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

andrx pharmaceuticals, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tablet - 7.5 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a schedule iii controlled substance. hydrocodone bitartrate and acetaminophen, and other opioids, used in analgesia can be abused and are subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a treatable disease utilizing a multidisciplinary approach, but relaps

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

andrx pharmaceuticals, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tablet - hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a schedule iii controlled substance. hydrocodone bitartrate and acetaminophen, and other opioids, used in analgesia can be abused and are subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a treatable disease utilizing a multidisciplinary approach, but relaps

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

andrx pharmaceuticals, inc. - propoxyphene napsylate (unii: 38m219l1oj) (propoxyphene - unii:s2f83w92tk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tablet, film coated - 100 mg - propoxyphene napsylate and acetaminophen tablets, 100 mg/500 mg are indicated for the relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever. contraindications hypersensitivity to propoxyphene or acetaminophen.

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

andrx pharmaceuticals, inc. - fosinopril sodium (unii: nw2rth6t2n) (fosinopril - unii:r43d2573wo), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - tablet - 10 mg - fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension. these fixed dose combinations are not indicated for initial therapy. (see dosage and administration .) in using fosinopril sodium-hydrochlorothiazide tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. available data are insufficient to show that fosinopril does not have a similar risk (see warnings: neutropenia/agranulocytosis ). ace inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see warnings: head and neck angioedema and intestinal angiodema .) fosinopril sodium and hydrochlorothiazide tablets are contraindicated in patients who are anuric. fosinopril sodium and hydrochlorothiazide tablets is also contraindicated in patients who are hypersensitive to fosinopril, to any

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

andrx pharmaceuticals, inc. - propoxyphene napsylate (unii: 38m219l1oj) (propoxyphene - unii:s2f83w92tk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tablet, film coated - propoxyphene napsylate and acetaminophen tablets, 100 mg/650 mg are indicated for the relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever. hypersensitivity to propoxyphene or acetaminophen

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

andrx pharmaceuticals, inc. - tamoxifen citrate (unii: 7frv7310n6) (tamoxifen - unii:094zi81y45) - tablet - 10 mg - metastatic breast cancer: tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. in premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. adjuvant treatment of breast cancer: tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. in some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with 4 or more positive axillary nodes. tamoxifen is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. the estrogen and progesterone receptor values may help to predict whet

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

andrx laboratories, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine - unii:q830pw7520) - tablet - 500 mg - codrix™ is indicated for the relief of mild to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. codrix™ is classified as a schedule iii controlled substance. codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

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

andrx laboratories, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine - unii:q830pw7520) - tablet - codrix™ is indicated for the relief of mild to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. codrix™ is classified as a schedule iii controlled substance. codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

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

andrx laboratories, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine - unii:q830pw7520) - tablet - codrix™ is indicated for the relief of mild to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. controlled substance codrix™ is classified as a schedule iii controlled substance. codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

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

teva pharmaceuticals, inc. - naproxen sodium (unii: 9tn87s3a3c) (naproxen - unii:57y76r9atq) - naproxen sodium extended-release tablets are indicated for the treatment of: - rheumatoid arthritis (ra) - osteoarthritis (oa) - ankylosing spondylitis (as) - tendinitis, bursitis - acute gout - primary dysmenorrhea (pd) - the relief of mild to moderate pain [see warnings and precautions (5)] . naproxen is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see warnings and precautions (5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] risk summary use of nsaids, including naproxen, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of naproxen sodium extended-release tablets use between about 20 and 30 weeks of gestation, and avoid naproxen sodium extended-release tablets use at about 30 weeks of gestation and later in pregnancy (see clinical considerations, data) . premature closure of fetal ductus arteriosus use of nsaids, including naproxen sodium extended-release tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment use of nsaids at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. data from observational studies regarding other potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in animal reproduction studies in rats, rabbit, and mice no evidence of teratogenicity or fetal harm when naproxen was administered during the period of organogenesis at doses 0.13, 0.26, and 0.6 times the maximum recommended human daily dose of 1,500 mg/day, respectively. based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. in animal studies, administration of prostaglandin synthesis inhibitors such as naproxen, resulted in increased pre and post-implantation loss. prostaglandins also have been shown to have an important role in fetal kidney development. in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. the estimated background risk of major birth defects and miscarriage for the indicated population(s) 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 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions premature closure of fetal ductus arteriosus: avoid use of nsaids in women at about 30 weeks gestation and later in pregnancy, because nsaids, including naproxen sodium extended-release tablets, can cause premature closure of the fetal ductus arteriosus (see data) . oligohydramnios/neonatal renal impairment: if an nsaid is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. if naproxen sodium extended-release tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. if oligohydramnios occurs, discontinue naproxen sodium extended-release tablets and follow up according to clinical practice (see data) . labor or delivery there are no studies on the effects of naproxen during labor or delivery. in animal studies, nsaids, including naproxen sodium, inhibit prostaglandin synthesis, cause delayed parturition, increase incidence of dystocia and increase the incidence of stillbirth. data human data there is some evidence to suggest that when inhibitors of prostaglandin synthesis are used to delay preterm labor, there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus, and intracranial hemorrhage. naproxen treatment given in late pregnancy to delay parturition has been associated with persistent pulmonary hypertension, renal dysfunction, and abnormal prostaglandin e levels in preterm infants. because of the known effect of drugs of this class on the human fetal cardiovascular system (closure of the ductus arteriosus), use during third trimester should be avoided. premature closure of fetal ductus arteriosus: published literature reports that the use of nsaids at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment: published studies and postmarketing reports describe maternal nsaid use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. these adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after nsaid initiation. in many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. there have been a limited number of case reports of maternal nsaid use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis. methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and concomitant use of other medications. these limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal nsaid use. because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to nsaids through maternal use is uncertain. animal data reproduction studies have been performed in rats at 20 mg/kg/day (0.13 times the maximum recommended human daily dose of 1,500 mg/day based on body surface area comparison) rabbits at 20 mg/kg/day (0.26 times the maximum recommended human daily dose, based on body surface area comparison), and mice at 170 mg/kg/day (0.6 times the maximum recommended human daily dose based on body surface area comparison) with no evidence of impaired fertility or harm to the fetus due to the drug. based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. in animal studies, administration of prostaglandin synthesis inhibitors such as naproxen sodium resulted in increased pre- and post-implantation loss. risk summary the naproxen anion has been found in the milk of lactating women at a concentration of approximately 1% of that found in the plasma. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for naproxen and any potential adverse effects on the breastfed infant from the naproxen or from the underlying maternal condition. infertility females based on the mechanism of action, the use of prostaglandin-mediated nsaids, including naproxen, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. small studies in women treated with nsaids have also shown a reversible delay in ovulation. consider withdrawal of nsaids, including naproxen sodium extended-release tablets, in women who have difficulties conceiving or who are undergoing investigation of infertility. the safety and effectiveness of naproxen sodium extended-release tablets in pediatric populations has not been established. elderly patients, compared to younger patients, are at greater risk for nsaid-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. if the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see warnings and precautions (5.1, 5.2, 5.3, 5.6, 5.14)] . naproxen and its metabolites are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, use caution in this patient population, and it may be useful to monitor renal function [see clinical pharmacology (12.3)] .