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)

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)

mylan pharmaceuticals inc. - 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 tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

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

jubilant cadista pharmaceuticals inc. - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 12.5 mg - meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. meclizine hydrochloride is 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 o

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

pd-rx pharmaceuticals, inc. - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 25 mg - meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system. meclizine hydrochloride tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

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

major pharmaceuticals - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 12.5 mg - management of nausea and vomiting, and dizziness associated with motion sickness. meclizine hcl, usp is contraindicated in individuals who have shown a previous hypersensitivity to it.

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

mylan institutional inc. - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 12.5 mg - for the management of nausea and vomiting, and dizziness associated with motion sickness. meclizine hydrochloride tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

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

nucare pharmaceuticals, inc. - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 25 mg - based on a review of this drug by the national academy of sciences - national research council and/or other information, fda has classified the indications as follows: effective: management of nausea and vomiting, and dizziness associated with motion sickness. final classification of the less than effective indications requires further investigation. meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.