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janssen pharmaceuticals, inc. - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperidone 0.25 mg - risperdal® (risperidone) is indicated for the treatment of schizophrenia. efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see clinical studies (14.1)] . monotherapy risperdal® is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see clinical studies (14.2)] . adjunctive therapy risperdal® adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in one short-term trial in adults [see clinical studies (14.3)] . risperdal® is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and

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janssen pharmaceuticals, inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg - sporanox ® (itraconazole) capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: - blastomycosis, pulmonary and extrapulmonary - histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and - aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin b therapy. specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before 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, antiinfective therapy should be adjusted accordingly. sporanox ® capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: - onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and - onychomycosis of the fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (see clinical pharmacology: special populations, contraindications, warnings, and adverse reactions: post-marketing experiencefor more information.) analyses were conducted on data from two open-label, non-concurrently controlled studies (n=73 combined) in patients with normal or abnormal immune status. the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. analyses were conducted on data from two open-label, non-concurrently controlled studies (n=34 combined) in patients with normal or abnormal immune status (not including hiv-infected patients). the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. data from a small number of hiv-infected patients suggested that the response rate of histoplasmosis in hiv-infected patients is similar to that of non-hiv-infected patients. the clinical course of histoplasmosis in hiv-infected patients is more severe and usually requires maintenance therapy to prevent relapse. analyses were conducted on data from an open-label, "single-patient-use" protocol designed to make itraconazole available in the u.s. for patients who either failed or were intolerant of amphotericin b therapy (n=190). the findings were corroborated by two smaller open-label studies (n=31 combined) in the same patient population. most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin b therapy. analyses were conducted on data from three double-blind, placebo-controlled studies (n=214 total; 110 given sporanox ® capsules) in which patients with onychomycosis of the toenails received 200 mg of sporanox ® capsules once daily for 12 consecutive weeks. results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative koh plus negative culture, in 54% of patients. thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). the mean time to overall success was approximately 10 months. twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of koh or culture from negative to positive). analyses were conducted on data from a double-blind, placebo-controlled study (n=73 total; 37 given sporanox ® capsules) in which patients with onychomycosis of the fingernails received a 1-week course (pulse) of 200 mg of sporanox ® capsules b.i.d., followed by a 3-week period without sporanox ® , which was followed by a second 1-week pulse of 200 mg of sporanox ® capsules b.i.d. results demonstrated mycologic cure in 61% of patients. fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. the mean time to overall success was approximately 5 months. none of the patients who achieved overall success relapsed. sporanox ® (itraconazole) capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (chf) or a history of chf. (see boxed warning, warnings, precautions: drug interactions-calcium channel blockers, adverse reactions: post-marketing experience, and clinical pharmacology: special populations.) coadministration of a number of cyp3a4 substrates are contraindicated with sporanox ® . some examples of drugs for which plasma concentrations increase are: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. in addition, coadministration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and coadministration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of cyp2d6 and in subjects taking strong or moderate cyp2d6 inhibitors. (see precautions: drug interactionssection for specific examples.) this increase in drug concentrations caused by coadministration with itraconazole may increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs. for example, increased plasma concentrations of some of these drugs can lead to qt prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes , a potentially fatal arrhythmia. some specific examples are listed in precautions: drug interactions. coadministration with venetoclax is contraindicated in patients with cll/sll during the dose initiation and ramp-up phase of venetoclax due to the potential for an increased risk of tumor lysis syndrome. sporanox ® should not be administered for the treatment of onychomycosis to pregnant patients or to women contemplating pregnancy. sporanox ® is contraindicated for patients who have shown hypersensitivity to itraconazole. there is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents. caution should be used when prescribing sporanox ® to patients with hypersensitivity to other azoles.

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janssen products, lp - ad26.cov2.s (unii: jt2ns6183b) (ad26.cov2.s - unii:jt2ns6183b) - janssen covid-19 vaccine is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 18 years of age and older for whom other fda-authorized or approved covid-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the janssen covid-19 vaccine because they would otherwise not receive a covid-19 vaccine. do not administer the janssen covid-19 vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the janssen covid-19 vaccine [see description (13)] . do not administer the janssen covid-19 vaccine to individuals with a history of thrombosis with thrombocytopenia following the janssen covid-19 vaccine or any other adenovirus-vectored covid-19 vaccine (e.g., astrazeneca's covid-19 vac

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pd-rx pharmaceuticals, inc. - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 500 mg - levaquin ® is indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus , pseudomonas aeruginosa , serratia marcescens , escherichia coli , klebsiella pneumoniae , haemophilus influenzae , or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1)] . levaquin ® is indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus , streptococcus pneumoniae (including multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae , haemophilus parainfluenzae , klebsiella pneumoniae , moraxella catarrhalis , chlamydophila pneumoniae , legionella pneumophila , or mycoplasma pneumoniae [see dosage and administration (2.1) and clinical studies (14.2)] . mdrsp isolates ar

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

pd-rx pharmaceuticals, inc. - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 750 mg - levaquin ® is indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus , pseudomonas aeruginosa , serratia marcescens , escherichia coli , klebsiella pneumoniae , haemophilus influenzae , or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1)] . levaquin ® is indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus , streptococcus pneumoniae (including multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae , haemophilus parainfluenzae , klebsiella pneumoniae , moraxella catarrhalis , chlamydophila pneumoniae , legionella pneumophila , or mycoplasma pneumoniae [see dosage and administration (2.1) and clinical studies (14.2)] . mdrsp isolates ar

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apotheca inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,

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

apotheca inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 100 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,

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

apotheca inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,

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

janssen pharmaceuticals, inc. - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone 3 mg - invega ® (paliperidone) extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)] . the efficacy of invega ® in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. invega ® (paliperidone) extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)] . the efficacy of invega ® in schizoaffective disorder was established in two 6-week trials in adults. invega ® is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the invega ® formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. pali

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janssen pharmaceuticals, inc. - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 5 mg - ditropan xl ® (oxybutynin chloride) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ditropan xl ® is also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). ditropan xl ® is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. ditropan xl ® is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. there have been reports of hypersensitivity reactions, including anaphylaxis and angioedema. risk summary there are no adequate data on ditropan xl ® use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscar