USA - engelsk - NLM (National Library of Medicine)

akorn - calcitriol (unii: fxc9231jvh) (calcitriol - unii:fxc9231jvh) - calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. it has been shown to significantly reduce elevated parathyroid hormone levels. reduction of pth has been shown to result in an improvement in renal osteodystrophy. calcitriol injection should not be given to patients with hypercalcemia or evidence of vitamin d toxicity. calcitriol injection is contraindicated in patients with previous hypersensitivity to calcitriol or any of its excipients.

USA - engelsk - NLM (National Library of Medicine)

akorn - chlorothiazide sodium (unii: sn86fg7n2k) (chlorothiazide - unii:77w477j15h) - intravenous sodium diuril is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. intravenous sodium diuril has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see precautions, pregnancy). dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through el

USA - engelsk - NLM (National Library of Medicine)

akorn - timolol (unii: 817w3c6175) (timolol anhydrous - unii:5jky92s7br) - preservative-free timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. preservative-free timolol maleate ophthalmic solution may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable. preservative-free timolol maleate ophthalmic solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see warnings); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see warnings); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

USA - engelsk - NLM (National Library of Medicine)

akorn - timolol (unii: 817w3c6175) (timolol anhydrous - unii:5jky92s7br) - timolol anhydrous 2.5 mg in 1 ml - timolol is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. timolol is contraindicated in patients with overt heart failure, cardiogenic shock, sinus bradycardia, second- or third-degree atrioventricular block, bronchial asthma or history of bronchial asthma, or severe chronic obstructive pulmonary disease, or hypersensitivity to any component of this product.

USA - engelsk - NLM (National Library of Medicine)

akorn - naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - naloxone hydrochloride 0.4 mg in 1 ml - naloxone hydrochloride injection, usp is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see clinical pharmacology, adjunctive use in septic shock). naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients contained in the formulation. naloxone hydrochloride injection is an opioid antagonist. physical dependence associated with the use of naloxone hydrochloride injection has not been reported. tolerance to the opioid antagonist effect of naloxone is not known to occur.

USA - engelsk - NLM (National Library of Medicine)

akorn - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987) - lidocaine hcl 2% jelly is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal). lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of lidocaine hcl 2% jelly.

USA - engelsk - NLM (National Library of Medicine)

akorn - timolol (unii: 817w3c6175) (timolol anhydrous - unii:5jky92s7br) - timolol anhydrous 2.56 mg in 1 ml - betimol® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. betimol® is contraindicated in patients with overt heart failure, cardiogenic shock, sinus bradycardia, second- or third-degree atrioventricular block, bronchial asthma or history of bronchial asthma, or severe chronic obstructive pulmonary disease, or hypersensitivity to any component of this product.

USA - engelsk - NLM (National Library of Medicine)

akorn - timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. timolol maleate is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see warnings); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see warnings); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

USA - engelsk - 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 adult and pediatric recipients 3 months of age and older 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 0.015 and 0.01 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 0.05 and 0.03 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 9 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 - oral contraceptive pill - transdermal patch - vaginal ring - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom - injection - implant - 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 1.25 times. thus, the risk of genotoxic effects on sperm cells cannot be excluded. based on this potential risk, s exually 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 have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogeneic kidney, heart or liver transplant. 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 (100 patients, 3 months to 18 years of age) [see dosage and administration (2.2), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)]. heart transplant and liver transplant use of mycophenolate mofetil in pediatric heart transplant and liver transplant patients is supported by adequate and well-controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients. additional supportive data include pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients (8 liver transplant patients, 9 months to 5 years of age, in an open-label, pharmacokinetic and safety study) and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients [see dosage and administration (2.3, 2.4), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)]. 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 geriatric and younger patients. in general, dose selection for a geriatric 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.

USA - engelsk - NLM (National Library of Medicine)

akorn - 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 adverse reactions (6.2) ]. pregnancy category d [see warnings and precautions (5.6) ].