Chlordiazepoxide Hydrochloride And Clidinium Bromide

• 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:
  
  
  
  Risks From Concomitant Use with Opioids
  
  

  Concomitant use of benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs - 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 Hydrochloride and Clidinium Bromide Capsule 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 Bromide Capsule 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 Capsule, 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 Capsule and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of Librax 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 Capsule 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 Capsule, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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 Capsule 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

  ).

  and
  
  

  PRECAUTIONS:

  CNS Adverse Reactions

  In geriatric or debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion (not more than 2 Chlordiazepoxide Hydrochloride and Clidinium Bromide capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed — particularly when the known potentiating compounds such as the MAO inhibitors and phenothiazines are to be used. The usual precautions in treating patients with impaired renal or hepatic function should be observed.

  Paradoxical reactions to chlordiazepoxide hydrochloride, e.g., excitement, stimulation and acute rage, have been reported in psychiatric patients and should be watched for during Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule therapy. The usual precautions are indicated when chlordiazepoxide hydrochloride is used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary.

  Information for Patients

  Abuse, Misuse, and Addiction

  Inform patients that the use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, 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 Capsule may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients 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 Capsule 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 Capsule is 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

  ).

  Drug Interactions

  Opioids

  The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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_Asites 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule and opioids, and follow patients closely for respiratory depression and sedation.
  
  

  Oral Anticoagulants

  Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule.

  Pediatric Use

  Safety and effectiveness in pediatric patients have not been established.

  Geriatric Use

  Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule. 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 Capsule is contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction (see

  CONTRAINDICATIONS

  ).

  and
  
  

  PRECAUTIONS:

  CNS Adverse Reactions

  In geriatric or debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion (not more than 2 Chlordiazepoxide Hydrochloride and Clidinium Bromide capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed — particularly when the known potentiating compounds such as the MAO inhibitors and phenothiazines are to be used. The usual precautions in treating patients with impaired renal or hepatic function should be observed.

  Paradoxical reactions to chlordiazepoxide hydrochloride, e.g., excitement, stimulation and acute rage, have been reported in psychiatric patients and should be watched for during Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule therapy. The usual precautions are indicated when chlordiazepoxide hydrochloride is used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary.

  Information for Patients

  Abuse, Misuse, and Addiction

  Inform patients that the use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, 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 Capsule may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients 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 Capsule 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 Capsule is 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

  ).

  Drug Interactions

  Opioids

  The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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_Asites 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule and opioids, and follow patients closely for respiratory depression and sedation.
  
  

  Oral Anticoagulants

  Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule.

  Pediatric Use

  Safety and effectiveness in pediatric patients have not been established.

  Geriatric Use

  Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule. 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 Capsule is contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction (see

  CONTRAINDICATIONS

  ).

  ,
  
  

  Drug Interactions

  Opioids

  The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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_Asites 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule and opioids, and follow patients closely for respiratory depression and sedation.
  
  

  Oral Anticoagulants

  Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule.

  ).
  
  
• The use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, 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 Capsule and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see
  
  

  WARNINGS:
  
  
  
  Risks From Concomitant Use with Opioids
  
  

  Concomitant use of benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs - 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 Hydrochloride and Clidinium Bromide Capsule 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 Bromide Capsule 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 Capsule, 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 Capsule and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of Librax 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 Capsule 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 Capsule, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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 Capsule 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

  ).

  ).
  
  
• The continued use of benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, may lead to clinically significant physical 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 Capsule 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 Capsule or reduce the dosage (see
  
  

  WARNINGS:
  
  
  
  Risks From Concomitant Use with Opioids
  
  

  Concomitant use of benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs - 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 Hydrochloride and Clidinium Bromide Capsule 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 Bromide Capsule 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 Capsule, 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 Capsule and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of Librax 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 Capsule 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 Capsule, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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 Capsule 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

  ).

  and
  
  

  DOSAGE AND ADMINISTRATION:

  Recommended Dosage

  Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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 Capsule

  To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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

  ).

  ).
  
  

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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.

Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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.

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 Capsule 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 — 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 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 Capsule therapy has been combined with other spasmolytic agents and/or a low residue diet.

To report SUSPECTED ADVERSE REACTIONS, contact Winder Laboratories LLC at 1-770-307-0703 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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
_Asites 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule and opioids, and follow patients closely for respiratory depression and sedation.

Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule.