União Europeia - inglês - EMA (European Medicines Agency)

nova laboratories ireland limited - 6-mercaptopurine monohydrate - leukemia, lymphoid - antineoplastic agents - xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (all) in adults, adolescents and children.

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

watson laboratories, inc. - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - tablet - 50 mg - trazodone hydrochloride is indicated for the treatment of depression. the efficacy of trazodone has been demonstrated in both inpatient and out-patient settings and for depressed patients with and without prominent anxiety. the depressive illness of patients studied corresponds to the major depressive episode criteria of the american psychiatric association’s diagnostic and statistical manual, iii.a major depressive episode 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 four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts. this product is contraindicated in patients hypersensitive to trazodone.

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

dr reddys laboratories inc - silver sulfadiazine (unii: w46jy43ejr) (sulfadiazine - unii:0n7609k889) - silver sulfadiazine 10 g in 1000 g - silver sulfadiazine cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns. silver sulfadiazine cream is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation. because sulfonamide therapy is known to increase the possibility of kernicterus, silver sulfadiazine cream should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life. prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain.  the burn wounds are then cleansed and debrided; silver sulfadiazine cream is then applied u

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

novel laboratories, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 16.05 mg in 1 ml - diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). diclofenac sodium topical solution is 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 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)] . pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation risk summary use of nsaids, including diclofenac sodium topical solution, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of ns

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

ranbaxy laboratories inc. - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - capsule, gelatin coated - 10 mg - sotret is indicated for the treatment of severe recalcitrant nodular acne. nodules are inflammatory lesions with a diameter of 5 mm or greater. the nodules may become suppurative or hemorrhagic. “severe,” by definition,2 means “many” as opposed to “few or several” nodules. because of significant adverse effects associated with its use, sotret should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. in addition, sotret is indicated only for those female patients who are not pregnant, because sotret can cause severe birth defects (see boxed contraindications and warnings ). a single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 if a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin caps

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

nucare pharmaceuticals,inc. - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam 15 mg - temazepam capsules, usp are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules, usp should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. benzodiazepines may cause fetal harm when administered to a pregnant woman. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. reproduction studies in animals with temazepam were performed in rats and rabbits. in a perinatal-postnatal study in rats, oral doses of 60

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

watson laboratories, inc. - mexiletine hydrochloride (unii: 606d60is38) (mexiletine - unii:1u511hhv4z) - capsule - 150 mg - mexiletine hydrochloride capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. mexiletine hydrochloride is contraindicated in the presence of cardiogenic shock or pre-existing second- or third-degree av block (if no pacemaker is present). acute liver injury: in post-marketing experience abnormal liver function tests have been reported, some in the first few weeks of therapy with mexiletine hydrochloride. most of these hav

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

larken laboratories, inc. - ofloxacin (unii: a4p49jaz9h) (ofloxacin - unii:a4p49jaz9h) - ofloxacin 400 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of ofloxacin tablets and other antibacterial drugs, ofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. ofloxacin tablets are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below. please see dosage and administration for specific recommendations. acute bacterial exacerbations of chronic bronchitis (abecb) due to haemophilus influenzae or streptococcus pneumoniae . because fluoroquinolones, including

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

nostrum laboratories, inc. - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 10 mg - piroxicam capsules are indicated: piroxicam capsules are contraindicated in the following patients: use of nsaids, including piroxicam capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including piroxicam capsules, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of piroxicam capsules in pregnant women. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. in animal reproduction studies in rats and rabbits, there was no evidence of teratogenicity at exposures up to 5 and 10 times the maximum recommended human dose (mrhd), respectively. in rat studies with

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

roxane laboratories, inc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)] . the clinical trials performed in support of efficacy were 4 to5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tabelts are contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . pregnancy category c there are no adequate and well-controlled studies of zolpidem in pregnant women. studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other cns-depressants. child