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west-ward pharmaceuticals corp. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride 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 oxycodone hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] oxycodone hydrochloride and acetaminophen tablets are contraindicated in patients with: oxycodone hydrochloride and acetaminophen tablets contain oxycodone, a schedule ii controlled substance. oxycodone hydrochloride and acetaminophen tablets contain 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 are subject to misuse, addiction, and criminal diversion [se

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

west-ward pharmaceuticals corp - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 250 mg - carefully consider the potential benefits and risks of naproxen and other treatment options before deciding to use naproxen tablets. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see warnings: gastrointestinal bleeding, ulceration, and perforation ). naproxen is indicated: - for the relief of the signs and symptoms of rheumatoid arthritis - for the relief of the signs and symptoms of osteoarthritis - for the relief of the signs and symptoms of ankylosing spondylitis - for the relief of the signs and symptoms of juvenile arthritis naproxen is also indicated: - for relief of the signs and symptoms of tendonitis - for relief of the signs and symptoms of bursitis - for relief of the signs and symptoms of acute gout - for the management of pain - for the management of primary dysmenorrhea naproxen is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen, naproxen sodiu

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

west-ward pharmaceuticals corp - mefloquine hydrochloride (unii: 5y9l3636o3) (mefloquine - unii:tml814419r) - mefloquine hydrochloride 250 mg - treatment of acute malaria infections :  mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of p. falciparum (both chloroquine-susceptible and resistant strains) or by plasmodium vivax. there are insufficient clinical data to document the effect of mefloquine in malaria caused by p. ovale or p. malariae.   note: patients with acute p. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. to avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine). prevention of malaria :  mefloquine hydrochloride tablets are indicated for the prophylaxis of p. falciparum and p. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of p. falciparum. use of mefloquine hydrochloride tablets is contraindica

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

west-ward pharmaceuticals corp. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 100 mg in 5 ml - oxycodone hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. oxycodone hydrochloride oral solution 100 mg per 5 ml (20 mg/ml) is indicated for the relief of pain in opioid-tolerant patients. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see warnings and precautions (5.2)] , reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: oxycodone hydrochloride oral solution is contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.5)] . available data with oxycodone hydrochloride oral solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. animal reproduction studi

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

west-ward pharmaceuticals corp. - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride 5 mg - dolophine tablets are indicated for the: limitations of use limitations of use methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 cfr 8.12 [see dosage and administration (2.1)]. dolophine tablets are contraindicated in patients with: risk summary the majority of available data from clinical trials, observational studies, case series, and case reports on methadone use in pregnancy do not indicate an increased risk of major malformations specifically due to methadone. pregnant women involved in methadone maintenance programs have been reported to have improved prenatal care leading to reduced incidence of obstetric and fetal complications and neonatal morbidity and mortality when compared to women using illicit drugs. several factors, including maternal use of illicit drugs, nutrition, infection and psychosocial circumstances, complicate the interpretation of investigations of the childr

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

west-ward pharmaceuticals corp. - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6)]. pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. physicians are advised to recommend that pregnant patients taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary there are no adequate and well-controlled studies of clobazam in pregnant women. available data suggest that the class of benzodiazepines

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

west-ward pharmaceuticals corp. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men. alosetron hydrochloride tablets should not be initiated in patients with constipation [see warnings and precautions (5.1) ]. alosetron hydrochloride tablets are contraindicated in patients with a history of the following: concomitant administration of alosetron hydrochloride tablets with fluvoxamine is contraindicated. fluvoxamine, a known strong inhibitor of cyp1a2, has been shown to increase mean alosetron plasma concentrations (auc) approximately 6

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

west-ward pharmaceuticals corp. - bosentan (unii: q326023r30) (bosentan anhydrous - unii:xul93r30k2) - bosentan is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): use of bosentan is contraindicated in females who are or may become pregnant. to prevent pregnancy, females of reproductive potential must use two reliable forms of contraception during treatment and for one month after stopping bosentan [see boxed warning, warnings and precautions (5.2),drug interactions (7.2), use in specific populations (8.1)] . co-administration of cyclosporine a and bosentan resulted in markedly increased plasma concentrations of bosentan. therefore, concomitant use of bosentan and cyclosporine a is contraindicated [see cytochrome p450 drug interactions (7.1) ] . an increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. therefore co-administration of glyburide and bosentan is contraindicated [see cytochrome p450 drug interactions (7.1) ] . bosentan is contraindicated in patients who are hypersensitive to bosentan or any component o

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

west-ward pharmaceuticals corp - escitalopram oxalate (unii: 5u85dbw7lo) (escitalopram - unii:4o4s742any) - escitalopram 10 mg - escitalopram tablets, usp are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [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 or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest 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. escitalopram tablets, usp are indicated for the acute treatment of generalized anxiety disorder (gad) in adults [see clinical studies (14.2)].   generalized anxiety disorder (dsm-iv) is characterized by excessive anxiety and worry (apprehensive expectation) that is persist

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

west-ward pharmaceuticals corp. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 1 mg - 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 tablets 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 lowes