Chlordiazepoxide Hydrochloride 25 mg Capsule, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Benzodiazepine class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Chlordiazepoxide is used to relieve anxiety and to control agitation caused by alcohol withdrawal. Chlordiazepoxide is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain.
Read the full MedlinePlus article ↗- Chlordiazepoxide is mainly used for three things: managing anxiety disorders, easing the symptoms of going through alcohol withdrawal, and calming pre-surgery anxiety. It's not mea...
- What exactly is chlordiazepoxide used for?
- Please don't stop on your own — this is one of the most important things to know about this medicine. Your body can become physically dependent on chlordiazepoxide, and stopping su...
- Can I stop taking it whenever I want if I feel better?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII CQ3XH3DET6
D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
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UNII 4AQJ3LG584
A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII Z82Y2C65EA
Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.160 | $15.99 / 100 capsule |
| Medicaid paysCMS SDUD · 12 mo | $1.02 | $101.87 / 100 capsule |
| Medicare drug plans payPart D · Q2 2026 | $0.2924 | $29.24 / 100 capsule |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Chlordiazepoxide Hydrochloride 25 mg 00555-0159-02 | Teva | 100 capsules | $0.160 | AB | Availability likely | — |
| Chlordiazepoxide Hydrochloride 25 mg 42806-0563-01 | Epic | 100 capsules | $0.160 | AB | Availability likely | — |
| Chlordiazepoxide Hydrochloride 25 mg 42806-0566-01 | Epic | 100 capsules | $0.160 | AB | Availability likely | — |
| Chlordiazepoxide Hydrochloride 25 mg 51079-0141-20 | Mylan | 100 capsules | $0.160 | AB | Availability likely | — |
| Chlordiazepoxide Hydrochloride 25 mgthis 60687-0807-01 | American | 100 capsules | $0.160 | AB | Availability likely | — |
| Chlordiazepoxide Hydrochloride 25 mg 62135-0222-60 | Chartwell | 60 capsules | $0.160 | AB | Availability likely | — |
| Chlordiazepoxide Hydrochloride 25 mg 43063-0046-03 | PD-Rx | 3 capsules | — | AB | FDA listed | — |
| Chlordiazepoxide Hydrochloride 25 mg 48433-0020-20 | Safecor | 100 capsules | — | AB | FDA listed | — |
| Chlordiazepoxide Hydrochloride 25 mg 58118-1590-08 | Clinical | 30 capsules | — | AB | FDA listed | — |
| Chlordiazepoxide Hydrochloride 25 mg 67046-0910-03 | Couper | 30 capsules | — | AB | FDA listed | — |
| Chlordiazepoxide Hydrochloride 25 mg 68071-5171-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Chlordiazepoxide Hydrochloride 25 mg 68071-5256-06 | NuCare | 6 capsules | — | AB | FDA listed | — |
| Chlordiazepoxide Hydrochloride 25 mg 70518-0015-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Chlordiazepoxide Hydrochloride 25 mg 70518-0157-01 | REMEDYREPACK | 100 capsules | — | AB | Discontinued | — |
| Chlordiazepoxide Hydrochloride 25 mg 87441-0015-01 | Unit | 30 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60687-0807-01 You're viewing this | 100 BLISTER PACK in 1 CARTON (60687-807-01) / 1 CAPSULE in 1 BLISTER PACK (60687-807-11) | 2024-07-03 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 for 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 WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including chlordiazepoxide hydrochloride capsules, 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 chlordiazepoxide hydrochloride capsules and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including chlordiazepoxide hydrochloride capsules, 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 chlordiazepoxide hydrochloride capsules 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 chlordiazepoxide hydrochloride capsules or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies.
The physician should periodically reassess the usefulness of the drug for the individual patient.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Because of the wide range of clinical indications for chlordiazepoxide HCl, the optimum dosage varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. ADULTS USUAL DAILY DOSE Relief of Mild and Moderate Anxiety Disorders and Symptoms of Anxiety 5 mg or 10 mg, 3 or 4 times daily Relief of Severe Anxiety Disorders and Symptoms of Anxiety 20 mg or 25 mg, 3 or 4 times daily Geriatric Patients , or in the presence of debilitating disease.
5 mg, 2 to 4 times daily Preoperative Apprehension and Anxiety On days preceding surgery, 5 to 10 mg orally, 3 or 4 times daily. If used as preoperative medication, 50 to 100 mg IM 1 hour prior to surgery. PEDIATRIC PATIENTS USUAL DAILY DOSE Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required.
Since clinical experience in pediatric patients under 6 years of age is limited, the use of the drug in this age group is not recommended. 5 mg, 2 to 4 times daily (may be increased in some pediatric patients to 10 mg, 2 to 3 times daily) For the relief of withdrawal symptoms of acute alcoholism, the parenteral form is usually used initially. If the drug is administered orally, the suggested initial dose is 50 to 100 mg, to be followed by repeated doses as needed until agitation is controlled up to 300 mg per day.
Dosage should then be reduced to maintenance levels. *See package insert for Sterile Chlordiazepoxide Hydrochloride. Discontinuation or Dosage Reduction of Chlordiazepoxide To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increase the dosage to the previous tapered dosage level.
Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence ).
⛔ Contraindications ▾
CONTRAINDICATIONS Chlordiazepoxide HCl capsules are contraindicated in patients with known hypersensitivity to the drug.
⚠️ Warnings ▾
WARNINGS Risks from Concomitant Use with Opioids 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 ). Abuse, Misuse, and Addiction The use of benzodiazepines, including chlordiazepoxide, 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 DRUG ABUSE AND DEPENDENCE: Abuse ) . Before prescribing chlordiazepoxide and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool).
Use of chlordiazepoxide, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of chlordiazepoxide 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 chlordiazepoxide or reduce the dosage (a patient-specific plan should be used to taper the dose) (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of chlordiazepoxide ). 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 chlordiazepoxide, may lead to clinically significant physical dependence.
Abrupt discontinuation or rapid dosage reduction of chlordiazepoxide after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE: Dependence ) . 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 DRUG ABUSE AND DEPENDENCE: Dependence ). Chlordiazepoxide HCl may impair the mental and/or physical…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 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 HCl treatment. Blood dyscrasias (including agranulocytosis), jaundice and hepatic dysfunction have occasionally been reported during therapy. When chlordiazepoxide HCl treatment is protracted, periodic blood counts and liver function tests are advisable.
To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.
🔄 Drug Interactions ▾
Drug Interactions 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 GABA A 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.
🤰 Pregnancy ▾
Pregnancy Advise pregnant females that use of chlordiazepoxide HCl 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 Warnings, Neonatal Sedation and Withdrawal Syndrome and Precautions , Pregnancy ). Instruct patients to inform their healthcare provider if they are pregnant. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to chlordiazepoxide HCl during pregnancy (see Precautions, Pregnancy ) .
Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including chlordiazepoxide HCl, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/ . Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal (see WARNINGS, Neonatal Sedation and Withdrawal Syndrome , and Clinical Considerations ) .
Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects ( see Data). 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 of 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 chlordiazepoxide HCl during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems.
Monitor neonates exposed to chlordiazepoxide HCl during pregnancy for signs of withdrawal. Manage these neonates accordingly (see WARNINGS, Neonatal Sedation and Withdrawal Syndrome ) . 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.
🧒 Pediatric Use ▾
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 chlordiazepoxide HCl 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 chlordiazepoxide HCl (see PRECAUTIONS ).
🆘 Overdosage ▾
Overdosage Overdosage of benzodiazepines 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. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS: Abuse, Misuse, and Addiction ). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage.
In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency.
The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage.
See the flumazenil injection Prescribing Information. Consider contacting a poison center (1-800-222-1222), poisoncontrol.org , or medical toxicologist for additional overdosage management recommendations.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Chlordiazepoxide HCl has antianxiety, sedative, appetite-stimulating and weak analgesic actions. The precise mechanism of action is not known. The drug blocks EEG arousal from stimulation of the brain stem reticular formation.
It takes several hours for peak blood levels to be reached and the half-life of the drug is between 24 and 48 hours. After the drug is discontinued plasma levels decline slowly over a period of several days. Chlordiazepoxide is excreted in the urine, with 1% to 2% unchanged and 3% to 6% as a conjugate.
Animal Pharmacology The drug has been studied extensively in many species of animals and these studies are suggestive of action on the limbic system of the brain, which recent evidence indicates is involved in emotional responses. Hostile monkeys were made tame by oral drug doses which did not cause sedation. Chlordiazepoxide HCl revealed a “taming” action with the elimination of fear and aggression.
The taming effect of chlordiazepoxide HCl was further demonstrated in rats made vicious by lesions in the septal area of the brain. The drug dosage which effectively blocked the vicious reaction was well below the dose which caused sedation in these animals. The LD 50 of parenterally administered chlordiazepoxide HCl was determined in mice (72 hours) and rats (5 days), and calculated according to the method of Miller and Tainter, with the following results: mice, IV, 123 ± 12 mg/kg; mice, IM, 366 ± 7 mg/kg; rats, IV, 120 ± 7 mg/kg; rats, IM, > 160 mg/kg.
Effects on Reproduction Reproduction studies in rats fed 10, 20 and 80 mg/kg daily and bred through one or two matings showed no congenital anomalies, nor were there adverse effects on lactation of the dams or 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 exhibited major skeletal defects. Further studies are in progress to determine the significance of these findings.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Chlordiazepoxide Hydrochloride Capsules USP, 25 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a white opaque body filled with white powder, imprinted in black ink “stylized barr” 159, available in Unit dose packages of 100 (10 x 10) NDC 60687-807-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Keep this and all medications out of the reach of children.
Dispense with Medication Guide To order more Medication Guides call American Health Packaging at 1‐800‐707‐4621.
📋 Description ▾
DESCRIPTION Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride, USP is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence.
Chlordiazepoxide hydrochloride, USP is 7-chloro-2-(methylamino)-5-phenyl-3 H -1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light.
The structural formula is: Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, FD&C blue no.
1 aluminum lake, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, propylene glycol, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10 aluminum lake, FD&C blue no.
2 aluminum lake, FD&C red no. 40 aluminum lake, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no.
33 and the 10 mg also contains FD&C red no. 40, povidone, and sodium hydroxide. Structural Formula
💬 Information for Patients ▾
Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide).
💬 Medication Guide ▾
MEDICATION GUIDE Dispense with Medication Guide To order more Medication Guides call American Health Packaging at 1‐800‐707‐4621. 8480701/0725 Chlordiazepoxide Hydrochloride (klorʺ dye azʺ e poxʹ ide hyeʺ droe klorʹ ide) Capsules, C-IV What is the most important information I should know about Chlordiazepoxide HCl? Chlordiazepoxide HCl is a benzodiazepine medicine.
Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (CNS) (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking Chlordiazepoxide HCl with opioids affects you. Risk of abuse, misuse, and addiction.
There is a risk of abuse, misuse, and addiction with benzodiazepines, including Chlordiazepoxide HCl, which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including Chlordiazepoxide HCl. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing.
Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. You can develop an addiction even if you take Chlordiazepoxide HCl exactly as prescribed by your healthcare provider. Take Chlordiazepoxide HCl exactly as your healthcare provider prescribed.
Do not share your Chlordiazepoxide HCl with other people. Keep Chlordiazepoxide HCl in a safe place and away from children. Physical dependence and withdrawal reactions .
Chlordiazepoxide HCl can cause physical dependence and withdrawal reactions, especially if you continue to take Chlordiazepoxide HCl for several days to several weeks. Do not suddenly stop taking Chlordiazepoxide HCl . Stopping Chlordiazepoxide HCl suddenly can cause serious and life-threatening side effects, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions.
Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms. Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months , including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. Physical dependence is not the same as drug addiction.
Your healthcare provider can tell you more about the differences between physical dependence and drug addiction. Do not take more Chlordiazepoxide HCl than prescribed or take Chlordiazepoxide HCl for longer than prescribed. What is Chlordiazepoxide HCl?
Chlordiazepoxide HCl is a prescription medicine used: to treat anxiety disorders for the short-term relief of the symptoms of anxiety to treat withdrawal symptoms of acute alcoholism preoperatively to treat apprehension and anxiety Chlordiazepoxide HCl is a federal controlled substance (C-IV) because it contains chlordiazepoxide that can be abused or lead to dependence. Keep Chlordiazepoxide HCl in a safe place to prevent misuse and abuse. Selling or giving away Chlordiazepoxide HCl may harm others, and is against the law.
Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs. It is not known if Chlordiazepoxide HCl is safe and effect…