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

alembic pharmaceuticals inc. - asenapine (unii: jkz19v908o) (asenapine - unii:jkz19v908o) - asenapine is indicated for: • bipolar i disorder [see clinical studies (14.2)] • acute monotherapy of manic or mixed episodes, in pediatric patients 10 to 17 years of age • adjunctive treatment to lithium or valproate in adults asenapine is contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations (8.7), clinical pharmacology (12.3)] . - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions (5.6), adverse reactions (6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asenapine during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk  summary neonates exposed to a

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

alembic pharmaceuticals limited - asenapine (unii: jkz19v908o) (asenapine - unii:jkz19v908o) - asenapine is indicated for: • bipolar i disorder [see clinical studies (14.2)] • acute monotherapy of manic or mixed episodes, in pediatric patients 10 to 17 years of age • adjunctive treatment to lithium or valproate in adults asenapine is contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations (8.7), clinical pharmacology (12.3)] . - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions (5.6), adverse reactions (6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asenapine during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk  summary neonates exposed to a

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

greenstone llc - asenapine maleate (unii: cu9463u2e2) (asenapine - unii:jkz19v908o) - asenapine sublingual tablets are indicated for: • schizophrenia in adults [see clinical studies ( 14.1 )]   • bipolar i disorder [see clinical studies ( 14.2 )] • acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age • adjunctive treatment to lithium or valproate in adults • maintenance monotherapy treatment in adults asenapine is contraindicated in patients with: • severe hepatic impairment (child-pugh c) [see specific populations ( 8.7 ), clinical pharmacology ( 12.3 )] . • a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions ( 5.6 ), adverse reactions ( 6 )]. pregnancy exposure registry       there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asenapine during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-23

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

sigmapharm laboratories, llc - asenapine (unii: jkz19v908o) (asenapine - unii:jkz19v908o) - asenapine sublingual tablet(s) is indicated for: - bipolar i disorder  [see clinical studies ( 14.2)] adjunctive treatment to lithium or valproate in adults - adjunctive treatment to lithium or valproate in adults asenapine is contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations ( 8.7), clinical pharmacology ( 12.3)]. severe hepatic impairment (child-pugh c) [see specific populations ( 8.7), clinical pharmacology ( 12.3)]. - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and ra

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

msn laboratories private limited - asenapine maleate (unii: cu9463u2e2) (asenapine - unii:jkz19v908o) - asenapine sublingual tablets are indicated for: - schizophrenia in adults [see clinical studies (14.1)] - bipolar i disorder [see clinical studies (14.2)] acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age adjunctive treatment to lithium or valproate in adults maintenance monotherapy treatment in adults - acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age - adjunctive treatment to lithium or valproate in adults - maintenance monotherapy treatment in adults asenapine sublingual tablets are contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations (8.7), clinical pharmacology (12.3)]. - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions (5.6), adverse reactions (6)]. pregnancy exposure registry there is a pregnancy

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

breckenridge pharmaceutical, inc. - asenapine maleate (unii: cu9463u2e2) (asenapine - unii:jkz19v908o) - asenapine sublingual tablets are indicated for: - schizophrenia in adults [see clinical studies (14.1)] - bipolar i disorder [see clinical studies (14.2)] acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age adjunctive treatment to lithium or valproate in adults maintenance monotherapy treatment in adults - acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age - adjunctive treatment to lithium or valproate in adults - maintenance monotherapy treatment in adults asenapine sublingual tablets are contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations (8.7), clinical pharmacology (12.3)]. - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions (5.6), adverse reactions (6)]. pregnancy exposure registry there is a pregnancy

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

organon pharmaceuticals usa - asenapine maleate (unii: cu9463u2e2) (asenapine - unii:jkz19v908o) - asenapine 5 mg - saphris is indicated for the treatment of schizophrenia. the efficacy of saphris was established in two 6-week trials and one maintenance trial in adults [ see clinical studies (14.1)] . monotherapy: saphris is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder. efficacy was established in two 3-week monotherapy trials in adults [see clinical studies (14.2)] . adjunctive therapy: saphris is indicated as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar i disorder. efficacy was established in one 3-week adjunctive trial in adults [see clinical studies (14.2)]. hypersensitivity reactions, including anaphylaxis and angioedema, have been observed in patients treated with asenapine. therefore, saphris is contraindicated in patients with a known hypersensitivity to the product [see warnings and precautions (5.7), adverse reactions (6) and patient counseling information (17.3)] . pregnancy cate

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

allergan, inc. - asenapine maleate (unii: cu9463u2e2) (asenapine - unii:jkz19v908o) - asenapine 2.5 mg - saphris is indicated for: - schizophrenia in adults [see clinical studies ( 14.1) ] - bipolar i disorder [see clinical studies ( 14.2) ] • acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age • adjunctive treatment to lithium or valproate in adults • maintenance monotherapy treatment in adults saphris is contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations ( 8.7 ), clinical pharmacology ( 12.3 )] . - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions ( 5.6 ), adverse reactions ( 6 )] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to saphris during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensme