アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

macleods pharmaceuticals limited - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - olanzapine 2.5 mg - oral olanzapine tablets are indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13-17), efficacy was established in one 6-week trial [see clinical studies (14.1)].  when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions (5.5)]. monotherapy — oral olanzapine tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patients with m

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

macleods pharmaceuticals limited - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - olanzapine 5 mg -       olanzapine orally disintegrating tablets are indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13-17), efficacy was established in one 6-week trial [see clinical studies (14.1)].         when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions (5.5)] .           monotherapy   — olanzapine orally disintegrating tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was es

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

macleods pharmaceuticals limited - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 150 mg - quetiapine extended-release tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with quetiapine [see clinical studies (14.1) ]. quetiapine  extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. the efficacy of quetiapine  extended-release tablets in manic or mixed episodes of bipolar i disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar i disorder. efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar i disorder as well as

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

macleods pharmaceuticals limited - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 ml/week because of the potential for the drug to suppress the hpa axis. this product is not recommended for use in pediatric patients under 12 years of age. clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

macleods pharmaceuticals limited - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. ibandronate sodium tablets increases bone mineral density (bmd) and reduce the incidence of vertebral fractures. the optimal duration of use has not been determined. the safety and effectiveness of ibandronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate sodium tablets are contraindicated in patients with the following conditions:   o abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see warnings and precautions [5.1] )   o inability to stand or sit upright for at le

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

macleods pharmaceuticals limited - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg - levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae. adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1) ]. levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus , streptococcus pneumoniae (including multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, moraxella catarrhalis, chlamydophila pneumoniae, legionella pneumophila , or mycoplasma pneumoniae [see dosage and administration ( 2.1 ) and clinical studies (14.2 )]. mdrsp i

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

macleods pharmaceuticals limited - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 50 mg - celecoxib capsules are indicated for the management of the signs and symptoms of oa [see clinical studies (14.1) ] for the management of the signs and symptoms of ra [see clinical studies (14.2) ] for the management of the signs and symptoms of jra in patients 2 years and older [see clinical studies (14.3) ] for the management of the signs and symptoms of as [see clinical studies (14.4) ] for the management of acute pain in adults [see clinical studies (14.5) ] for the management of primary dysmenorrhea [see clinical studies (14.5) ] • celecoxib capsules are contraindicated in the following patients: known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [see warnings and precautions (5.7, 5.9) ]. • 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 and precautions (5.7, 5.8)

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

macleods pharmaceuticals limited - 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 • chronic musculoskeletal pain in adults the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules are contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules 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 delayed-release capsules 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

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

macleods pharmaceuticals limited - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets are indicated in adults 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 and precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: • have not been tolerated or are not expected to be tolerated. • have not provided adequate analgesia or are not expected to provide adequate analgesia. tramadol hydrochloride tablets are contraindicated for: • all children younger than 12 years of age [see warnings and precautions (5.4)]. • postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and precautions (5.4)]. tramadol hydrochloride tablets is also contraindicated in patients with: • significant respiratory depression

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

macleods pharmaceuticals limited - escitalopram oxalate (unii: 5u85dbw7lo) (escitalopram - unii:4o4s742any) - escitalopram 5 mg in 5 ml - escitalopram oral solution is indicated for the treatment of: • major depressive disorder (mdd) in adults and pediatric patients 12 years of age and older. • generalized anxiety disorder (gad) in adults. additional pediatric use information is approved for abbvie inc.’s lexapro (escitalopram) tablets and lexapro (escitalopram) oral solution. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that information. escitalopram is contraindicated in patients: • taking maois with escitalopram or within 14 days of stopping treatment with escitalopram because of an increased risk of serotonin syndrome. the use of escitalopram within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.7), and warnings and precautions (5.2)] . starting escitalopram 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 se