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

taro pharmaceuticals u.s.a., inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 5 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 (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 adults (aged 1

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

taro pharmaceuticals u.s.a., inc. - nortriptyline hydrochloride (unii: 00fn6ih15d) (nortriptyline - unii:bl03sy4lxb) - solution - 10 mg in 5 ml - nortriptyline hydrochloride is indicated for the relief of symptoms of depression. endogenous depressions are more likely to be alleviated than are other depressive states. the concurrent use of nortriptyline hydrochloride or other tricyclic antidepressants with a monoamine oxidase (mao) inhibitor is contraindicated. hyperpyretic crises, severe convulsions, and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. it is advisable to discontinue the mao inhibitor at least 2 weeks before treatment with nortriptyline hydrochloride is to be started. patients hypersensitive to nortriptyline hydrochloride should not be given the drug. cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.

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

taro pharmaceuticals u.s.a., inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 250 mg - ciprofloxacin tablets, usp are indicated in adult patients for treatment of skin and skin structure infections caused by escherichia coli, klebsiella pneumoniae, enterobacter cloacae, proteus mirabilis, proteus vulgaris, providencia stuartii, morganella morganii, citrobacter freundii, pseudomonas aeruginosa, methicillin-susceptible staphylococcus aureus, methicillin-susceptible staphylococcus epidermidis, or streptococcus pyogenes. ciprofloxacin tablets, usp are indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae, serratia marcescens, or pseudomonas aeruginosa. ciprofloxacin tablets, usp are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by escherichia coli, pseudomonas aeruginosa, proteus mirabilis, klebsiella pneumoniae, or bacteroides fragilis. ciprofloxacin tablets, usp are indicated in adult patients for treatment of infectious diarrhea caused by escherichia coli (e

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

taro pharmaceuticals u.s.a., inc. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin cream is indicated for topical application in the treatment of acne vulgaris. the safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

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

taro pharmaceuticals u.s.a., inc. - dapsone (unii: 8w5c518302) (dapsone - unii:8w5c518302) - dermatitis herpetiformis: (d.h.) leprosy: all forms of leprosy except for cases of proven dapsone resistance. mfd. by: taro pharmaceutical industries, ltd. haifa bay, israel 2624761 dist. by: taro pharmaceuticals u.s.a., inc. hawthorne, ny 10532 revised: december 2018 20991-1218-2

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

taro pharmaceuticals u.s.a. inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - adults sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (pah) (world health organization [who] group i) in adults to improve exercise ability and delay clinical worsening [see clinical studies (14)] . pediatric use information is approved for viatris specialty llc's revatio ® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. sildenafil for oral suspension is contraindicated in patients with: - concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see warnings and precautions (5.1)] . - concomitant use of riociguat, a guanylate cyclase stimulator. phosphodiesterase-5 (pde-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. - known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. risk summary limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. there are risks to the mother and fetus from untreated pulmonary arterial hypertension (see clinical considerations). animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (rhd) of 20 mg three times a day in rats and rabbits, respectively (see data) . 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. 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 disease-associated maternal and/or embryo/fetal risk pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. data animal data no evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m 2 basis, 32- and 65-times, respectively, the recommended human dose (rhd) of 20 mg three times a day. in a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the rhd on a mg/m 2 basis). risk summary limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. there is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation. the safety and effectiveness of sildenafil have not been established in pediatric patients younger than 1 year of age. pediatric use information is approved for viatris specialty llc's revatio ® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of sildenafil for oral suspension did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)] . no dose adjustment for mild to moderate impairment is required. severe impairment has not been studied [see clinical pharmacology (12.3)] . no dose adjustment is required (including severe impairment clcr <30 ml/min) [see clinical pharmacology (12.3)] . instructions for use sildenafil (sil den⸍ a fil) oral suspension read this instructions for use before you start taking sildenafil oral suspension and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important information: - ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of sildenafil oral suspension. - your pharmacist will mix (reconstitute) sildenafil oral suspension before it is given to you. do not take or give sildenafil oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. - always use the oral dosing syringe that comes with sildenafil oral suspension. if your carton does not come with an oral dosing syringe, contact your pharmacist. - do not take or give sildenafil oral suspension if the bottle adaptor is not in the bottle. if the bottle adaptor is not in the bottle, contact your pharmacist. - sildenafil oral suspension should not be mixed with any other medicine or flavoring. supplies you will need to take or give a dose of sildenafil oral suspension (see figure a): - 1 bottle of sildenafil oral suspension with pre-inserted bottle adaptor - 1 oral dosing syringe (provided in the carton) how should i store sildenafil oral suspension? - store mixed (reconstituted) sildenafil oral suspension below 86°f (30°c) or in a refrigerator between 36°f to 46°f (2°c to 8°c). - do not freeze mixed sildenafil oral suspension - throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. see the "discard after" date written on the bottle label. keep sildenafil oral suspension and all medicines out of the reach of children. pediatric use information is approved for viatris specialty llc's revatio ® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. mfd. by: taro pharmaceutical industries ltd. haifa bay, israel 2624761 dist. by: taro pharmaceuticals u.s.a., inc . hawthorne, ny 10532 this instruction for use has been approved by the u.s. food and drug administration. revised: december 2023

Canada - English - Health Canada

taro pharmaceuticals inc - adapalene; benzoyl peroxide - gel - 0.1%; 2.5% - adapalene 0.1%; benzoyl peroxide 2.5% - keratolytic agents

Canada - English - Health Canada

taro pharmaceuticals inc - adapalene; benzoyl peroxide - gel - 0.3%; 2.5% - adapalene 0.3%; benzoyl peroxide 2.5% - keratolytic agents

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

pd-rx pharmaceuticals, inc. - clorazepate dipotassium (unii: 63fn7g03xy) (clorazepic acid - unii:d51wo0g0l4) - clorazepate dipotassium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. the effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. long-term studies in epileptic patients, however, have shown continued therapeutic activity. the physician should reassess periodically the usefulness of the drug for the individual patient. clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal. clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma. clorazepate dipotassium tablets contain clorazepate, a schedule iv controlled substance. clorazepate dipotassium is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings: abuse, misuse, and addiction ). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). clorazepate dipotassium may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings: dependence and withdrawal reactions ). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue clorazepate dipotassium or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of clorazepate dipotassiumand warnings: dependence and withdrawal reactions ). acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality. protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance to clorazepate dipotassium may develop from continued therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of clorazepate dipotassium may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Canada - English - Health Canada

taro pharmaceuticals inc - temozolomide - capsule - 5mg - temozolomide 5mg - antineoplastic agents