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sun pharmaceutical industries, inc. - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam 7.5 mg - 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

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

sun pharmaceutical industries, inc. - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - codeine phosphate 30 mg - acetaminophen and codeine phosphate tablets, usp are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve acetaminophen and codeine phosphate tablets, usp for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] controlled substance acetaminophen and codeine phosphate tablets, usp contain codeine. codeine in combination with acetaminophen, is a schedule iii controlled substance. abuse acetaminophen and codeine phosphate tablets, usp contain codeine, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. acetaminophen and codeine phosphate tablets, usp can be abused and is subject to misuse, addiction, and criminal diversi

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sun pharmaceutical industries, inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 10 mg - major depressive disorder paroxetine tablets, usp is indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets, usp in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology–clinical trials). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets, usp in hospitalized depressed patients have not been adequ

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

sun pharmaceutical industries, inc. - levorphanol tartrate (unii: 04wqu6t9qi) (levorphanol - unii:27618j1n2x) - levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings] , reserve levorphanol tartrate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: levorphanol tartrate tablets are contraindicated in patients with: levorphanol tartrate tablets contains levorphanol, a schedule ii controlled substance. levorphanol tartrate tablets contains levorphanol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone and tapentadol. levorphanol can be abused and is subject to misuse, addiction, and criminal diversion [see warnings ]. all patients treated with opioids require careful monitoring for signs of abuse and

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

sun pharmaceutical industries, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 5 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a schedule ii controlled substance. hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol, can be abused and is subject to misuse, addiction, and criminal diversion [see warnings ]. all patients treated with o

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

sun pharmaceutical industries, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets, usp is indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of 

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

sun pharmaceutical industries, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve oxycodone hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] oxycodone hydrochloride and acetaminophen tablets is contraindicated in patients with: controlled substance oxycodone hydrochloride and acetaminophen tablets n contain oxycodone, a schedule ii controlled substance. abuse oxycodone hydrochloride and acetaminophen tablets contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. oxycodone hydrochloride and acetaminophen tablets can be abused and is subject to misuse

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

sun pharmaceutical industries, inc. - pentazocine (unii: rp4a60d26l) (pentazocine - unii:rp4a60d26l), naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - pentazocine and naloxone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve pentazocine and naloxone tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] pentazocine and naloxone hydrochloride tablets, are contraindicated in patients with: pentazocine and naloxone tablets contain pentazocine, a schedule iv controlled substance. pentazocine and naloxone tablets contain pentazocine, a substance with a high potential for abuse similar to other opioids including tramadol. pentazocine and naloxone tablets can be abused and is subject to misuse, addiction, and criminal diversion [see warnings ]. all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the ri

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

sun pharmaceutical industries, inc. - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - amphetamine sulfate tablets, usp are indicated for: - narcolepsy - attention deficit-disorder with hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability , and impulsivity. the diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. - exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. the limited usefulness of amphetamines (see clinical pharmacology) should be weighed against possible risks inherent in use of the drug, such as those described below. - known hypersensitivity to amphetamine products. - during or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result). controlled substance amphetamine sulfate tablets contains amphetamine, a schedule ii controlled substance. abuse amphetamine sulfate tablets has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see warnings). amphetamine sulfate tablets can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care 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. misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including amphetamine sulfate, can result in overdose and death (see overdosage), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. dependence physical dependence amphetamine sulfate tablets may produce physical dependence. 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. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including amphetamine sulfate tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance amphetamine sulfate tablets may produce tolerance. 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).

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sun pharmaceutical industries, inc. - sonidegib phosphate (unii: w421ai34uw) (sonidegib - unii:0rlu3vtk5m) - sonidegib 200 mg - odomzo (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (bcc) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. none. risk summary based on its mechanism of action and data from animal reproduction studies, odomzo can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ]. there are no available data on the use of odomzo in pregnant women. in animal reproduction studies, oral administration of sonidegib during organogenesis at doses below the recommended human dose of 200 mg resulted in embryotoxicity, fetotoxicity, and teratogenicity in rabbits (see data). teratogenic effects observed included severe midline defects, missing digits, and other irreversible malformations. advise pregnant women of the potential risk to a fetus. report pregnancies to sun pharmaceutical industries, inc. at 1-800-406-7984. in the u.s. general population, the estimated background risk of major birth defects is 2-4% and of miscarriage in clinically recognized pregnancies is 15-20%. data animal data daily oral administration of sonidegib to pregnant rabbits resulted in abortion, complete resorption of fetuses, or severe malformations at ≥ 5 mg/kg/day (approximately 0.05 times the recommended human dose based on auc). teratogenic effects included vertebral, distal limb and digit malformations, severe craniofacial malformations, and other severe midline defects. skeletal variations were observed when maternal exposure to sonidegib was below the limit of detection. no data are available regarding the presence of sonidegib in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with odomzo and for 20 months after the last dose. based on its mechanism of action and animal data, odomzo can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1) ] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating odomzo treatment. contraception females advise females of reproductive potential to use effective contraception during treatment with odomzo and for at least 20 months after the last dose. males it is not known if sonidegib is present in semen. advise male patients to use condoms, even after a vasectomy, to avoid potential drug exposure to pregnant partners and female partners of reproductive potential during treatment with odomzo and for at least 8 months after the last dose. advise males not to donate semen during treatment with odomzo and for at least 8 months after the last dose. infertility based on findings from animal studies, female fertility may be compromised with odomzo [see nonclinical toxicology (13.1) ] . the safety and effectiveness of odomzo have not been established in pediatric patients. epiphyseal disorders, including premature fusion of the epiphyses, have been reported in pediatric patients exposed to odomzo in a clinical trial. in some cases, pediatric patients treated with other hh pathway inhibitors have experienced progression of epiphyseal fusion despite discontinuation of the hh pathway inhibitor. juvenile animal data in a 5-week juvenile rat toxicology study, effects of sonidegib were observed in bone, teeth, reproductive tissues, and nerves at doses ≥10 mg/kg/day (approximately 1.2 times the recommended human dose based on auc). bone findings included thinning/closure of bone growth plate, decreased bone length and width, and hyperostosis. findings in teeth included missing or fractured teeth, and atrophy. reproductive tissue toxicity was evidenced by atrophy of testes, ovaries, and uterus, partial development of the prostate gland and seminal vesicles, and inflammation and aspermia of the epididymis. nerve degeneration was also noted. of the 229 patients who received odomzo (79 patients receiving 200 mg daily and 150 patients receiving 800 mg daily) in bolt, 54% were 65 years and older, while 28% were 75 years and older. no overall differences in effectiveness were observed between these patients and younger patients. there was a higher incidence of serious adverse reactions, grade 3 and 4 adverse reactions, and adverse reactions requiring dose interruption or discontinuation in patients ≥65 years compared with younger patients; this was not attributable to an increase in any specific adverse event.