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

biomarin pharmaceutical inc. - pegvaliase (unii: n6uah27euv) (pegvaliase - unii:n6uah27euv) - palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (pku) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/l on existing management. none. risk summary based on findings in studies of pregnant animals without pku treated with pegvaliase-pqpz, palynziq may cause fetal harm when administered to a pregnant woman. limited available data with pegvaliase-pqpz use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. there are risks to the fetus associated with poorly controlled phenylalanine concentrations in women with pku during pregnancy including increased risk for miscarriage, major birth defects (including microcephaly, major cardiac malformations), intrauterine fetal growth retardation, and future intellectual disability with low iq; therefore, phenylalanine concentrations should be closely monitored in women with pku during pregnancy (see clinical considerations and data).

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

oceanside pharmaceuticals - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults. mesalamine extended-release capsules are contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of mesalamine extended-release capsules [ see warnings and precautions (5.3), adverse reactions (6.2), description (11) ] . risk summary published data from meta-analyses, cohort studies and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . in animal reproduction studies, there were no adverse developmental outcomes with administration of oral mesalamine during organogenesis to pregnant rats and rabbits at doses 1.7 and 5.4 times, respectively, the maximum recommended human dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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 embryo/fetal risk published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. data human data published data from meta-analyses, cohort studies and case series on the use of mesalamine during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes. there is no clear evidence that mesalamine exposure in early pregnancy is associated with an increased risk in major congenital malformations, including cardiac malformations. published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products. animal data reproduction studies with mesalamine during organogenesis have been performed in rats at oral doses up to 320 mg/kg/day (about 1.7 times the recommended human dose based on a body surface area comparison) and rabbits at doses up to 495 mg/kg/day (about 5.4 times the recommended human dose based on a body surface area comparison) and have revealed no evidence of harm to the fetus due to mesalamine. risk summary data from published literature report the presence of mesalamine and its metabolite, n-acetyl 5-aminosalicylic acid in human milk in small amounts with relative infant doses (rid) of 2% or less (see data) . there are case reports of diarrhea in breastfed infants exposed to mesalamine (see clinical considerations) . there is no information on the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of mesalamine extended-release capsules to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mesalamine extended-release capsules and any potential adverse effects on the breastfed child from mesalamine extended-release capsules or from the underlying maternal condition. clinical considerations advise the caregiver to monitor the breastfed infant for diarrhea. data in published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 4.8 g daily. the average concentration of mesalamine in milk ranged from non-detectable to 0.5 mg/l. the average concentration of the n-acetyl-5-aminosalicylic acid in milk ranged from 0.2 to 9.3 mg/l. based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.075 mg/kg/day (rid 0 to 0.1%) of mesalamine and 0.03 to 1.4 mg/kg/day of n-acetyl-5-aminosalicylic acid. safety and effectiveness of mesalamine extended-release capsules in pediatric patients have not been established. clinical studies of mesalamine extended-release capsules did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia and pancytopenia) in patients who were 65 years or older compared to younger patients taking mesalamine-containing products such as mesalamine extended-release capsules. monitor complete blood cell counts and platelet counts in elderly patients during treatment with mesalamine extended-release capsules. in general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing mesalamine extended-release capsules [ see use in specific populations (8.6)] . mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on mesalamine extended-release capsules therapy. monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. discontinue mesalamine extended-release capsules if renal function deteriorates while on therapy [ see warnings and precautions (5.1) , adverse reactions (6.2), drug interactions (7.2)] .

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

fresenius kabi usa, llc - 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 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. develo

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

virtus pharmaceuticals, llc - 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, miscarriage or oth

United Kingdom - English - myHealthbox

lupin (europe) limited - gestodene - film-coated tablets - 20/75 microgram - hormonal contraceptives for systemic use, progestogens and estrogens, fixed combinations - oral contraception

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

mylan institutional inc. - trifluoperazine hydrochloride (unii: 6p1y2snf5v) (trifluoperazine - unii:214izi85k3) - trifluoperazine 1 mg - for the management of schizophrenia. trifluoperazine hydrochloride tablets, usp are effective for the short-term treatment of generalized non-psychotic anxiety. however, trifluoperazine hydrochloride 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 (i.e., benzodiazepines). when used in the treatment of non-psychotic anxiety, trifluoperazine hydrochloride tablets should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine hydrochloride tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see warnings). the effectiveness of trifluoperazine hydrochloride tablets as a treatment for non-psychotic anxiety was established in a 4-week clinical multicenter study of outpatients with generalized anxiety disorder (dsm-iii). this evidence doe

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

aidarex pharmaceuticals llc - 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)

mylan institutional 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 excessiv

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)

mylan institutional 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-we