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

ajanta pharma usa inc. - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - epilepsy   carbamazepine extended-release tablets are indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine extended-release tablets as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by carbamazepine extended-release tablets (see precautions, general). trigeminal neuralgia carbamazepine extended-release tablets are indicated in the treatment of the pain associated with true trigeminal neuralgia. beneficial results have also been reported in glossopharyngeal neuralgia.  this drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. likewise, on theoretical grounds its use with monoamine oxidase (mao) inhibitors is not recommended. before administration of carbamazepine, mao inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. coadministration of carbamazepine with nefazodone is contraindicated. no evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

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

ajanta pharma usa 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

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

ajanta pharma usa inc. - brexpiprazole (unii: 2j3ybm1k8c) (brexpiprazole - unii:2j3ybm1k8c) - brexpiprazole tablets are indicated for: - adjunctive treatment of major depressive disorder (mdd) in adults. - treatment of schizophrenia in adults. brexpiprazole tablets are contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. reactions have included rash, facial swelling, urticaria, and anaphylaxis. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to brexpiprazole tablets during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary adequate and well-controlled studies have not been conducted with brexpiprazole tablets in pregnant women to inform drug-associated risks. however, neonates whose mothers are exposed to antipsychotic drugs, like brexpiprazole tablets, during the third trimester of pregnancy are at risk for extrapyrami

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

ajanta pharma usa inc. - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington’s disease. tetrabenazine is contraindicated in patients: - who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings and precautions (5.1)]. - with hepatic impairment [see use in specific populations (8.6), clinical pharmacology (12.3)]. - taking monoamine oxidase inhibitors (maois). tetrabenazine should not be used in combination with an maoi, or within a minimum of 14 days of discontinuing therapy with an maoi [see drug interactions (7.3)] . - taking reserpine. at least 20 days should elapse after stopping reserpine before starting tetrabenazine[see drug interactions (7.2)] . - taking deutetrabenazine or valbenazine [see drug interactions (7.7)]. risk summary there are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in

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

ajanta pharma usa inc. - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole sodium for delayed-release oral suspension is indicated for: pantoprazole sodium for delayed-release oral suspension is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium for delayed-release oral suspension may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium for delayed-release oral suspension is indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium for delayed-release oral suspension is indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. - pan

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

ajanta pharma usa inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9), sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - omeprazole 20 mg - omeprazole and sodium bicarbonate capsules are indicated in adults for the : - short-term treatment of active duodenal ulcer. most patients heal within four weeks. some patients may require an additional four weeks of therapy. - short-term treatment (4 to 8 weeks) of active benign gastric ulcer. - treatment of heartburn and other symptoms associated with gerd for up to 4 weeks. - short-term treatment (4 to 8 weeks) of ee due to acid-mediated gerd which has been diagnosed by endoscopy in adults. the efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with ee has not been established. if a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. if there is recurrence of ee or gerd symptoms (e.g., heartburn), additional 4 to 8-week courses of omeprazole and sodium bicarbonate capsules may be considered. - the efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with ee has not been established. if a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. if there is recurrence of ee or gerd symptoms (e.g., heartburn), additional 4 to 8-week courses of omeprazole and sodium bicarbonate capsules may be considered. - maintenance of healing of ee due to acid-mediated gerd. controlled studies do not extend beyond 12 months. omeprazole and sodium bicarbonate capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any components of the formulation. hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see warnings and precautions (5.2), adverse reactions (6.2)]. proton pump inhibitors (ppis), including omeprazole and sodium bicarbonate capsules, are contraindicated in patients receiving rilpivirine containing products[see drug interactions (7)].   risk summary there are no adequate and well-controlled studies with omeprazole and sodium bicarbonate capsules in pregnant women. omeprazole and sodium bicarbonate capsules contains omeprazole and sodium bicarbonate. omeprazole there are no adequate and well-controlled studies with omeprazole in pregnant women. available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole (based on body surface area for a 60 kg person). changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole. when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age (see data). sodium bicarbonate available data with sodium bicarbonate use in pregnant women are insufficient to identify a drug associated risk of major birth defects or miscarriage. published animal studies report that sodium bicarbonate administered to rats, mice or rabbits during pregnancy did not cause adverse developmental effects in offspring. the estimated background risks of major birth defects and miscarriage for the indicated population are 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. data human data there are no adequate and well-controlled studies with omeprazole and sodium bicarbonate capsules in pregnant women. four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to h2 -receptor antagonists or other controls. a population-based retrospective cohort epidemiological study from the swedish medical birth register, covering approximately 99% of pregnancies, from 1995-99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. the number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low apgar score, or hospitalization was similar to the number observed in this population. the number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. a population-based retrospective cohort study covering all live births in denmark from 1996-2009 reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any ppi. the overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any ppi during the first trimester. a retrospective cohort study reported on 689 pregnant women exposed to either h2 -blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. the overall malformation rate in offspring born to mothers with first trimester exposure to omeprazole, an h2 -blocker, or were unexposed was 3.6%, 5.5%, and 4.1%, respectively. a small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% first trimester exposures). the reported rate of major congenital malformations was 4%, in the omeprazole group, 2% in controls exposed to non-teratogens, and 2.8% in disease-paired controls. rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups. several studies have reported no apparent adverse short-term effects on the infant when single-dose oral or intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia. animal data omeprazole reproductive studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) and in rabbits at doses up to 69.1 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) during organogenesis did not disclose any evidence for a teratogenic potential of omeprazole. in rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/kg/day (about 3.4 to 34 times an oral human dose of 40 mg on a body surface area basis) administered during organogenesis produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy disruptions. in rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138 mg/kg/day (about 3.4 to 34 times an oral human dose of 40 mg on a body surface area basis), administered prior to mating through the lactation period. esomeprazole the data described below was generated from studies using esomeprazole, an enantiomer of omeprazole. the animal to human dose multiples are based on the assumption of equal systemic exposure to esomeprazole in humans following oral administration of either 40 mg esomeprazole or 40 mg omeprazole. no effects on embryo-fetal development were observed in reproduction studies with esomeprazole magnesium in rats at oral doses up to 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) and in rabbits at oral doses up to 86 mg/kg/day (about 42 times an oral human dose of 40 mg of esomeprazole or 40 mg omeprazole on a body surface area basis) administered during organogenesis. a pre- and postnatal developmental toxicity study in rats with additional  endpoints to evaluate bone development were performed with esomeprazole magnesium at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg of esomeprazole or 40 mg omeprazole on a body surface area basis). neonatal/early postnatal (birth to weaning) survival was decreased at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). body weight and body weight gain were reduced and neurobehavioral or general developmental delays in the immediate post-weaning timeframe were evident at doses equal to or greater than 69 mg/kg/day (about 17 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). in addition, decreased femur length, width and thickness of cortical bone, decreased thickness of the tibial growth plate and minimal to mild bone marrow hypocellularity were noted at doses of esomeprazole magnesium equal to or greater than 14 mg/kg/day (about 3.4 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). physeal dysplasia in the femur was observed in offspring of rats treated with oral doses of esomeprazole magnesium at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). effects on maternal bone were observed in pregnant and lactating rats in a pre- and postnatal toxicity study when esomeprazole magnesium was administered at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). when rats were dosed from gestational day 7 through weaning on postnatal day 21, a statistically significant decrease in maternal femur weight of up to 14% (as compared to placebo treatment) was observed at doses of esomeprazole magnesium equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis). a pre- and postnatal development study in rats with esomeprazole strontium (using equimolar doses compared to esomeprazole magnesium study) produced similar results in dams and pups as described above. a follow-up developmental toxicity study in rats with further time points to evaluate pup bone development from postnatal day 2 to adulthood was performed with esomeprazole magnesium at oral doses of 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) where esomeprazole administration was from either gestational day 7 or gestational day 16 until parturition. when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age. risk summary available data from the published literature suggest both components of omeprazole and sodium bicarbonate capsules, omeprazole and sodium bicarbonate, are present in human milk. there are no clinical data on the effects of omeprazole or sodium bicarbonate on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for omeprazole and sodium bicarbonate capsules and any potential adverse effects on the breastfed infant from omeprazole and sodium bicarbonate capsules or from the underlying maternal condition. safety and effectiveness of omeprazole and sodium bicarbonate capsules have not been established in pediatric patients. juvenile animal data esomeprazole, an enantiomer of omeprazole, was shown to decrease body weight, body weight gain, femur weight, femur length, and overall growth at oral doses about 34 to 68 times a daily human dose of 40 mg esomeprazole or 40 mg omeprazole based on body surface area in a juvenile rat toxicity study. the animal to human dose multiples are based on the assumption of equal systemic exposure to esomeprazole in humans following oral administration of either 40 mg esomeprazole or 40 mg omeprazole. a 28-day toxicity study with a 14-day recovery phase was conducted in juvenile rats with esomeprazole magnesium at doses of 70 to 280 mg/kg/day (about 17 to 68 times a daily oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). an increase in the number of deaths at the high dose of 280 mg/kg/day was observed when juvenile rats were administered esomeprazole magnesium from postnatal day 7 through postnatal day 35. in addition, doses equal to or greater than 140 mg/kg/day (about 34 times a daily oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis), produced treatment-related decreases in body weight (approximately 14%) and body weight gain, decreases in femur weight and femur length, and affected overall growth. comparable findings described above have also been observed in this study with another esomeprazole salt, esomeprazole strontium, at equimolar doses of esomeprazole. omeprazole was administered to over 2,000 elderly individuals (≥65 years of age) in clinical trials in the u.s. and europe. there were no differences in safety and effectiveness between the elderly and younger subjects. other reported clinical experience has not identified differences in response between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. pharmacokinetic studies with buffered omeprazole have shown the elimination rate was somewhat decreased in the elderly and bioavailability was increased. the plasma clearance of omeprazole was 250 ml/min (about half that of young subjects). the plasma half-life averaged one hour, about twice that in nonelderly, healthy subjects taking omeprazole and sodium bicarbonate capsules. however, no dosage adjustment is necessary in the elderly [see clinical pharmacology (12.3)]. in patients with hepatic impairment (child-pugh class a, b, or c) exposure to omeprazole substantially increased compared to healthy subjects. avoid use of omeprazole and sodium bicarbonate capsules in patients with hepatic impairment for maintenance of healing of erosive esophagitis [see clinical pharmacology (12.3)]. in studies of healthy subjects, asians had approximately a four-fold higher exposure than caucasians. avoid use of omeprazole and sodium bicarbonate capsules in asian patients for maintenance of healing of erosive esophagitis [see clinical pharmacology (12.5)].

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

ajanta pharma usa inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole oral tablets are indicated for the treatment of: - schizophrenia - irritability associated with autistic disorder - treatment of tourette’s disorder aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs, including aripiprazole, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see clinical considerations) . overall av

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

ajanta pharma usa inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 20 mg - duloxetine delayed-release capsules are indicated for the treatment of: - major depressive disorder in adults - generalized anxiety disorder in adults and pediatric patients 7 years of age and older - diabetic peripheral neuropathic pain in adults - fibromyalgia in adults and pediatric patients 13 years of age and older - chronic musculoskeletal pain in adults the use of maois intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)]. starting duloxetine in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2.9) and warnings and precautions (5.4)]. pregnancy

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

ajanta pharma usa inc. - clomipramine hydrochloride (unii: 2lxw0l6gwj) (clomipramine - unii:nuv44l116d) - clomipramine hydrochloride capsules, usp is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (ocd). the obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the dsm-iii-r (circa 1989) diagnosis of ocd. obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. the effectiveness of clomipramine hydrochloride for the treatment of ocd was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. patients in all studies had moderate-to-severe ocd (dsm-iii), with mean baseline ratings on the yale-brown

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

ajanta pharma usa inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine extended-release tablets are indicated for the treatment of major depressive disorder (mdd). efficacy of venlafaxine in mdd was shown in both short-term trials and a longer-term trial in mdd [see clinical studies (14.1)]. a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. venlafaxine extended-release tablets are indicated for the treatment of social anxiety disorder (sad), also kn