Medication Guide

Chlordiazepoxide and Amitriptyline Hydrochloride Tablets, USP    CIV
(klorʺ dye azʺ e poxʹ ide amʺ i tripʹ ti leen hyeʺ droe klorʹ ide)

What is the most important information I should know about chlordiazepoxide and amitriptyline hydrochloride tablets?

• • Chlordiazepoxide is a benzodiazepine medicine. Taking benzodiazepines 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:
  • oshallow or slowed breathing
  • obreathing stops (which may lead to the heart stopping)
  • oexcessive sleepiness (sedation)
• Do not drive or operate heavy machinery until you know how taking chlordiazepoxide and amitriptyline hydrochloride tablets with opioids affect you.
• • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets, which can lead to overdose and serious side effects including coma and death.
  • o Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets. 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.
  • o You can develop an addiction even if you take chlordiazepoxide and amitriptyline hydrochloride tablets exactly as prescribed by your healthcare provider.
  • o Take chlordiazepoxide and amitriptyline hydrochloride tablets exactly as your healthcare provider prescribed.
  • oDo not share your chlordiazepoxide and amitriptyline hydrochloride tablets with other people.
  • oKeep chlordiazepoxide and amitriptyline hydrochloride tablets in a safe place and away from children.
• • Physical dependence and withdrawal reactions. Chlordiazepoxide and amitriptyline hydrochloride tablets can cause physical dependence and withdrawal reactions.
  • o Do not suddenly stop taking chlordiazepoxide and amitriptyline hydrochloride tablets. Stopping chlordiazepoxide and amitriptyline hydrochloride tablets 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.
  • o 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.
  • oPhysical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
  • oDo not take more chlordiazepoxide and amitriptyline hydrochloride tablets than prescribed or take chlordiazepoxide and amitriptyline hydrochloride tablets for longer than prescribed.
• • Increased risk of suicidal thoughts or actions in children, adolescents and young adults. Chlordiazepoxide and amitriptyline hydrochloride tablets and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
  • o Depression or other serious mental illnesses are the most important cause of suicidal thoughts or actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or a history of suicidal thoughts or actions.
• How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
  1. oPay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings or if you or your family member develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
  2. oCall your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you or your family member develop suicidal thoughts or actions.
  3. oKeep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
• Call your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:

• •thoughts about suicide or dying
• •new or worse depression
• •feeling agitated or restless
• •trouble sleeping
• •acting aggressive, being angry or violent
• •other unusual changes in behavior or mood

• •attempts to commit suicide
• •new or worse anxiety or irritability
• •an extreme increase in activity and talking
• •new or worse panic attacks
• •acting on dangerous impulses

• • Serotonin Syndrome. This condition can be life-threatening and symptoms may include:
  • •agitation, hallucinations, coma, or other changes in mental status
  • •racing heartbeat, high or low blood pressure
  • •coordination problems or muscle twitching (overactive reflexes)
  • •nausea, vomiting, or diarrhea
  • •sweating or fever
  • •muscle rigidity

What are chlordiazepoxide and amitriptyline hydrochloride tablets?

• •Chlordiazepoxide and amitriptyline hydrochloride tablets are a prescription medicine used to treat moderate to severe depression that can happen with moderate to severe anxiety.
• • Chlordiazepoxide and amitriptyline hydrochloride tablets are a federal controlled substance (C-IV) because they contain chlordiazepoxide that can be abused or lead to dependence. Keep chlordiazepoxide and amitriptyline hydrochloride tablets in a safe place to prevent misuse and abuse. Selling or giving away chlordiazepoxide and amitriptyline hydrochloride tablets may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
• •It is not known if chlordiazepoxide and amitriptyline hydrochloride tablets are safe and effective in children.

Do not take chlordiazepoxide and amitriptyline hydrochloride tablets if you:

• •are allergic to chlordiazepoxide and amitriptyline hydrochloride or any of the ingredients in chlordiazepoxide and amitriptyline hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in chlordiazepoxide and amitriptyline hydrochloride tablets.
• •have had an allergic reaction to other benzodiazepines or tricyclic antidepressant medicines
• •take a medicine called a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI.
• •are recovering from a heart attack

Before you take chlordiazepoxide and amitriptyline hydrochloride tablets, tell your healthcare provider about all of your medical conditions, including if you:

• •have or have a family history of suicide, bipolar disorder, or depression
• •have a history of drug or alcohol abuse or addiction
• •have eye problems
• •have problems urinating or emptying your bladder
• •have kidney or liver problems
• •have or had heart problems, including heart attack or a stroke
• •have or have had seizures
• •have a thyroid problem
• •plan to have surgery
• •have low sodium levels in your blood
• •receive electroconvulsive therapy (ECT)
• •are pregnant or plan to become pregnant.
  • •Taking chlordiazepoxide and amitriptyline hydrochloride tablets late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
  • •Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with chlordiazepoxide and amitriptyline hydrochloride tablets.
  • •There is a pregnancy registry for women who take chlordiazepoxide and amitriptyline hydrochloride tablets during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. If you become pregnant during treatment with chlordiazepoxide and amitriptyline hydrochloride tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. You can register by calling 1-866-961-2388 or visiting https://womansmentalhealth.org/pregnancyregistry/.
• •are breastfeeding or plan to breastfeed. It is not known if chlordiazepoxide and amitriptyline hydrochloride pass into your breastmilk.
  • •Talk to your healthcare provider about the best way to feed your baby if you take chlordiazepoxide and amitriptyline hydrochloride tablets.
  • •Breastfeeding is not recommended during treatment with chlordiazepoxide and amitriptyline hydrochloride tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking chlordiazepoxide and amitriptyline hydrochloride tablets with certain other medicines can cause side effects or affect how well chlordiazepoxide and amitriptyline hydrochloride tablets or the other medicines work.

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take chlordiazepoxide and amitriptyline hydrochloride tablets with your other medicines.

Do not start or stop any other medicines during treatment with chlordiazepoxide and amitriptyline hydrochloride tablets without talking to your healthcare provider first. Stopping chlordiazepoxide and amitriptyline hydrochloride tablets suddenly may cause you to have serious side effects. See, “What are the possible side effects of chlordiazepoxide and amitriptyline hydrochloride tablets?”

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take chlordiazepoxide and amitriptyline hydrochloride tablets?

• •Take chlordiazepoxide and amitriptyline hydrochloride tablets exactly as your healthcare provider tells you to take them.
• •If you take too many chlordiazepoxide and amitriptyline hydrochloride tablets, call your healthcare provider or go to the nearest emergency room right away.

What are the possible side effects of chlordiazepoxide and amitriptyline hydrochloride tablets?

Chlordiazepoxide and amitriptyline hydrochloride tablets may cause serious side effects, including:

• • See “What is the most important information I should know about chlordiazepoxide and amitriptyline hydrochloride tablets?”
• • Chlordiazepoxide and amitriptyline hydrochloride tablets can make you sleepy or dizzy, and can slow your thinking and motor skills.
  • oDo not drive, operate heavy machinery, or do other dangerous activities until you know how chlordiazepoxide and amitriptyline hydrochloride tablets affect you.
  • o Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking chlordiazepoxide and amitriptyline hydrochloride tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, chlordiazepoxide and amitriptyline hydrochloride tablets may make your sleepiness or dizziness much worse.
• • Low sodium levels in your blood (hyponatremia). Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with chlordiazepoxide and amitriptyline hydrochloride tablets. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include:
  • •headache
  • •difficulty concentrating
  • •memory changes
  • •confusion
  • •weakness and unsteadiness on your feet which can lead to falls
  • o In more severe or more sudden cases, signs and symptoms include:
    • •seeing or hearing things that are not real (hallucinations)
    • •fainting
    • •seizures
    • •coma
    • •stopping breathing (respiratory arrest)

The most common side effects of chlordiazepoxide and amitriptyline hydrochloride tablets include:

• •drowsiness
• •dizziness
• •blurred vision

• •constipation
• •dry mouth
• •bloating

These are not all the possible side effects of chlordiazepoxide and amitriptyline hydrochloride tablets.

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 and amitriptyline hydrochloride tablets?

• •Store chlordiazepoxide and amitriptyline hydrochloride tablets at room temperature between 20° to 25°C (68° to 77°F).
• •Store in a dry place.
• •Keep chlordiazepoxide and amitriptyline hydrochloride tablets in a tightly closed, child-resistant container and out of the light.

Keep chlordiazepoxide and amitriptyline hydrochloride tablets and all medicines out of the reach of children.

General information about the safe and effective use of chlordiazepoxide and amitriptyline hydrochloride tablets.

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

What are the ingredients in chlordiazepoxide and amitriptyline hydrochloride tablets?

Active ingredients: chlordiazepoxide, amitriptyline hydrochloride

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. In addition, the
5 mg/12.5 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake and the 10 mg/25 mg tablets also contain polydextrose and triacetin.

Distributed by: Mylan Pharmaceuticals Inc., a Viatris Company

Morgantown, WV 26505 U.S.A.

For more information, call Viatris at 1-877-446-3679 (1-877-4-INFO-RX).

The brands listed are trademarks of their respective owners.
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
Mylan Pharmaceuticals Inc., a Viatris Company
Morgantown, WV 26505 U.S.A.