United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

agepha pharma s.r.o. - oral tablet

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

agepha pharma s.r.o. - oral tablet

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

agepha pharma usa, llc - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - lodoco is indicated to reduce the risk of myocardial infarction (mi), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease. concurrent use of strong cyp3a4 inhibitors or p-glycoprotein inhibitors with lodoco is contraindicated, because life-threatening and fatal colchicine toxicity has been reported in these patients with colchicine taken in therapeutic doses [see drug interactions (7)] . lodoco use is contraindicated in patients with renal failure (creatinine clearance less than 15 ml/minute) and severe hepatic impairment. lodoco is contraindicated in patients with pre-existing blood dyscrasias and in patients hypersensitive to this drug or any inactive ingredient of lodoco [see description (11)] . 8.1 pregnancy risk summary available human data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major bir

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

heritage pharmaceuticals inc. - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 5 mg - rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. limitations of use - rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. if a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. - rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see contraindications (4)] . - rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. - safety and effectiveness of rizatriptan benzoate tablets has not been established for cluster headache rizatriptan benzoate tablets are contraindicated in patients with: - ischemic coronary artery disease (angina pectoris, histo

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

heritage pharmaceuticals inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for treatment of paget's disease of bone in men and women. treatment is indicated in patients with paget's disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see clinical studies (14.5) ]. zoledronic acid injection is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.2) ] - creatinine clearance less than 35 ml/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see warnings and precautions (5.3) ]. - known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see adverse reactions (6.2) ]. pregnancy category d [see warnings and precautions (5.6)

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

heritage pharmaceuticals inc - propoxyphene hydrochloride (unii: cb2tl9ps0t) (propoxyphene - unii:s2f83w92tk) - propoxyphene hydrochloride 65 mg - propoxyphene hydrochloride capsule is a schedule iv narcotic under the u.s. controlled substances act. propoxyphene hydrochloride capsule can produce drug dependence of the morphine type, and therefore, has the potential for being abused. psychic dependence, physical dependence and tolerance may develop upon repeated administration. propoxyphene hydrochloride capsule should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-containing medications. since propoxyphene hydrochloride capsule is a mu-opioid agonist, it may be subject to misuse, abuse, and addiction. addiction to opioids prescribed for pain management has not been estimated. however, requests for opioids from opioid-addicted patients occur. as such, physicians should take appropriate care in prescribing propoxyphene hydrochloride capsule. opioid analgesics may cause psychological and physical dependence. physical dependence results in withdrawal symptoms in patients who abruptly discontinue the d

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

heritage pharmaceuticals inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine is indicated for the treatment of: - major depressive disorder [see clinical studies (14.1)] - generalized anxiety disorder [see clinical studies (14.2)] - diabetic peripheral neuropathy [see clinical studies (14.3)] - chronic musculoskeletal pain [see clinical studies (14.5)]         monoamine oxidase inhibitors (maois) -the use of maois intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)] .         starting duloxetine in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2.9) and warnings and precautions (5.4)].         pregnancy

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

preferred pharmaceuticals, inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 25 mg - risk summary clinical considerations labor or delivery data animal data risk summary data infertility females

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

heritage pharmaceuticals inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 5 mg in 100 ml - zoledronic acid injection is indicated for treatment of paget's disease of bone in men and women. treatment is indicated in patients with paget's disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see clinical studies (14.5) ]. zoledronic acid injection is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.2) ] - creatinine clearance less than 35 ml/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see warnings and precautions (5.3) ]. - known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see post-marketing experience (6.2) ]. pregnancy category d [see warnings and precautio

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

village pharma llc - triamcinolone acetonide (unii: f446c597ka) (triamcinolone acetonide - unii:f446c597ka) -