United States - English - 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.

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

par pharmaceutical, inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin 150 mg - doxepin hcl is recommended for the treatment of: - •psychoneurotic patients with depression and/or anxiety. - •depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). - •depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). - •psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. the target symptoms of psychoneurosis that respond particularly well to doxepin hcl include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin hcl is safe and well tolerated even in the elderly patient. owing to lack of clinical experience in the pediatric population, doxepin hcl is not recommended for use in children under 12 years of age. doxepin hcl is contraindicated in individuals

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

watson laboratories, inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - capsule - 10 mg - doxepin hydrochloride capsules are recommended for the treatment of: - psychoneurotic patients with depression and/or anxiety. psychoneurotic patients with depression and/or anxiety. - depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). - depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). - psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. the target symptoms of psychoneurosis that

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

physicians total care, inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin hydrochloride 25 mg - doxepin hcl is recommended for the treatment of: - psychoneurotic patients with depression and/or anxiety. - depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). - depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). - psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. the target symptoms of psychoneurosis that respond particularly well to doxepin hcl include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin hcl is safe and well tolerated even in the elderly patient. owing to lack of clinical experience in the pediatric population, doxepin hcl is not recommended for use in children under 12 years of age. doxepin hcl is contraindicated in indi

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

remedyrepack inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin hydrochloride capsules are recommended for the treatment of:                          1.  psychoneurotic patients with depression and/or anxiety.           2.  depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).           3.  depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).           4.  psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. the target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly pa

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

medsource pharmaceuticals - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin hydrochloride capsules are recommended for the treatment of:                          1.  psychoneurotic patients with depression and/or anxiety.           2.  depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).           3.  depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).           4.  psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. the target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly pa

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

remedyrepack inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin hydrochloride capsules, usp are recommended for the treatment of: - psychoneurotic patients with depression and/or anxiety. - depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). - depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). - psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. the target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin hydrochloride capsules is safe and well tolerated even in the elderly patient. owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age. doxepin is contraindicated in individuals who have shown hypersensitivity to the drug. possibility of cross sensitivity with other dibenzoxepines should be kept in mind. doxepin is contraindicated in patients with glaucoma or a tendency to urinary retention. these disorders should be ruled out, particularly in older patients.

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

lake erie medical & surgical supply dba quality care products llc - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin 10 mg - doxepin is recommended for the treatment of: - psychoneurotic patients with depression and/or anxiety. - depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). - depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). - psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. the target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age. doxepin is contraindicated in individuals who have shown hypersens

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

contract pharmacy services-pa - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin hydrochloride 50 mg - doxepin is recommended for the treatment of: - psychoneurotic patients with depression and/or anxiety. - depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). - depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). - psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. the target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age. doxepin is contraindicated in individuals who have shown hypersens

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

h.j. harkins company, inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin 50 mg - doxepin is recommended for the treatment of: - psychoneurotic patients with depression and/or anxiety. - depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). - depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). - psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. the target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age. doxepin is contraindicated in individuals who have shown hypersens