Chlordiazepoxide and amitriptyline (Oral route)

Pronunciation:

klor-dye-az-e-POX-ide, am-i-TRIP-ti-leen hye-droe-KLOR-ide

Brand Names:

  • Limbitrol
  • Limbitrol DS

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Warning: Risks from concomitant use with opioids, abuse, misuse, addition, dependence, withdrawal reactions, and suicidal thoughts and behaviors: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.The use of benzodiazepines, including amitriptyline/chlordiazepoxide, 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 amitriptyline/chlordiazepoxide and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.The continued use of benzodiazepines, including amitriptyline/chlordiazepoxide, 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 amitriptyline/chlordiazepoxide 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 amitriptyline/chlordiazepoxide or reduce the dosage.Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Amitriptyline/chlordiazepoxide is not approved for use in pediatric patients .

Classifications:

Therapeutic—

Tricyclic Antidepressant/Benzodiazepine Combination

Pharmacologic—

Benzodiazepine, Long Acting

Uses of This Medicine:

Chlordiazepoxide and amitriptyline combination is used to treat mental depression that occurs with anxiety or nervous tension.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of chlordiazepoxide and amitriptyline combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of chlordiazepoxide and amitriptyline combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving chlordiazepoxide and amitriptyline combination. .

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Bepridil
  • Bromopride
  • Cisapride
  • Clorgyline
  • Dronedarone
  • Flumazenil
  • Furazolidone
  • Grepafloxacin
  • Iproniazid
  • Isocarboxazid
  • Levoketoconazole
  • Levomethadyl
  • Linezolid
  • Mesoridazine
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Pimozide
  • Piperaquine
  • Potassium Citrate
  • Procarbazine
  • Ranolazine
  • Safinamide
  • Saquinavir
  • Selegiline
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Toloxatone
  • Tranylcypromine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acecainide
  • Aceclofenac
  • Acemetacin
  • Albuterol
  • Alfentanil
  • Alfuzosin
  • Almotriptan
  • Alprazolam
  • Amiodarone
  • Amisulpride
  • Amobarbital
  • Amoxapine
  • Amphetamine
  • Amtolmetin Guacil
  • Anagrelide
  • Apomorphine
  • Aprindine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Aspirin
  • Astemizole
  • Atazanavir
  • Azimilide
  • Azithromycin
  • Benzhydrocodone
  • Benzphetamine
  • Bretylium
  • Bromazepam
  • Bromfenac
  • Bromopride
  • Brompheniramine
  • Bufexamac
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Buspirone
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Calcium Oxybate
  • Cannabidiol
  • Carbinoxamine
  • Carisoprodol
  • Celecoxib
  • Ceritinib
  • Cetirizine
  • Chloral Hydrate
  • Chloroquine
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Choline Salicylate
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clofazimine
  • Clomipramine
  • Clonazepam
  • Clonidine
  • Clonixin
  • Clozapine
  • Cocaine
  • Codeine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dantrolene
  • Daridorexant
  • Darunavir
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Desmopressin
  • Desvenlafaxine
  • Deutetrabenazine
  • Dexibuprofen
  • Dexketoprofen
  • Dextroamphetamine
  • Dextromethorphan
  • Diclofenac
  • Diflunisal
  • Dihydrocodeine
  • Dipyrone
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Doxylamine
  • Droperidol
  • Droxicam
  • Efavirenz
  • Eletriptan
  • Encorafenib
  • Enflurane
  • Entrectinib
  • Epinephrine
  • Erythromycin
  • Escitalopram
  • Esketamine
  • Eslicarbazepine Acetate
  • Ethchlorvynol
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Fedratinib
  • Felbinac
  • Fenfluramine
  • Fenoprofen
  • Fentanyl
  • Fepradinol
  • Feprazone
  • Fexinidazole
  • Fingolimod
  • Flecainide
  • Flibanserin
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Fluoxetine
  • Flurbiprofen
  • Foscarnet
  • Fospropofol
  • Fostemsavir
  • Frovatriptan
  • Gabapentin
  • Gabapentin Enacarbil
  • Gatifloxacin
  • Gemifloxacin
  • Glasdegib
  • Glucagon
  • Glycopyrrolate
  • Glycopyrronium Tosylate
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Histrelin
  • Hydrocodone
  • Hydromorphone
  • Hydroxychloroquine
  • Hydroxytryptophan
  • Hydroxyzine
  • Ibuprofen
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indomethacin
  • Inotuzumab Ozogamicin
  • Iobenguane I 123
  • Iobenguane I 131
  • Isoflurane
  • Isradipine
  • Ivabradine
  • Ivosidenib
  • Ketamine
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Lacosamide
  • Lapatinib
  • Lasmiditan
  • Lefamulin
  • Lemborexant
  • Lenvatinib
  • Leuprolide
  • Levalbuterol
  • Levocetirizine
  • Levofloxacin
  • Levomilnacipran
  • Levorphanol
  • Lidoflazine
  • Lisdexamfetamine
  • Lithium
  • Lofexidine
  • Lopinavir
  • Lorcainide
  • Lorcaserin
  • Lornoxicam
  • Loxapine
  • Loxoprofen
  • Lumefantrine
  • Lumiracoxib
  • Macimorelin
  • Magnesium Oxybate
  • Meclizine
  • Meclofenamate
  • Mefenamic Acid
  • Mefloquine
  • Meloxicam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methacholine
  • Methadone
  • Methamphetamine
  • Methocarbamol
  • Methohexital
  • Metoclopramide
  • Metronidazole
  • Midazolam
  • Milnacipran
  • Mirtazapine
  • Mobocertinib
  • Moricizine
  • Morniflumate
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nabumetone
  • Nafarelin
  • Nalbuphine
  • Naproxen
  • Naratriptan
  • Nefazodone
  • Nefopam
  • Nepafenac
  • Niflumic Acid
  • Nilotinib
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Norepinephrine
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Osilodrostat
  • Osimertinib
  • Oxaliplatin
  • Oxaprozin
  • Oxycodone
  • Oxymetazoline
  • Oxymorphone
  • Oxyphenbutazone
  • Ozanimod
  • Pacritinib
  • Paliperidone
  • Palonosetron
  • Panobinostat
  • Parecoxib
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Peginterferon Alfa-2b
  • Pentamidine
  • Pentazocine
  • Pentobarbital
  • Periciazine
  • Phenobarbital
  • Phenylbutazone
  • Piketoprofen
  • Pimavanserin
  • Piroxicam
  • Pitolisant
  • Pixantrone
  • Ponesimod
  • Posaconazole
  • Potassium Oxybate
  • Pranoprofen
  • Pregabalin
  • Primidone
  • Procainamide
  • Prochlorperazine
  • Proglumetacin
  • Promethazine
  • Propafenone
  • Propofol
  • Propoxyphene
  • Propyphenazone
  • Proquazone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Rasagiline
  • Remifentanil
  • Remimazolam
  • Revefenacin
  • Ribociclib
  • Risperidone
  • Rizatriptan
  • Rofecoxib
  • Ropeginterferon Alfa-2b-njft
  • Salicylic Acid
  • Salsalate
  • Scopolamine
  • Secobarbital
  • Secretin Human
  • Selpercatinib
  • Sematilide
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sibutramine
  • Siponimod
  • Sodium Oxybate
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Sodium Salicylate
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Spiramycin
  • Sufentanil
  • Sulfamethoxazole
  • Sulindac
  • Sulpiride
  • Sultopride
  • Sumatriptan
  • Sunitinib
  • Tacrolimus
  • Tapentadol
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Tenoxicam
  • Tetrabenazine
  • Thiopental
  • Tiaprofenic Acid
  • Tiotropium
  • Tolfenamic Acid
  • Tolmetin
  • Toremifene
  • Tramadol
  • Trazodone
  • Triclabendazole
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Triptorelin
  • Tryptophan
  • Valdecoxib
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vilazodone
  • Vinflunine
  • Voclosporin
  • Voriconazole
  • Vortioxetine
  • Zolmitriptan
  • Zolpidem
  • Zotepine
  • Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Arbutamine
  • Atomoxetine
  • Bethanidine
  • Carbamazepine
  • Cimetidine
  • Desogestrel
  • Diazepam
  • Dicumarol
  • Dienogest
  • Drospirenone
  • Ethinyl Estradiol
  • Ethynodiol
  • Fluvoxamine
  • Fosphenytoin
  • Galantamine
  • Gestodene
  • Guanethidine
  • Ketoconazole
  • Levonorgestrel
  • Mestranol
  • Nomegestrol
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Phenprocoumon
  • Phenytoin
  • Rifapentine
  • Ritonavir
  • S-Adenosylmethionine
  • St John's Wort
  • Theophylline
  • Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol or drug abuse, history of or
  • Bipolar disorder (manic-depressive illness) or
  • Blood problems or
  • Difficulty in urinating or
  • Enlarged prostate or
  • Glaucoma, acute angle-closure or increased eye pressure or
  • Heart disease or
  • Hyperthyroidism or
  • Lung or breathing problems (eg, emphysema, asthma, bronchitis, or other chronic lung disease) or
  • Mental illness (severe) or
  • Myasthenia gravis or
  • Porphyria or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Heart attack, recent—Should not be used in patients with this condition.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. If too much of this medicine is used for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For depression:
      • Adults—At first, 5 milligrams (mg) of chlordiazepoxide and 12.5 milligrams (mg) of amitriptyline or 10 mg of chlordiazepoxide and 25 mg of amitriptyline, taken 3 or 4 times a day. The doctor may adjust your dose if needed. However, the dose is usually not greater than 10 mg of chlordiazepoxide and 25 mg of amitriptyline taken 6 times a day.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Do not take chlordiazepoxide and amitriptyline combination with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitor activity (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor within 14 days of taking chlordiazepoxide and amitriptyline combination. If you do, you may develop extremely high blood pressure or seizures. .

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not change your dose or stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms including headache, nausea, a general feeling of discomfort or illness, seizures, stomach or muscle cramps, tremors, or unusual behavior.

Symptoms of an overdose include: blurred vision, confusion, difficulty sleeping, disorientation, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast, slow, or irregular heartbeat, headache, loss of consciousness, mood or other mental changes, seeing, hearing, or feeling things that are not there, seizures, sweating, trouble breathing, or unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness. Call your doctor right away if you notice these symptoms.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates, medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause some people, especially elderly patients, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking amitriptyline together with medicines used during surgery may increase the risk of side effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
Blurred vision or other changes in vision
confusion
constipation
difficulty in urinating
dizziness or lightheadedness
eye pain
fainting
irregular heartbeat
irritability
mental depression
nervousness
seeing, hearing, or feeling things that are not there
shakiness
talking, feeling, and acting with excitement
trouble in sleeping
Incidence not known
Actions that are out of control
chest pain or discomfort
decreased interest in sexual intercourse
false or unusual sense of well-being
fast, slow, or irregular heartbeat
inability to have or keep an erection
increased in sexual ability, desire, drive, or performance
increased interest in sexual intercourse
increased sensitivity to sunlight
loss in sexual ability, desire, drive, or performance
pain or discomfort in the arms, jaw, back or neck
redness or other discoloration of skin
severe sunburn
shakiness and unsteady walk
skin rash
sore throat and fever
sweating
swelling of the breasts or breast soreness in males
swelling of the testicles
swelling or inflammation of the mouth
unexpected or excess milk flow from breasts
unsteadiness, trembling, or other problems with muscle control or coordination

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
Disorientation
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
headache
loss of consciousness
mood or other mental changes
seizures
trouble breathing, unusual tiredness or weakness
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Bloating
clumsiness or unsteadiness
dryness of mouth or unpleasant taste
weight gain
Less common
Diarrhea
nausea or vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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


Last Updated: 6/2/2022

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.

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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
All rights reserved.