CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

Chlordiazepoxide Hydrochloride and Clidinium Bromide by

Drug Labeling and Warnings

Chlordiazepoxide Hydrochloride and Clidinium Bromide by is a Prescription medication manufactured, distributed, or labeled by Xiromed, LLC, Misemer Pharmaceuticals, Inc., Belcher Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Safety and effectiveness in pediatric patients have not been established.

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).

  • 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 Xiromed, LLC at 1-844-XIROMED (1-844-947-6633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • DRUG ABUSE AND DEPENDENCE

    Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. General milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving chlordiazepoxide or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

    Controlled Substance

    Chlordiazepoxide hydrochloride and clidinium bromide capsules contain chlordiazepoxide hydrochloride, a Schedule IV controlled substance and clidinium bromide, which is not a controlled substance. Chlordiazepoxide hydrochloride and clidinium bromide capsules are exempted from Schedule IV and are not controlled under the Controlled Substances Act.

    Abuse

    Chlordiazepoxide hydrochloride, a component of chlordiazepoxide hydrochloride and clidinium bromide capsules, 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 WARNINGS).

    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

    Chlordiazepoxide hydrochloride and clidinium bromide capsules 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 WARNINGS).

    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).

    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.

    Tolerance

    Tolerance to chlordiazepoxide hydrochloride and clidinium bromide capsules 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 chlordiazepoxide hydrochloride and clidinium bromide capsules may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

  • 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 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 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 DRUGABUSE AND DEPENDENCE).

  • HOW SUPPLIED

    Chlordiazepoxide hydrochloride and clidinium bromide capsules are available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide in bottles of 100 capsules (NDC: 70700-185-01), with “VP302” imprinted on the cap 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.

    Manufactured for:
    Xiromed, LLC
    Florham Park, NJ 07932

    Made in the USA

    PI-185-00 Rev. 03/2021
    L41I-XIR, R-2103

  • MEDICATION GUIDE

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    PIL-185-00 Rev. 03/2021
    L41I-XIR, R-2103

    MEDICATION GUIDE
    Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules
    (klor´´ dye az´´ e pox´ ide hye´´ droe klor´ ide and kli din´ ee um broe´ mide)
    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 affects 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 a 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
    • Chlordiazepoxide hydrochloride and clidinium bromide capsules contain the medicines chlordiazepoxide HCl and clidinium bromide.
    • Chlordiazepoxide hydrochloride and clidinium bromide capsules contain chlordiazepoxide hydrochloride that can be abused or lead to dependence. Keep chlordiazepoxide hydrochloride and clidinium bromide capsules in a safe place to prevent misuse and abuse. Selling or giving away chlordiazepoxide hydrochloride and clidinium bromide capsules may harm others. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
    • It is not known if chlordiazepoxide hydrochloride and clidinium bromide capsules is safe and effective in children.

    Do not take chlordiazepoxide hydrochloride and clidinium bromide capsules if you:

    • have glaucoma
    • have an enlarged prostate
    • have a blockage of your bladder that causes problems with urination
    • are allergic to chlordiazepoxide hydrochloride or clidinium bromide

    Before you take chlordiazepoxide hydrochloride and clidinium bromide capsules, tell your healthcare provider about all of your medical conditions, including if you:

    • have eye problems
    • have problems urinating or emptying your bladder
    • have coordination problems
    • have kidney or liver problems
    • have a history of depression, mental illness, or suicidal thoughts
    • have a history of drug or alcohol abuse or addiction
    • have bleeding problems
    • are pregnant or plan to become pregnant. Chlordiazepoxide hydrochloride and clidinium bromide capsules may harm your unborn baby. Avoid taking chlordiazepoxide hydrochloride and clidinium bromide capsules during the first trimester of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment with chlordiazepoxide hydrochloride and clidinium bromide capsules.
    • are breastfeeding or plan to breastfeed. Chlordiazepoxide hydrochloride and clidinium bromide capsules may pass through your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Chlordiazepoxide hydrochloride and clidinium bromide capsules. Chlordiazepoxide hydrochloride and clidinium bromide capsules may decrease the amount of breast milk your body makes.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Chlordiazepoxide hydrochloride and clidinium bromide capsules with certain other medicines can cause side effects or affect how well chlordiazepoxide hydrochloride and clidinium bromide capsules or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

    Especially tell your healthcare provider if you:

    • take a monoamine oxidase inhibitor (MAOI) medicine or an anti-psychotic medicine called phenothiazine.

    How should I take chlordiazepoxide hydrochloride and clidinium bromide capsules?

    • Take chlordiazepoxide hydrochloride and clidinium bromide capsules exactly as your healthcare provider tells you to take it.
    • Your healthcare provider may change your dose of chlordiazepoxide hydrochloride and clidinium bromide capsules if needed. Do not change your dose of chlordiazepoxide hydrochloride and clidinium bromide capsules or suddenly stop taking chlordiazepoxide hydrochloride and clidinium bromide capsules without talking with your healthcare provider.
    • If you take too much chlordiazepoxide hydrochloride and clidinium bromide capsules, call your healthcare provider or go to the nearest hospital emergency room right away.

    What are the possible side effects of chlordiazepoxide hydrochloride and clidinium bromide capsules?

    Chlordiazepoxide hydrochloride and clidinium bromide capsules may cause serious side effects, including: See “What is the most important information I should know about Chlordiazepoxide hydrochloride and clidinium bromide capsules?”

    • Chlordiazepoxide hydrochloride and clidinium bromide capsules can make you sleepy or dizzy and can slow your thinking and motor skills.
      • Do not drive, operate heavy machinery, or do other dangerous activities until you know how chlordiazepoxide hydrochloride and clidinium bromide capsules affect you.
      • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking chlordiazepoxide hydrochloride and clidinium bromide capsules without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, chlordiazepoxide hydrochloride and clidinium bromide capsules may make your sleepiness or dizziness much worse.

    The most common side effects of Chlordiazepoxide Hydrochloride/Clidinium Bromide include:

    • dry mouth
    • blurred vision
    • nausea
    • constipation
    • skin problems
    • swelling
    • irregular menstrual (periods) cycles
    • increase and decreased desire for sex (libido)
    • problems starting to urinate
    • drowsiness, coordination problems, and confusion may happen, especially in people who are elderly or weak

    These are not all the possible side effects of chlordiazepoxide hydrochloride and clidinium bromide capsules.

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

    How should I store chlordiazepoxide hydrochloride and clidinium bromide capsules?

    • Store chlordiazepoxide hydrochloride and clidinium bromide capsules at room temperature 77°F (25°C).
    • Keep chlordiazepoxide hydrochloride and clidinium bromide capsules and all medicines out of the reach of children.

    General information about the safe and effective use of chlordiazepoxide hydrochloride and clidinium bromide capsules.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take chlordiazepoxide hydrochloride and clidinium bromide capsules for a condition for which it was not prescribed. Do not give chlordiazepoxide hydrochloride and clidinium bromide capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about chlordiazepoxide hydrochloride and clidinium bromide capsules that is written for health professionals.

    What are the ingredients in chlordiazepoxide hydrochloride and clidinium bromide capsules?

    Active ingredients: chlordiazepoxide hydrochloride and clidinium bromide

    Inactive ingredients: lactose monohydrate, pregelatinized starch, talc. Gelatin capsule shells may contain titanium dioxide with the following dye systems: D&C Yellow #10, FD&C Green #3 and gelatin.

    Manufactured for:
    Xiromed, LLC
    Florham Park, NJ 07932

    Made in the USA

  • Package Label

    label

  • INGREDIENTS AND APPEARANCE
    CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 
    chlordiazepoxide hydrochloride and clidinium bromide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70700-185
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORDIAZEPOXIDE (UNII: 6RZ6XEZ3CR) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR) CHLORDIAZEPOXIDE5 mg
    CLIDINIUM BROMIDE (UNII: 91ZQW5JF1Z) (CLIDINIUM - UNII:BO76JF850N) CLIDINIUM BROMIDE2.5 
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    Colorgreen (light green opaque capsules) Score4 pieces
    ShapeCAPSULESize14mm
    FlavorImprint Code VP302
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70700-185-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21057904/05/2021
    Labeler - Xiromed, LLC (080228637)
    Registrant - Misemer Pharmaceuticals, Inc. (784121365)
    Establishment
    NameAddressID/FEIBusiness Operations
    Belcher Pharmaceuticals, LLC965082543manufacture(70700-185) , analysis(70700-185) , pack(70700-185) , label(70700-185)

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