Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

akorn - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate 10 mg in 1 ml - atropine sulfate ophthalmic solution, usp 1% is indicated for: atropine sulfate ophthalmic solution should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur. pregnancy category c: there are no adequate and well-controlled studies of atropine sulfate in pregnant women. animal development and reproduction studies have not been conducted with atropine sulfate. since it is not known whether topically administered atropine sulfate can cause fetal harm, atropine sulfate ophthalmic solution 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. traces of atropine have been found in human milk following administration of atropine solution for injection. because some systemic absorption occurs from topical administration, caution should be exercised when atropine sulfate ophthalmic solution 1% is administered to a nursing woman. due to the potential for systemic

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

akorn - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 500 mg in 20 ml - mycophenolate mofetil (mmf) is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see clinical studies (14.1)] , heart [see clinical studies (14.2)] or liver transplants [see clinical studies (14.3)] , in combination with other immunosuppressants. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product. mycophenolate mofetil for injection is contraindicated in patients who are allergic to polysorbate 80 (tween). pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-617-8191. risk summary use of mycophenolate mofetil (mmf) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see human data]. oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.02 to 0.1 times the recommended clinical doses in kidney and heart transplant patients) [see animal data] . consider alternative immunosuppressants with less potential for embryofetal toxicity. risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman. the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. 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 15 to 20%, respectively. data human data a spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in mmf exposed pregnancies, based on published data from pregnancy registries. malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following mmf exposure. animal data in animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. oral administration of mmf to pregnant rats from gestational day 7 to day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to 0.03 and 0.02 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa. oral administration of mmf to pregnant rabbits from gestational day 7 to day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.1 and 0.06 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa. risk summary there are no data on the presence of mycophenolate in human milk, or the effects on milk production. there are limited data in the national transplantation pregnancy registry on the effects of mycophenolate on a breastfed child [see data]. studies in rats treated with mmf have shown mycophenolic acid (mpa) to be present in milk. because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mycophenolate mofetil and any potential adverse effects on the breastfed infant from mycophenolate mofetil or from the underlying maternal condition. data limited information is available from the national transplantation pregnancy registry. of seven infants reported by the national transplantation pregnancy registry to have been breastfed while the mother was taking mycophenolate, all were born at 34 to 40 weeks gestation, and breastfed for up to 14 months. no adverse events were reported. females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning. pregnancy planning for patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. risks and benefits of mycophenolate mofetil should be discussed with the patient. pregnancy testing to prevent unplanned exposure during pregnancy, all females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 miu/ml immediately before starting mycophenolate mofetil. another pregnancy test with the same sensitivity should be done 8 to 10 days later. repeat pregnancy tests should be performed during routine follow-up visits. results of all pregnancy tests should be discussed with the patient. in the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. contraception female patients females of reproductive potential taking mycophenolate mofetil must receive contraceptive counseling and use acceptable contraception (see table 7 for acceptable contraception methods). patients must use acceptable birth control during the entire mycophenolate mofetil therapy, and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence. patients should be aware that mycophenolate mofetil reduces blood levels of the hormones from the oral contraceptive pill and could theoretically reduce its effectiveness [see drug interactions (7.2)]. - intrauterine devices (iuds) - tubal sterilization - patient's partner vasectomy or - oral contraceptive pill - transdermal patch - vaginal ring - injection - implant - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom or - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom male patients genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 2.5 times. thus, the risk of genotoxic effects on sperm cells cannot be excluded. based on this potential risk, sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with mycophenolate mofetil and for at least 90 days after cessation of treatment [see use in specific populations (8.1), nonclinical toxicology (13.1), patient counseling information (17.9)]. safety and effectiveness of mycophenolate mofetil have been established in pediatric patients 3 months and older for the prophylaxis of kidney rejection after allogeneic kidney transplant. use of mycophenolate mofetil in this population is supported by evidence from adequate and well-controlled studies of mycophenolate mofetil in adults with additional data from one open-label, pharmacokinetic and safety study of mycophenolate mofetil in pediatric patients after receiving allogeneic kidney transplant [see dosage and administration (2.2), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)]. safety and effectiveness in pediatric patients receiving allogeneic heart or liver transplants have not been established. clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies [see adverse reactions (6.1), drug interactions (7)]. patients with kidney transplant no dose adjustments are needed in kidney transplant patients experiencing delayed graft function postoperatively but patients should be carefully monitored [see clinical pharmacology (12.3)] . in kidney transplant patients with severe chronic impairment of the graft (gfr < 25 ml/min/1.73 m2 ), no dose adjustments are necessary; however, doses greater than 1 g administered twice a day should be avoided. patients with heart and liver transplant no data are available for heart or liver transplant patients with severe chronic renal impairment. mycophenolate mofetil may be used for heart or liver transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks. patients with kidney transplant no dose adjustments are recommended for kidney transplant patients with severe hepatic parenchymal disease. however, it is not known whether dose adjustments are needed for hepatic disease with other etiologies [see clinical pharmacology (12.3)]. patients with heart transplant no data are available for heart transplant patients with severe hepatic parenchymal disease.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

akorn - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. ketorolac tromethamine ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation [see adverse reactions (6.1)] . risk summary there are no adequate or well-controlled studies with ketorolac tromethamine ophthalmic solution in pregnant women. no evidence of teratogenicity has been observed in rats or rabbits with ketorolac tromethamine ophthalmic solution at clinically relevant doses. risk summary it is not known whether ketorolac when given topically is present in human milk. because many drugs are excreted in human milk, caution should be exercised when ketorolac tromethamine ophthalmic solution is administered to a nursing woman. safety and effectiveness of ketorolac tromethamine in pediatric patients below the age of 3 have not been established. no overall differences in safety

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

akorn - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution usp, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. none. teratogenic effects: pregnancy category c olopatadine was found not to be teratogenic in rats and rabbits. however, rats treated at 600 mg/kg/day, or 150,000 times the mrohd and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the mrohd, during organogenesis showed a decrease in live fetuses. in addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight. further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. there are, however, no adequate and well-controlled studies in pregnant women. because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fe

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

akorn - epinastine hydrochloride (unii: gfm415s5xl) (epinastine - unii:q13wx941ef) - epinastine hydrochloride ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis. none teratogenic effects pregnancy category c in an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (mrohd) of 0.0014 mg/kg/day on a mg/kg basis. total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the mrohd. in both studies, no drug-induced teratogenic effects were noted. epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the mrohd. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, epinastine hydrochloride ophthalmic solution should be used during pregnancy only if the

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

akorn - proparacaine hydrochloride (unii: u96ol57goy) (proparacaine - unii:b4ob0jhi1x) - proparacaine hydrochloride ophthalmic solution is indicated for topical anesthesia in ophthalmic practice. representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction. this preparation is contraindicated in patients with known hypersensitivity to any component of the solution.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

akorn - sevoflurane (unii: 38lvp0k73a) (sevoflurane - unii:38lvp0k73a) - sevoflurane is indicated for induction and maintenance of general anesthesia in dogs. sevoflurane is contraindicated in dogs with a known sensitivity to sevoflurane or other halogenated agents.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

akorn - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate ophthalmic solution, usp 1% is indicated for: atropine sulfate ophthalmic solution should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur. pregnancy category c: there are no adequate and well-controlled studies of atropine sulfate in pregnant women. animal development and reproduction studies have not been conducted with atropine sulfate. since it is not known whether topically administered atropine sulfate can cause fetal harm, atropine sulfate ophthalmic solution, usp 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. traces of atropine have been found in human milk following administration of atropine solution for injection. because some systemic absorption occurs from topical administration, caution should be exercised when atropine sulfate ophthalmic solution, usp 1% is administered to a nursing woman. due to the potential fo

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

akorn - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - bacitracin 500 [usp'u] in 1 g - 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.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

akorn - calcipotriene hydrate (unii: s7499tyy6g) (calcipotriene - unii:143nq3779b) - calcipotriene 0.05 mg in 1 ml - calcipotriene topical solution, 0.005% (scalp solution), is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. the safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. calcipotriene topical solution, 0.005% (scalp solution), is contraindicated in those patients with acute psoriatic eruptions or a history of hypersensitivity to any of the components of the preparation. it should not be used by patients with demonstrated hypercalcemia or evidence of vitamin d toxicity.