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

ncs healthcare of ky, llc dba vangard labs - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system. meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

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

direct_rx - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see adverse reactions (6) and description (11)]. 7.1 cns depressants there may be increased cns depression when meclizine hydrochloride is administered concurrently with other cns depressants, including alcohol [see warnings and precautions (5.1)]. 7.2 cyp2d6 inhibitors based on in-vitro evaluation, meclizine is metabolized by cyp2d6. therefore, there is a possibility for a drug interaction between meclizine hydrochloride and cyp2d6 inhibitors. therefore, monitor for adverse reactions and clinical effect accordingly.

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

direct_rx - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see adverse reactions (6) and description (11)]. 8.1 pregnancy risk summary data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. however, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data human data e

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

direct_rx - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see adverse reactions (6) and description (11)]. 8.1 pregnancy risk summary data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. however, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data human data e

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

par pharmaceutical, inc. - trientine hydrochloride (unii: hc3nx54582) (trientine - unii:sj76y07h5f) - trientine hydrochloride capsules are indicated in the treatment of patients with wilson's disease who are intolerant of penicillamine. clinical experience with trientine hydrochloride capsules is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. trientine hydrochloride capsules and penicillamine cannot be considered interchangeable. trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. unlike penicillamine, trientine hydrochloride capsules are not recommended in cystinuria or rheumatoid arthritis. the absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. in 15 patients with rheumatoid arthritis, trientine hydrochloride capsules was reported not to be effective in improving any clinical or biochemical parameter after 12 wee

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

kadmon pharmaceuticals, llc - trientine hydrochloride (unii: hc3nx54582) (trientine - unii:sj76y07h5f) - trientine hydrochloride is indicated in the treatment of patients with wilson’s disease who are intolerant of penicillamine. clinical experience with trientine hydrochloride is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient’s dose have not been well defined. trientine hydrochloride and penicillamine cannot be considered interchangeable. trientine hydrochloride should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. unlike penicillamine, trientine hydrochloride is not recommended in cystinuria or rheumatoid arthritis. the absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. in 15 patients with rheumatoid arthritis, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. trientine hydrochloride is not indicated f

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

westminster pharmaceuticals - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. the use of levocetirizine dihydrochloride is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2)]. patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis children 6 months to 11 years of age with impaired renal function risk summary available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by the oral route to

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

quality care products, llc - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see adverse reactions (6) and description (11)] . risk summary data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. however, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data human data epidemiologic

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

rising pharmaceuticals, inc. - trientine hydrochloride (unii: hc3nx54582) (trientine - unii:sj76y07h5f) - trientine hydrochloride is indicated in the treatment of patients with wilson's disease who are intolerant of penicillamine. clinical experience with trientine hydrochloride is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. trientine hydrochloride and penicillamine cannot be considered interchangeable. trientine hydrochloride should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. unlike penicillamine, trientine hydrochloride is not recommended in cystinuria or rheumatoid arthritis. the absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. in 15 patients with rheumatoid arthritis, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. trientine hydrochloride is not indicated f

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

proficient rx lp - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. the use of levocetirizine dihydrochloride is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2)]. patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis children 6 months to 11 years of age with impaired renal function risk summary available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by the oral route to