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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)]. 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 have b

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

h.j. harkins company, inc. - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin - unii:6gnt3y5lmf) - levofloxacin 500 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. culture and susceptibility testing appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see cli

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

h.j. harkins company, inc. - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 100 mg - carefully consider the potential benefits and risks of celebrex and other treatment options before deciding to use celebrex. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see warnings and precautions (5) ] celebrex is indicated for relief of the signs and symptoms of oa [see clinical studies (14.1) ] celebrex is indicated for relief of the signs and symptoms of ra [see clinical studies (14.2) ] celebrex is indicated for relief of the signs and symptoms of jra in patients 2 years and older [see clinical studies (14.3) ] celebrex is indicated for the relief of signs and symptoms of as [see clinical studies (14.4) ] celebrex is indicated for the management of ap in adults [see clinical studies (14.5) ] celebrex is indicated for the treatment of pd [see clinical studies (14.5) ] celebrex is contraindicated: - in patients with known hypersensitivity to celecoxib, aspirin, or other nsaids. - in patients who have demonstrated allergic-type reactions to su

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

h.j. harkins company, inc. - nabumetone (unii: lw0tiw155z) (nabumetone - unii:lw0tiw155z) - nabumetone 500 mg - carefully consider the potential benefits and risks of nabumetone tablets 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 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: pre-existing asthma:) nabumetone tablets 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. - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 500 mg - carefully consider the potential benefits and risks of naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). naproxen delayed-release tablets are 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 naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. naproxen delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products (see clinical pharmacology and dosage and administratio

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

h.j. harkins company, inc. - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - clonazepam 0.5 mg - seizure disorders: clonazepam tablets, usp are useful alone or as an adjunct in the treatment of the lennox-gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. in some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. in some cases, dosage adjustment may reestablish efficacy. panic disorder: clonazepam tablets, usp are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-iv. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir

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

h.j. harkins company, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 15.75 mg - sprix is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. - known hypersensitivity to ketorolac tromethamine [see warnings and precautions (5.5, 5.7, 5.11)] - use in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding [see warnings and precautions (5.2)] - use in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids [see warnings and precautions (5.5, 5.7, 5.11)] - use as a prophylactic analgesic before any major surgery [see warnings and precautions (5.3)] - use during the perioperative period in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.6)] - use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion [see wa

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

h.j. harkins company, inc. - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen 10 mg - baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. the efficacy of baclofen in stroke, cerebral palsy, and parkinson’s disease has not been established and, therefore, it is not recommended for these conditions. hypersensitivity to baclofen.

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h.j. harkins company, inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 15 mg - morphine sulfate extended-release tablets are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. morphine sulfate extended-release tablets are not intended for use as a prn analgesic. the morphine sulfate extended-release tablets 100 and 200 mg tablet strengths are high dose, extended-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. morphine sulfate extended-release tablets are

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

h.j. harkins company, inc. - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 375 mg - carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). naproxen as naproxen or naproxen sodium tablets are 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 naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. naproxen as naproxen and naproxen sodium tablets are also indicated: - for relief of the signs and symptoms of tendonitis - for relief of the signs and symptoms of bursitis - for relief of the signs and symptoms of acute gout - for the managem