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

nucare pharmaceuticals, inc. - ketoprofen (unii: 90y4qc304k) (ketoprofen - unii:90y4qc304k) - ketoprofen 75 mg - carefully consider the potential benefits and risks of ketoprofen capsules usp and other treatment options before deciding to use ketoprofen capsules usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketoprofen capsules usp are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ketoprofen capsules usp are indicated for the management of pain. ketoprofen capsules usp 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 ,

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

par pharmaceutical, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 7.5 mg - hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see warnings: cardiovascular thrombotic events, gastrointestinal bleeding, ulceration, and perforation) . do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see warnings: addiction, abuse, and misuse) , reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom alternative treatment options (e.g., non-opioid anal

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stat rx usa llc - etodolac (unii: 2m36281008) (etodolac - unii:2m36281008) - etodolac 300 mg - carefully consider the potential benefits and risks of etodolac capsules and tablets, usp, and other treatment options before deciding to use etodolac capsules and tablets, usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). etodolac capsules and tablets, usp are indicated: - for acute and long-term use in the management of signs and symptoms of the following: osteoarthritis rheumatoid arthritis - osteoarthritis - rheumatoid arthritis - for the management of acute pain etodolac capsules and tablets, usp are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac. etodolac capsules and tablets, usp 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, p

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

takeda pharmaceuticals america, inc. - vedolizumab (unii: 9rv78q2002) (vedolizumab - unii:9rv78q2002) - vedolizumab 300 mg in 5 ml - entyvio is indicated in adults for the treatment of: - moderately to severely active ulcerative colitis (uc). - moderately to severely active crohn's disease (cd). entyvio is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to entyvio or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate) [see warnings and precautions (5.1)] . risk summary available data from the organization of teratology information specialists (otis)/mothertobaby entyvio pregnancy registry, published literature and pharmacovigilance in pregnant women have not reliably identified an entyvio-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see data) . there are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy (see clinical considerations) . no fetal harm was observed in animal reproduction studies with intravenous administration of vedolizumab to rabbits and monkeys at dose levels 20 times the recommended human dosage (see data) . the background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and miscarriage is 15 to 20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions entyvio administered during pregnancy could affect immune responses in the in utero exposed newborn and infant. the clinical significance of low levels of entyvio in utero-exposed infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. data human data the vedolizumab pregnancy exposure registry conducted by otis/mothertobaby study in the united states and canada collected prospective observational data between 2015 and 2022 to assess the risk of major birth defects in live-born infants of women with ulcerative colitis (uc) or crohn’s disease (cd) treated with vedolizumab during pregnancy. the study compared pregnant patients with uc or cd exposed to vedolizumab with pregnant patients with uc or cd treated with other biological products. the registry included 99 women (58 with uc, 41 with cd) treated with vedolizumab during pregnancy, and 76 women (27 with uc, 49 with cd) exposed to other biological products during pregnancy. the proportion of major birth defects among live-born infants in patients with uc or cd treated with vedolizumab and patients with uc or cd treated with other biological products was 7.4% (7/94) and 5.6% (4/71), respectively. overall, there was no evidence of increased risk for major structural birth defects (adjusted rr 1.07, 95% ci: 0.33, 3.52). the methodological limitations of the registry, including small sample size and the non-randomized design, resulted in a limited ability to estimate the risk of major birth defects and other maternal and infant outcomes. the conclusions from the pregnancy registry were consistent with the published literature and pharmacovigilance. animal data a reproduction study has been performed in pregnant rabbits at single intravenous doses up to 100 mg/kg administered on gestation day 7 (about 20 times the recommended human dosage) and has revealed no evidence of impaired fertility or harm to the fetus due to vedolizumab. a pre- and post-natal development study in monkeys showed no evidence of any adverse effect on pre- and post-natal development at intravenous doses up to 100 mg/kg (about 20 times the recommended human dosage). risk summary data from a clinical lactation study show the presence of vedolizumab in human milk. the mean calculated daily infant dosage was 0.02 mg/kg/day orally (see data) . systemic exposure in a breastfed infant is expected to be low because monoclonal antibodies are largely degraded in the gastrointestinal tract. there are no data on the effects of vedolizumab on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for entyvio and any potential adverse effects on the breastfed infant from entyvio or from the underlying maternal condition. data a milk-only lactation study was conducted in 9 adult lactating women being treated for active ulcerative colitis or crohn's disease with intravenous entyvio every 8 weeks after reaching steady state and completing the induction phase (entyvio administration at 0, 2, and 6 weeks). mean concentrations of entyvio in human milk ranged from 0.03 to 0.26 mcg/ml. the mean calculated daily infant oral dosage was 0.02 mg/kg/day calculated as a product of the average concentration over the 8-week dosing interval and the standardized milk consumption of 150 ml/kg/day. safety and effectiveness of entyvio in pediatric patients have not been established. clinical trials of entyvio did not include sufficient numbers of subjects aged 65 and over (56 crohn's and ulcerative colitis patients aged 65 and over were treated with entyvio during controlled phase 3 trials) to determine whether they respond differently from younger subjects. however, no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. entyvio ® (en ti' vee oh) pen (vedolizumab) injection, for subcutaneous use single-dose prefilled pen this instructions for use contains information on how to inject entyvio. your entyvio single-dose prefilled pen - read and follow this instructions for use before you inject entyvio. - your healthcare provider should show you how to use the entyvio pen before you use it for the first time. - entyvio pen is for subcutaneous injection only (inject directly into fatty layer under the skin). - do not shake the prefilled pen. - do not remove the purple cap from the prefilled pen until you are ready to inject. - do not put or press your thumb, fingers, or hand over the yellow needle shield. the yellow needle shield is visible when the purple cap is removed. - do not use the prefilled pen if it is dropped or damaged. storing entyvio - store your prefilled pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - your prefilled pen can be left in its box at room temperature up to 77°f (25°c) for up to 7 days (for example, when traveling). do not use the prefilled pen if it is left out of the refrigerator for more than 7 days. - do not freeze the prefilled pen. - do not leave the prefilled pen in direct sunlight. - throw away the prefilled pen in a fda-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight. see step 14 for instructions on how to throw away (dispose of) the prefilled pen. - always keep entyvio pens, the sharps disposal container, and all medicines out of the reach of children. - do not use the prefilled pen if any of the seals on the box are broken. - do not use the prefilled pen if the expiration date on the box has passed. - do not warm the prefilled pen any other way. - do not let the prefilled pen sit in direct sunlight. - do not take the prefilled pen out of its tray until you are ready to inject. - alcohol pad - cotton ball or gauze - sharps disposal container (see step 14 "throw away (dispose of) the prefilled pen") - do not shake the prefilled pen. - do not remove the purple cap from the prefilled pen until step 9 . - do not use the prefilled pen if the expiration date on the prefilled pen has passed. - do not use the prefilled pen if the medicine is cloudy or has particles floating in it. - do not use the prefilled pen if any part of it is damaged. - do not inject into the same spot you used for your last injection. - do not inject into moles, scars, bruises, or skin that is tender, hard, red, or damaged. - do not touch or blow on the cleaned injection site before you inject. - the needle is inside the yellow needle shield (under purple cap). - do not put or press your thumb, fingers, or hand over the yellow needle shield. - do not put the purple cap back on. this could accidentally start the injection. - hold the prefilled pen so you can see the viewing window. - place the yellow end of the prefilled pen flat on your skin at 90 degrees to the injection site (see figure j ). - the needle is inside the yellow needle shield. - do not push down on the prefilled pen until you are ready to inject. - you may hear a first click when the injection starts. - you may hear a second click. this is not the end of the injection. - continue holding the prefilled pen with constant pressure and watch the window turn purple. - you will see a small amount of gray in the viewing window. this is normal. - if the viewing window did not fill with purple, you may not have received your full dose. call your pharmacy or healthcare provider. - when you remove the prefilled pen, if the window has not turned purple, or it looks like the medicine is still coming out of the prefilled pen, this means you have not received a full dose. call your pharmacy or healthcare provider right away. - you may see a small amount of blood at the injection site. if you do, press on your skin with a cotton ball or gauze. - throw away the remaining supplies in your household trash or sharps disposal container. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be local or state laws about how you should throw away needles and syringes. - for more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. this instructions for use has been approved by the u.s. food and drug administration. approved: 9/2023 entyvio® (en ti' vee oh) (vedolizumab) injection, for subcutaneous use single-dose prefilled syringe this instructions for use contains information on how to inject entyvio. your entyvio single-dose prefilled syringe - read and follow this instructions for use before you inject entyvio. - your healthcare provider should show you how to use the entyvio prefilled syringe before you use it for the first time. - entyvio prefilled syringe is for subcutaneous injection only (inject directly into fatty layer under the skin). - do not shake the prefilled syringe. - do not remove the needle cap from the prefilled syringe until you are ready to inject. - do not use the prefilled syringe if it is dropped or damaged. - each prefilled syringe has a needle guard. it will automatically cover the needle after the injection is completed to reduce the risk of accidental needle sticks. storing entyvio - store your prefilled syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - your prefilled syringe can be left in its box at room temperature up to 77°f (25°c) for up to 7 days (for example, when traveling). do not use the prefilled syringe if it is left out of the refrigerator for more than 7 days. - do not freeze the prefilled syringe. - do not leave the prefilled syringe in direct sunlight. - throw away the prefilled syringe in a fda-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight. see step 14 for instructions on how to throw away (dispose of) the prefilled syringe. - always keep entyvio prefilled syringes, the sharps disposal container, and all medicines out of the reach of children. - do not use the prefilled syringe if any of the seals on the box are broken. - do not use the prefilled syringe if the expiration date on the box has passed. - do not warm the prefilled syringe any other way. - do not let the prefilled syringe sit in direct sunlight. - do not take the prefilled syringe out of its tray until you are ready to inject. - alcohol pad - cotton ball or gauze - sharps disposal container (see step 14 "throw away (dispose of) the prefilled syringe") - do not lift from the purple plunger. - do not shake the prefilled syringe. - do not remove the needle cap from the prefilled syringe until step 9 . - do not use the prefilled syringe if the expiration date on the prefilled syringe has passed. - do not use the prefilled syringe if the medicine is cloudy or has particles floating in it. - do not use the prefilled syringe if any part of it is damaged. - do not try to remove air bubbles from the prefilled syringe. - do not inject into the same spot you used for your last injection. - do not inject into moles, scars, bruises, or skin that is tender, hard, red, or damaged. - do not touch or blow on the cleaned injection site before you inject. - do not touch or pull back the purple plunger. - do not touch or re-cap the needle. - do not use a prefilled syringe with a bent or broken needle. - hold the pinch until the injection is completed. - avoid touching the plunger until the needle is inserted. - keep pressure on the plunger and take the needle out of the skin. - if you are not able to start or cannot complete the injection by pushing the plunger all the way down, you may not have received your full dose. call your pharmacy or healthcare provider. - you may see a small amount of blood at the injection site. if you do, press on your skin with a cotton ball or gauze. - throw away the remaining supplies in your household trash or sharps disposal container. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be local or state laws about how you should throw away needles and syringes. - for more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. this instructions for use has been approved by the u.s. food and drug administration. approved: 9/2023

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contract pharmacy services-pa - valproic acid (unii: 614oi1z5wi) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg - valproic acid capsules are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. valproic acid capsules are indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. complex absence is the term used when other signs are also present. see warnings and precaution (5.1) for statement regarding fatal hepatic dysfunction. because of the risk to the fetus of decreased iq, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unle

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contract pharmacy services-pa - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 40 mg - pantoprazole sodium delayed-release tablets are indicated for: pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison syndrome. - pantoprazole sodium delayed-release tablets are contraindicated

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contract pharmacy services-pa - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 75 mg - venlafaxine tablets, usp is indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets usp 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 concentration, and a suicide attempt or suicidal ide

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par pharmaceutical, inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - butalbital 50 mg - butalbital, acetaminophen, caffeine, and codeine phosphate capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see warnings and precautions (5.1)], reserve butalbital, acetaminophen, caffeine, and codeine phosphate capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia. butalbital, acetaminophen, caffeine, and codeine phosphate capsules are contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.5)]. - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoide

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ge healthcare inc. - iohexol (unii: 4419t9mx03) (iohexol - unii:4419t9mx03) - iodine 140 mg in 1 ml - adults omnipaque 180, 240, and 300 - myelography (lumbar, thoracic, cervical, total columnar) - computerized tomography (ct) (myelography, cisternography, ventriculography) pediatrics omnipaque 180 - myelography (lumbar, thoracic, cervical, total columnar) - ct (myelography, cisternography) adults omnipaque 140 - intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels omnipaque 240 - ct head imaging - peripheral venography (phlebography) omnipaque 300 - aortography including studies of the aortic arch, abdominal aorta and its branches - ct head and body imaging - cerebral arteriography - peripheral venography (phlebography) - peripheral arteriography - excretory urography omnipaque 350 - angiocardiography (ventriculography, selective coronary arteriography) - aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches - ct head and body imaging - intravenous digital subtraction angiography of the head, neck,

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contract pharmacy services-pa - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram 10 mg - citalopram tablets (citalopram hydrobromide) are indicated for the treatment of depression. the efficacy of citalopram tablets in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the dsm-iii and dsm-iii-r category of major depressive disorder (see clinical pharmacology). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. the antidepressant action of citalopram tablets in hospitalized depressed patients has not b