Brand Name
Librax
Generic Name
Clidinium
View Brand Information FDA approval date: September 01, 1966
Classification: Anticholinergic
Form: Capsule
What is Librax (Clidinium)?
Living with digestive problems like irritable bowel syndrome (IBS) or peptic ulcers can be a painful and frustrating experience. The persistent stomach cramps, bloating and discomfort can disrupt your daily life. Often, these physical symptoms are made worse by stress and anxiety, creating a difficult cycle where the mind and the gut seem to be working against each other. For people caught in this cycle, a medication that addresses both issues can be a source of significant relief. This is where Librax comes in.
Librax is a well-established prescription medication combining chlordiazepoxide (a benzodiazepine for anxiety) and clidinium bromide (an anticholinergic for stomach acid and spasms). It treats stomach and intestinal disorders often linked to emotional distress.
Because of its dual-action formula, Librax is typically prescribed as an adjunctive therapy, meaning it is used alongside other treatments like diet changes, when physical and emotional symptoms are intertwined.
What does Librax do?
Librax is primarily prescribed to help manage a range of gastrointestinal (GI) conditions where anxiety is a contributing factor. Its goal is to calm both the mind and the digestive system to provide comprehensive symptom relief.
It is used in the treatment of:
- Irritable Bowel Syndrome (IBS): Helps to reduce abdominal cramps, pain and the anxiety that can trigger IBS flare-ups.
- Peptic Ulcers: Used as part of a broader treatment plan to decrease stomach acid and painful muscle spasms, which can help ulcers heal.
- Acute Enterocolitis: Helps to manage inflammation of the small intestine and colon by reducing spasms and cramping.
Librax reduces GI discomfort, worry and tension by breaking the cycle of anxiety worsening stomach problems and vice versa.
How does Librax work?
Librax provides its benefits through the distinct actions of its two active ingredients, which work on different systems in the body.
The first component, chlordiazepoxide, works on the central nervous system. It belongs to the benzodiazepine family of drugs, which enhance the effects of a natural calming chemical in the brain called gamma-aminobutyric acid (GABA). Think of GABA as the brain’s “brake pedal.” By making this brake pedal more effective, chlordiazepoxide slows down excessive nerve activity, leading to a reduction in anxiety and a sense of relaxation.
The second component, clidinium bromide, works directly on the digestive tract. As an anticholinergic, it blocks the action of a neurotransmitter called acetylcholine. Acetylcholine acts like a “go signal” for the muscles in your gut, telling them to contract and for your stomach to produce acid. By blocking this signal, clidinium helps to relax the intestinal muscles, which eases cramping and spasms. It also helps to reduce the amount of stomach acid, which is beneficial for conditions like peptic ulcers.
This two-pronged approach is what makes Librax clinically effective for conditions where the brain-gut connection plays a significant role.
Librax side effects
Because Librax is a combination of two different types of drugs, it carries the potential side effects of both. The most significant risks are associated with chlordiazepoxide, the benzodiazepine component.
Common side effects may include:
- Drowsiness, dizziness or fatigue
- Dry mouth
- Blurred vision
- Constipation
- Nausea
- Confusion, especially in older adults
Librax can cause physical dependence, abuse and withdrawal due to its benzodiazepine component. This risk increases with long-term or high-dose use. Never stop Librax suddenly after prolonged use; your doctor will create a tapering plan to prevent severe withdrawal.
Avoid Librax with glaucoma, enlarged prostate or bladder neck obstruction due to clidinium. Do not mix with alcohol or CNS depressants to prevent extreme drowsiness and slowed breathing. Do not drive or operate machinery until you know its effects. Seek immediate medical help for allergic reactions, severe confusion, depression, or suicidal thoughts (U.S. Food and Drug Administration, 2016).
Librax dosage
Librax is available as an oral capsule. It is typically taken before meals and at bedtime to help manage symptoms throughout the day and night. Your doctor will determine the right dose for you and will likely prescribe the lowest effective dose for the shortest possible duration to minimize the risk of dependence.
Given that Librax contains a benzodiazepine, which is a controlled substance, its use requires careful medical supervision. Your doctor will monitor your response to the medication and assess the ongoing need for it. For older adults, doctors often prescribe a lower dose, as they can be more sensitive to the sedative and cognitive side effects. Periodic blood tests may be ordered during long-term therapy to check liver and blood cell counts (National Institutes of Health, 2017).
Does Librax have a generic version?
Yes, Librax is available as a generic medication. The generic version contains the same active ingredients in the same amounts: chlordiazepoxide and clidinium bromide. The FDA requires that generic drugs meet the same rigorous standards for safety, efficacy, and quality as the brand-name product. Opting for the generic version is a common way to make the treatment more affordable while receiving the same therapeutic benefit.
Conclusion
Librax offers a unique, dual-action approach for managing difficult gastrointestinal conditions where stress and anxiety play a significant role. By simultaneously calming the central nervous system and relaxing the muscles of the gut, it can provide effective relief from both physical and emotional symptoms.
However, because it contains a benzodiazepine, Librax must be used with caution and strictly as prescribed by a qualified healthcare provider. The risks of dependence and side effects mean that it is not suitable for everyone and is intended for short-term or intermittent use. Open communication with your doctor about your symptoms, concerns, and any side affects your experience is essential for using this medication safely and effectively as part of your overall health journey.
References
- National Institutes of Health. (2017). Chlordiazepoxide and Clidinium. MedlinePlus. https://medlineplus.gov/druginfo/meds/a601026.html
- U.S. Food and Drug Administration. (2016). LIBRAX (chlordiazepoxide hydrochloride and clidinium bromide) Label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012246s051lbl.pdf
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Brand Information
Librax (Chlordiazepoxide Hydrochloride and Clidinium Bromide)
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS
- 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
- The use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Librax, 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 Librax and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see
- The continued use of benzodiazepines, including Librax, 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 Librax 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 Librax or reduce the dosage (see
1DESCRIPTION:
Librax capsules is a fixed-combination of chlordiazepoxide hydrochloride, a benzodiazepine, and clidinium bromide, an anticholinergic.
Each Librax capsule contains the active ingredients 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains the inactive ingredients corn starch, lactose monohydrate, talc, methylparaben, propylparaben, potassium sorbate, D&C Yellow No. 10, FD&C Green No. 3, titanium dioxide, and gelatin.
Chlordiazepoxide hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of chlordiazepoxide hydrochloride is as follows:
Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have antispasmodic and antisecretory effects on the gastrointestinal tract.
Structurally clidinium bromide is:
2ANIMAL PHARMACOLOGY AND/OR ANIMAL TOXICOLOGY:
Effects on Reproduction
Reproduction studies in rats fed chlordiazepoxide hydrochloride, 10, 20 and 80 mg/kg daily (2.4, 4.8 and 19.4 times, respectively, the maximum recommended clinical dose of 40 mg/day, based on body surface area), and bred through one or two matings showed no congenital anomalies, nor were there adverse effects on growth of the newborn. However, in another study at 100 mg/kg daily there was noted a significant decrease in the fertilization rate and a marked decrease in the viability and body weight of offspring which may be attributable to sedative activity, thus resulting in lack of interest in mating and lessened maternal nursing and care of the young. One neonate in each of the first and second matings in the rat reproduction study at the 100 mg/kg dose (24.2 times the maximum recommended human dose of 40 mg/day, based on body surface area) exhibited major skeletal defects.
Reproduction studies in rats fed chlordiazepoxide hydrochloride, 10, 20 and 80 mg/kg daily (2.4, 4.8 and 19.4 times, respectively, the maximum recommended clinical dose of 40 mg/day, based on body surface area), and bred through one or two matings showed no congenital anomalies, nor were there adverse effects on growth of the newborn. However, in another study at 100 mg/kg daily there was noted a significant decrease in the fertilization rate and a marked decrease in the viability and body weight of offspring which may be attributable to sedative activity, thus resulting in lack of interest in mating and lessened maternal nursing and care of the young. One neonate in each of the first and second matings in the rat reproduction study at the 100 mg/kg dose (24.2 times the maximum recommended human dose of 40 mg/day, based on body surface area) exhibited major skeletal defects.
Two series of reproduction experiments with clidinium bromide were carried out in rats, employing dosages of 2.5 and 10 mg/kg daily (1.2 and 4.9 times, respectively, the maximum recommended clinical dose of 20 mg/day, based on body surface area) in each experiment. In the first experiment, clidinium bromide was administered for a 9-week interval prior to mating; no untoward effect on fertilization or gestation was noted. The offspring were taken by caesarean section and did not show a significant incidence of congenital anomalies when compared to control animals. In the second experiment, adult animals were given clidinium bromide for 10 days prior to and through two mating cycles. No significant effects were observed on fertility, gestation, viability of offspring or lactation, as compared to control animals, nor was there a significant incidence of congenital anomalies in the offspring derived from these experiments.
A reproduction study was carried out in rats through two successive matings with administration of oral daily doses of 2.5 mg/kg chlordiazepoxide hydrochloride and 1.25 mg/kg clidinium bromide (0.6 times the maximum recommended clinical dose for both drugs, based on body surface area) or 25 mg/kg chlordiazepoxide hydrochloride and 12.5 mg/kg clidinium bromide (6.1 times the maximum recommended clinical dose for both drugs, based on body surface area). In the first mating, no significant differences were noted between the control or the treated groups, with the exception of a slight decrease in the number of animals surviving during lactation among those receiving the high dosage. In the second mating, similar results were obtained except for a slight decrease in the number of pregnant females and in the percentage of offspring surviving until weaning. No congenital anomalies were observed in both matings in either the control or treated groups.
3INDICATIONS AND USAGE:
Librax is indicated to control emotional and somatic factors in gastrointestinal disorders. Librax 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.
4CONTRAINDICATIONS:
Librax is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide.
5WARNINGS:
Risks From Concomitant Use with Opioids
Concomitant use of benzodiazepines, including Librax, 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 Librax 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 Librax is used with opioids (see
Abuse, Misuse, and Addiction
The use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Librax, 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
Before prescribing Librax and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of Librax, 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 Librax or reduce the dosage (a patient-specific plan should be used to taper the dosage) (see
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 Librax, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of Librax after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see
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
Effects on the Ability to Drive or Operate Machinery
As in the case of other preparations containing CNS-acting drugs, patients receiving Librax 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.
Neonatal Sedation and Withdrawal Syndrome
Use of benzodiazepines late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate (see PRECAUTIONS, Pregnancy). Monitor neonates exposed to Librax, which contains a benzodiazepine (chlordiazepoxide hydrochloride), during pregnancy and labor for signs of sedation and monitor neonates exposed to Librax during pregnancy for signs of withdrawal; manage these neonates accordingly.
Use of benzodiazepines late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate (see PRECAUTIONS, Pregnancy). Monitor neonates exposed to Librax, which contains a benzodiazepine (chlordiazepoxide hydrochloride), during pregnancy and labor for signs of sedation and monitor neonates exposed to Librax during pregnancy for signs of withdrawal; manage these neonates accordingly.
6PRECAUTIONS:
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 Librax capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Librax 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 Librax 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.
6.1Information for Patients
Abuse, Misuse, and Addiction
Inform patients that the use of Librax, 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
Withdrawal Reactions
Inform patients that the continued use of Librax may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Librax 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 Librax may require a slow taper (see
Concomitant Use with Opioids and Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if Librax is used with opioids or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider (see
Pregnancy
Advise pregnant females that use of Librax late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and /or withdrawal symptoms (hyperreflexia, irritability, restlessness,
Advise pregnant females that use of Librax late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and /or withdrawal symptoms (hyperreflexia, irritability, restlessness,
tremors, inconsolable crying, and feeding difficulties) in newborns (see
Nursing
Instruct patients to notify their healthcare provider if they are breastfeeding or intend to breastfeed (see
6.2Drug Interactions
Opioids
The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Librax, 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
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 Librax 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 Librax.
Pregnancy
Risk Summary
Chlordiazepoxide Hydrochloride
Risk Summary
Chlordiazepoxide Hydrochloride
Neonates born to mothers using benzodiazepines during the later stages of pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal (see
Clidinium Bromide
Over decades of use, there is an absence of published data on orally administered clidinium bromide in pregnant women, including an absence of any reports of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Fetal/Neonatal Adverse Reactions
Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia and sedation in neonates. Monitor neonates exposed to Librax, which contains a benzodiazepine (chlordiazepoxide hydrochloride), during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to Librax during pregnancy for signs of withdrawal. Manage these neonates accordingly (see
Data
Human Data
Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol. Tobacco and other medications, have not confirmed these findings.
Animal Data
Oral daily doses of 2.5 mg/kg chlordiazepoxide hydrochloride with 1.25 mg/kg clidinium bromide or 25 mg/kg chlordiazepoxide hydrochloride with 12.5 mg/kg clidinium bromide (0.6 and 6.1 times, respectively, the maximum recommended clinical dose for both drugs, based on body surface area) were administered to rats in a reproduction study through two successive matings. In the first mating, no significant differences were noted between the control or the treated groups, with the exception of a slight decrease in the number of animals surviving during lactation among those receiving the highest dosage. In the second mating, similar results were obtained except for a slight decrease in the number of pregnant females and in the percentage of offspring surviving until weaning. No congenital anomalies were observed in both matings in either the control or treated groups.
Nursing Mothers
Chlordiazepoxide Hydrochloride
There are no data on the presence of chlordiazepoxide in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. However, there are reports of sedation, poor feeding and poor weight gain in infants exposed to other benzodiazepines through breast milk. Reproduction studies in rats fed chlordiazepoxide hydrochloride, 10, 20 and 80 mg/kg daily (2.4, 4.8 and 19.4 times respectively, the maximum recommended clinical dose of 40 mg/day, based on body surface area), and bred through one or two matings showed no adverse effects on lactation of the dams.
Clidinium Bromide
There are no data on the presence of clidinium in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. As with other anticholinergic drugs, clidinium may cause suppression of lactation.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Librax and any potential adverse effects on the breastfed infant from Librax. Infants exposed to Librax through breast milk should be monitored for sedation, poor feeding and poor weight gain.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
6.3Geriatric Use
Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Librax. 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
7ADVERSE REACTIONS:
No side effects or manifestations not seen with either compound alone have been reported with the administration of Librax. However, since Librax 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 Librax 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 Librax therapy has been combined with other spasmolytic agents and/or a low residue diet.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
8DRUG ABUSE AND DEPENDENCE:
Controlled Substance
Librax contains chlordiazepoxide hydrochloride, a Schedule IV controlled substance and clidinium bromide, which is not a controlled substance. Librax is exempted from Schedule IV and is not controlled under the Controlled Substances Act.
Abuse
Chlordiazepoxide hydrochloride, a component of Librax, is a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction.
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. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see
The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol).
Dependence
Physical Dependence
Librax may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see
To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Librax or reduce the dosage (see
Acute Withdrawal Signs and Symptoms
Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality.
Protracted Withdrawal Syndrome
Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.
Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.
Tolerance
Tolerance to Librax may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effects of Librax may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.
OVERDOSAGE
Overdosage of Librax, which contains a benzodiazepine (chlordiazepoxide hydrochloride) and an anticholinergic (clidinium bromide) may manifest signs and symptoms related to either of its components, although some effects such as altered levels of consciousness may be synergistic. Overdosage of benzodiazepines, such as chlordiazepoxide hydrochloride, is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma.
Signs and symptoms of anticholinergic overdosage are related to excessive anti-muscarinic anticholinergic activity. Peripheral signs and symptoms may include dry mucous membranes and skin, flushing, tachycardia, hypertension, ileus, urinary retention, and mydriasis. Garbled speech is often pathognomonic. Central signs and symptoms may include agitation and delirium, seizures, and hyperthermia. Benzodiazepines are considered a first-line treatment for anticholinergic toxicity acting to treat mild to moderate agitation and prevent seizures.
Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see
Flumazenil, a specific benzodiazepine receptor antagonist is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage. Use of flumazenil may increase the risk of seizures in mixed overdosage with drugs that may precipitate seizures, including anticholinergic medications. Benzodiazepines are used to treat agitated delirium from anticholinergic toxicity. Therefore flumazenil administration may worsen the anticholinergic delirium and should generally be avoided.
Anticholinesterase inhibitors may reverse severe agitated delirium that is not controlled by benzodiazepines. They may also improve the airway and breathing in CNS depressed patients. Caution is warranted especially in mixed drug overdoses.
Consider contacting a poison center (1-800-222-1222) or a medical toxicologist for overdosage management recommendations.
9DOSAGE AND ADMINISTRATION:
Recommended Dosage
Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Librax 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 Librax capsules per day, to be increased gradually as needed and tolerated. Elderly patients have an increased risk of dose-related adverse reactions (see
Discontinuation or Dosage Reduction of Librax
To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Librax 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
10HOW SUPPLIED:
Librax is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide in bottles of 100 (NDC 0187-4100-10), with “LIBRAX® ICN” imprinted on the body of the capsule.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Keep out of reach of children.
Dispense in tight, light-resistant container as defined in USP/NF.
Distributed by:Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Bridgewater, NJ 08807 USA
Manufactured by:Bausch Health Companies Inc.
Steinbach, MB R5G 1Z7, Canada
Steinbach, MB R5G 1Z7, Canada
LIBRAX is a trademark of Bausch Health Companies Inc. or its affiliates.
© 2023 Bausch Health Companies Inc. or its affiliates
Revised: 01/2023
9548904
11Medication Guide
- This Medication Guide has been approved by the U.S. Food and Drug Administration.
- Revised: 01/2023
12PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - Label
NDC 0187-4100-10
Rx only
Librax®
(chlordiazepoxide hydrochloride
5 mg
and
2.5 mg
and
2.5 mg
100 Capsules
Each capsule contains 5 mg chlordiazepoxide hydrochloride
MEDICATION GUIDE TO BE DISPENSED
WITH EACH PRESCRIPTION
WITH EACH PRESCRIPTION
BAUSCH Health
9581702
