Amitriptyline is a tricyclic antidepressant. Chlordiazepoxide is a benzodiazepine (ben-zoe-dye-AZE-eh-peen).

Amitriptyline and chlordiazepoxide is a combination medicine used to treat moderate to severe depression and anxiety.

Amitriptyline and chlordiazepoxide may also be used for purposes not listed in this medication guide.

This medicine can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.

MISUSE OF AMITRIPTYLINE AND CHLORDIAZEPOXIDE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

You should not use this medicine if you have recently had a heart attack, or if you have used an MAO inhibitor in the past 14 days (such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine).

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Follow the directions on your prescription label and read all medication guides. Never use amitriptyline and chlordiazepoxide in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Do not stop using amitriptyline and chlordiazepoxide suddenly, or you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Usual Adult Dose for Anxiety:

Amitriptyline 25 mg-chlordiazepoxide 10 mg tablets:
-Initial dose: 3 to 4 tablets orally per day, given in divided doses
-Maintenance dose: 2 to 6 tablets orally per day, given in divided doses
Maximum dose: 6 tablets/day

Comments:
-Doses should be reduced to the lowest effective amount once a satisfactory response is obtained.
-The larger portion of the total dose may be given at bedtime.
-A single daily dose (given at bedtime) may be sufficient for some patients.

Use: Treatment of patients with moderate to severe depression associated with moderate to severe anxiety

Usual Adult Dose for Depression:

Amitriptyline 25 mg-chlordiazepoxide 10 mg tablets:
-Initial dose: 3 to 4 tablets orally per day, given in divided doses
-Maintenance dose: 2 to 6 tablets orally per day, given in divided doses
Maximum dose: 6 tablets/day

Comments:
-Doses should be reduced to the lowest effective amount once a satisfactory response is obtained.
-The larger portion of the total dose may be given at bedtime.
-A single daily dose (given at bedtime) may be sufficient for some patients.

Use: Treatment of patients with moderate to severe depression associated with moderate to severe anxiety

You should not use amitriptyline and chlordiazepoxide if you are allergic to amitriptyline or chlordiazepoxide, or:

• if you recently had a heart attack;

• if you are allergic to any antidepressant like amitriptyline (clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, trimipramine); or

• if you are allergic to Valium or other medicines like chlordiazepoxide (alprazolam, diazepam, lorazepam, midazolam, triazolam, Xanax, Ativan, Tranxene, and others).

Do not use amitriptyline and chlordiazepoxide if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone.

Tell your doctor if you have ever had:

• depression or bipolar disorder (manic depression);

• suicidal thoughts or actions;

• drug or alcohol addiction;

• heart disease;

• a heart attack, stroke, or seizures;

• liver or kidney disease;

• a thyroid disorder;

• problems with urination;

• glaucoma; or

• if you are receiving electroshock treatment.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or plan to become pregnant. Amitriptyline and chlordiazepoxide may harm an unborn baby. Avoid taking this medicine during the first trimester of pregnancy.

If you use amitriptyline and chlordiazepoxide while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amitriptyline and chlordiazepoxide can be fatal.

Overdose symptoms may include confusion, drowsiness, hallucinations, irregular heart rhythm, muscle stiffness, vomiting, dilated pupils, feeling hot or cold, feeling like you might pass out, seizure, or coma.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how amitriptyline and chlordiazepoxide will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Amitriptyline and chlordiazepoxide can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Amitriptyline and chlordiazepoxide may cause serious side effects. Call your doctor at once if you have:

• severe constipation;

• confusion, hallucinations, unusual thoughts or behavior;

• chest pain or heavy feeling, pain spreading to the jaw or shoulder;

• pounding heartbeats or fluttering in your chest;

• a light-headed feeling, like you might pass out; or

• little or no urination.

The sedative effects of amitriptyline and chlordiazepoxide may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury.

Common side effects of amitriptyline and chlordiazepoxide may include:

• dizziness, drowsiness;

• blurred vision;

• dry mouth; or

• constipation, bloating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, prescription cough medicine, or medicine for depression or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• any other antidepressants;

• heart or blood pressure medication; or

• medicine to treat mental illness.

This list is not complete. Other drugs may affect amitriptyline and chlordiazepoxide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.