Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg; 2.5 mg Capsule, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Anticholinergic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
The combination of chlordiazepoxide and clidinium is used along with other medications to treat peptic ulcers, irritable bowel syndrome (IBS; a condition that causes stomach pain, bloating, constipation, and diarrhea), and enterocolitis (swelling in the intestines). Chlordiazepoxide is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain. Clidinium is in a class of medications called anticholinergics. It helps to decrease stomach spasms and cramps.
Read the full MedlinePlus article ↗- It combines two drugs in one capsule to tackle digestive problems from two directions. One ingredient — chlordiazepoxide — calms the anxiety and tension that often make gut symptom...
- What exactly is this medication supposed to do for me?
- No — please avoid alcohol entirely while you're on this medication. Both alcohol and this drug slow down your central nervous system, and combining them greatly increases the risk...
- Yes, drowsiness is one of the most common side effects — especially when you first start or if your dose is adjusted. It tends to be more noticeable in older adults. Avoid driving...
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Supplement & herbal interactions
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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.
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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 3P3ONR6O1S
A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
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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 EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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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.
7 inactive ingredients listed in the exact product block matched to this NDC.
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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 | $0.255 | $25.45 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $0.4711 | $47.11 / 100 capsules |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 11534-0197-01 You're viewing this | 100 CAPSULE in 1 BOTTLE (11534-197-01) | 2020-07-09 | 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 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 WARNINGS and PRECAUTIONS and PRECAUTIONS , Drug Interactions ). • The use of benzodiazepines, including chlodiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide 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 and Clidinium Bromide Capsules and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). • The continued use of benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide 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 and Clidinium Bromide 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 and Clidinium Bromide Capsules or reduce the dosage (see WARNINGS and DOSAGE AND ADMINISTRATION ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Recommended Dosage Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules vary 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide capsules per day, to be increased gradually as needed and tolerated. Elderly patients have an increased risk of dose-related adverse reactions (see PRECAUTIONS ).
Discontinuation or Dosage Reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules 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 WARNINGS and DRUG ABUSE AND DEPENDENCE ).
⛔ Contraindications ▾
CONTRAINDICATIONS Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are 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.
⚠️ Warnings ▾
WARNINGS Risks From Concomitant Use with Opioids Concomitant use of benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are used with opioids (see PRECAUTIONS ). Abuse, Misuse, and Addiction The use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, 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 ). Before prescribing Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool).
Use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules 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 Hydrochloride and Clidinium Bromide Capsules or reduce the dosage (a patient-specific plan should be used to taper the dosage) (see DOSAGE AND ADMINISTRATION ). 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 Hydrochloride and Clidinium Bromide Capsules, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules 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 ). 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 ).
Effects on the Ability to Drive or Operate Machinery As in the case of other preparations containing CNS-acting drugs, patients receivin…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS No side effects or manifestations not seen with either compound alone have been reported with the administration of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules. However, since Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules contain 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules therapy has been combined with other spasmolytic agents and/or a low residue diet. To report SUSPECTED ADVERSE REACTIONS, contact Sunrise Pharmaceutical, Inc. at 732-382-6085 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug Interactions Opioids The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules. 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 DOSAGE AND ADMINISTRATION ).
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction (see CONTRAINDICATIONS ).
🆘 Overdosage ▾
OVERDOSAGE Manifestations of chlordiazepoxide hydrochloride overdosage include somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following chlordiazepoxide hydrochloride overdosage. While the signs and symptoms of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules overdosage may be produced by either of its components, usually such symptoms will be overshadowed by the anticholinergic actions of clidinium bromide.
The symptoms of overdosage of clidinium bromide are excessive dryness of mouth, blurring of vision, urinary hesitancy and constipation. General supportive measures should be employed, along with immediate gastric lavage. Administer physostigmine 0.5 to 2 mg at a rate of no more than 1 mg per minute.
This may be repeated in 1 to 4 mg doses if arrhythmias, convulsions or deep coma recur. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol.
Methylphenidate or caffeine and sodium benzoate may be given to combat CNS-depressive effects. Dialysis is of limited value. Should excitation occur, barbiturates should not be used.
As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested. Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE ).
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are available in light green opaque cap and light green opaque body containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide, in bottle of 100 (NDC 11534-197-01), with black imprint “N36” on both the cap and body. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep out of reach of children.
Dispense in a tight, light-resistant container as defined in USP/NF. Manufactured by: Sunrise Pharmaceutical, Inc. Rahway, NJ 07065 5355/00 Rev.
07/2021
📋 Description ▾
DESCRIPTION Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules is a fixed-combination of chlordiazepoxide hydrochloride, a benzodiazepine, and clidinium bromide, an anticholinergic. Each Chlordiazepoxide Hydrochloride and Clidinium Bromide 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, 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 a antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally clidinium bromide is: image description image description
💬 Information for Patients ▾
Information for Patients Abuse, Misuse, and Addiction Inform patients that the use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, 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 WARNINGS ).
Withdrawal Reactions Inform patients that the continued use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules may require a slow taper (see WARNINGS and DRUG ABUSE AND DEPENDENCE ). Concomitant Use With Opioids and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules is used with opioids or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider (see WARNINGS and PRECAUTIONS , Drug Interactions ).
💬 Medication Guide ▾
MEDICATION GUIDE Chlordiazepoxide Hydrochloride and Clidinium Bromide (klor dye az e POKS ide hahy druh klohr id & kli DI nee um broh myde) Capsules, USP for oral use What is the most important information I should know about Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules? Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules contain a benzodiazepine medicine. Taking Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules with opioid medicines, alcohol, or other central nervous system (CNS) depressants (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 Hydrochloride and Clidinium Bromide Capsules with opioids affect you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, which can lead to overdose or death.
Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules. 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 Hydrochloride and Clidinium Bromide Capsules as prescribed by your healthcare provider. Take Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules exactly as your healthcare provider prescribed. Do not share your Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules with other people.
Keep Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules in a safe place and away from children. Physical dependence and withdrawal reactions. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules can cause physical dependence and withdrawal reactions.
Do not suddenly stop using Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules. Stopping Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules 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 twitches, 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 Hydrochloride and Clidinium Bromide Capsules than prescribed or take Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules for longer than prescribed. What are Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules? Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are prescription medicine that is used with other therapies for the treatment of: stomach (peptic) ulcers irritable bowel syndrome (IBS) inflammation of the colon called acute enterocolitis C…