Chlordiazepoxide hydrochloride (Oral)

Chlordiazepoxide hydrochloride is a generic anti-anxiety drug sold in the US under the brand Librium. It treats symptoms of anxiety and acute alcohol withdrawal.

Overview

Chlordiazepoxide hydrochloride is commonly used on a short-term basis to relieve symptoms of anxiety, which include worry, fear and nervousness. These symptoms can be more acute leading up to a major or life-changing event, such as surgery.

The medicine is also most commonly used as a 'detoxification' therapy in patients going through withdrawal from acute alcoholism. It helps to reduce the effects of symptoms that tend to drive an alcoholic to drink more alcohol, such as nausea and trembling.

The prescription-only medicine is sold as a tablet or capsule and is taken by mouth. Its anti-anxiety and sedative properties affect certain chemicals in the brain and produce a calming effect. Because of its potential to be habit-forming and cause dependence, the treatment is prescribed for the shortest possible duration (typically 7 to 10 days).

The use of the medicine is restricted in certain patients, such as children under the age of six, because of safety and efficacy concerns and its potential to cause harm.

The medication is also used to treat other conditions not discussed here, such as when it is used together with clinidium bromide to treat symptoms of irritable bowel syndrome (IBS).

Condition(s) treated

  • anxiety
  • alcohol withdrawal

Type of medicine

  • benzodiazepine

Side effects

Even though they rarely occur, serious side effects, such as fainting, require urgent medical attention. This is in addition to the risk of other serious side effects and adverse interactions that may occur if other drugs are used together with Librium.

Symptoms such as rash, hives, swelling of the mouth, lips, tongue or face, and breathing difficulties are signs of an allergic reaction. Seek medical attention right away.

Unusual or strange behaviors and thoughts of suicide have occurred in patients taking chlordiazepoxide. Speak to your doctor right away if you experience any of these symptoms.

Although the side effects listed below are unlikely to occur, they are considered as rare but serious and will require immediate medical attention. Call your doctor immediately if you experience any of these symptoms:

Rarely occurs

  • lack of muscle co-ordination, including trembling and unsteadiness
  • change in mood
  • slurred speech
  • facial or muscle twitching
  • uncontrollable movements, such as an inability to sit still
  • irregular heartbeat
  • fainting
  • difficulty breathing or swallowing
  • severe skin rash

Incidence unknown

The following symptoms are highly unlikely to occur. If they do, call your doctor right away.

  • nausea and vomiting
  • headache
  • dizziness
  • pain in the abdomen or stomach
  • chills
  • muscle cramps or cramps in the abdomen
  • vomiting blood
  • convulsions
  • drooling
  • unable to sleep
  • fever (including fever with chills)
  • itching
  • rash
  • pale skin
  • yellowing of the skin or eyes
  • sleep disturbances
  • movements that cannot be controlled (especially of the face, neck, and back)
  • unpleasant breath odor
  • light-colored stool
  • clay-colored stool
  • loss of desire to eat
  • restlessness
  • unusual bruising or bleeding
  • cough or hoarseness
  • difficulty speaking
  • shaky arms, hands, legs or feet
  • shaky, unsteady or shuffling walk
  • muscle problems such as stiffness, jerking or trembling
  • unable to balance the body
  • soreness of the throat
  • swelling
  • dark urine
  • sweating
  • pain or difficulty urinating
  • feeling of stiffness in the limbs
  • white spots, ulcers or sores in the mouth or on the lips
  • pain in the sides or lower back
  • feeling unusually weak or tired

There are adverse effects that are highly unlikely to occur, but if they do, they may not require medical care. As the body get used to the new medicine, the following side effects usually wear off:

  • Incidence unknown
  • blisters on the skin
  • constipation
  • loss of sexual desire, drive or performance
  • trouble having or keeping an erection
  • increase in desire for sexual intercourse
  • menstrual changes or irregularities

The lists above do not include all possible side effects. If side effects not needing medical attention do occur but persist or get worse, tell your doctor.

Adverse reactions that are rare or their incidence is unknown (and are not considered serious) may be controlled. Your doctor or healthcare professional may adjust your dosage accordingly. In severe cases, the medicine should be discontinued.

You may ask your doctor about ways to prevent or reduce side effects. You may also call the FDA at 1-800-FDA-1088 to report side effects.

Dosage

Dosage depends on the individual patient's age, the condition being treated and its severity, and the patient's reaction to the first dose. Your doctor will determine your proper dosage, including the strength of each dose, the time you should leave between each, and the duration of your treatment.

Carefully follow all directions given by your doctor, pharmacist, prescription label and patient information leaflet (if one is given). If the information given is not clear, ask your pharmacist to explain further.

  • Guide for general dosage by capsules
  • For anxiety
  • Adults: Take 5 to 25 milligrams (mg) 3 to 4 times a day.
  • Older adults: Take 5 milligrams (mg) 2 to 4 times a day.
  • Children (age six years and older): At first, take 5 milligrams (mg) 2 to four 4 times a day. The dosage may be increased by your doctor if needed.
  • Children (age six years and younger): Use not recommended. Use and dose should be calculated by your health care professional if necessary.
  • For pre-surgery anxiety symptoms
  • Adults: Take 5 to 10 milligrams (mg) 3 to 4 times a day, as needed, taken several days prior to surgery.
  • Children: Use and dose should be calculated by your health care professional if necessary.
  • For treating symptoms of alcohol withdrawal
  • Adults: At first, take 50 to 100 milligrams (mg). Follow up with repeat doses if needed until agitation is controlled. A maximum of 300 mg per day is recommended.
  • Children: Use and dose should be calculated by your health care professional if necessary.

Missed dose

If you miss a dose, take it as soon as possible, providing it is not yet time for your next dose. Otherwise, skip the missed dose and take the next dose at the scheduled time. Do not take extra doses to make up for a skipped dose. This can cause serious side effects or an overdose.

Overdose

In case of an overdose, call 911 and get emergency help right away. You can call the local poison control center on 1-800-222-1222. Symptoms of overdose are as follows:

  • loss of consciousness
  • sleepiness or unusual drowsiness
  • change in consciousness
  • lack of coordination

Withdrawal from chlordiazepoxide hydrochloride

Withdrawal symptoms, such as abdominal and muscle cramps, tremors and vomiting, have occurred when chlordiazepoxide therapy is suddenly ended. The symptoms may be more severe in patients who were undergoing extended treatment. To avoid this, patients should be gradually weaned off the medication.

Interactions

Other drugs (both prescription and over the counter), medical problems, foods, tobacco and other agents may interact with chlordiazepoxide if taken during treatment. Interaction is expected and sometimes required when other drugs are used during therapy. They should not be used if they increase the risk for serious adverse reactions.

Chlordiazepoxide is not recommended to be used with the following other medicine:

  • flumazenil

Your doctor may still decide to treat you with this medicine or change any of the other medicines you take.

The following list of medicines is not recommended to be used with chlordiazepoxide, but may be the best treatment for you. If a combination drug therapy with any of them is necessary, your doctor may change the dose and how often you take any or all of the medicines.

  • Mephenesin
  • Hydrocodone
  • Pentazocine
  • Oxycodone
  • Pentobarbital
  • Levorphanol
  • Fospropofol
  • Ethchlorvynol
  • Carisoprodol
  • Fentanyl
  • Bromopride
  • Morphine Sulfate Liposome
  • Chloral Hydrate
  • Remifentanil
  • Sufentanil
  • Amobarbital
  • Butalbital
  • Dihydrocodeine
  • Lacosamide
  • Meperidine
  • Dantrolene
  • Methocarbamol
  • Oxymorphone
  • Metaxalone
  • Codeine
  • Phenobarbital
  • Mirtazapine
  • Flibanserin
  • Hydromorphone
  • Meclizine
  • Doxylamine
  • Bromazepam
  • Carbinoxamine
  • Meprobamate
  • Thiopental
  • Propofol
  • Anileridine
  • Butabarbital
  • Butorphanol
  • Morphine
  • Primidone
  • Alfentanil
  • Methohexital
  • Periciazine
  • Buprenorphine
  • Chlorzoxazone
  • Mephobarbital
  • Secobarbital
  • Tapentadol
  • Methadone
  • Propoxyphene
  • Tramadol
  • Sodium Oxybate
  • Zolpidem

An increased risk of certain side effects is possible if this medicine is used together with the following other medicines:

  • St John's wort
  • theophylline
  • ketoconazole

Other interactions

Ethanol

Using this substance during treatment may cause an increased risk of certain side effects. However, its use may be necessary. Your doctor may change your dose or how often you use this medicine.

Tobacco and alcohol

Smoking cigarettes may interact and reduce the effectiveness of the medicine. Drinking alcohol may cause severe impairment of alertness and physical abilities.

CNS depressants

Other medicines that slow down the central nervous system (CNS depressants) can cause severe drowsiness and confusion if they are used during treatment with chlordiazepoxide. CNS depressants include antihistamines, medicines for colds, sedatives and medicines used for numbing (anesthetic).

Medical problems

Liver disease

Side effects may be worse because the medicine takes a longer time to be removed from the body. Use the medicine with caution.

Porphyria (genetic disorder)

Use the medicine with caution, as it may make this condition worse.

Kidney disease

Tell your doctor if you have this condition, as it may adversely interact with the medicine.

This is not an all-inclusive list of possible interactions. If any unusual symptom occurs and is bothersome or gets worse, call your doctor.

Warnings

Before using chlordiazepoxide hydrochloride

A thorough discussion with your doctor can answer questions and abate concerns about side effects and possible interactions of the medication with other prescription and over the counter medicines.

Tell your doctor of any allergies to this medicine, foods, preservatives, dyes or animals. Disclose health problems (or history of), and all medicines you are taking or plan to take. If you are pregnant or breastfeeding, mention this as well. This can help your doctor determine whether this drug is safe for you.

Pediatrics

The safety and efficacy of the use of chlordiazepoxide in children under six years of age has not been established.

Geriatrics

While there is no specific limitation on using the medicine for treating elderly patients, it should be prescribed with caution. Geriatrics are most likely to experience side effects that impair alertness, such as severe drowsiness, dizziness and confusion. The drug is not recommended for use in patients 65 years of age and older, due to safety and efficacy concerns.

Pregnancy

Studies show potential for harm to an unborn baby when the medicine is used in pregnancy. Use and dose should be calculated by your health care professional if necessary.

Breastfeeding

  • Caution should be taken in prescribing the medicine, since it may cause harm if it passes through breast milk to a breastfeeding infant.
  • Do not use this medicine if you are allergic or hypersensitive to it, or have a medical problem that may severely interact with it.
  • Do not drive a vehicle or operate machinery while taking this drug. The medicine can severely impair mental alertness necessary for performing those tasks.
  • This drug can be habit-forming and cause dependence. Take your dose exactly as prescribed. Do not increase your dose or take it more often than directed. Do not use the drug for longer than prescribed.
  • Patients undergoing extended treatment should not stop using the medicine abruptly, as this can worsen your symptoms and put you at risk of serious side effects, such as seizures. Extended use of this drug can cause it to lose its effectiveness. Tell your doctor if the medication is no longer relieving your symptoms or if they become worse.
  • Do not share the medicine with anyone, even if they have similar symptoms to you. Also, do not use this medication if it was prescribed for someone else with similar symptoms.
  • Avoid using alcohol or central nervous system depressants (CNS depressants) while taking chlordiazepoxide. They can cause severe drowsiness, impair physical abilities, or cause addiction to this drug.
  • This medicine is not intended for use in treating anxiety or tension associated with stress caused by everyday life.
  • Keep all follow-up appointments so your doctor can determine whether the medicine is working well.

Storage

Keep the medicine in a closed container and store at room temperature. Keep from freezing. Avoid exposure to heat, moisture, and direct light. Keep away from children and pets.

Do not continue to store expired medicine or medicine no longer needed. Safely dispose of it as directed by a healthcare professional or your local waste disposal company.

Summary

Chlordiazepoxide hydrochloride (Librium) is clinically approved for treating symptoms of anxiety.

The safety and efficacy of this anti-anxiety drug is well established, except for children under the age of six and elderly adults over the age of 65. The drug may severely impair alertness and physical abilities in these patients. It can also cause harm to an unborn baby and should be used with caution in breastfeeding women.

Long-term use of the medication is not recommended since it has the potential to be habit-forming and cause dependence. Patients undergoing extended therapy must be gradually withdrawn from treatment. Abrupt removal of the drug from the body may cause severe withdrawal symptoms, such as nausea, vomiting, and sweating.

Chlordiazepoxide can trigger suicidal thoughts and strange or unusual behaviors. Therefore, it may not be appropriate for patients with suicidal tendencies.

Smoking, drinking alcohol, or using other drugs that also cause drowsiness or impair alertness is not recommended during treatment with chlordiazepoxide. Similarly, patients with certain medical problems, such as liver or kidney disease, may be severely affected by the use of this anti-anxiety medicine.

For these reasons, the medication should only be used if the benefits outweigh the risks.