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
Adagrasib
Albuterol
Alfentanil
Alfuzosin
Almotriptan
Alprazolam
Amantadine
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
Cannabis
Carbamazepine
Carbinoxamine
Carisoprodol
Celecoxib
Ceritinib
Cetirizine
Chloral Hydrate
Chloroquine
Chlorpheniramine
Chlorpromazine
Chlorzoxazone
Choline Salicylate
Ciprofloxacin
Citalopram
Clarithromycin
Clobazam
Clofazimine
Clomipramine
Clonazepam
Clonidine
Clonixin
Clothiapine
Clozapine
Cocaine
Codeine
Crizotinib
Cyclobenzaprine
Dabrafenib
Dantrolene
Daridorexant
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Desmopressin
Desvenlafaxine
Deutetrabenazine
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Diclofenac
Diflunisal
Dihydrocodeine
Dipyrone
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Doxorubicin
Doxorubicin Hydrochloride Liposome
Doxylamine
Droperidol
Droxicam
Duloxetine
Efavirenz
Eletriptan
Encorafenib
Enflurane
Entrectinib
Epinephrine
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Ethchlorvynol
Etodolac
Etofenamate
Etoricoxib
Etrasimod
Fedratinib
Felbinac
Fenfluramine
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Fexinidazole
Fingolimod
Flecainide
Flibanserin
Floctafenine
Fluconazole
Flufenamic Acid
Fluoxetine
Flurbiprofen
Fluvoxamine
Formoterol
Foscarnet
Fospropofol
Fostemsavir
Frovatriptan
Gabapentin
Gabapentin Enacarbil
Gatifloxacin
Gemifloxacin
Gepirone
Glasdegib
Glucagon
Glycopyrrolate
Glycopyrronium Tosylate
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Halothane
Histrelin
Hydrocodone
Hydromorphone
Hydroxyamphetamine
Hydroxychloroquine
Hydroxytryptophan
Hydroxyzine
Ibuprofen
Ibutilide
Iloperidone
Imipramine
Indomethacin
Inotuzumab Ozogamicin
Iobenguane I 123
Iobenguane I 131
Isoflurane
Isradipine
Ivabradine
Ivacaftor
Ivosidenib
Ketamine
Ketoconazole
Ketoprofen
Ketorolac
Lacosamide
Lapatinib
Lasmiditan
Lefamulin
Lemborexant
Lenvatinib
LetibotulinumtoxinA-wlbg
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
Olanzapine
Oliceridine
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
Quizartinib
Rasagiline
Relugolix
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
Topiramate
Toremifene
Tramadol
Trazodone
Triclabendazole
Trifluoperazine
Trimethoprim
Trimipramine
Triptorelin
Tryptophan
Valdecoxib
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vilanterol
Vilazodone
Vinflunine
Voclosporin
Voriconazole
Vortioxetine
Zolmitriptan
Zolpidem
Zotepine
Zuclopenthixol
Zuranolone

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
Cimetidine
Desogestrel
Diazepam
Dicumarol
Dienogest
Drospirenone
Ethinyl Estradiol
Ethynodiol
Fosphenytoin
Galantamine
Gestodene
Guanethidine
Ketoconazole
Levonorgestrel
Mestranol
Nomegestrol
Norethindrone
Norgestimate
Norgestrel
Phenprocoumon
Phenytoin
Rifapentine
Ritonavir
S-Adenosylmethionine
St John's Wort
Theophylline
Valproic Acid
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 if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

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, hallucinations, headache, loss of consciousness, mood or other mental changes, seeing, hearing, or feeling things that are not there, nightmares, seizures, sweating, trouble breathing, trouble sleeping, unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness, or unusual excitement, nervousness, restlessness, or irritability. 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: Agitation; changes in patterns and rhythms of speech; confusion; disorientation; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; hallucinations; headache; loss of consciousness; loss of strength or energy; mood or other mental changes; seizures; shakiness and unsteady walk; slurred speech; trouble breathing; trouble sleeping; trouble speaking; unsteadiness, trembling, or other problems with muscle control or coordination; unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness; unusual excitement, nervousness, restlessness, or irritability

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: 4/24/2024

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