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

pd-rx pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 50 mg - carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see warnings; gastrointestinal bleeding, ulceration, and perforation ). diclofenac is indicated: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis - for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis diclofenac sodium delayed-release tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product ( see warnings; anaphylactic reactions, serious skin reactions ). - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsa

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

liberty pharmaceuticals, inc. - nabumetone (unii: lw0tiw155z) (nabumetone - unii:lw0tiw155z) - nabumetone 500 mg - carefully consider the potential benefits and risks of nabumetone tablets, usp and other treatment options before deciding to use nabumetone tablets, usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). nabumetone tablets, usp are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or its excipients. nabumetone tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions, and precautions, general, preexisting asthma ). nabumetone tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery (see warnings

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

mylan pharmaceuticals inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine 2 mg - buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. buprenorphine sublingual tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions (5.9) ]. the data on use of buprenorphine, the active ingredient in buprenorphine sublingual tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. there are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see data] . observational studies have reported on congenital malformations among buprenorphine-exposed pregnancies, but w

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

mylan pharmaceuticals inc. - desvenlafaxine succinate (unii: zb22enf0xr) (desvenlafaxine - unii:ng99554anw) - desvenlafaxine 50 mg - desvenlafaxine extended-release tablets are indicated for the treatment of adults with major depressive disorder (mdd) [see clinical studies (14) ] . there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185. there are no published studies on desvenlafaxine extended-release tablets in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes (see data) . there are risks associated with untreated depression in pregnancy and with exposure to snris and ssris, including desvenlafaxine extended-release tablets, during pregnancy (see clinical considerations). in reproductive developmental studies in rats and rabbits treated with desvenlafaxine succinate, there was no evidence of

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specgx llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 10 mg - methylphenidate hcl extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in pediatric patients 6 to 15 years of age. methylphenidate hcl extended-release capsules are contraindicated in patients with: - known hypersensitivity to methylphenidate or other component of methylphenidate hcl extended-release capsules. angioedema has been reported in patients treated with methylphenidate hcl extended-release capsules. anaphylactic reactions have been reported in patients treated with other methylphenidate products [see adverse reactions (6)] . - concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crisis [see drug interactions (7)] . - methylphenidate hcl extended-release capsules contain sucrose. therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not

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

sanofi pasteur inc. - rabies virus strain pm-1503-3m antigen (propiolactone inactivated) (unii: c4hqf74xmw) (rabies virus strain pm-1503-3m antigen (propiolactone inactivated) - unii:c4hqf74xmw) - rabies virus strain pm-1503-3m antigen (propiolactone inactivated) 2.5 [iu] in 1 ml - imovax rabies is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies. imovax rabies vaccine is approved for use in all age groups. physicians must evaluate each possible rabies exposure. local or state public health officials should be consulted if questions arise about the need for prophylaxis. (11) the following factors should be considered before antirabies prophylaxis is initiated. rabid bats have been documented in the 49 continental states, and bats are increasingly implicated as important wildlife reservoirs for variants of rabies virus transmitted to humans. transmission of rabies virus can occur from minor, seemingly underappreciated or unrecognized bites from bats (see table 2). (11) raccoons, skunks, and foxes are the terrestrial carnivores most often infected with rabies in the united states. suggestive clinical signs of rabies among wildlife cannot be interpreted reliably. all bites by such wildlife should be considered possible exposures to rabies virus. post-exposu

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pd-rx pharmaceuticals, inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 20 mg - omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. dual therapy omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance

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

mylan pharmaceuticals inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 10 mg - omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. omeprazole delayed-release capsules in combination with clarithromycin is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in patients who fail therapy, susceptibility testing should be done. if

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

mylan pharmaceuticals inc. - rabeprazole sodium (unii: 3l36p16u4r) (rabeprazole - unii:32828355ll) - rabeprazole sodium 20 mg - rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (gerd). for those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered. rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (gerd maintenance). controlled studies do not extend beyond 12 months. rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with gerd in adults for up to 4 weeks. rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. most patients heal within four weeks. rabeprazole

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

sun pharmaceutical industries, inc. - oxcarbazepine (unii: vzi5b1w380) (oxcarbazepine - unii:vzi5b1w380) - oxcarbazepine 150 mg - oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. oxcarbazepine tablets are contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate  [see warnings and precautions ( 5.2, 5.3 )]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as oxcarbazepine, during pregnancy. encourage women who are taking oxcarbazepine during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use o