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

denton pharma, inc. dba northwind pharmaceuticals - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 75 mg - carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). indomethacin extended-release capsules have been found effective in active stages of the following: 1. moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. moderate to severe ankylosing spondylitis. 3. moderate to severe osteoarthritis. 4. acute painful shoulder (bursitis and/or tendinitis). indomethacin extended-release capsules, usp are not recommended for the treatment of acute gouty arthritis. indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. in such instances the steroid dosage should be reduced

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

denton pharma, inc. dba northwind pharmaceuticals - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). indomethacin capsule, usp has been found effective in active stages of the following: - moderate to severe rheumatoid arthritis including acute flares of chronic disease. - moderate to severe ankylosing spondylitis. - moderate to severe osteoarthritis. - acute painful shoulder (bursitis and/or tendinitis). - acute gouty arthritis. indomethacin capsule, usp is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see description). indomethacin capsule, usp 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/anaphylactoid reactions to nsaids have been reported in such pat

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

denton pharma, inc. dba northwind pharmaceuticals - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine tablets are indicated for the treatment of major depressive disorder.    the efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ).   a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentra

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

denton pharma, inc. dba northwind pharmaceuticals - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam tablets usp are indicated for treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam tablets usp are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets usp are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions ( 5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam during pregnancy to enroll in the north american antiepileptic drug (na

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

denton pharma, inc. dba northwind pharmaceuticals - sulindac (unii: 184sns8vuh) (sulindac - unii:184sns8vuh) - carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). sulindac tablets, usp are indicated for acute or long-term use in the relief of signs and symptoms of the following: - osteoarthritis osteoarthritis - rheumatoid arthritis** rheumatoid arthritis** - ankylosing spondylitis ankylosing spondylitis - acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) - acute gouty arthritis acute gouty arthritis sulindac tablets are contraindicated in patients with known hypersensitivity to sulindac or the excipients (see description ). sulindac tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rar

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

denton pharma, inc. dba northwind pharmaceuticals - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate tablets usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures.                                                                                                                                   topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age 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. topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache. none pregnancy category d   [see   warnings and precautions 5.7 ] topiramate  can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts)

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

denton pharma, inc. dba northwind pharmaceuticals - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 10 mg - carefully consider the potential benefits and risks of ketorolac tromethamine tablets usp and other treatment options before deciding to use ketorolac tromethamine tablets usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets usp are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine and ketorolac tromethamine tablets usp are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets usp and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings , precautions , dosage and administrati

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

denton pharma, inc. dba northwind pharmaceuticals - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 100 mg - carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, usp and other treatment options before deciding to use diclofenac sodium extended-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). diclofenac sodium extended-release tablets are indicated: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis diclofenac sodium extended-release tablets, usp are contraindicated in patients with known hypersensitivity to diclofenac. diclofenac sodium 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, anaphylactic reactions , and precautions, general: preexisting asthma )

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

denton pharma, inc. dba northwind pharmaceuticals - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age 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. topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache. none. pregnancy category d   [see warnings and precautions ( 5.7)] topiramate can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts) and for being small for gestational age. when multiple species of pregnant animals received topiramate at clinically relevant doses,

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

denton pharma, inc. dba northwind pharmaceuticals - nabumetone (unii: lw0tiw155z) (nabumetone - unii:lw0tiw155z) - carefully consider the potential benefits and risks of nabumetone tablets, usp and other treatment options before deciding to use nabumetone tablets. 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 ). nabumeto