Chlordiazepoxide hydrochloride (oral route)


    Brand Name

    US Brand Name

    Librium

    Canadian Brand Name

    chlordiazePOXIDE


    Description

    Chlordiazepoxide is used to relieve symptoms of anxiety, including nervousness or anxiety that happens before a surgery. It may also be used to treat symptoms of alcohol withdrawal.

    Chlordiazepoxide is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Capsule

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of chlordiazepoxide in children below 6 years of age. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of chlordiazepoxide in the elderly. However, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of chlordiazepoxide. Elderly patients may require a lower dose to help reduce unwanted effects.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Flumazenil

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Alfentanil
    • Alprazolam
    • Amobarbital
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Benzhydrocodone
    • Bromazepam
    • Bromopride
    • Buprenorphine
    • Butabarbital
    • Butalbital
    • Butorphanol
    • Calcium Oxybate
    • Cannabidiol
    • Cannabis
    • Carbinoxamine
    • Carisoprodol
    • Cetirizine
    • Chloral Hydrate
    • Chlorzoxazone
    • Clobazam
    • Clonazepam
    • Codeine
    • Dantrolene
    • Daridorexant
    • Dexmedetomidine
    • Diazepam
    • Dihydrocodeine
    • Doxylamine
    • Esketamine
    • Ethchlorvynol
    • Fentanyl
    • Flibanserin
    • Fospropofol
    • Gabapentin
    • Gabapentin Enacarbil
    • Hydrocodone
    • Hydromorphone
    • Ivacaftor
    • Ketamine

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Ketoconazole
    • Rifapentine
    • St John's Wort
    • Theophylline

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Kidney disease or
    • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
    • Porphyria (genetic disorder)—Use with caution. May make this condition worse.

    Proper Use

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (capsules):
      • For anxiety:
        • Adults—5 to 25 milligrams (mg) three or four times a day.
        • Older adults—5 milligrams (mg) two to four times a day.
        • Children 6 years of age and older—At first, 5 milligrams (mg) two to four times a day. Your doctor may increase your dose if needed.
        • Children younger than 6 years of age—Use and dose must be determined by your doctor.
      • For apprehension and anxiety before a surgery:
        • Adults—5 to 10 milligrams (mg) three or four times a day, taken several days before the surgery.
        • Children—Use and dose must be determined by your doctor.
      • For symptoms of alcohol withdrawal:
        • Adults—At first, 50 to 100 milligrams (mg). The dose may be repeated until agitation is controlled. However, the dose is usually not more than 300 mg per day.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

    Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

    This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

    This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

    If you develop any unusual and strange thoughts or behavior while you are taking chlordiazepoxide, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

    Do not stop taking it without checking with your doctor first.. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), stomach or muscle cramps, tremors, or unusual behavior.

    This medicine is for short-term use only (usually 7 to 10 days). If your condition does not improve or if it becomes worse, check with your doctor.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Rare

    • Fainting
    • mood or mental changes
    • shakiness and unsteady walk
    • unsteadiness, trembling, or other problems with muscle control or coordination

    Incidence not known

    • Abdominal and muscle cramps
    • chills
    • clay-colored stools
    • convulsions
    • cough or hoarseness
    • dark urine
    • difficulty in speaking
    • dizziness
    • drooling
    • fever with or without chills
    • general feeling of tiredness or weakness
    • headache
    • itching
    • light-colored stools
    • loss of appetite
    • loss of balance control
    • lower back or side pain
    • muscle trembling, jerking, or stiffness
    • nausea and vomiting
    • painful or difficult urination
    • pale skin
    • rash
    • restlessness
    • shakiness in the legs, arms, hands, or feet
    • shuffling walk
    • sleeplessness
    • sore throat
    • sores, ulcers, or white spots on the lips or in the mouth
    • stiffness of the limbs
    • stomach pain
    • sweating
    • swelling
    • trouble sleeping
    • twisting movements of the body
    • unable to sleep
    • uncontrolled movements, especially of the face, neck, and back
    • unpleasant breath odor
    • unusual bruising or bleeding
    • unusual tiredness or weakness
    • vomiting of blood
    • yellow eyes or skin

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

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

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Incidence not known

    • Decreased interest in sexual intercourse
    • difficulty having a bowel movement (stool)
    • inability to have or keep an erection
    • increased in sexual ability, desire, drive, or performance
    • increased interest in sexual intercourse
    • loss in sexual ability, desire, drive, or performance
    • menstrual changes
    • skin blisters

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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