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genentech, inc. - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 500 mg - carefully consider the potential benefits and risks of naprosyn, ec-naprosyn, anaprox, anaprox ds or naprosyn suspension and other treatment options before deciding to use naprosyn, ec-naprosyn, anaprox, anaprox ds or naprosyn suspension. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). naproxen as naprosyn, ec-naprosyn, anaprox, anaprox ds or naprosyn suspension 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 as naprosyn suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. naproxen as naprosyn, anaprox, anaprox ds and naprosyn suspension is also indicated: - for relief of the signs and symptoms of tendonitis - for r

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par pharmaceutical - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 100 mg in 1 ml - levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. none. levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.9) ]. pregnancy category c there are no adequate and controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam should be used during pregnancy only if the potential benefit just

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unit dose services - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 200 mg - tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings ], reserve tramadol hydrochloride extended-release tablets or use in patients for whom alternative treatment options [e.g., non-opioid analgesics or immediate-release opioids], are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. tramadol hydrochloride extended-release tablets are contraindicated for: - all children younger than 12 years of age [see warnings ] - postoperative management in children younger than

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american health packaging - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - esomeprazole 20 mg - healing of erosive esophagitis esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered. in infants 1 month to less than 1 year, esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated gerd. maintenance of healing of erosive esophagitis esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. controlled studies do not extend beyond 6 months. symptomatic gastroesophageal reflux disease esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with

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boehringer ingelheim pharmaceuticals, inc. - olodaterol hydrochloride (unii: 65r445w3v9) (olodaterol - unii:vd2ysn1afd) - olodaterol 2.5 ug - striverdi respimat is a long-acting beta2 -agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. striverdi respimat is not indicated to treat acute deteriorations of copd [see warnings and precautions (5.2) ]. striverdi respimat is not indicated to treat asthma. the safety and effectiveness of striverdi respimat in asthma have not been established. use of a laba, including striverdi respimat, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1) ]. striverdi respimat is not indicated for the treatment of asthma. risk summary there are no adequate and well-controlled clinical studies with striverdi respimat in pregnant women to inform of drug-associated risk of adverse pregnancy-related outcomes. there are clinical considerations with the use of striverdi respimat in pregnant women [see clinica

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vernalis therapeutics, inc. - codeine phosphate anhydrous (unii: 2x585m1m3t) (codeine - unii:q830pw7520) - codeine phosphate anhydrous 14.7 mg in 5 ml - tuzistra xr is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. important limitations of use - not indicated for pediatric patients under 18 years of age [see use in specific populations (8.4) ]. not indicated for pediatric patients under 18 years of age [see use in specific populations (8.4) ]. - contraindicated in pediatric patients under 12 years of age [see contraindications (4),use in specific populations (8.4) ]. contraindicated in pediatric patients under 12 years of age [see contraindications (4),use in specific populations (8.4) ]. - contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see contraindications (4), use in specific populations (8.4 ) ].                                                                                                                                                                                                        

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paddock laboratories, llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - hydrocodone bitartrate 5 mg in 5 ml - hydrocodone bitartrate and homatropine methylbromide oral solution is indicated for the symptomatic relief of cough in patients 18 years of age and older. important limitations of use : hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated for: hydrocodone bitartrate and homatropine methylbromide oral solution is also contraindicated in patients with: risk summary hydrocodone bitartrate and homatropine methylbromide oral solution is not recommended for use in pregnant women, including during or immediately prior to labor. prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.13), clinical considerations ]. there are no available data with hydrocodone bitartrate and homatropine methylbromide oral solution use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. published studies with hydrocodone have reported inconsistent findings and have important methodological limitations (s

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

lake erie medical & surgical supply dba quality care products llc - etodolac (unii: 2m36281008) (etodolac - unii:2m36281008) - etodolac 500 mg - carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). etodolac extended-release tablets are indicated: - for relief of signs and symptoms of juvenile arthritis. - for relief of the signs and symptoms of rheumatoid arthritis. - for relief of the signs and symptoms of osteoarthritis. etodolac extended-release tablets are contraindicated in patients with known hypersensitivity to etodolac. etodolac extended-release 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, preexisting asthma ). etodolac extended-release tablets are contr

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remedyrepack inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 200 mg - quetiapine fumarate extended-release tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate 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 (13-17 years) treated with quetiapine fumarate tablets [see clinical studies (14.1)]. quetiapine fumarate 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 fumarate 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

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

unit dose services - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 100 mg - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. the efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone [see clinical studies (14)]. none. teratogenic effects pregnancy category c trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. there was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. trazodone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human milk. caut