Product Elements:
Chlordiazepoxide hydrochloride and clidinium bromide chlordiazepoxide hydrochloride and clidinium bromide chlordiazepoxide hydrochloride chlordiazepoxide clidinium bromide clidinium starch, corn lactose monohydrate talc methylparaben propylparaben potassium sorbate d&c yellow no. 10 fd&c green no. 3 titanium dioxide gelatin, unspecified light green opaque librax;icn
Drug Interactions:
Drug interactions the concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the cns that control respiration. benzodiazepines interact at gaba a sites and opioids interact primarily at mu receptors. when benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation.
Boxed Warning:
Warning: risks from concomitant use with opioids concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see warnings and precautions). ⢠reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. ⢠limit dosages and durations to the minimum required. ⢠follow patients for signs and symptoms of respiratory depression and sedation.
Indications and Usage:
Indications and usage chlordiazepoxide hcl/clidinium bromide is indicated to control emotional and somatic factors in gastrointestinal disorders. chlordiazepoxide hcl/clidinium bromide 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.
Warnings:
Warnings concomitant use of benzodiazepines, including chlordiazepoxide hcl/clidinium bromide, and opioids may result in profound sedation, respiratory depression, coma, and death. because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. if a decision is made to prescribe chlordiazepoxide hcl/clidinium bromide concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. advise both patients and caregivers about the risks of respiratory depression and sedation when chlordiazepoxide hcl/clidinium bromide is used with opioids (see precautions ). as in the case of other preparations conta
Read more...ining cns-acting drugs, patients receiving chlordiazepoxide hcl/clidinium bromide should be cautioned about possible combined effects with opioids, alcohol and other cns depressants. for the same reason, they should be cautioned against hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle. usage in pregnancy an increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. the possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. as with all anticholinergic drugs, an inhibiting effect on lactation may occur (see animal pharmacology ).
Dosage and Administration:
Dosage and administration because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of chlordiazepoxide hcl/clidinium bromide varies with the diagnosis and response of the individual patient. the dosage, therefore, should be individualized for maximum beneficial effects. the usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime. geriatric dosing dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. the initial dose should not exceed 2 chlordiazepoxide hcl/clidinium bromide capsules per day, to be increased gradually as needed and tolerated.
Contraindications:
Contraindications 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.
Adverse Reactions:
Adverse reactions no side effects or manifestations not seen with either compound alone have been reported with the administration of chlordiazepoxide hcl/clidinium bromide. however, since chlordiazepoxide hcl/clidinium bromide contains chlordiazepoxide hydrochloride and clidinium bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded. when chlordiazepoxide hydrochloride has been used alone the necessity of discontinuing therapy because of undesirable effects has been rare. drowsiness, ataxia and confusion have been reported in some patients â particularly the elderly and debilitated. while these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. in a few instances syncope has been reported. other adverse reactions reported during therapy with chlordiazepoxide hydrochloride include isolated instances of skin eruptions, edema, minor
Read more... menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. such side effects have been infrequent and are generally controlled with reduction of dosage. changes in eeg patterns (low-voltage fast activity) have been observed in patients during and after chlordiazepoxide hydrochloride treatment. blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction have occasionally been reported during therapy with chlordiazepoxide hydrochloride. when chlordiazepoxide hydrochloride treatment is protracted, periodic blood counts and liver function tests are advisable. adverse effects reported with use of chlordiazepoxide hcl/clidinium bromide are those typical of anticholinergic agents, i.e., dryness of the mouth, blurring of vision, urinary hesitancy and constipation. constipation has occurred most often when chlordiazepoxide hcl/clidinium bromide therapy has been combined with other spasmolytic agents and/or a low residue diet. to report suspected adverse reactions, contact valeant pharmaceuticals north america llc at 1-800-321-4576 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Drug Interactions:
Drug interactions the concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the cns that control respiration. benzodiazepines interact at gaba a sites and opioids interact primarily at mu receptors. when benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation.
Use in Pregnancy:
Usage in pregnancy an increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. the possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. as with all anticholinergic drugs, an inhibiting effect on lactation may occur (see animal pharmacology ).
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
Geriatric use geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving chlordiazepoxide hcl/clidinium bromide. these effects can usually be avoided with proper dosage adjustment, although they have occasionally been observed even at the lower dosage ranges. dosing in geriatric subjects should be initiated cautiously (no more than 2 capsules per day) and increased gradually if needed and tolerated (see dosage and administration ). chlordiazepoxide hcl/clidinium bromide is contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction (see contraindications ).
Overdosage:
Overdosage manifestations of chlordiazepoxide hydrochloride overdosage include somnolence, confusion, coma and diminished reflexes. respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following chlordiazepoxide hydrochloride overdosage. while the signs and symptoms of chlordiazepoxide hcl/clidinium bromide overdosage may be produced by either of its components, usually such symptoms will be overshadowed by the anticholinergic actions of clidinium bromide. the symptoms of overdosage of clidinium bromide are excessive dryness of mouth, blurring of vision, urinary hesitancy and constipation. general supportive measures should be employed, along with immediate gastric lavage. administer physostigmine 0.5 to 2 mg at a rate of no more than 1 mg per minute. this may be repeated in 1 to 4 mg doses if arrhythmias, convulsions or deep coma recur. intravenous fluids should be administered and an adequate airway maintained. hypotension may be combated by the use of levarterenol or metaraminol. methylphenidate or caffeine and sodium benzoate may be given to combat cns-depressive effects. dialysis is of limited value. should excitation occur, barbiturates should not be used. as with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested. withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see drug abuse and dependence ).
Description:
Description chlordiazepoxide hcl/clidinium bromide combines in a single capsule formulation the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide. each chlordiazepoxide hcl/clidinium bromide capsule contains the active ingredients 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. each capsule also contains the inactive ingredients corn starch, lactose monohydrate, talc, methylparaben, propylparaben, potassium sorbate, d&c yellow no. 10, fd&c green no. 3, titanium dioxide, and gelatin. chlordiazepoxide hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. it is indicated when anxiety, tension or apprehension are significant components of the clinical profile. it is among the safer of the effective psychopharmacologic compounds. chlordiazepoxide hydrochloride is 7-chloro-2-methylamino-5-phenyl-3h-1,4-benzodiazepine 4-oxide hydrochloride. a colorless, crystalline substance, it is soluble in water. it is unstable in solution and the powder must be protected from light. the molecular weight is 336.22. the structural formula of chlordiazepoxide hydrochloride is as follows: clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. structurally clidinium bromide is: structure1 structure2
How Supplied:
How supplied chlordiazepoxide hcl/clidinium bromide is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide, in bottles of 100 (ndc 42494-409-01), with librax ® icn imprinted on the body of the capsule. store at 25°c (77°f); excursions permitted to 15° to 30°c (59° to 86°f). keep out of reach of children. dispense in a tight, light-resistant container as defined in usp/nf. distributed by: cameron pharmaceuticals louisville, ky 40245 usa manufactured by: valeant pharmaceuticals international, inc. steinbach, mb r5g 1z7 canada librax is a trademark of valeant pharmaceuticals international, inc. or its affiliates. ©valeant pharmaceuticals north america llc 9542102 20001848 revised: 04/2017
Information for Patients:
Information for patients inform patients and caregivers that potentially fatal additive effects may occur if chlordiazepoxide hcl/clidinium bromide is used with opioids or other cns depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider (see warnings and precautions ). to assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.
Package Label Principal Display Panel:
Principal display panel - 100 capsule bottle label ndc 42494-409-01 rx only chlordiazepoxide hcl/ clidinium bromide capsules 5 mg/2.5mg medication guide to be dispensed with each prescription 100 capsules cameron pharmaceuticals carton.jpg