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

shionogi inc. - naproxen sodium (unii: 9tn87s3a3c) (naproxen - unii:57y76r9atq) - naproxen 375 mg - carefully consider the potential benefits and risks of naprelan®  tablets and other treatment options before deciding to use naprelan®  tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). naprelan®  tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. it is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea. naprelan®  is contraindicated in patients with known hypersensitivity to naproxen. naprelan®  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- preexisting asthma). naprelan®  is contraindicated for the treatment of peri-operative pain in the setting of corona

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

shionogi inc. - naldemedine tosylate (unii: v1n8f1rvvo) (naldemedine - unii:03ksi6wlxh) - symproic is indicated for the treatment of opioid-induced constipation (oic) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. symproic is contraindicated in: - patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation [see warnings and precautions (5.1)]. - patients with a history of a hypersensitivity reaction to naldemedine. reactions have included bronchospasm and rash [see adverse reactions (6.1)] . risk summary there are no available data with naldemedine in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. there is a potential for opioid withdrawal in a fetus when symproic is used in pregnant women [see

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

shionogi inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg in 5 ml - methylin is indicated for the treatment of: - attention deficit hyperactivity disorder (adhd) in adults and pediatric patients 6 years of age and older - narcolepsy methylin is contraindicated in patients: - with known hypersensitivity to methylphenidate or other components of methylin. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6)] . - receiving concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylin, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychostimulants at 1-866-961-2388. risk summary published studies

European Union - English - EMA (European Medicines Agency)

shionogi b.v. - lusutrombopag - thrombocytopenia - antihemorrhagics - mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures

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

shionogi inc. - mefenamic acid (unii: 367589pj2c) (mefenamic acid - unii:367589pj2c) - mefenamic acid 250 mg - carefully consider the potential benefits and risks of ponstel and other treatment options before deciding to use ponstel. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation ). ponstel is indicated: - for relief of mild to moderate pain in patients ≥ 14 years of age, when therapy will not exceed one week (7 days). - for treatment of primary dysmenorrhea. ponstel is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to mefenamic acid 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 nsaids have been reported in such patients (see warnings; anaphylactic reaction, exacerbation of asthma related to aspirin sensit

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

shionogi inc. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate 1 mg - for use as adjunctive therapy in the treatment of peptic ulcer. glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. robinul (glycopyrrolate) tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

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

shionogi inc. - doripenem (unii: bhv525jobh) (doripenem - unii:bhv525jobh) - doripenem 500 mg in 10 ml - doribax ® (doripenem for injection) is indicated as a single agent for the treatment of complicated intra-abdominal infections caused by escherichia coli, klebsiella pneumoniae, pseudomonas aeruginosa, bacteroides caccae, bacteroides fragilis, bacteroides thetaiotaomicron, bacteroides uniformis, bacteroides vulgatus, streptococcus intermedius, streptococcus constellatus and peptostreptococcus micros . doribax ® (doripenem for injection) is indicated as a single agent for the treatment of complicated urinary tract infections, including pyelonephritis caused by escherichia coli including cases with concurrent bacteremia, klebsiella pneumoniae , proteus mirabilis , pseudomonas aeruginosa ,  and acinetobacter baumannii . to reduce the development of drug-resistant bacteria and maintain the effectiveness of doribax ® and other antibacterial drugs, doribax ® should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility infor

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

shionogi inc. - fenofibrate (unii: u202363uos) (fenofibrate - unii:u202363uos) - fenofibrate 160 mg - triglide is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides, and apolipoprotein b (apo b), and to increase high-density lipoprotein cholesterol (hdl-c) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. triglide is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g., >2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenofibrate therapy on reducing this risk has not been adequately studied. fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes

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

shionogi inc. - cephalexin (unii: obn7uds42y) (cephalexin anhydrous - unii:5sff1w6677) - cephalexin anhydrous 250 mg - keflex is indicated for the treatment of respiratory tract infections caused by susceptible isolates of streptococcus pneumoniae and streptococcus pyogenes. keflex is indicated for the treatment of otitis media caused by susceptible isolates of streptococcus pneumoniae , haemophilus influenzae , staphylococcus aureus , streptococcus pyogenes , and moraxella catarrhalis. keflex is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus and streptococcus pyogenes . keflex is indicated for the treatment of bone infections caused by susceptible isolates of staphylococcus aureus and proteus mirabilis. keflex is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of escherichia coli , proteus mirabilis , and klebsiella pneumoniae . to reduce the development of drug-resistant bacteria and maintain the effectiveness of keflex and other antiba

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

shionogi inc. - nitrofurantoin (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l) - furadantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of escherichia coli , enterococci, staphylococcus aureus , and certain susceptible strains of klebsiella and enterobacter species. nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. consequently, many patients who are treated with furadantin are predisposed to persistence or reappearance of bacteriuria. urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. if persistence or reappearance of bacteriuria occurs after treatment with furadantin , other therapeutic agents with broader tissue distribution should be selected. in considering the use of furadantin , lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development