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

rpk pharmaceuticals, inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin b sulfate. this product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

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

rpk pharmaceuticals, inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - polycin® ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis. polycin® ophthalmic ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

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

rpk pharmaceuticals, inc. - naproxen sodium (unii: 9tn87s3a3c) (naproxen - unii:57y76r9atq) - naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis - tendonitis - bursitis - acute gout  the management of: - pain - primary dysmenorrhea naproxen sodium tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen 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 been reported in such patients [see warnings and precautions (5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] risk summary use of nsaids, including naproxen sodium, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oli

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

rpk pharmaceuticals, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 150 mg - venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: -   major depressive disorder (mdd) [see clinical studies (14.1)] - generalized anxiety disorder (gad) [see clinical studies (14.2)] -   social anxiety disorder (sad) [see clinical studies (14.3)] -   panic disorder (pd) [see clinical studies (14.4)] venlafaxine hydrochloride extended-release capsules are contraindicated in patients: - with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see adverse reactions (6.2)]. - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see dosage and administration (2.11), warnings and precautions (5.2), and drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including venlafaxine hydrochloride exten

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

rpk pharmaceuticals, inc. - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 50 mg - sertraline tablets are indicated for the treatment of the following [see clinical studies (14)] : - major depressive disorder (mdd) - obsessive-compulsive disorder (ocd) - panic disorder (pd) - posttraumatic stress disorder (ptsd) - social anxiety disorder (sad) - premenstrual dysphoric disorder (pmdd) sertraline is contraindicated in patients: - taking, or within 14 days of stopping, maois, (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)] . - taking pimozide [see drug interactions (7.1)] . - with known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [see adverse reactions (6.1, 6.2)]. risk summary overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. some studies have reported in

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

rpk pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. - diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder. diclofenac sodium topical gel is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac 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 been reported in such patients [see warnings and precautions(5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation  risk summary use of nsaids, including diclofenac sodium topical gel, during t

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

rpk pharmaceuticals, inc. - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline hydrochloride tablets are indicated for the treatment of the following [see clinical studies (14)] : - major depressive disorder (mdd) - obsessive-compulsive disorder (ocd) - panic disorder (pd) - posttraumatic stress disorder (ptsd) - social anxiety disorder (sad) - premenstrual dysphoric disorder (pmdd) sertraline hydrochloride tablets are contraindicated in patients: - taking, or within 14 days of stopping, maois, (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)] . - taking pimozide [see drug interactions (7.1)] . - with known hypersensitivity to sertr

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

rpk pharmaceuticals, inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin capsules are indicated for: • 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 capsules are contraindicated in the following patients: • known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin 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 been reported in such patients [ see warnings and precautions ( 5.7, 5.8) ] • in the set

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

rpk pharmaceuticals, inc. - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: the management of: naproxen tablets and naproxen sodium tablets are contraindicated in the following patients: risk summary use of nsaids, including naproxen tablets and naproxen sodium tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of naproxen tablets or naproxen sodium tablets use between about 20 and 30 weeks of gestation, and avoid naproxen tablets and naproxen sodium tablets use at about 30 weeks of gestation and later in pregnancy (see clinical considerations, data). premature closure of fetal ductus arteriosus use of nsaids, including naproxen tablets and naproxen sodium tablets, at about 30 weeks gestation or later in pregnanc

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

rpk pharmaceuticals, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - 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 administration , and adverse reactions ). patients s