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)

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

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

nucare pharmaceuticals,inc. - prochlorperazine maleate (unii: i1t8o1jtl6) (prochlorperazine - unii:yhp6ylt61t) - 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 pr