Estados Unidos - inglés - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - adjunctive therapy lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic seizures (pgtc) seizures. - generalized seizures of lennox-gastaut syndrome. monotherapy lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. lamotrigine is indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients

Filipinas - inglés - FDA (Food And Drug Administration)

n/a; importer: zydus healthcare philippines, inc.; distributor: zydus healthcare philippines, inc. - atorvastatin (as calcium) - film-coated tablet - 10 mg

Filipinas - inglés - FDA (Food And Drug Administration)

n/a; importer: zydus healthcare philippines inc.; distributor: zydus healthcare philippines inc. - atorvastatin (as calcium) - film coated tablet - 80 mg

Filipinas - inglés - FDA (Food And Drug Administration)

n/a; importer: zydus healthcare philippines inc.; distributor: zydus healthcare philippines inc. - atorvastatin (as calcium) - film coated tablet - 20 mg

Filipinas - inglés - FDA (Food And Drug Administration)

n/a; importer: zydus healthcare philippines inc.; distributor: zydus healthcare philippines inc. - atorvastatin (as calcium) - film coated tablet - 10 mg

Estados Unidos - inglés - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - etodolac (unii: 2m36281008) (etodolac - unii:2m36281008) - etodolac 400 mg - carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). etodolac extended-release tablets are indicated: *    for relief of signs and symptoms of juvenile arthritis *    for relief of the signs and symptoms of rheumatoid arthritis *    for relief of the signs and symptoms of osteoarthritis etodolac extended-release tablets are contraindicated in patients with known hypersensitivity to etodolac. etodolac extended-release tablets 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-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions   and precautions, preexisting asthma). etodolac extended-release tablets are

Estados Unidos - inglés - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - diflunisal (unii: 7c546u4den) (diflunisal - unii:7c546u4den) - carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following: 1. mild to moderate pain 2. osteoarthritis 3. rheumatoid arthritis diflunisal tablets are contraindicated in patients with known hypersensitivity to diflunisal or the excipients (see description ). diflunisal tablets 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/analphylactoid reactions to nsaids have been reported in such patients (see warnings, anaphylactic/anaphylactoid reactions and precautions, preexisting asthma ). diflunisal tablets are contraindicated in the setting of coronary artery bypass graft (cabg) surger

Estados Unidos - inglés - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve oxycodone hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid 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 oxycodone hydrochloride and acetaminophen tablets are contraindicated in patients with: - significant respiratory depression [see warnings] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings] - hypersensitivity to oxycodone, acetaminophen, or

Estados Unidos - inglés - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - carefully consider the potential benefits and risks of diclofenac potassium immediate-release tablets and other treatment options before deciding to use diclofenac potassium tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation). diclofenac potassium tablets are indicated: - for treatment of primary dysmenorrhea - for relief of mild to moderate pain - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis diclofenac potassium tablets are 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; anaphylactic reactions, serious skin reactions). - history of asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients ( see warnings; anaphylactic reactions, exacerbation of asthma related to aspirin sensitivity). - in the setting of coronary artery bypass graft (cabg) surgery ( see warnings; cardiovascular thrombotic events).

Estados Unidos - inglés - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (mds) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. lenalidomide is not indicated and is not recommended for the treatment of patients with cll outside of controlled clinical trials [see warnings and precautions (5.5)] . lenalidomide can cause fetal harm when administered to a pregnant female. limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. this effect was seen at all doses tested. due to the results of this developmental monkey study, and lenalidomide's structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant [see boxed warning ]. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus [see warnings and precautions (5.1, 5.2), use in special populations (8.1, 8.3)] . lenalidomide is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, stevens-johnson syndrome, toxic epidermal necrolysis) to lenalidomide [see warnings and precautions (5.9, 5.15)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to lenalidomide during pregnancy as well as female partners of male patients who are exposed to lenalidomide. this registry is also used to understand the root cause for the pregnancy. report any suspected fetal exposure to lenalidomide to the fda via the medwatch program at 1-800-fda-1088 and also to the rems call center at 1‐888‐423‐5436. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies [see data ], lenalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy [see boxed warning, contraindications (4.1), and use in specific populations (5.1)] . lenalidomide is a thalidomide analogue. thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects. alimentary tract, urinary tract, and genital malformations have also been documented and mortality at or shortly after birth has been reported in about 40% of infants. lenalidomide caused thalidomide-type limb defects in monkey offspring. lenalidomide crossed the placenta after administration to pregnant rabbits and pregnant rats [see data ]. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. if pregnancy does occur during treatment, immediately discontinue the drug. under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. report any suspected fetal exposure to lenalidomide to the fda via the medwatch program at 1-800-fda-1088 and also to rems call center at 1‐888‐423‐5436. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in an embryo-fetal developmental toxicity study in monkeys, teratogenicity, including thalidomide-like limb defects, occurred in offspring when pregnant monkeys received oral lenalidomide during organogenesis. exposure (auc) in monkeys at the lowest dose was 0.17 times the human exposure at the maximum recommended human dose (mrhd) of 25 mg. similar studies in pregnant rabbits and rats at 20 times and 200 times the mrhd respectively, produced embryo lethality in rabbits and no adverse reproductive effects in rats. in a pre- and post-natal development study in rats, animals received lenalidomide from organogenesis through lactation. the study revealed a few adverse effects on the offspring of female rats treated with lenalidomide at doses up to 500 mg/kg (approximately 200 times the human dose of 25 mg based on body surface area). the male offspring exhibited slightly delayed sexual maturation and the female offspring had slightly lower body weight gains during gestation when bred to male offspring. as with thalidomide, the rat model may not adequately address the full spectrum of potential human embryo-fetal developmental effects for lenalidomide. following daily oral administration of lenalidomide from gestation day 7 through gestation day 20 in pregnant rabbits, fetal plasma lenalidomide concentrations were approximately 20-40% of the maternal cmax . following a single oral dose to pregnant rats, lenalidomide was detected in fetal plasma and tissues; concentrations of radioactivity in fetal tissues were generally lower than those in maternal tissues. these data indicated that lenalidomide crossed the placenta. risk summary there is no information regarding the presence of lenalidomide in human milk, the effects of lenalidomide on the breastfed child, or the effects of lenalidomide on milk production. because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children from lenalidomide, advise women not to breastfeed during treatment with lenalidomide. pregnancy testing lenalidomide can cause fetal harm when administered during pregnancy [see use in specific populations (8.1)] . verify the pregnancy status of females of reproductive potential prior to initiating lenalidomide therapy and during therapy. advise females of reproductive potential that they must avoid pregnancy 4 weeks before therapy, while taking lenalidomide, during dose interruptions and for at least 4 weeks after completing therapy. females of reproductive potential must have 2 negative pregnancy tests before initiating lenalidomide. the first test should be performed within 10-14 days, and the second test within 24 hours prior to prescribing lenalidomide. once treatment has started and during dose interruptions, pregnancy testing for females of reproductive potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. if menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. lenalidomide treatment must be discontinued during this evaluation. contraception females females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception – tubal ligation, iud, hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner's vasectomy, and 1 additional effective contraceptive method – male latex or synthetic condom, diaphragm, or cervical cap. contraception must begin 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of lenalidomide therapy. reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed. males lenalidomide is present in the semen of males who take lenalidomide. therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide and for up to 4 weeks after discontinuing lenalidomide, even if they have undergone a successful vasectomy. male patients taking lenalidomide must not donate sperm and for up to 4 weeks after discontinuing lenalidomide. safety and effectiveness have not been established in pediatric patients. mm in combination : overall, of the 1613 patients in the ndmm study who received study treatment, 94% (1521 /1613) were 65 years of age or older, while 35% (561/1613) were over 75 years of age. the percentage of patients over age 75 was similar between study arms (rd continuous: 33%; rd18: 34%; mpt: 33%). overall, across all treatment arms, the frequency in most of the adverse reaction categories (e.g., all adverse reactions, grade 3/4 adverse reactions, serious adverse reactions) was higher in older (> 75 years of age) than in younger (≤ 75 years of age) subjects. grade 3 or 4 adverse reactions in the general disorders and administration site conditions body system were consistently reported at a higher frequency (with a difference of at least 5%) in older subjects than in younger subjects across all treatment arms. grade 3 or 4 adverse reactions in the infections and infestations, cardiac disorders (including cardiac failure and congestive cardiac failure), skin and subcutaneous tissue disorders, and renal and urinary disorders (including renal failure) body systems were also reported slightly, but consistently, more frequently (<5% difference), in older subjects than in younger subjects across all treatment arms. for other body systems (e.g., blood and lymphatic system disorders, infections and infestations, cardiac disorders, vascular disorders), there was a less consistent trend for increased frequency of grade 3/4 adverse reactions in older vs younger subjects across all treatment arms serious adverse reactions were generally reported at a higher frequency in the older subjects than in the younger subjects across all treatment arms. of the 703 mm patients who received study treatment in studies 1 and 2, 45% were age 65 or over while 12% of patients were age 75 and over. the percentage of patients age 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups. of the 353 patients who received lenalidomide/dexamethasone, 46% were age 65 and over. in both studies, patients > 65 years of age were more likely than patients ≤ 65 years of age to experience dvt, pulmonary embolism, atrial fibrillation, and renal failure following use of lenalidomide. no differences in efficacy were observed between patients over 65 years of age and younger patients. of the 148 patients with del 5q mds enrolled in the major study, 38% were age 65 and over, while 33% were age 75 and over. although the overall frequency of adverse reactions (100%) was the same in patients over 65 years of age as in younger patients, the frequency of serious adverse reactions was higher in patients over 65 years of age than in younger patients (54% vs. 33%). a greater proportion of patients over 65 years of age discontinued from the clinical studies because of adverse reactions than the proportion of younger patients (27% vs.16%). no differences in efficacy were observed between patients over 65 years of age and younger patients. since elderly patients are more likely to have decreased renal function, care should be taken in dose selection. monitor renal function. adjust the starting dose of lenalidomide based on the creatinine clearance value and for patients on dialysis [see dosage and administration (2.6)] .