Estats Units - anglès - NLM (National Library of Medicine)

zydus lifesciences limited - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings , precautions , dosage and administration , and adverse reactions ). patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days. (see also boxed warning) ketorolac tromethamine tablets are contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. ketorolac tromethamine tablets are contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. ketorolac tromethamine 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 ). ketorolac tromethamine tablets are contraindicated as prophylactic analgesic before any major surgery. ketorolac tromethamine tablets are contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ). ketorolac tromethamine tablets are contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see warnings for correction of volume depletion). ketorolac tromethamine tablets are contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage. ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see warnings and precautions ). ketorolac tromethamine tablets are contraindicated in patients currently receiving aspirin or nsaids because of the cumulative risks of inducing serious nsaid-related adverse events. the concomitant use of ketorolac tromethamine and probenecid is contraindicated. the concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.

Estats Units - anglès - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings , precautions , dosage and administration , and adverse reactions ). patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days. (see also boxed warning) ketorolac tromethamine tablets are contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. ketorolac tromethamine tablets are contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. ketorolac tromethamine 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 ). ketorolac tromethamine tablets are contraindicated as prophylactic analgesic before any major surgery. ketorolac tromethamine tablets are contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ). ketorolac tromethamine tablets are contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see warnings for correction of volume depletion). ketorolac tromethamine tablets are contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage. ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see warnings and precautions ). ketorolac tromethamine tablets are contraindicated in patients currently receiving aspirin or nsaids because of the cumulative risks of inducing serious nsaid-related adverse events. the concomitant use of ketorolac tromethamine and probenecid is contraindicated. the concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.

República de Sud-àfrica - anglès - South African Health Products Regulatory Authority (SAHPRA)

dr-reddy -

Estats Units - anglès - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of ven

Estats Units - anglès - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate 5 mg - dextroamphetamine sulfate tablets usp are indicated for: - narcolepsy . - attention deficit disorder with hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympath

Estats Units - anglès - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide delayed-release capsules (enteric coated) are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. budesonide delayed-release capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations]. in animal reproduction studies with pregnant rats

Estats Units - anglès - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc - ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - ritonavir 100 mg - ritonavir is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. - when co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. - ritonavir is contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (ten) or stevens-johnson syndrome) to ritonavir or any of its ingredients. - ritonavir is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see drug interactions (7.1) and clinical pharmacology (12.3)] . alpha 1- adrenoreceptor antagonist : alfuzosin antianginal: ranolazine antiarrhythmics: amiodarone, dronedarone, flecainide, propafenone, quinidine antifungal: voriconazole anti-gout: colchicine antipsychotics: lurasidone, pimozide ergot derivatives: dih

Estats Units - anglès - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - zonisamide (unii: 459384h98v) (zonisamide - unii:459384h98v) - zonisamide 25 mg - zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. zonisamide capsules are contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide. the abuse and dependence potential of zonisamide has not been evaluated in human studies (see warnings, cognitive/neuropsychiatric adverse events subsection ). in a series of animal studies, zonisamide did not demonstrate abuse liability and dependence potential. monkeys did not self-administer zonisamide in a standard reinforcing paradigm. rats exposed to zonisamide did not exhibit signs of physical dependence of the cns-depressant type. rats did not generalize the effects of diazepam to zonisamide in a standard discrimination paradigm after training, suggesting that zonisamide does not have abuse potential of the benzodiazepine-cns depressant type.

Estats Units - anglès - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy) - fluconazole tablets are indicated for the treatment of: - vaginal candidiasis (vaginal yeast infections due to candida ). - oropharyngeal and esophageal candidiasis. in open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of candida urinary tract infections, peritonitis, and systemic candida infections including candidemia, disseminated candidiasis, and pneumonia. - cryptococcal meningitis. before prescribing fluconazole tablets for aids patients with cryptococcal meningitis, please see clinical studies section. studies comparing fluconazole tablets to amphotericin b in non-hiv infected patients have not been conducted. prophylaxis: fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained pr

Estats Units - anglès - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy) - fluconazole tablets are indicated for the treatment of: prophylaxis: fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. fluconazole is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. there is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles. coadministration of terfenadine is contraindicated in