Generic drug: chlordiazepoxide amitriptyline ds
Brand name: Limbitrol
What is Limbitrol (chlordiazepoxide amitriptyline ds), and how does it work?
- Limbitrol is a prescription medicine used to treat moderate to severe depression that can happen with moderate to severe anxiety.
- Limbitrol is a federally controlled substance (C-IV) because it contains chlordiazepoxide that can be abused or lead to dependence. Keep Limbitrol in a safe place to prevent misuse and abuse. Selling or giving away Limbitrol 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 Limbitrol is safe and effective in children.
What are the side effects of Limbitrol?
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Chlordiazepoxide and Amitriptyline Hydrochloride Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.
Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in the risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Limbitrol is not approved for use in pediatric patients.
Limbitrol may cause serious side effects, including:
- Limbitrol 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 Limbitrol affects you.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Limbitrol without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Limbitrol may make your sleepiness or dizziness much worse.
The most common side effects of Limbitrol include:
These are not all the possible side effects of Limbitrol.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Limbitrol?
- Optimum dosage varies with the severity of the symptoms and the response of the individual patient. When a satisfactory response is obtained, dosage should be reduced to the smallest amount needed to maintain the remission. The larger portion of the total daily dose may be taken at bedtime. In some patients, a single dose at bedtime may be sufficient. In general, lower dosages are recommended for elderly patients.
- Limbitrol DS (double strength) Tablets are recommended in an initial dosage of 3 or 4 tablets daily in divided doses; this may be increased to 6 tablets daily as required. Some patients respond to smaller doses and can be maintained on 2 tablets daily.
- Limbitrol Tablets in an initial dosage of 3 or 4 tablets daily in divided doses may be satisfactory in patients who do not tolerate higher doses.
Screen For Bipolar Disorder Prior To Starting Limbitrol
- Prior to initiating treatment with Limbitrol or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.
Discontinuation Or Dosage Reduction Of Limbitrol
- To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Limbitrol 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.
Does Limbitrol cause addiction or withdrawal symptoms?
Drug Abuse And Dependence
- Limbitrol contains chlordiazepoxide, a Schedule IV controlled substance.
- Limbitrol is a benzodiazepine and 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.
- 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).
- Limbitrol 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.
- To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Limbitrol or reduce the dosage.
Acute Withdrawal Signs And Symptoms
- Acute withdrawal signs and symptoms associated with benzodiazepines have included
- abnormal involuntary movements,
- blurred vision,
- gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite),
- memory impairment,
- muscle pain and stiffness,
- panic attacks,
- tachycardia, and
- More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included
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 to Limbitrol 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 effect of Limbitrol may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.
- Childhood Autism Diagnosis Is Getting Better, But Not for Everyone
- Mom's Exposure to Dirty Air in Pregnancy Could Harm a Toddler's Development
- Could Bad Sleep in Teen Years Raise Risks for MS?
- Women, Keep Moving to Help Keep Mental Decline at Bay
- Updated Boosters Cut Risk of XBB Variant Infection by Nearly Half
- More Health News »
What drugs interact with Limbitrol?
- 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 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 benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
- Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels.
Drug And Treatment Interactions
- Because of its amitriptyline component, Limbitrol may block the antihypertensive action of guanethidine or compounds with a similar mechanism of action.
Drugs Metabolized By P450 2D6
- The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% of Caucasians are so called “poor metabolizers”); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available.
- Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small or quite large (8-fold increase in plasma AUC of the TCA).
- In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy.
- The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the type 1c antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition.
- The extent to which SSRI TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other.
- Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).
- Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from cotherapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be coadministered with another drug known to be an inhibitor of P450 2D6.
- The effects of concomitant administration of Limbitrol and other psychotropic drugs have not been evaluated. Sedative effects may be additive.
- Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants and benzodiazepines, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine (Tagamet).
- The drug should be discontinued several days before elective surgery.
- Concurrent administration of ECT and Limbitrol should be limited to those patients for whom it is essential.
Is Limbitrol safe to use while pregnant or breastfeeding?
- Safe use of Limbitrol during pregnancy and lactation has not been established. Because of the chlordiazepoxide component, please note the following:
- An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies.
- Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided.
- The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.
- Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.
- It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug, since many drugs are excreted in human milk.
Limbitrol is a prescription medicine used to treat moderate to severe depression that can happen with moderate to severe anxiety. Limbitrol is a federally controlled substance (C-IV) because it contains chlordiazepoxide that can be abused or lead to dependence. Serious side effects of Limbitrol include feeling sleepy or dizzy, and slowed thinking and motor skills.
Multimedia: Slideshows, Images & Quizzes
Learn to Spot Depression: Symptoms, Warning Signs, Medication
Know when you or someone else is depressed. Get information on depression symptoms, signs, tests, and treatments for many types...
What Is Bipolar Disorder? Symptoms, Manic Episodes, Testing
Bipolar disorder (formerly "manic depression") causes extreme mood shifts and manic episodes. Learn about bipolar 1, bipolar 2,...
Depression Quiz: Signs & Symptoms
Many people do not recognize the symptoms and warning signs of depression and depressive disorders in children and adults. With...
Myths and Facts About Therapy
False ideas scare many depression suffers away from therapy and the quick relief and help these pros can provide. Let our experts...
17 Everyday Ways to Ease Depression
The right exercise, diet, and activities -- even playing with a pet --can help you recover from depression. Learn simple...
Healthy Aging: Sneaky Depression Triggers in Pictures
There are many causes and triggers of depression. From too little vitamin B12 to too much time alone, look at these surprising...
Postpartum Depression: Symptoms, Diagnosis and Treatment
Postpartum depression symptoms include insomnia, anger, and irritability after giving birth. Learn about postpartum depression...
Foods That Help Fight Depression
Foods that help fight depression include turkey, Brazil nuts, carrots, shellfish, coffee, leafy greens, salmon, milk, and...
Holiday Depression: 10 Triggers That Cause Holiday Blues
10 holiday depression and stress triggers, and ways to cope. From anxiety over bills to social commitments and travel, WebMD...
Depression Myths: Overwork, Recklessness and More in Pictures
Folk remedies and half-truths still prevent many from getting treatment for depression. WebMD's pictures show unusual symptoms in...
Physical Symptoms of Depression in Pictures
Depression can cause physical problems such as insomnia, chest pain, fatigue, headaches, and more. Learn the signs of depression...
Depression: Visual Guide to Seasonal Affective Disorder (SAD)
Do you find yourself getting depressed as winter approaches each year? Or when you don't see the sun for a while? You may have...
Related Disease Conditions
Second Source article from WebMD
Second Source article from WebMD
Depression: The Basics
Second Source article from WebMD
Second Source article from WebMD
When a Loved One Has Depression
Second Source article from WebMD
Schizophrenia and Electroconvulsive Therapy (ECT)
Second Source article from WebMD
Depression: Causes of Depression
Second Source article from The Cleveland Clinic
Depression Treatment Options
Second Source article from WebMD
Depression is an illness that involves the body, mood, and thoughts and affects the way a person eats and sleeps, the way one feels about oneself, and the way one thinks about things. The principal types of depression are major depression, dysthymia, and bipolar disease (also called manic-depressive disease).
Depression in teenagers may be caused by many factors. Symptoms of teen depression include apathy, irresponsible behavior, sadness, sudden drop in grades, withdrawal from friends, and alcohol and drug use. Treatment of depression in adolescents may involve psychotherapy and medications.
What Is Major Depression Disorder?
The American Psychiatric Association defines major depressive disorder (depression) as a common, but serious, medical illness that negatively affects how one feels, thinks and acts. Depression causes sadness and/or a loss of interest in activities once enjoyed. Depression can lead to a variety of emotional and physical problems and decrease a person’s ability to function at work and home.
Depression in Children
Childhood depression can interfere with social activities, interests, schoolwork and family life. Symptoms and signs include anger, social withdrawal, vocal outbursts, fatigue, physical complaints, and thoughts of suicide. Treatment may involve psychotherapy and medication.
Postpartum depression is a form of depression that occurs within a year after delivery. It is thought that rapid hormone changes after childbirth may lead to depression. Symptoms of postpartum depression include crying a lot, headaches, chest pains, eating too little or too much, sleeping too little or too much, withdrawal from friends and family, and feeling irritable, sad, hopeless, worthless, guilty, and overwhelmed. Treatment typically involves talk therapy and medication.
What Is a Nervous Breakdown?
A nervous or mental breakdown is a general term used to describe a period of overwhelming mental distress. This term is usually used to refer to an intense set of emotions a person experiences in a wide variety of mental illnesses, including depression, stress disorder, and anxiety.
Is Melancholy the Same as Depression?
Melancholy or melancholia is a severe form of depression and it is now termed "melancholic depression." The word “melancholia” is a Greek word to describe the feeling of intense sadness and hopelessness. Melancholic depression makes people lose interest in almost all activities.
Holiday Depression, Anxiety, and Stress
Though the holidays are a fun time for most, for others, they're a sad, lonely and anxiety-filled time. Get tips on how to avoid depression and stress during the holiday season.
Depression in the Elderly
Depression in the elderly is very common. That doesn't mean, though, it's normal. Treatment may involve antidepressants, psychotherapy, or electroconvulsive therapy.
Depression and Suicide
Depression is a psychiatric illness that affects one in six people in the United States. Nearly two-thirds of people with depression do not realize that they have a treatable illness and do not seek treatment. Depression could happen when there is a decrease in the functional balance of the brain chemicals e.g., serotonin and norepinephrine.
Can Blue Light Cause Depression?
Yes, in humans, there is evidence that supports that blue light disrupts the normal circadian rhythms (biological clock), resulting in mood disorders such as depression.
Treatment & Diagnosis
- Depression FAQs
- Does Depression Cause Obesity or Does Obesity Cause Depression?
- Depression - St. John's Wort
- Miscarriage - Depression Risk Increased
- Accutane (isotretinoin) for Acne linked to birth defects, depression and suicide
- Depression and Women
- Is Depression a Side Effect of Celebrex?
- Do Statins Cause Depression?
- What Is CNS Depression?
- 11 Common Depression Symptoms
- Diet and Depression: How Food Can Help with Depression Symptoms
Medications & Supplements
- clidinium/chlordiazepoxide - oral, Librax
- amitriptyline (Elavil, Endep)
- Side Effects of Elavil (amitriptyline)
- chlordiazepoxide-injection, Librium
- chlordiazepoxide (Librium)
- Side Effects of Librium (chlordiazepoxide)
- chlordiazepoxide hydrochloride and clidinium bromide (Librax)
- amitriptyline/chlordiazepoxide - oral, Limbitrol
- Side Effects of Librax (chlordiazepoxide hydrochloride and clidinium bromide)
- perphenazine and amitriptyline hydrochloride (Etrafon - brand no longer available in the US)
- Side Effects of Etrafon (perphenazine/amitriptyline)
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.