Израел - Енглески - Ministry of Health

boehringer ingelheim israel ltd. - ipratropium bromide - inhaler - ipratropium bromide 0.02 mg - ipratropium bromide - ipratropium bromide - for the relief of symptoms of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema.

Израел - Енглески - Ministry of Health

boehringer ingelheim israel ltd. - ipratropium bromide - respirator solution - ipratropium bromide 0.25 mg/ml - ipratropium bromide - ipratropium bromide - for the relief of symptoms of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema . aerovent respirator solution is of particular benefit in relieving acute bronchospasm when used concomitantly with inhaled beta agonists.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

currax pharmaceuticals llc - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin 3 mg - silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. the clinical trials performed in support of efficacy were up to 3 months in duration . silenor is contraindicated in individuals who have shown hypersensitivity to doxepin hcl, any of its inactive ingredients, or other dibenzoxepines. serious side effects and even death have been reported following the concomitant use of certain drugs with mao inhibitors. do not administer silenor if patient is currently on maois or has used maois within the past two weeks. the exact length of time may vary depending on the particular maoi dosage and duration of treatment. silenor is contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention. risk summary available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see data) . there are risks of poor neonatal adaptation with exposure to tricy

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

currax pharmaceuticals llc dba cypress, hawthorn, macoven - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin hcl tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. the clinical trials performed in support of efficacy were up to 3 months in duration. doxepin hcl tablets is contraindicated in individuals who have shown hypersensitivity to doxepin hcl, any of its inactive ingredients, or other dibenzoxepines. serious side effects and even death have been reported following the concomitant use of certain drugs with mao inhibitors. do not administer doxepin hcl tablets if patient is currently on maois or has used maois within the past two weeks. the exact length of time may vary depending on the particular maoi dosage and duration of treatment. doxepin hcl tablets is contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention. risk summary available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see data) . there are risks of poo

Израел - Енглески - Ministry of Health

boehringer ingelheim israel ltd. - ipratropium bromide - respirator solution - ipratropium bromide 0.25 mg/ml - ipratropium bromide - for the relief of symptoms of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema . aerovent respirator solution is of particular benefit in relieving acute bronchospasm when used concomitantly with inhaled beta agonists.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin hydrochloride tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. the clinical trials performed in support of efficacy were up to 3 months in duration [see clinical studies (14) ]. doxepin hydrochloride tablets are contraindicated in individuals who have shown hypersensitivity to doxepin hcl, any of its inactive ingredients, or other dibenzoxepines. serious side effects and even death have been reported following the concomitant use of certain drugs with mao inhibitors. do not administer doxepin hydrochloride tablets if patient is currently on maois or has used maois within the past two weeks. the exact length of time may vary depending on the particular maoi dosage and duration of treatment. doxepin hydrochloride tablets are contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention. there are no adequate and well-controlled studies of doxepin hydrochloride tablets in pregnant women. doxepin hydrochloride tablets

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

actavis pharma, inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. the clinical trials performed in support of efficacy were up to 3 months in duration. doxepin is contraindicated in individuals who have shown hypersensitivity to doxepin hcl, any of its inactive ingredients, or other dibenzoxepines. serious side effects and even death have been reported following the concomitant use of certain drugs with mao inhibitors. do not administer doxepin if patient is currently on maois or has used maois within the past two weeks. the exact length of time may vary depending on the particular maoi dosage and duration of treatment. doxepin is contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention.  risk summary available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see data) . there are risks of poor neonatal adaptation with exposure to

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. the clinical trials performed in support of efficacy were up to 3 months in duration. doxepin tablets are contraindicated in individuals who have shown hypersensitivity to doxepin hcl, any of its inactive ingredients, or other dibenzoxepines. serious side effects and even death have been reported following the concomitant use of certain drugs with mao inhibitors. do not administer doxepin tablets if patient is currently on maois or has used maois within the past two weeks. the exact length of time may vary depending on the particular maoi dosage and duration of treatment. doxepin tablets are contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention. available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see data) . there are risks of poor neonatal adaptation with

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

archis pharma llc - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. the clinical trials performed in support of efficacy were up to 3 months in duration. doxepin tablets are contraindicated in individuals who have shown hypersensitivity to doxepin hcl, any of its inactive ingredients, or other dibenzoxepines. serious side effects and even death have been reported following the concomitant use of certain drugs with mao inhibitors. do not administer doxepin tablets if patient is currently on maois or has used maois within the past two weeks. the exact length of time may vary depending on the particular maoi dosage and duration of treatment. doxepin tablets are contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention. risk summary available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see data) . there are risks of poor neonatal adaptation with exposure to tricyclic antidepressants (tcas), including doxepin, during pregnancy (see clinical  considerations). in animal reproduction studies, oral administration of doxepin to rats and rabbits during the period of organogenesis caused adverse developmental effects at doses 65 and 23 times the maximum recommended human dose (mrhd) of 6 mg/day based on auc, respectively. oral administration of doxepin to pregnant rats during pregnancy and lactation resulted in decreased pup survival and a delay in pup growth at doses 60 times the mrhd based on auc (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of major 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: neonates exposed to tcas, including doxepin, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hyperreflexia, tremor, jitteriness, irritability and constant crying. these findings are consistent with either direct toxic effects of tcas or possibly a drug discontinuation syndrome. monitor neonates who were exposed to doxepin in the third trimester of pregnancy for poor neonatal adaptation syndrome . data human data published epidemiologic studies of pregnant women exposed to tcas, including doxepin, have not established an association with major birth defects, miscarriage or adverse maternal outcomes. methodological limitations of these observational studies include small sample size and lack of adequate controls. animal data when doxepin (30, 100, and 150 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, developmental toxicity (increased incidences of fetal structural abnormalities consisting of non-ossified bones in the skull and sternum and decreased fetal body weights) and maternal toxicity were noted at ≥100 mg/kg/day, which produced plasma exposures (aucs) of doxepin and nordoxepin (the primary metabolite in humans) approximately 65 and 53 times, respectively, the plasma aucs at the mrhd. the plasma exposures at the no-effect dose for embryo-fetal developmental toxicity in rats (30 mg/kg/day) are approximately 6 and 5 times the plasma aucs for doxepin and nordoxepin, respectively, at the mrhd. when doxepin (10, 30, and 60 mg/kg/day) was administered orally to pregnant rabbits during the period of organogenesis, fetal body weights were reduced at the highest dose in the absence of maternal toxicity, which produced plasma aucs of doxepin and nordoxepin approximately 23 and 56 times, respectively, the plasma aucs at the mrhd. the plasma exposures at the no-effect dose for developmental effects (30 mg/kg/day) are approximately 8 and 25 times the plasma aucs for doxepin and nordoxepin, respectively, at the mrhd. oral administration of doxepin (10, 30, and 100 mg/kg/day) to rats throughout pregnancy and lactation resulted in decreased pup survival and transient growth delay at the highest dose, which produced plasma aucs of doxepin and nordoxepin approximately 60 and 39 times, respectively, the plasma aucs at the mrhd. the plasma exposures at the no-effect dose for adverse effects on pre- and postnatal development in rats (30 mg/kg/day) are approximately 2 and 1 times the plasma aucs for doxepin and nordoxepin, respectively, at the mrhd. risk summary data from the published literature report the presence of doxepin and nordoxepin in human milk. there are reports of excess sedation, respiratory depression, poor sucking and swallowing, and hypotonia in breastfed infants exposed to doxepin. there are no data on the effects of doxepin on milk production. because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, clinicians should advise patients that breastfeeding is not recommended during treatment with doxepin tablets. clinical considerations infants exposed to doxepin through breast milk should be monitored for excess sedation, respiratory depression and hypotonia. infertility based on results from animal fertility studies conducted in rats, doxepin may reduce fertility in females and males of reproductive potential [see nonclinical toxicology ( 13.1)] . it is unknown if the effects are reversible. the safety and effectiveness of doxepin tablets in pediatric patients have not been evaluated. a total of 362 subjects who were ≥ 65 years and 86 subjects who were ≥ 75 years received doxepin tablets in controlled clinical studies. no overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. greater sensitivity of some older individuals cannot be ruled out. sleep-promoting drugs may cause confusion and over-sedation in the elderly. a starting dose of 3 mg is recommended in this population and evaluation prior to considering dose escalation is recommended [ see  dosage and administration ( 2.2) ]. patients with hepatic impairment may display higher doxepin concentrations than healthy individuals. initiate doxepin tablets treatment with 3 mg in patients with hepatic impairment and monitor closely for adverse daytime effects [ see  clinical pharmacology ( 12.3) ]. doxepin tablets has not been studied in patients with obstructive sleep apnea. since hypnotics have the capacity to depress respiratory drive, precautions should be taken if doxepin tablets are prescribed to patients with compromised respiratory function. in patients with severe sleep apnea, doxepin tablets are ordinarily not recommended for use. doxepin is not a controlled substance. doxepin is not associated with abuse potential in animals or in humans. physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of doxepin (e.g., incrementation of dose, drug-seeking behavior). in a brief assessment of adverse events observed during discontinuation of doxepin following chronic administration, no symptoms indicative of a withdrawal syndrome were observed. thus, doxepin does not appear to produce physical dependence.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

remedyrepack inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. the clinical trials performed in support of efficacy were up to 3 months in duration. doxepin is contraindicated in individuals who have shown hypersensitivity to doxepin hcl, any of its inactive ingredients, or other dibenzoxepines. serious side effects and even death have been reported following the concomitant use of certain drugs with mao inhibitors. do not administer doxepin if patient is currently on maois or has used maois within the past two weeks. the exact length of time may vary depending on the particular maoi dosage and duration of treatment. doxepin is contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention.   risk summary available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see data) . there are risks of poor neonatal adaptation with exposure to tricyclic antidepressants (tcas), including doxepin, during pregnancy (see clinical  considerations). in animal reproduction studies, oral administration of doxepin to rats and rabbits during the period of organogenesis caused adverse developmental effects at doses 65 and 23 times the maximum recommended human dose (mrhd) of 6 mg/day based on auc, respectively. oral administration of doxepin to pregnant rats during pregnancy and lactation resulted in decreased pup survival and a delay in pup growth at doses 60 times the mrhd based on auc (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of major 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 neonates exposed to tcas, including doxepin, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hyperreflexia, tremor, jitteriness, irritability and constant crying. these findings are consistent with either direct toxic effects of tcas or possibly a drug discontinuation syndrome. monitor neonates who were exposed to doxepin in the third trimester of pregnancy for poor neonatal adaptation syndrome . data human data published epidemiologic studies of pregnant women exposed to tcas, including doxepin, have not established an association with major birth defects, miscarriage or adverse maternal outcomes. methodological limitations of these observational studies include small sample size and lack of adequate controls. animal data when doxepin (30, 100, and 150 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, developmental toxicity (increased incidences of fetal structural abnormalities consisting of non-ossified bones in the skull and sternum and decreased fetal body weights) and maternal toxicity were noted at ≥100 mg/kg/day, which produced plasma exposures (aucs) of doxepin and nordoxepin (the primary metabolite in humans) approximately 65 and 53 times, respectively, the plasma aucs at the mrhd. the plasma exposures at the no-effect dose for embryo-fetal developmental toxicity in rats (30 mg/kg/day) are approximately 6 and 5 times the plasma aucs for doxepin and nordoxepin, respectively, at the mrhd. when doxepin (10, 30, and 60 mg/kg/day) was administered orally to pregnant rabbits during the period of organogenesis, fetal body weights were reduced at the highest dose in the absence of maternal toxicity, which produced plasma aucs of doxepin and nordoxepin approximately 23 and 56 times, respectively, the plasma aucs at the mrhd. the plasma exposures at the no-effect dose for developmental effects (30 mg/kg/day) are approximately 8 and 25 times the plasma aucs for doxepin and nordoxepin, respectively, at the mrhd. oral administration of doxepin (10, 30, and 100 mg/kg/day) to rats throughout pregnancy and lactation resulted in decreased pup survival and transient growth delay at the highest dose, which produced plasma aucs of doxepin and nordoxepin approximately 60 and 39 times, respectively, the plasma aucs at the mrhd. the plasma exposures at the no-effect dose for adverse effects on pre- and postnatal development in rats (30 mg/kg/day) are approximately 2 and 1 times the plasma aucs for doxepin and nordoxepin, respectively, at the mrhd. risk summary data from the published literature report the presence of doxepin and nordoxepin in human milk. there are reports of excess sedation, respiratory depression, poor sucking and swallowing, and hypotonia in breastfed infants exposed to doxepin. there are no data on the effects of doxepin on milk production. because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, clinicians should advise patients that breastfeeding is not recommended during treatment with doxepin. clinical considerations infants exposed to doxepin through breast milk should be monitored for excess sedation, respiratory depression and hypotonia. infertility based on results from animal fertility studies conducted in rats, doxepin may reduce fertility in females and males of reproductive potential [see nonclinical toxicology (13.1)] . it is unknown if the effects are reversible. the safety and effectiveness of doxepin in pediatric patients have not been evaluated. a total of 362 subjects who were ≥ 65 years and 86 subjects who were ≥ 75 years received doxepin in controlled clinical studies. no overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. greater sensitivity of some older individuals cannot be ruled out. sleep-promoting drugs may cause confusion and over-sedation in the elderly. a starting dose of 3 mg is recommended in this population and evaluation prior to considering dose escalation is recommended [ see  dosage and administration ( 2.2) ]. patients with hepatic impairment may display higher doxepin concentrations than healthy individuals. initiate doxepin treatment with 3 mg in patients with hepatic impairment and monitor closely for adverse daytime effects [ see  clinical pharmacology ( 12.3) ]. doxepin has not been studied in patients with obstructive sleep apnea. since hypnotics have the capacity to depress respiratory drive, precautions should be taken if doxepin is prescribed to patients with compromised respiratory function. in patients with severe sleep apnea, doxepin is ordinarily not recommended for use. doxepin is not a controlled substance. doxepin is not associated with abuse potential in animals or in humans. physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of doxepin (e.g., incrementation of dose, drug-seeking behavior). in a brief assessment of adverse events observed during discontinuation of doxepin following chronic administration, no symptoms indicative of a withdrawal syndrome were observed. thus, doxepin does not appear to produce physical dependence.