Chlordiazepoxide; Amitriptyline Tablets

What is this medication?

CHLORDIAZEPOXIDE; AMITRIPTYLINE (klor dye az e POX ide; a mee TRIP ti leen;) treats depression and anxiety. It increases the amount of serotonin and norepinephrine in the brain, substances that help regulate mood. It also works by helping your nervous system calm down. It is a combination of a tricyclic antidepressant (TCA) and a benzodiazepine.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Limbitrol, Limbitrol DS

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bipolar disorder or schizophrenia
• Difficulty passing urine, prostate trouble
• Glaucoma
• Heart disease or previous heart attack
• Kidney or liver disease
• Over active thyroid
• Seizures
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to chlordiazepoxide, amitriptyline, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a drink of water. Follow the directions on the prescription label. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking this medication suddenly except upon the advice of your care team. Stopping this medication too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Amoxapine
• Cisapride
• Dronedarone
• Linezolid
• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Maprotiline
• Methylene blue
• Opioid medications for cough
• Phenothiazines, such as mesoridazine and thioridazine
• Pimozide
• Quinidine
• Sodium oxybate

This medication may also interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Antiviral medications for HIV or AIDS
• Atropine
• Certain medications for anxiety or sleep
• Certain medications for bladder problems, such as oxybutynin, tolterodine
• Certain medications for depression, such as amitriptyline, fluoxetine, sertraline
• Certain medications for Parkinson's diseasem, such as benztropine, trihexyphenidyl
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin, primidone
• Certain medications for stomach problems, such as dicyclomine, hyoscyamine
• Certain medications for travel sickness, such as scopolamine
• Cimetidine
• Disulfiram
• General anesthetics, such as halothane, isoflurane, methoxyflurane, propofol
• Ipratropium
• Local anesthetics, such as lidocaine, pramoxine, tetracaine
• Medications that relax muscles for surgery
• Opioid medications for pain
• Other medications that cause heart rhythm changes
• Other phenothiazines, such as chlorpromazine and prochlorperazine
• Thyroid hormones, such as levothyroxine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Manic episodes may happen in patients with bipolar disorder who take this medication. Watch for changes in feelings or behaviors such as feeling anxious, nervous, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or trouble sleeping. These symptoms can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you notice any of these symptoms.

Serotonin syndrome is when your body has too much serotonin in it. This happens when this medication is used with other ones that increase serotonin levels. Common medications that increase serotonin levels are antidepressants, some medications for migraines, and some antibiotics. The symptoms of serotonin syndrome include irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, and diarrhea. Contact your care team right away if you think you have serotonin syndrome.

Do not stop taking this medication except on your care team's advice. You may develop a severe reaction. Your care team will tell you how much medication to take. Long term use of this medication may cause your brain and body to depend on it. This can happen even when used as directed by your care team. You and your care team will work together to determine how long you will need to take this medication.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

If you are taking another medication that also causes drowsiness, you may have more side effects. Give your care team a list of all medications you use. Your care team will tell you how much medication to take. Do not take more medication than directed. Get emergency help right away if you have problems breathing or unusual sleepiness.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help. Contact your care team if the problem does not go away or is severe.

This medication may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye care team if the problem does not go away or is severe.

This medication can cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your care team.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your care team right away.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects. Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Heart rhythm changes— fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Tremors or shaking

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.