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h.j. harkins company, inc. - ketoprofen (unii: 90y4qc304k) (ketoprofen - unii:90y4qc304k) - ketoprofen 50 mg - carefully consider the potential benefits and risks of ketoprofen capsules and other treatment options before deciding to use ketoprofen capsules. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketoprofen capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ketoprofen capsules are indicated for the management of pain. ketoprofen capsules are also indicated for treatment of primary dysmenorrhea. ketoprofen capsules are contraindicated in patients who have shown hypersensitivity to ketoprofen. ketoprofen capsules 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 reactions to ketoprofen have been reported in such patients (see warnings , anaphylactoid reactions and precautions , preexisting asthma ). ketoprofen capsules are contraindicated for the treatment

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h.j. harkins company, inc. - etodolac (unii: 2m36281008) (etodolac - unii:2m36281008) - etodolac 400 mg - carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). etodolac tablets are indicated: - for acute and long-term use in the management of signs and symptoms of the following:   1. osteoarthritis   2. rheumatoid arthritis - for the management of acute pain etodolac tablets are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac tablets. etodolac tablets should not be given to patients who have experienced asthma, urticaria, or other 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 tablets are contraindicated for the treatment of peri-operative pain in the sett

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h.j. harkins company, inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 5 mg - abilify is indicated for the treatment of schizophrenia. the efficacy of abilify was established in four 4-6 week trials in adults and one 6-week trial in adolescents (13 to 17 years). maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents [see clinical studies (14.1)] . acute treatment of manic and mixed episodes abilify is indicated for the acute treatment of manic and mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or valproate. efficacy as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in pediatric patients (10 to 17 years). efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults [see clinical studies (14.2)] . maintenance treatment of bipolar i disorder abilify is indicated for the maintenance treatment of bipolar i disorder, both as monotherapy and as an adjunct to either lithium or valproate. maintenance efficacy was

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h.j. harkins company, inc. - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - diclofenac potassium 50 mg - carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). diclofenac potassium tablets are indicated: - for treatment of primary dysmenorrhea - for relief of mild to moderate pain - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis diclofenac potassium tablets are contraindicated in patients with known hypersensitivity to diclofenac. diclofenac potassium 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 , anaphylactic reactions and precautions , preexisting asthma ). diclofenac potassium tablets are contraindicate

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h.j. harkins company, inc. - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 10 mg - carefully consider the potential benefits and risks of piroxicam capsules and other treatment options before deciding to use piroxicam capsules. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). piroxicam capsules are indicated: - for relief of the signs and symptoms of osteoarthritis. - for relief of the signs and symptoms of rheumatoid arthritis. piroxicam capsules are contraindicated in patients with known hypersensitivity to piroxicam. piroxicam capsules 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 ). piroxicam capsules are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

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h.j. harkins company, inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies (14.1)]. topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients  2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies (14.2)]. none. pregnancy category c. topiramate may cause serious adverse fetal effects, based on clinical and nonclinical data.   topiramate treatment is associated with metabolic acidosis [see warnings and precau

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h.j. harkins company, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 600 mg - gabapentin tablets usp are indicated for the management of postherpetic neuralgia in adults. gabapentin tablets usp are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. gabapentin tablets usp are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years. gabapentin tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. the abuse and dependence potential of gabapentin has not been evaluated in human studies.

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h.j harkins company inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)]. the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. 8.1 pregnancy pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other cns-depressants. children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period. neonatal flaccidity has also been

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h. j. harkins company inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 750 mg - ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. 1.1 urinary tract infections ciprofloxacin is indicated in adult patients for treatment of urinary tract infections caused by escherichia coli, klebsiella pneumoniae, enterobacter cloacae, serratia marcescens, proteus mirabilis, providencia rettgeri, morganella morganii, citrobacter koseri, citrobacter freundii, pseudomonas aeruginosa, methicillin-susceptible staphylococcus epidermidis, staphylococcus saprophyticus, or enterococcus faecalis. 1.2 acute uncomplicated cystitis ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by escherichia coli or staphylococcus saprophyticus. 1.3 chronic bacterial prostatitis ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by escherichia coli or proteus mirabilis. 1.4 lower respiratory tract infec

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h.j. harkins company, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - 1.1 osteoarthritis (oa) meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies (14.1)]. 1.2 rheumatoid arthritis (ra) meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see clinical studies (14.1)]. 1.3 juvenile rheumatoid arthritis (jra) pauciarticular and polyarticular course meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg [see dosage and administration (2.4) and clinical studies (14.2)]. close meloxicam tablets are contraindicated in the following patients: known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or 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 h