Marekani - Kiingereza - NLM (National Library of Medicine)

clinical solutions wholesale, llc - chlordiazepoxide hydrochloride (unii: mfm6k1xwdk) (chlordiazepoxide - unii:6rz6xez3cr) - chlordiazepoxide hcl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the effectiveness of chlordiazepoxide hcl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. chlordiazepoxide hcl capsules are contraindicated in patients with known hypersensitivity to the drug. chlordiazepoxide hydrochloride capsules are classified by the drug enforcement administration as a schedule iv controlled substance. withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide. the more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving chlordiazepoxide or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

Marekani - Kiingereza - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - chlordiazepoxide hydrochloride (unii: mfm6k1xwdk) (chlordiazepoxide - unii:6rz6xez3cr) - chlordiazepoxide hcl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the effectiveness of chlordiazepoxide hcl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. chlordiazepoxide hcl capsules are contraindicated in patients with known hypersensitivity to the drug. chlordiazepoxide hydrochloride capsules are classified by the drug enforcement administration as a schedule iv controlled substance. withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discon

Marekani - Kiingereza - NLM (National Library of Medicine)

bryant ranch prepack - chlordiazepoxide hydrochloride (unii: mfm6k1xwdk) (chlordiazepoxide - unii:6rz6xez3cr), clidinium bromide (unii: 91zqw5jf1z) (clidinium - unii:bo76jf850n) - chlordiazepoxide hydrochloride and clidinium bromide capsules are indicated to control emotional and somatic factors in gastrointestinal disorders. chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. chlordiazepoxide hydrochloride and clidinium bromide capsules are contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. it is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide. withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide.

Marekani - Kiingereza - NLM (National Library of Medicine)

carilion materials management - chlordiazepoxide hydrochloride (unii: mfm6k1xwdk) (chlordiazepoxide - unii:6rz6xez3cr), clidinium bromide (unii: 91zqw5jf1z) (clidinium - unii:bo76jf850n) - chlordiazepoxide hydrochloride 5 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: "possibly" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. final classification of the less-than-effective indications requires further investigation. chlordiazepoxide hcl/clidinium bromide is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. it is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide. withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt disc

Marekani - Kiingereza - NLM (National Library of Medicine)

american health packaging - chlordiazepoxide hydrochloride (unii: mfm6k1xwdk) (chlordiazepoxide - unii:6rz6xez3cr), clidinium bromide (unii: 91zqw5jf1z) (clidinium - unii:bo76jf850n) - chlordiazepoxide hydrochloride and clidinium bromide capsules is indicated to control emotional and somatic factors in gastrointestinal disorders. chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. chlordiazepoxide hydrochloride and clidinium bromide capsules is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. it is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide. chlordiazepoxide hydrochloride and clidinium bromide capsules contains chlordiazepoxide hydrochloride, a schedule iv controlled substance and clidinium bromide, which is not a controlled substance. chlordiazepoxide hydrochloride a

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

galderma international - benzoyl peroxide - gel - 5 percent weight/weight - peroxides; benzoyl peroxide

Marekani - Kiingereza - NLM (National Library of Medicine)

tya pharmaceuticals - chlordiazepoxide hydrochloride (unii: mfm6k1xwdk) (chlordiazepoxide - unii:6rz6xez3cr) - chlordiazepoxide hydrochloride 25 mg - chlordiazepoxide hcl capsules usp are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the effectiveness of chlordiazepoxide hcl capsules usp in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. chlordiazepoxide hcl capsules are contraindicated in patients with known hypersensitivity to the drug. chlordiazepoxide hydrochloride capsules are classified by the drug enforcement administration as a schedule iv controlled substance. withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrup

Kanada - Kiingereza - Health Canada

sandoz canada incorporated - adapalene; benzoyl peroxide - gel - 0.3%; 2.5% - adapalene 0.3%; benzoyl peroxide 2.5% - keratolytic agents

Marekani - Kiingereza - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. adapalene and benzoyl peroxide topical gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide topical gel. risk summary available pharmacovigilance data with adapalene and benzoyl peroxide topical gel use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.  animal reproduction studies have not been conducted with the combination gel. adapalene gel, 0.3% available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 41 and 81 times, respectively, the human exposure at the maximum recommended human dose (mrhd) of 2 g resulted in fetal skeletal and visceral malformations (see data) . benzoyl peroxide gel, 2.5% the systemic exposure of benzoyl peroxide is unknown.  based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. hence, maternal use is not expected to result in fetal exposure of the drug.  the background risk of major birth defects and miscarriage for the indicated population is unknown.  all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data  no malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 8 times the mrhd of 2 grams of adapalene and benzoyl peroxide topical gel based on a mg/m2 comparison. however, malformations were observed in rats and rabbits when treated with oral doses of  ≥ 25 mg/kg/day adapalene (41 and 81 times the mrhd, respectively, based on a mg/m2 comparison). findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (9.7 and 19.5 times the mrhd, respectively, based on a mg/m2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits). risk sumary   adapalene gel, 0.3% there are no data on the presence of adapalene topical gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. in animal studies, adapalene is present in rat milk with oral administration of the drug. when a drug is present in animal milk, it is likely that the drug will be present in human milk. it is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk (see clinical considerations).   benzoyl peroxide gel, 2.5% the systemic exposure of benzoyl peroxide is unknown. based on the published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. any amount of benzoyl peroxide excreted into human milk by a nursing mother would be expected to be rapidly metabolized by tissue and stomach esterases. there are no data on the presence of benzoyl peroxide in human milk, its effects on the breastfed infant or its effects on milk production.  the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adapalene and benzoyl peroxide topical gel and any potential adverse effects on the breastfed child from adapalene and benzoyl peroxide topical gel or from the underlying maternal condition. clinical considerations   to minimize potential exposure to the breastfed infant via breastmilk, use adapalene and benzoyl peroxide topical gel on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply adapalene and benzoyl peroxide topical gel directly to the nipple and areola to avoid direct infant exposure. safety and effectiveness of adapalene and benzoyl peroxide topical gel in pediatric patients under the age of 12 have not been established. clinical studies of adapalene and benzoyl peroxide topical gel did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

Kanada - Kiingereza - Health Canada

taro pharmaceuticals inc - adapalene; benzoyl peroxide - gel - 0.3%; 2.5% - adapalene 0.3%; benzoyl peroxide 2.5% - keratolytic agents