Limbitrol DS

In the U.S.

• Limbitrol
• Limbitrol DS

Available Dosage Forms:

• Tablet

Therapeutic Class: Tricyclic Antidepressant/Benzodiazepine Combination

Pharmacologic Class: Benzodiazepine, Long Acting

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.

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.

Pediatric

Appropriate studies performed to date have not demonstrated any benefit to using chlordiazepoxide and amitriptyline combination in children with depression. Studies have shown that some children, teenagers, and young adults think about suicide or attempt suicide when taking the medicine. Because of this toxicity, use in children is not recommended .

Geriatric

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 .

Pregnancy

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.

Interactions with 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.

• Amifampridine
• Bepridil
• Bromopride
• Cisapride
• Clorgyline
• Dronedarone
• Flumazenil
• Furazolidone
• Grepafloxacin
• Iproniazid
• Isocarboxazid
• Levomethadyl
• Linezolid
• Mesoridazine
• Methylene Blue
• Metoclopramide
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Pimozide
• Piperaquine
• 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
• Amiodarone
• Amisulpride
• Amobarbital
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anagrelide
• Apomorphine
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Benzphetamine
• Bretylium
• Bromazepam
• Bromfenac
• Bromopride
• Brompheniramine
• Bufexamac
• Buprenorphine
• Bupropion
• Buserelin
• Buspirone
• Butabarbital
• Butalbital
• Butorphanol
• Carbinoxamine
• Carisoprodol
• Celecoxib
• Chloral Hydrate
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Choline Salicylate
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clonidine
• Clonixin
• Clozapine
• Cocaine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dantrolene
• 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
• Eliglustat
• Enflurane
• Epinephrine
• Erythromycin
• Escitalopram
• Eslicarbazepine Acetate
• Ethchlorvynol
• Etilefrine
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fingolimod
• Flecainide
• Flibanserin
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Foscarnet
• Fospropofol
• Frovatriptan
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Ibuprofen
• Ibutilide
• Iloperidone
• Imipramine
• Indomethacin
• Iobenguane I 123
• Isoflurane
• Isradipine
• Ivabradine
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lacosamide
• Lapatinib
• Leuprolide
• Levalbuterol
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Levothyroxine
• Lidoflazine
• Lisdexamfetamine
• Lithium
• Lopinavir
• Lorcainide
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Meclizine
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Meloxicam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methamphetamine
• Methocarbamol
• Methohexital
• Methoxamine
• Metronidazole
• Midodrine
• Milnacipran
• Mirtazapine
• 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
• Oxaprozin
• Oxilofrine
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Oxyphenbutazone
• Paliperidone
• Palonosetron
• Panobinostat
• Parecoxib
• Paroxetine
• Pasireotide
• Pazopanib
• Peginterferon Alfa-2b
• Pentamidine
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Phenylbutazone
• Phenylephrine
• Piketoprofen
• Pimavanserin
• Piroxicam
• Pitolisant
• Pixantrone
• Posaconazole
• Pranoprofen
• Primidone
• Procainamide
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propofol
• Propoxyphene
• Propyphenazone
• Proquazone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Rasagiline
• Remifentanil
• Ribociclib
• Risperidone
• Rizatriptan
• Rofecoxib
• Salicylic Acid
• Salsalate
• Secobarbital
• Sematilide
• Sertindole
• Sertraline
• Sevoflurane
• Sibutramine
• 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
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Tryptophan
• Valdecoxib
• Vandetanib
• Vardenafil
• Vasopressin
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vinflunine
• 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
• Diazepam
• Dicumarol
• Fluvoxamine
• Fosphenytoin
• Galantamine
• Guanethidine
• Ketoconazole
• Phenprocoumon
• Phenytoin
• Rifapentine
• Ritonavir
• S-Adenosylmethionine
• St John's Wort
• Theophylline
• 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 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 abuse (or history of) or
• Drug abuse or dependence (or history of)—Dependence on this medicine may develop.

• Bipolar disorder (manic-depressive illness) or
• Blood problems or
• Difficulty in urinating or
• Emphysema, asthma, bronchitis, or other chronic lung disease or
• Enlarged prostate or
• Glaucoma or increased eye pressure or
• Heart disease or
• Mental illness (severe) or
• Myasthenia gravis or
• Porphyria—Chlordiazepoxide and amitriptyline combination may make the condition worse.

• Epilepsy or history of seizures—The risk of seizures may be increased.

• Heart attack, recent—Should not be used in patients with this condition .

• Hyperactivity—Chlordiazepoxide and amitriptyline combination may cause unexpected effects.

• Kidney disease or
• Liver disease—Higher blood levels of chlordiazepoxide and amitriptyline may occur, increasing the chance of side effects.

• Overactive thyroid or
• Stomach or intestinal problems—Use of this combination medicine may result in more serious problems.

This section provides information on the proper use of a number of products that contain chlordiazepoxide and amitriptyline. It may not be specific to Limbitrol DS. Please read with care.

To reduce stomach upset, take this medicine immediately after meals or with food unless your doctor has told you to take it on an empty stomach.

Sometimes this medicine must be taken for several weeks before you begin to feel better. Your doctor should check your progress at regular visits.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer period of time than your doctor ordered. If too much is taken, it may increase unwanted effects or become habit-forming (causing mental or physical dependence).

If you think this medicine is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your doctor.

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 three or four 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 six times a day.
    • Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, 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.

It is very important that your doctor check your progress at regular visits to allow dose adjustments and help reduce side effects.

Do not take chlordiazepoxide and amitriptyline combination 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 chlordiazepoxide and amitriptyline combination. If you do, you may develop extremely high blood pressure or convulsions (seizures) .

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are using before stopping completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, and/or an overall feeling of discomfort.

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.

For diabetic patients:
• This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of the metyrapone test may be affected by this medicine.

Chlordiazepoxide and amitriptyline combination 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. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away .

Before having any surgery, any dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking chlordiazepoxide and amitriptyline combination together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. 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 dizzy or are not alert.

Dizziness, lightheadedness, or fainting may occur when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Chlordiazepoxide and amitriptyline combination may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Chlordiazepoxide and amitriptyline combination may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

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 as soon as possible if any of the following side effects occur:

• Blurred vision or other changes in vision
• confusion or hallucinations (seeing, hearing, or feeling things that are not there)
• constipation
• difficulty in urinating
• eye pain
• fainting
• irregular heartbeat
• mental depression
• shakiness
• trouble in sleeping
• unusual excitement, nervousness, or irritability

• Convulsions (seizures)
• increased sensitivity to sunlight
• skin rash and itching
• sore throat and fever
• yellow eyes or skin

• Agitation
• confusion
• convulsions (seizures)
• dizziness or lightheadedness (severe)
• drowsiness (severe)
• enlarged pupils
• fast or irregular heartbeat
• fever
• hallucinations
• muscle stiffness or rigidity
• vomiting (severe)

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:

• Bloating
• clumsiness or unsteadiness
• dizziness or lightheadedness
• drowsiness
• dryness of mouth or unpleasant taste
• headache
• weight gain

• Diarrhea
• nausea or vomiting
• unusual tiredness or weakness

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Convulsions (seizures)
• headache
• increased sweating
• irritability or restlessness
• muscle cramps
• nausea or vomiting
• stomach cramps
• trembling
• trouble with sleeping, and vivid dreams

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.

Applies to amitriptyline / chlordiazepoxide: oral tablet

Along with its needed effects, amitriptyline / chlordiazepoxide 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 as soon as possible if any of the following side effects occur while taking amitriptyline / chlordiazepoxide:

• Blurred vision or other changes in vision
• confusion or hallucinations (seeing, hearing, or feeling things that are not there)
• constipation
• difficulty in urinating
• eye pain
• fainting
• irregular heartbeat
• mental depression
• shakiness
• trouble in sleeping
• unusual excitement, nervousness, or irritability

• Convulsions (seizures)
• increased sensitivity to sunlight
• skin rash and itching
• sore throat and fever
• yellow eyes or skin

• Agitation
• confusion
• convulsions (seizures)
• dizziness or lightheadedness (severe)
• drowsiness (severe)
• enlarged pupils
• fast or irregular heartbeat
• fever
• hallucinations
• muscle stiffness or rigidity
• vomiting (severe)

Some side effects of amitriptyline / chlordiazepoxide 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:

• Bloating
• clumsiness or unsteadiness
• dizziness or lightheadedness
• drowsiness
• dryness of mouth or unpleasant taste
• headache
• weight gain

• Diarrhea
• nausea or vomiting
• unusual tiredness or weakness

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Convulsions (seizures)
• headache
• increased sweating
• irritability or restlessness
• muscle cramps
• nausea or vomiting
• stomach cramps
• trembling
• trouble with sleeping, and vivid dreams

Applies to amitriptyline / chlordiazepoxide: oral tablet

General

The most frequently reported side effects included drowsiness, dry mouth, constipation, and blurred vision.[Ref]

Psychiatric

Frequency not reported: Apprehension, confusion, delusions, drug habituation/dependence, dysphoria, euphoria, hallucinations, hypomania, impotence, increased/decreased libido, insomnia, poor concentration, restlessness, vivid dreams, withdrawal symptoms[Ref]

Nervous system

Frequency not reported: Ataxia, convulsions, dizziness, drowsiness, EEG pattern changes, extrapyramidal symptoms, extremity numbness/tingling/paresthesia, headache, incoordination, peculiar taste, stroke, syncope, tremor[Ref]

Gastrointestinal

Frequency not reported: Abdominal cramps, black tongue, bloating, constipation, diarrhea, dry mouth, epigastric distress, nausea, paralytic ileus, parotid swelling, stomatitis, tongue edema, vomiting[Ref]

Dermatologic

Frequency not reported: Alopecia, face edema, increased perspiration, photosensitization, pruritus, purpura, skin rash, sweating, urticaria[Ref]

Cardiovascular

Frequency not reported: Arrhythmias, heart block, hypertension, hypotension, myocardial infarction, palpitations, tachycardia[Ref]

Genitourinary

Frequency not reported: Breast enlargement, galactorrhea, minor menstrual abnormalities, testicular swelling, urinary frequency, urinary retention, urinary tract dilation[Ref]

Hematologic

Frequency not reported: Agranulocytosis, bone marrow depression, eosinophilia, granulocytopenia, thrombocytopenia

Metabolic

Frequency not reported: Anorexia, blood sugar level elevation/lowering, weight gain/loss[Ref]

Other

Frequency not reported: Fatigue, lethargy, malaise, weakness[Ref]

Ocular

Frequency not reported: Accommodation disturbance, blurred vision, mydriasis[Ref]

Hepatic

Frequency not reported: Hepatic dysfunction, jaundice[Ref]

Endocrine

Frequency not reported: Gynecomastia, syndrome of inappropriate antidiuretic hormone (SIADH) secretion[Ref]

Musculoskeletal

Frequency not reported: Muscle cramps[Ref]

Respiratory

Frequency not reported: Nasal congestion[Ref]

Some side effects of Limbitrol DS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.