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

avkare - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 12.5 mg - 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)

american health packaging - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 12.5 mg - 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 epidemiological studies reporting on pregnancies exposed to meclizine have not identified an association between the use of meclizine during pregnancy and an increased risk of major birth defects. animal data in a published study, oral administration of meclizine (25 mg/kg to 250 mg/kg) to pregnant rats during the period of organogenesis resulted in a high incidence of fetal malformations. these effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m 2 ) basis. risk summary there are no data on the presence of meclizine in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for meclizine hydrochloride and any potential adverse effects on the breastfed infant from meclizine hydrochloride or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. the effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. as meclizine hydrochloride undergoes metabolism, hepatic impairment may result in increased systemic exposure of meclizine. treatment with meclizine hydrochloride should be administered with caution in patients with hepatic impairment. the effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. because of a potential for drug/metabolite accumulation, meclizine hydrochloride should be administered with caution in patients with renal impairment and in the elderly, as renal function generally declines with age. the genetic polymorphism of cyp2d6 that results in poor-, intermediate-, extensive-, and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure. therefore, when meclizine hydrochloride is administered to patients with cyp2d6 polymorphism, monitor for adverse reactions and clinical effect accordingly.

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

avpak - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 12.5 mg - 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)

amneal pharmaceuticals llc - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 12.5 mg - 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)

hospira, inc. - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - lidocaine hydrochloride anhydrous 15 mg in 1 ml - lidocaine hydrochloride and epinephrine injection, usp is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

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

proficient rx lp - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older. 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 tablets 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 pregnancy category b

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

carlsbad technology, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older. 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 tablets 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 (cl cr < 10 ml/min)

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

sciegen pharmaceuticals, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - 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 levoce

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

vensun pharmaceuticals, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - 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 tablet 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. pregnancy category b there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, levocetirizine dihydrochloride should be used during pregnancy only if clearly needed. teratogenic effects in rats and rabbits, levocetirizine was not teratogenic at oral doses approximately 320 a

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

general injectables & vaccines, inc - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - lidocaine hydrochloride anhydrous 10 mg in 1 ml - lidocaine hydrochloride and epinephrine injection, usp is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.