Chlordiazepoxide

Chlordiazepoxide HCI may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Similarly, it may impair mental alertness in children. The concomitant use of alcohol or other central nervous system depressants may have an additive effect. PATIENTS SHOULD BE WARNED ACCORDINGLY.

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.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines. (See DRUG ABUSE AND DEPENDENCE section.)

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if chlordiazepoxide crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using chlordiazepoxide.

Take chlordiazepoxide exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The chlordiazepoxide dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose range for chlordiazepoxide in adults is 5 to 25 mg, two to four times a day.

The recommended dose range for chlordiazepoxide to treat anxiety prior to surgery is 5 to 10 mg orally, 3 or 4 times daily on days preceding surgery.

The recommended dose for chlordiazepoxide in children (6 years of age and older) is 5 to 10 mg, two to four times a day.

Do not drink alcohol while taking chlordiazepoxide. This medication can increase the effects of alcohol.

Chlordiazepoxide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, or depression can add to sleepiness caused by chlordiazepoxide. Tell your doctor if you regularly use any of these medicines, or any other anxiety medications.

Your pharmacist can provide more information about chlordiazepoxide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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• Anxiety
• Benzodiazepines
• Panic Attacks
• Prescription Anxiety Medications

You should not use chlordiazepoxide if you are allergic to it.

To make sure chlordiazepoxide is safe for you, tell your doctor if:

• you have porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• you take a blood thinner such as warfarin (Coumadin, Jantoven); or

• you take a narcotic (opioid) medication.

The sedative effects of chlordiazepoxide may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking chlordiazepoxide.

Do not use chlordiazepoxide if you are pregnant. This medicine can cause birth defects. Your baby could also become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while you are taking chlordiazepoxide.

It is not known whether chlordiazepoxide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Chlordiazepoxide is not approved for use by anyone younger than 6 years old.

Avoid drinking alcohol. Dangerous side effects could occur.

Chlordiazepoxide may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Taking chlordiazepoxide with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with chlordiazepoxide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may be habit-forming with long-term use.
• Do not stop taking chlordiazepoxide all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
• Have your blood work checked if you are on chlordiazepoxide for a long time. Talk with your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this medicine affects you.
• Avoid alcohol or other drugs and natural products that slow your actions.
• If you are 65 or older, use chlordiazepoxide with care. You could have more side effects.
• Do not give this medicine to a child younger than 6 years of age.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking chlordiazepoxide, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Concomitant use of benzodiazepines, including Chlordiazepoxide, 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 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. In patients already receiving an opioid analgesic, prescribe a lower initial dose of Chlordiazepoxide than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking Chlordiazepoxide, prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Advise both patients and caregivers about the risks of respiratory depression and sedation when Chlordiazepoxide is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see DRUG INTERACTIONS).

Chlordiazepoxide HCl may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Similarly, it may impair mental alertness in children. The concomitant use of alcohol or other central nervous system depressants may have an additive effect. PATIENTS SHOULD BE WARNED ACCORDINGLY.

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 GABAA 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 monitor patients closely for respiratory depression and sedation.

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.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Concerns related to adverse effects:

• Anterograde amnesia: Benzodiazepines have been associated with anterograde amnesia (Nelson 1999).

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Paradoxical reactions: Paradoxical reactions, including hyperactive or aggressive behavior, have been reported with benzodiazepines, particularly in adolescent/pediatric or psychiatric patients.

Disease-related concerns:

• Depression: Use caution in patients with depression, particularly if suicidal risk may be present.

• Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. Psychological and physical dependence, as well as tolerance to sedative and anticonvulsive effects, may occur with prolonged use (Vinkers 2012).

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Porphyria: Use with caution in patients with porphyria.

• Renal impairment: Use with caution in patients with renal impairment.

• Respiratory disease: Use with caution in patients with respiratory disease (Smoller 1996).

Concurrent drug therapy issues:

• Benzodiazepines and opioids: [US Boxed Warning]: The concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. 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.

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions for more detailed information.

Special populations:

• Debilitated patients: Use with caution in debilitated patients; active metabolites with extended half-lives may lead to delayed accumulation and adverse effects, including ataxia and over-sedation.

• Elderly: Avoid use; if used, use with caution in the elderly; active metabolites with extended half-lives may lead to delayed accumulation and adverse effects, including ataxia and over-sedation.

• Fall risk: Use with extreme caution in patients who are at risk of falls; benzodiazepines have been associated with falls and traumatic injury (Nelson 1999).

• Pediatric: Use with caution in children; active metabolites with extended half-lives may lead to delayed accumulation and adverse effects, including ataxia and over-sedation.

Other warnings/precautions:

• Tolerance: Chlordiazepoxide is a long half-life benzodiazepine. Duration of action after a single dose is determined by redistribution rather than metabolism. Tolerance does not develop to the anxiolytic effects (Vinkers, 2012). Chronic use of this agent may increase the perioperative benzodiazepine dose needed to achieve desired sedative effect.

• Withdrawal: Rebound or withdrawal symptoms may occur following abrupt discontinuation or large decreases in dose. Use caution when reducing dose or withdrawing therapy; decrease slowly and monitor for withdrawal symptoms. Flumazenil may cause withdrawal in patients receiving long-term benzodiazepine therapy.

50 to 100 mg orally, followed by repeated doses as needed until agitation is controlled
Maximum dose: 300 mg orally per day

Use: Relief of withdrawal symptoms of acute alcoholism

6 years or older:
5 mg orally, 2 to 4 times per day; this may be increased to 10 mg orally, 2 to 3 times per day

Use: Relief of mild, moderate, and severe anxiety disorders

Hepatic impairment: Use with caution

Data not available

UK: Use should be avoided. US: The manufacturer makes no recommendation regarding use during lactation. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.