Chlordiazepoxide and amitriptyline (oral)

Chlordiazepoxide and amitriptyline (oral)

Chlordiazepoxide and amitriptyline (oral) Oral (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 cause profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these medications to patients for whom alternative treatment options are inadequate. Limit dosages and duration to the minimum necessary. Observe patients for signs and symptoms of respiratory depression and sedation.

The use of benzodiazepines, including amitriptyline/chlordiazepoxide, places users at risk of misuse, misuse, and addiction, which may result in overdose or death. Misuse and misuse of benzodiazepines are often accompanied by concomitant use of other medications, alcohol and/or illicit substances, which is associated with an increased frequency of serious adverse consequences. Before prescribing amitriptyline/chlordiazepoxide and throughout treatment, assess each patient's risk for misuse, misuse, and addiction.

Continued use of benzodiazepines, including amitriptyline/chlordiazepoxide, may result in clinically significant physical dependence. The risk of dependence and withdrawal increases with longer duration of treatment and higher daily dosage. Abrupt discontinuation or rapid dose reduction of amitriptyline/chlordiazepoxide after continued use may result in acute withdrawal reactions that may be life-threatening. To reduce the risk of withdrawal reactions, you should gradually taper off or reduce the dosage of amitriptyline/chlordiazepoxide.

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Monitor all patients treated with antidepressants closely for clinical deterioration and for the emergence of suicidal thoughts and behavior. Amitriptyline/chlordiazepoxide is not approved for use in pediatric patients.

Used for chlordiazepoxide and amitriptyline

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

Before using chlordiazepoxide and amitriptyline

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

No appropriate studies have been conducted on the relationship between age and the effects of the combination of chlordiazepoxide and amitriptyline in children and adolescents. Safety and effectiveness have not been established.

geriatrics

Studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of the combination of chlordiazepoxide and amitriptyline in the elderly. However, older patients are at higher risk of age-related liver, kidney, or heart problems, which may require dose adjustments in patients receiving a combination of chlordiazepoxide and amitriptyline. .

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Bepridil
• Bromoprid
• Cisaprid
• Clogyline
• Dronedaron
• Flumazenil
• Furazolidon
• Grepafloxacin
• Iproniazid
• Isocarboxazid
• Levoketoconazol
• Levomethadyl
• Linezolid
• Mesoridazin
• Methylenblau
• Metoclopramid
• Moclobemid
• Nialamid
• Pargyline
• Phenelzin
• Pimozid
• Piperaquin
• Kaliumcitrat
• Procarbazin
• Ranolazin
• Safinamid
• Saquinavir
• Selegilin
• Sparfloxacin
• Terfenadin
• Thioridazin
• Toloxaton
• Tranylcypromin
• Ziprasidon

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

• Acecainid
• Aceclofenac
• Acemetacin
• Adagrasib
• Albuterol
• Alfentanil
• Alfuzosin
• Almotriptan
• Alprazolam
• Amantadin
• Amiodaron
• Amisulprid
• Amobarbital
• Amoxapin
• Amphetamin
• Amtolmetin Guacil
• Anagrelid
• Apomorphin
• Aprindin
• Aripiprazol
• Aripiprazol Lauroxil
• Arsentrioxid
• Artemether
• Asenapin
• Aspirin
• Astemizol
• Atazanavir
• Azimilid
• Azithromycin
• Benzhydrocodon
• Benzphetamin
• Bretylium
• Bromazepam
• Bromfenac
• Bromoprid
• Brompheniramin
• Bufexamac
• Buprenorphin
• Bupropion
• Buserelin
• Buspiron
• Butabarbital
• Butalbital
• Butorphanol
• Calciumoxybat
• Cannabidiol
• Cannabis
• Carbinoxamin
• Carisoprodol
• Celecoxib
• Ceritinib
• Cetirizin
• Chloralhydrat
• Chloroquin
• Chlorpheniramin
• Chlorpromazin
• Chlorzoxazon
• Cholinsalicylat
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimin
• Clomipramin
• Clonazepam
• Clonidin
• Clonixin
• Clotiapin
• Clozapin
• Kokain
• Kodein
• Crizotinib
• Cyclobenzaprin
• Dabrafenib
• Dantrolen
• Daridorexant
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desipramin
• Deslorelin
• Desmopressin
• Desvenlafaxin
• Deutetrabenazin
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidin
• Dextroamphetamin
• Dextromethorphan
• Diclofenac
• Diflunisal
• Dihydrocodein
• Dipyron
• Disopyramid
• Dofetilid
• Dolasetron
• Domperidon
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin-Hydrochlorid-Liposom
• Doxylamin
• Droperidol
• Droxicam
• Duloxetin
• Efavirenz
• Eletriptan
• Encorafenib
• Enfluran
• Entrectinib
• Adrenalin
• Erythromycin
• Escitalopram
• Esketamin
• Eslicarbazepinacetat
• Ethchlorvinyl
• Etodolac
• Etofenamat
• Etoricoxib
• Etrasimod
• Fedratinib
• Felbinac
• Fenfluramin
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazon
• Fexinidazol
• Fingolimod
• Flecainid
• Flibanserin
• Floctafenin
• Fluconazol
• Flufenaminsäure
• Fluoxetin
• Flurbiprofen
• Fluvoxamin
• Formoterol
• Foscarnet
• Fospropofol
• Fostemsavir
• Frovatriptan
• Gabapentin
• Gabapentin Enacarbil
• Gatifloxacin
• Gemifloxacin
• Gepiron
• Glasdegib
• Glucagon
• Glycopyrrolat
• Glycopyrroniumtosylat
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrin
• Haloperidol
• Halothan
• Histrelin
• Hydrocodon
• Hydromorphon
• Hydroxyamphetamin
• Hydroxychloroquin
• Hydroxytryptophan
• Hydroxyzin
• Ibuprofen
• Ibutilid
• Iloperidon
• Imipramin
• Indomethacin
• Inotuzumab Ozogamicin
• Iobenguane I 123
• Iobenguane I 131
• Isofluran
• Isradipin
• Ivabradin
• Ivacaftor
• Ivosidenib
• Ketamin
• Ketoconazol
• Ketoprofen
• Ketorolac
• Lacosamid
• Lapatinib
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenvatinib
• Leuprolid
• Levalbuterol
• Levocetirizin
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lidoflazin
• Lisdexamfetamin
• Lithium
• Lofexidin
• Lopinavir
• Lorcainid
• Lorcaserin
• Lornoxicam
• Loxapin
• Loxoprofen
• Lumefantrin
• Lumiracoxib
• Macimorelin
• Magnesiumoxybat
• Meclizin
• Meclofenamat
• Mefenaminsäure
• Mefloquin
• Meloxicam
• Meperidin
• Mephenesin
• Mephobarbital
• Meprobamat
• Metaxalone
• Methacholin
• Methadon
• Methamphetamin
• Methocarbamol
• Methohexital
• Metoclopramid
• Metronidazol
• Midazolam
• Milnacipran
• Mirtazapin
• Mobocertinib
• Moricizin
• Morniflumate
• Morphium
• Morphinsulfat-Liposom
• Moxifloxacin
• Nabumeton
• Nafarelin
• Nalbuphin
• Naproxen
• Naratriptan
• Nefazodon
• Nefopam
• Nepafenac
• Nifluminsäure
• Nilotinib
• Nimesulid
• Nimesulid Beta Cyclodextrin
• Noradrenalin
• Norfloxacin
• Nortriptylin
• Octreotid
• Ofloxacin
• Olanzapin
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxaprozin
• Oxycodon
• Oxymetazolin
• Oxymorphon
• Oxyphenbutazon
• Ozanimod
• Pacritinib
• Paliperidon
• Palonosetron
• Panobinostat
• Parecoxib
• Paroxetin
• Pasireotid
• Pazopanib
• Peginterferon Alfa-2b
• Pentamidin
• Pentazocin
• Pentobarbital
• Periciazin
• Phenobarbital
• Phenylbutazon
• Piketoprofen
• Pimavanserin
• Piroxicam
• Pitolisant
• Pixantrone
• Ponesimod
• Posaconazol
• Kaliumoxybat
• Pranoprofen
• Pregabalin
• Primidon
• Procainamid
• Prochlorperazin
• Proglumetacin
• Promethazin
• Propafenon
• Propofol
• Propoxyphen
• Propyphenazon
• Proquazone
• Protriptylin
• Quetiapin
• Chinidin
• Chinin
• Quizartinib
• Rasagilin
• Relugolix
• Remifentanil
• Remimazolam
• Revefenacin
• Ribociclib
• Risperidon
• Rizatriptan
• Rofecoxib
• Ropeginterferon Alfa-2b-njft
• Salicylsäure
• Salsalat
• Scopolamin
• Secobarbital
• Secretin Human
• Selpercatinib
• Sematilid
• Sertindol
• Sertralin
• Sevofluran
• Sibutramin
• Siponimod
• Natriumoxybat
• Natriumphosphat
• Natriumphosphat, zweibasisch
• Natriumphosphat, einbasisch
• Natriumsalicylat
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• Sufentanil
• Sulfamethoxazol
• Sulindac
• Sulpirid
• Sultoprid
• Sumatriptan
• Sunitinib
• Tacrolimus
• Tapentadol
• Tedisamil
• Telavancin
• Telithromycin
• Tenoxicam
• Tetrabenazin
• Thiopental
• Tiaprofensäure
• Tiotropium
• Tolfenaminsäure
• Tolmetin
• Topiramat
• Toremifen
• Tramadol
• Trazodon
• Triclabendazol
• Trifluoperazin
• Trimethoprim
• Trimipramin
• Triptorelin
• Tryptophan
• Valdecoxib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxin
• Vilanterol
• Vilazodon
• Vinflunin
• Voclosporin
• Voriconazol
• Vortioxetin
• Zolmitriptan
• Zolpidem
• Zotepin
• Zuclopenthixol
• Zuranolon

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but using both medicines 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 medicines.

• Acenocoumarol
• Arbutamin
• Atomoxetin
• Bethanidin
• Carbamazepin
• Cimetidin
• Desogestrel
• Diazepam
• Dicumarol
• Dienogest
• Drospirenon
• Ethinylestradiol
• Ethynodiol
• Fosphenytoin
• Galantamin
• Gestoden
• Guanethidin
• Ketoconazol
• Levonorgestrel
• Mestranol
• Nomegestrol
• Norethindron
• Norgestimate
• Norgestrel
• Phenprocoumon
• Phenytoin
• Rifapentin
• Ritonavir
• S-Adenosylmethionin
• Johanniskraut
• Theophyllin
• Valproinsäure
• Warfarin

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine for any of the following conditions is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of use of this medication, or give you special instructions about food, alcohol, or tobacco consumption.

• Tabak

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

• Ethanol

Other medical problems

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

• Alkohol- oder Drogenmissbrauch, Vorgeschichte von oder
• Bipolare Störung (manisch-depressive Erkrankung) oder
• Blutprobleme bzw
• Schwierigkeiten beim Wasserlassen bzw
• Vergrößerte Prostata bzw
• Glaukom, akuter Engwinkel oder erhöhter Augendruck oder
• Herzkrankheit bzw
• Hyperthyreose bzw
• Lungen- oder Atemprobleme (z. B. Emphysem, Asthma, Bronchitis oder andere chronische Lungenerkrankungen) oder
• Geisteskrankheit (schwer) oder
• Myasthenia gravis oder
• Porphyrie bzw
• Anfälle, Anamnese: Mit Vorsicht verwenden. Kann diese Bedingungen verschlimmern.

• Herzinfarkt, frisch – Sollte bei Patienten mit dieser Erkrankung nicht angewendet werden.

• Nierenerkrankung bzw
• Lebererkrankung – Mit Vorsicht anwenden. Die Wirkung kann durch die langsamere Entfernung des Arzneimittels aus dem Körper verstärkt werden.

Proper use of chlordiazepoxide and amitriptyline

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often or for longer than prescribed by your doctor. Taking too much of this medicine over a long period of time may cause habit-forming (leading to mental or physical dependence) or overdose.

This medicine should be accompanied by a medication guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

dosage

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

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Für orale Darreichungsform (Tabletten):
  • Bei Depressionen:
    • Erwachsene – Zunächst 5 Milligramm (mg) Chlordiazepoxid und 12,5 Milligramm (mg) Amitriptylin oder 10 mg Chlordiazepoxid und 25 mg Amitriptylin, drei- oder viermal täglich eingenommen. Bei Bedarf kann der Arzt Ihre Dosis anpassen. Die Dosis beträgt jedoch normalerweise nicht mehr als 10 mg Chlordiazepoxid und 25 mg Amitriptylin, eingenommen sechsmal täglich.
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.

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 return to your regular dosing schedule. Do not double the dose.

storage

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

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Ask your doctor how to throw away medicines you don't use.

Precautions when using chlordiazepoxide and amitriptyline

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 adverse effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medication later in pregnancy may cause problems in your newborn baby (e.g., sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, problems feeding, a high-pitched cry, irritability, low muscle tone, restlessness, shaking or shaking, sluggishness, difficulty breathing, weight loss, vomiting, or failing to gain weight. If you think you have become pregnant while using this medicine, tell your doctor immediately.

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

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

Do not change your dose or stop taking this medication without first checking with your doctor. Your doctor may want you to gradually reduce the amount you take before stopping it completely. This can help prevent possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, general malaise or feeling sick, seizures, stomach or muscle cramps, tremors, or unusual behavior.

Symptoms of overdose include: blurred vision, confusion, difficulty sleeping, disorientation, dizziness, fainting or lightheadedness when standing up suddenly from lying or sitting, fast, slow or irregular heartbeat, hallucinations, headache, loss of consciousness, loss of mood or other mental changes, seeing, hearing or feeling things that are not there, nightmares, seizures, sweating, difficulty breathing, difficulty sleeping, unusual sleepiness, dullness, tiredness, weakness or feeling sluggish, or unusual agitation, nervousness, restlessness or irritability. Call your doctor immediately if you notice these symptoms.

This medicine increases the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants include antihistamines or medications for hay fever, other allergies or colds, sedatives, sedatives or sleeping pills, prescription painkillers or narcotics, barbiturates, anti-seizure medications, muscle relaxants or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Consult your doctor before taking any of the above medicines while using this medicine.

This medicine may make some people feel restless, irritable, or exhibit other abnormal behavior. It can 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: B. Nervousness, anger, restlessness, violence or fear. If you or your caregiver notice any of these side effects, tell your doctor immediately.

This medicine may make some people, especially older patients, feel sleepy, dizzy, light-headed, clumsy or unsteady, or less alert than they normally are. Make sure you know how you react to this medicine before driving, operating machinery, or doing other activities that could be dangerous if you are not alert or unable to think or see well.

Contact your doctor immediately if blurred vision, difficulty reading, or other vision problems occur during or after treatment. Your doctor may want your eyes examined by an ophthalmologist.

Before any surgery, tell your doctor that you are using this medicine. Taking amitriptyline with drugs used during surgery may increase the risk of side effects.

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

Side effects of chlordiazepoxide and amitriptyline

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

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

Less common

• Verschwommenes Sehen oder andere Sehstörungen
• Verwirrung
• Verstopfung
• Schwierigkeiten beim Wasserlassen
• Schwindel oder Benommenheit
• Augenschmerzen
• Ohnmacht
• Herzrhythmusstörung
• Reizbarkeit
• mentale Depression
• Nervosität
• Dinge sehen, hören oder fühlen, die nicht da sind
• Zittern
• Mit Begeisterung reden, fühlen und handeln
• Schlafstörungen

Incident not known

• Handlungen, die außer Kontrolle geraten
• Brustschmerzen oder Unwohlsein
• vermindertes Interesse am Geschlechtsverkehr
• falsches oder ungewöhnliches Wohlbefinden
• schneller, langsamer oder unregelmäßiger Herzschlag
• Unfähigkeit, eine Erektion zu haben oder aufrechtzuerhalten
• Steigerung der sexuellen Fähigkeiten, des Verlangens, des Antriebs oder der Leistung
• erhöhtes Interesse am Geschlechtsverkehr
• erhöhte Empfindlichkeit gegenüber Sonnenlicht
• Verlust der sexuellen Fähigkeiten, des Verlangens, des Antriebs oder der Leistung
• Schmerzen oder Beschwerden in Armen, Kiefer, Rücken oder Nacken
• Rötung oder andere Verfärbung der Haut
• schwerer Sonnenbrand
• Zittern und unsicherer Gang
• Hautausschlag
• Halsschmerzen und Fieber
• Schwitzen
• Schwellung der Brüste oder Brustschmerzen bei Männern
• Schwellung der Hoden
• Schwellung oder Entzündung des Mundes
• unerwarteter oder übermäßiger Milchfluss aus den Brüsten
• Unsicherheit, Zittern oder andere Probleme mit der Muskelkontrolle oder -koordination

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

Symptoms of overdose

• Agitation
• Veränderungen in den Mustern und Rhythmen der Sprache
• Verwirrung
• Orientierungslosigkeit
• Schwindel, Ohnmacht oder Benommenheit beim plötzlichen Aufstehen aus einer liegenden oder sitzenden Position
• Halluzinationen
• Kopfschmerzen
• Bewusstlosigkeit
• Verlust von Kraft oder Energie
• Stimmung oder andere mentale Veränderungen
• Anfälle
• Zittern und unsicherer Gang
• undeutliches Sprechen
• Atembeschwerden
• Schlafstörungen
• Schwierigkeiten beim Sprechen
• Unsicherheit, Zittern oder andere Probleme mit der Muskelkontrolle oder -koordination
• ungewöhnliche Schläfrigkeit, Mattheit, Müdigkeit, Schwäche oder Trägheitsgefühl
• ungewöhnliche Erregung, Nervosität, Unruhe oder Reizbarkeit

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

More common

• Blähungen
• Ungeschicklichkeit oder Unsicherheit
• Mundtrockenheit oder unangenehmer Geschmack
• Gewichtszunahme

Less common

• Durchfall
• Übelkeit oder Erbrechen

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

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

Commonly used brand names

In the USA

• Limbitrol
• Limbitrol DS

Available dosage forms:

• Tablette

Therapeutic class: Combination of tricyclic antidepressant and benzodiazepine

Pharmacological class: Benzodiazepine, long-acting

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