Product Elements:
Chlordiazepoxide hydrochloride and clidinium bromide chlordiazepoxide hydrochloride and clidinium bromide starch, pregelatinized corn talc lactose monohydrate gelatin titanium dioxide d&c yellow no. 10 fd&c green no. 3 chlordiazepoxide chlordiazepoxide clidinium bromide clidinium light green opaque capsules vp302
Boxed Warning:
Warning: risks from concomitant use with opioids; abuse, misuse, and addiction; and dependence and withdrawal reactions concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. reserve concomitant prescribing of these drugs 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 (see warnings and precautions and precautions, drug interactions ). the use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of chlordiazepoxide hydrochloride and clidinium bromide capsules, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/ or illicit substances, which is associated with an increased frequency of serious adverse outcomes. before prescribing chlordiazepoxide hydrochloride and clidinium bromide capsules and throughout treatment, assess each patientâs risk for abuse, misuse, and addiction (see warnings ). the continued use of benzodiazepines, including chlordiazepoxide hydrochloride and clidinium bromide dependence. the risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. abrupt discontinuation or rapid dosage reduction of chlordiazepoxide hydrochloride and clidinium bromide capsules after continued use may precipitate acute withdrawal reactions, which can be life-threatening. to reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride and clidinium bromide capsules or reduce the dosage (see warnings and dosage and administration).
Indications and Usage:
Indications and usage 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.
Warnings:
Warnings risks from concomitant use with opioids concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride and clidinium bromide capsules, and opioids may result in profound sedation, respiratory depression, coma, and death. because of these risks, reserve concomitant prescribing of these drugsâin patients for whom alternative treatment options are inadequate. observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drugrelated mortality compared to use of opioids alone. if a decision is made to prescribe chlordiazepoxide hydrochloride and clidinium bromide capsules 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 hydrochloride and clidi
Read more...nium bromide capsules is used with opioids (see precautions ). abuse, misuse, and addiction the use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of chlordiazepoxide hydrochloride and clidinium bromide capsules, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see drug abuse and dependence ). before prescribing chlordiazepoxide hydrochloride and clidinium bromide capsules and throughout treatment, assess each patientâs risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). use of chlordiazepoxide hydrochloride and clidinium bromide capsules, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of chlordiazepoxide hydrochloride and clidinium bromide capsules along with monitoring for signs and symptoms of abuse, misuse, and addiction. prescribe the lowest effective dosage; avoid or minimize concomitant use of cns depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. if a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. dependence and withdrawal reactions to reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride and clidinium bromide capsules or reduce the dosage (a patient-specific plan should be used to taper the dosage) (see dosage and administration ). patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. acute withdrawal reactions the continued use of benzodiazepines, including chlordiazepoxide hydrochloride and clidinium bromide capsules, may lead to clinically significant physical dependence. abrupt discontinuation or rapid dosage reduction of chlordiazepoxide hydrochloride and clidinium bromide capsules after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see drug abuse and dependence ). protracted withdrawal syndrome in some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see drug abuse and dependence ). effects on the ability to drive or operate machinery as in the case of other preparations containing cns-acting drugs, patients receiving chlordiazepoxide hydrochloride and clidinium bromide capsules 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 ).
Risks from concomitant use with opioids concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride and clidinium bromide capsules, and opioids may result in profound sedation, respiratory depression, coma, and death. because of these risks, reserve concomitant prescribing of these drugsâin patients for whom alternative treatment options are inadequate. observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drugrelated mortality compared to use of opioids alone. if a decision is made to prescribe chlordiazepoxide hydrochloride and clidinium bromide capsules 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 hydrochloride and clidinium brom
Read more...ide capsules is used with opioids (see precautions ).
Abuse, misuse, and addiction the use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of chlordiazepoxide hydrochloride and clidinium bromide capsules, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see drug abuse and dependence ). before prescribing chlordiazepoxide hydrochloride and clidinium bromide capsules and throughout treatment, assess each patientâs risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). use of chlordiazepoxide hydrochloride and clidinium bromide capsules, particularly in patients at elevated risk, necessita
Read more...tes counseling about the risks and proper use of chlordiazepoxide hydrochloride and clidinium bromide capsules along with monitoring for signs and symptoms of abuse, misuse, and addiction. prescribe the lowest effective dosage; avoid or minimize concomitant use of cns depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. if a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.
Dependence and withdrawal reactions to reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride and clidinium bromide capsules or reduce the dosage (a patient-specific plan should be used to taper the dosage) (see dosage and administration ). patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. acute withdrawal reactions the continued use of benzodiazepines, including chlordiazepoxide hydrochloride and clidinium bromide capsules, may lead to clinically significant physical dependence. abrupt discontinuation or rapid dosage reduction of chlordiazepoxide hydrochloride and clidinium bromide capsules after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see drug abu
Read more...se and dependence ). protracted withdrawal syndrome in some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see drug abuse and dependence ).
Effects on the ability to drive or operate machinery as in the case of other preparations containing cns-acting drugs, patients receiving chlordiazepoxide hydrochloride and clidinium bromide capsules 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 recommended dosage because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of chlordiazepoxide hydrochloride and clidinium bromide capsules 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. recommended geriatric dosage 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 hydrochloride and clidinium bromide capsules per day, to be increased gradually as needed and tolerated. elderly patients have an increased risk of dose-related adverse reactions (see precautions ). discontinuation or dosage reduction of chlordiazepoxide hydrochloride and clidinium bromide capsules to reduce the risk of withdr
Read more...awal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride and clidinium bromide capsules or reduce the dosage. if a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. subsequently decrease the dosage more slowly (see warnings and drug abuse and dependence ).
Recommended dosage because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of chlordiazepoxide hydrochloride and clidinium bromide capsules 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.
Discontinuation or dosage reduction of chlordiazepoxide hydrochloride and clidinium bromide capsules to reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride and clidinium bromide capsules or reduce the dosage. if a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. subsequently decrease the dosage more slowly (see warnings and drug abuse and dependence ).
Contraindications:
Contraindications 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.
Adverse Reactions:
Adverse reactions no side effects or manifestations not seen with either compound alone have been reported with the administration of chlordiazepoxide hydrochloride and clidinium bromide capsules. however, since chlordiazepoxide hydrochloride and clidinium bromide capsules contain 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 patientsâparticularly 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 isolate
Read more...d instances of skin eruptions, edema, minor 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 hydrochloride and clidinium bromide capsules 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 hydrochloride and clidinium bromide capsules therapy has been combined with other spasmolytic agents and/or a low residue diet. to report suspected adverse reactions, contact xiromed, llc at 1-844-xiromed (1-844-947-6633) or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
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 hydrochloride and clidinium bromide capsules. 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 hydrochloride and clidinium bromide capsules are 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 hydrochloride and clidinium bromide capsules 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 hydrochloride and clidinium bromide capsules are a fixed-combination of chlordiazepoxide hydrochloride, a benzodiazepine, and clidinium bromide, an anticholinergic. each capsule contains the active ingredients 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. each capsule also contains the inactive ingredients lactose monohydrate, pregelatinized starch, talc. gelatin capsule shells may contain titanium dioxide with the following dye systems: d&c yellow #10, fd&c green #3 and gelatin. imprinting ink is composed of shellac, propylene glycol, black iron oxide, strong ammonia solution and potassium hydroxide. 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 antispasmodic and antisecretory effects on the gastrointestinal tract. structurally clidinium bromide is: chlordiazepoxide clidinium
How Supplied:
How supplied chlordiazepoxide hydrochloride and clidinium bromide capsules are available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide in bottles of 100 capsules (ndc 70700-185-01), with âvp302â imprinted on the cap of the capsule. store at 25°c (77°f); excursions permitted to 15°c to 30°c (59°f to 86°f). keep out of reach of children. dispense in tight, light-resistant container as defined in usp/nf. manufactured for: xiromed, llc florham park, nj 07932 made in the usa pi-185-00 rev. 03/2021 l41i-xir, r-2103
Information for Patients:
Information for patients abuse, misuse, and addiction inform patients that the use of chlordiazepoxide hydrochloride and clidinium bromide capsules, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see warnings ). withdrawal reactions inform patients that the continued use of chlordiazepoxide hydrochloride and clidinium bromide capsules may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of chlordiazepoxide hydrochloride and clidinium bromide capsules may precipitate acute withdrawal reactions, which can be life-threatening. inform pat
Read more...ients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. instruct patients that discontinuation or dosage reduction of chlordiazepoxide hydrochloride and clidinium bromide capsules may require a slow taper (see warnings and drug abuse and dependence ). concomitant use with opioids and other cns depressants inform patients and caregivers that potentially fatal additive effects may occur if chlordiazepoxide hydrochloride and clidinium bromide capsules are used with opioids or other cns depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider (see warnings and precautions , drug interactions ).
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