rats throughout organogenesis produced an increase in resorptions and an increased incidence of fetal variations at the highest dose tested. the higher no-effect dose for embryofetal developmental toxicity (100 mg/kg/day) was associated with a plasma armodafinil auc less than that in humans at the mrhd of armodafinil. however, in a subsequent rat study of up to 480 mg/kg/day of modafinil, no adverse effects on embryofetal development were observed. in a study in which modafinil (45, 90, or 180 mg/kg/day) was orally administered to pregnant rabbits during organogenesis, embryofetal death was increased at the highest dose. the highest no-effect dose for developmental toxicity (100 mg/kg/day) was associated with a plasma armodafinil auc less than that in humans at the mrhd of armodafinil. modafinil administration to rats throughout gestation and lactation at oral doses of up to 200 mg/kg/day resulted in decreased viability in the offspring at doses greater than 20 mg/kg/day, a dose resulting in a plasma armodafinil auc less than that in humans at the mrhd of armodafinil. no effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring. risk summary there are no data on the presence of armodafinil or its metabolites in human milk, the effects on the breastfed infant, or the effect of this drug on milk production. modafinil was present in rat milk when animals were dosed during the lactation period. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for armodafinil and any potential adverse effects on the breastfed child from armodafinil or from the underlying maternal condition. the effectiveness of hormonal contraceptives may be reduced when used with armodafinil and for one month after discontinuation of therapy. advise women who are using a hormonal method of contraception to use an additional barrier method or an alternative non-hormonal method of contraception during treatment with armodafinil and for one month after discontinuation of armodafinil treatment [see drug interactions (7) and clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients have not been established. serious rash has been seen in pediatric patients receiving modafinil [see warnings and precautions (5.1)] . in elderly patients, elimination of armodafinil and its metabolites may be reduced as a consequence of aging. therefore, consideration should be given to the use of lower doses and close monitoring in this population [see dosage and administration (2.4) and clinical pharmacology (12.3)]. the dosage of armodafinil should be reduced in patients with severe hepatic impairment [see dosage and administration (2.3) and clinical pharmacology (12.3)] . armodafinil is a schedule iv controlled substance. abuse of armodafinil has been reported in patients treated with armodafinil. patterns of abuse have included euphoric mood and use of increasingly large doses or recurrent use of armodafinil for a desired effect. drug diversion has also been noted. during the postmarketing period, misuse of armodafinil has been observed (e.g., taking armodafinil against a physician’s advice, and obtaining armodafinil from multiple physicians). abuse of armodafinil, the active ingredient of armodafinil, poses a risk of overdosage similar to that seen for modafinil, which may lead to tachycardia, insomnia, agitation, dizziness, anxiety, nausea, headache, dystonia, tremor, chest pain, hypertension, seizures, delirium, or hallucinations. other signs and symptoms of cns stimulant abuse include tachypnea, sweating, dilated pupils, hyperactivity, restlessness, decreased appetite, loss of coordination, flushed skin, vomiting, and abdominal pain. in humans, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings, typical of other cns stimulants. in in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. in some studies, modafinil was also partially discriminated as stimulant-like. physicians should follow patients closely, especially those with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) abuse. patients should be observed for signs of misuse or abuse (e.g., incrementation of doses or drug-seeking behavior). the abuse potential of modafinil (200, 400, and 800 mg) was assessed relative to methylphenidate (45 and 90 mg) in an inpatient study in individuals experienced with drugs of abuse. results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled cns stimulants (methylphenidate). 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. physical dependence can occur in patients treated with armodafinil. abrupt cessation or dose reduction following chronic use can result in withdrawal symptoms, including shaking, sweating, chills, nausea, vomiting, confusion, aggression, and atrial fibrillation. drug withdrawal convulsions, suicidality, fatigue, insomnia, aches, depression and headache have also been observed during the postmarketing period. also, abrupt withdrawal has caused deterioration of psychiatric symptoms such as depression. 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). multiple cases of development of tolerance to armodafinil have been reported during the postmarketing period.

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

preferred pharmaceuticals, inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablets are indicated to reduce the rate of mi and stroke. clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions (6.2)] . risk summary clinical considerations disease-associated maternal and/or embryo/fetal risk myocardial infarction and stroke are medic

Singapore - English - HSA (Health Sciences Authority)

sleep care pte. ltd. - ear, nose & throat - the device record electrocardiogram(ecg), actigraphy, snoring and body position during sleep. the sleep data recorder is intended for the collection of physiological (actigraphy) and electrocardiogram(ecg) recordings during sleep that will be used the sleepimage application software for screening different sleep associated disorders.

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

pd-rx pharmaceuticals, inc. - armodafinil (unii: v63xwa605i) (armodafinil - unii:v63xwa605i) - armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (osa), narcolepsy, or shift work disorder (swd). limitations of use in osa, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. if continuous positive airway pressure (cpap) is the treatment of choice for a patient, a maximal effort to treat with cpap for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness. armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions ( 5.1, 5.2, 5.3)] . pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to armodafinil during pregnancy. healthcare providers are encouraged to register pregna

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

preferred pharmaceuticals, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration.  the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). risk summary available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity. administration of eszopiclone to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; the lowest dose w

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

graviti pharmaceuticals private limited - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - - clopidogrel is indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel should be administered in conjunction with aspirin. - clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel is indicated to reduce the rate of mi and stroke. clopidogrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel is contraindicated in patients with hypersensitivity (e.g., anaph

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

spirit pharmaceuticals llc - diphenhydramine hydrochloride (unii: tc2d6jad40) (diphenhydramine - unii:8gts82s83m) - nighttime sleep-aid - for the relief of occasional sleeplessness - reduces time to fall asleep if you have difficulty falling asleep