Limbitrol (Oral)

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

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

It is very important for your doctor to check your progress at regular visits to ensure 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 late pregnancy may cause problems in your newborn baby (for example, sedation or withdrawal symptoms). Tell your doctor immediately if your baby has unusual sleep patterns, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or does not 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 any drug that is a monoamine oxidase (MAO) inhibitor (for example, 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 experience 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 take more than your prescribed dose. Call your doctor for instructions.

Do not change your dose or stop taking this medicine without first checking 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 chance 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 sluggish, or unusual excitement, nervousness, restlessness, or irritability. Call your doctor right away if you notice these symptoms.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, which may cause drowsiness). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, barbiturates, medicines 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 make some people feel agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or become more depressed. Also, tell your doctor if you experience 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 immediately.

This medicine may cause some people, especially elderly patients, to feel drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than usual. Make sure you know how this medicine affects you before driving, operating machinery, or doing 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 you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want your eyes checked by an ophthalmologist (eye doctor).

Before any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking amitriptyline 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.

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform 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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific issues that would limit the usefulness of chlordiazepoxide and amitriptyline combination in the elderly. Nevertheless, 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 chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances before using this medicine while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different drugs 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 using this drug, it is especially important that your healthcare professional know if you are taking any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following drugs is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medications 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 medication with any of the following medicines is usually not recommended, but may be required in some cases. If both medications are prescribed together, your physician may change the dose or how often you use one or both of the drugs.

• 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
• 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
• 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
• 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 drug 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 medications are prescribed together, your clinician 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
• 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

Interactions with Food/Tobacco/Alcohol

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 medications 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 medication with any of the following is normally not advised, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

Using this drug with any of the following may cause an increased risk of certain adverse effects but may be unavoidable in some cases. If used together, your physician may change the dose or how frequently you use this drug, 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 inform your doctor if you have any other medical issues, 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 issues (eg, emphysema, asthma, bronchitis, or other chronic lung disease) or
• Mental illness (serious) 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 drug from the body.

Along with its necessary effects, Limbitrol (Oral) may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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 Limbitrol. 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.

In the U.S.

• Limbitrol
• Limbitrol DS

Available Dosage Forms:

• Tablet

Therapeutic Class: Tricyclic Antidepressant/Benzodiazepine Combination

Pharmacologic Class: Benzodiazepine, Long Acting

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.