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vistapharm, inc. - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. lacosamide oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. developmental neurotoxicity was observed in rats followin

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

gland pharma limited - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) injection. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, mi

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aurobindo pharma limited - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1)]. triple therapy: lansoprazole delayed-release orally disintegrating tablets /amoxicillin/clarithromycin lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)]. please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole delayed-release orally disintegrating tablets /amoxicillin lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy

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

e.r. squibb & sons, l.l.c. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir 150 mg - reyataz® is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. limitations of use: reyataz is contraindicated: table 6 displays drugs that are contraindicated with reyataz. drug class drugs within class that are contraindicated with reyataz alpha 1-adrenoreceptor antagonist alfuzosin anticonvulsants carbamazepine, phenobarbital, phenytoin antiarrhythmics amiodarone (with ritonavir), quinidine (with ritonavir) antimycobacterials rifampin antineoplastics apalutamide, encorafenib, irinotecan, ivosidenib antipsychotics lurasidone (with ritonavir), pimozide benzodiazepines orally administered midazolama , triazolam ergot derivatives dihydroergotamine, ergonovine, ergotamine, methylergonovine gi motility agent cisapride hepatitis c direct-acting antivirals elbasvir/grazoprevir; glecaprevir/pibrentasvir herbal products st. john’s wort (hypericum perforatum) lipid-modifying agents: lomitapide, l

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

sandoz inc - trifluoperazine hydrochloride (unii: 6p1y2snf5v) (trifluoperazine - unii:214izi85k3) - trifluoperazine hydrochloride 1 mg - for the management of schizophrenia. trifluoperazine hcl is effective for the short-term treatment of generalized non-psychotic anxiety. however, trifluoperazine hcl is not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines). when used in the treatment of non-psychotic anxiety, trifluoperazine hcl should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine hcl at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see warnings ). the effectiveness of trifluoperazine hcl as a treatment for non-psychotic anxiety was established in a four-week clinical multicenter study of outpatients with generalized anxiety disorder (dsm-iii). this evidence does not predict that trifluoperazine hcl will be useful in patients with other non-psychotic conditions in w

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jubilant cadista pharmaceuticals inc. - prochlorperazine maleate (unii: i1t8o1jtl6) (prochlorperazine - unii:yhp6ylt61t) - prochlorperazine 5 mg - for control of severe nausea and vomiting. for the treatment of schizophrenia. prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. however, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). when used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see warnings ). the effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. this evidence does not predict that prochlorperazine will be useful in patients with other non-psychoti

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

upsher-smith laboratories, inc. - chlorpromazine hydrochloride (unii: 9wp59609j6) (chlorpromazine - unii:u42b7vya4p) - chlorpromazine hydrochloride 10 mg - for the management of manifestations of psychotic disorders. for the treatment of schizophrenia. to control nausea and vomiting. for relief of restlessness and apprehension before surgery. for acute intermittent porphyria. as an adjunct in the treatment of tetanus. to control the manifestations of the manic type of manic-depressive illness. for relief of intractable hiccups. for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance. do not use in patients with known hypersensitivity to phenothiazines. do not use in comatose states or in the presence of large amounts of central nervo

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

pd-rx pharmaceuticals, inc. - prochlorperazine maleate (unii: i1t8o1jtl6) (prochlorperazine - unii:yhp6ylt61t) - prochlorperazine 5 mg - prochlorperazine maleate tablets are indicated for the control of severe nausea and vomiting. prochlorperazine maleate tablets are also indicated for the treatment of schizophrenia. prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. however, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). when used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see warnings). the effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with

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

lupin pharmaceuticals, inc. - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime anhydrous 400 mg - suprax is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . suprax is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes. (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator [see clinical studies (14)]. suprax is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections. suprax is generally effective in the eradication of streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of suprax in the subsequent prevention of rheumatic fever is not available.) suprax is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae and haemophilus influenzae. suprax is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates). to reduce the development of drug resistant bacteria and maintain the effectiveness of suprax and other antibacterial drugs, suprax should be used only to treat 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 antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. suprax  (cefixime) is contraindicated in patients with known allergy to cefixime or other cephalosporins. pregnancy category b reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. cefixime has not been studied for use during labor and delivery. treatment should only be given if clearly needed. it is not known whether cefixime is excreted in human milk. consideration should be given to discontinuing nursing temporarily during treatment with this drug. safety and effectiveness of cefixime in children aged less than six months old have not been established. the incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets. clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. a pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see clinical pharmacology (12.3)] . these differences were small and do not indicate a need for dosage adjustment of the drug in the elderly. the dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (capd) and hemodialysis (hd). patients on dialysis should be monitored carefully [see dosage and administration (2.3)] .

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

cosette pharmaceuticals, inc. - prochlorperazine (unii: yhp6ylt61t) (prochlorperazine - unii:yhp6ylt61t) - prochlorperazine 25 mg - prochlorperazine suppositories, usp 25 mg are indicated in the control of severe nausea and vomiting in adults. do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.). do not use in pediatric surgery. do not use in children under 2 years of age or under 20 lbs. do not use in children for conditions for which dosage has not been established.