Librium

Name: Librium

Librium Precautions

Serious side effects have been reported with Librium including the following:

  • paradoxical reactions. Tell your healthcare provider right away if you are experiencing any of the following symptoms of a paradoxical reaction:
    • excitement
    • increased stimulation
    • sudden feelings of rage
  • behavioral changes. All patients being treated with Librium should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when increasing or decreasing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients who show symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, or abrupt in onset. Families and caregivers of patients should be alerted about the need to monitor patients daily. In addition,
    • pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
  • psychological and physical dependence. It is recommended that you talk with your doctor before either increasing the dose or abruptly stopping use of this drug.
  • withdrawal side effects. To avoid these side effects, do not suddenly stop taking this medication. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether. Tell your healthcare provider right away if you have any or all of the following symptoms:
    • feeling generally unwell or uneasy
    • insomnia
    • shakes
    • tremors
    • stomach cramps
    • muscle cramps
    • vomiting
    • sweating

Librium can cause drowsiness. Do not drive or operate heavy machinery until you know how Librium affects you.

Do not take Librium if you are allergic to Librium or to any of its ingredients.

Inform MD

Before taking Librium, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Librium or to any of its ingredients
  • have a condition called porphyria
  • have a bleeding disorder
  • have glaucoma
  • have a history of seizures
  • have lung problems
  • have heart problems
  • have liver problems
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Librium and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

The category for Librium is unknown. However, an increased risk of malformations linked with the use of Librium 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.

Librium and Lactation

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

It is not known if Librium 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 Librium.

Interactions for Librium

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Antacids (aluminum- and magnesium-containing)

Possible decrease in rate, but not extent, of chlordiazepoxide absorption b

Anticoagulants, oral

Manufacturers state that variable effects on coagulation have been reported;b c e however, several studies found no clinically important effect on hypoprothrombinemiab

Cimetidine

Possible decreased clearance and increased plasma concentrations of chlordiazepoxide

Use with caution; consider reduction of chlordiazepoxide dosage

CNS depressants (e.g., alcohol, anticonvulsants, psychotropic drugs, sedatives)

Additive CNS effectb c d

Use caution to avoid overdosageb

Concomitant use of chlordiazepoxide with other psychotropic agents generally is not recommendedc d

Disulfiram

Reduced plasma clearance and increased plasma half-life of chlordiazepoxide

Reduce chlordiazepoxide dosage as necessary

Levodopa

Possible decreased control of parkinsonian symptomsb

Use with cautionb

Test for pregnancy (Gravindex test)

Possible false-positive reaction b

Tests for urinary alkaloids

Possible interference with Frings thin layer chromatography procedure, resulting in falsely elevated readings b

Tests for urinary 17-ketosteroids

Possible interference with Zimmerman reaction, resulting in falsely elevated or decreased concentrationsb

Uses For Librium

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.

Precautions While Using Librium

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.

Precautions

In elderly and debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (10 mg or less per day initially, to be increased gradually as needed and tolerated).  In general, the concomitant administration of Librium 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 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, eg, excitement, stimulation and acute rage, have been reported in psychiatric patients and in hyperactive aggressive pediatric patients, and should be watched for during Librium therapy.  The usual precautions are indicated when Librium 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.  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 Librium.  In view of isolated reports associating chlordiazepoxide with exacerbation of porphyria, caution should be exercised in prescribing chlordiazepoxide to patients suffering from this disease.

Pediatric Use

Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required (see DOSAGE AND ADMINISTRATION).  Since clinical experience with Librium in pediatric patients under 6 years of age is limited, use in this age group is not recommended.  Hyperactive aggressive pediatric patients should be monitored for paradoxical reactions to Librium (see PRECAUTIONS).

Information for Patients

To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

Drug Abuse and Dependence

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 (eg, 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.

PRINCIPAL DISPLAY PANEL - 5 mg Bottle Label

NDC 0187-3750-10
Rx Only

Librium® CIV
(chlordiazepoxide HCl)

5 mg
100 Capsules

Each capsule
contains 5 mg
chlordiazepoxide
HCl

VALEANT™

For the Consumer

Applies to chlordiazepoxide: oral capsule, oral tablet

Along with its needed effects, chlordiazepoxide (the active ingredient contained in Librium) 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 while taking chlordiazepoxide:

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 while taking chlordiazepoxide:

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

Some side effects of chlordiazepoxide 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

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