amitriptyline-chlordiazepoxide 25 mg-10 mg tablet

Generic name:
Amitriptyline/chlordiazepoxide - oral

Pronunciation
(A-mi-TRIP-ti-leen/KLOR-dye-AZ-e-POX-ide)

Brand name(s)
Limbitrol

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

Chlordiazepoxide has a risk for abuse and addiction, which can lead to overdose and death. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems (especially opioid medications such as codeine, hydrocodone) may cause very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of chlordiazepoxide that works, and take it for the shortest possible time. Be sure you know how to take chlordiazepoxide and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Suddenly stopping this medication may cause serious (possibly fatal) withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as headaches, trouble sleeping, restlessness, hallucinations/confusion, depression, nausea, or seizures. Withdrawal symptoms may sometimes last weeks to months.

This combination medication is used to treat depression with symptoms of anxiety. Amitriptyline belongs to a class of drugs known as tricyclic antidepressants. It works by helping to restore the balance of certain natural substances in the brain. Chlordiazepoxide belongs to a class of drugs known as benzodiazepines. It acts on the brain and nerves to produce a calming effect.

See also Warning section.

Read the Medication Guide available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

Take this medication by mouth as directed by your doctor, usually 1 to 4 times daily. The larger portion of the total daily dose may be taken at bedtime to help reduce daytime sleepiness. The dosage is based on your medical condition, age, and response to treatment.

To reduce your risk of side effects (such as drowsiness, dry mouth, dizziness), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

This medication may not work right away. You may feel some benefit the first week. However, it may take up to 4 weeks before you experience the full effect.

Keep taking this medication even if you feel well. Do not suddenly stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.

When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition lasts or gets worse (such as nervousness or feelings of sadness get worse, or you have thoughts of suicide).

See also Warning section.

Drowsiness, dizziness, dry mouth, blurred vision, constipation, bloating, trouble urinating, and weight gain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and fainting, get up slowly when rising from a sitting or lying position.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• heartburn that doesn't go away
• nausea/vomiting that doesn't stop
• easy bleeding/bruising
• loss of balance
• mental/mood changes (such as confusion, excitement, memory problems, suicidal thoughts)
• shaking (tremor)
• decreased sexual ability/desire
• signs of infection (such as sore throat that doesn't go away, fever)
• severe stomach/abdominal pain
• dark urine
• yellowing eyes/skin

Get medical help right away if you have any very serious side effects, including:

• black stools
• chest pain
• severe dizziness
• fainting
• fast/irregular heartbeat
• seizures
• trouble speaking
• weakness on one side of the body
• eye pain/swelling/redness
• widened pupils
• vision changes (such as seeing rainbows around lights at night)
• vomit that looks like coffee grounds

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as diazepam, lorazepam, alprazolam), or to other tricyclic antidepressants (such as nortriptyline), or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• personal or family history of glaucoma (angle-closure type)
• bleeding problems
• breathing/lung problems
• diabetes
• kidney problems
• liver problems
• heart problems (such as chest pain, irregular heartbeat, recent heart attack)
• problems urinating (such as due to enlarged prostate)
• chronic constipation
• overactive thyroid (hyperthyroidism)
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• personal or family history of mental/mood conditions (such as bipolar disorder, psychosis)
• family history of suicide
• seizures
• conditions that may increase your risk of seizures (such as brain disease/injury/tumor, alcohol withdrawal)

Amitriptyline/chlordiazepoxide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using amitriptyline/chlordiazepoxide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using amitriptyline/chlordiazepoxide safely.

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and tell your doctor of the results. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery or imaging procedures (such as certain X-rays, CT scans) requiring the use of contrast dye (such as metrizamide), tell your doctor or dentist that you are using this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this product, especially bleeding, confusion, dizziness, drowsiness, constipation, difficulty urinating, and QT prolongation (see above). Your doctor may start the medication at a lower dose to prevent side effects. Confusion, dizziness, drowsiness can increase the risk of falling.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using amitriptyline/chlordiazepoxide. This medication may harm an unborn baby. Newborn babies of mothers who use this medication late in pregnancy may have symptoms such as slow/shallow breathing, nonstop crying, shaking, or trouble feeding. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this product are:

• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as dabigatran/warfarin)
• certain drugs for high blood pressure (drugs that work in the brain such as clonidine, guanabenz)
• clozapine
• thyroid supplements

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

Other medications can affect the removal of amitriptyline and chlordiazepoxide from your body, thereby affecting how amitriptyline/chlordiazepoxide works. These drugs include cimetidine, disulfiram, drugs to treat irregular heart rate (such as quinidine/propafenone/flecainide), antidepressants (such as SSRIs like citalopram/fluvoxamine/paroxetine/sertraline). This is not a complete list.

Many drugs besides amitriptyline may affect the heart rhythm (QT prolongation in the EKG), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Before using amitriptyline/chlordiazepoxide, report all medications you are currently using to your doctor or pharmacist.

Cigarette smoking decreases blood levels of chlordiazepoxide. Tell your doctor if you smoke or if you have recently stopped smoking.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

Amitriptyline is very similar to nortriptyline. Do not use medications containing nortriptyline while using amitriptyline.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: slow/shallow breathing, inability to wake up (coma).

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, liver function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.