Brand Names: Limbitrol, Limbitrol DS

Generic Name: amitriptyline and chlordiazepoxide (Pronunciation: a mi TRIP ti leen and klor dye az e POX ide)

• What is amitriptyline and chlordiazepoxide (Limbitrol)?
• What are the possible side effects of amitriptyline and chlordiazepoxide (Limbitrol)?
• What is the most important information I should know about amitriptyline and chlordiazepoxide (Limbitrol)?
• What should I discuss with my healthcare provider before taking amitriptyline and chlordiazepoxide (Limbitrol)?
• How should I take amitriptyline and chlordiazepoxide (Limbitrol)?
• What happens if I miss a dose (Limbitrol)?
• What happens if I overdose (Limbitrol)?
• What should I avoid while taking amitriptyline and chlordiazepoxide (Limbitrol)?
• What other drugs will affect amitriptyline and chlordiazepoxide (Limbitrol)?
• Where can I get more information?

What is amitriptyline and chlordiazepoxide (Limbitrol)?

Amitriptyline is in a group of drugs called tricyclic antidepressants. Amitriptyline affects chemicals in the brain that may become unbalanced.

Chlordiazepoxide is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Chlordiazepoxide affects chemicals in the brain that may become unbalanced and cause anxiety.

Amitriptyline and chlordiazepoxide is used to treat depression and anxiety.

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

Amitriptyline-Chlordiazepoxide 25 mg-10 mg-MYL

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Chlordiazepoxide-Amitriptyline 5-12.5 mg-MYL

round, green, imprinted with MYLAN, 211

What are the possible side effects of amitriptyline and chlordiazepoxide (Limbitrol)?

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

Call your doctor at once if you have any new or worsening symptoms 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.

Other serious side effects include:

• fast, pounding, or uneven heart rate, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness (especially on one side of the body), headache, confusion, problems with vision, speech, or balance;
• hallucinations, or seizures (convulsions), feeling light-headed, fainting;
• easy bruising or bleeding;
• jaundice (yellowing of your skin or eyes); or
• urinating less than usual or not at all.

Less serious side effects may be more likely to occur, such as:

• feeling dizzy, drowsy, or tired;
• blurred vision, trouble concentrating;
• dry mouth, unusual or unpleasant taste;
• loss of appetite, nausea, vomiting, stomach pain, constipation;
• weight changes;
• strange dreams or nightmares;
• breast or testicle swelling in men; or
• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amitriptyline and chlordiazepoxide (Limbitrol)?

Do not use this medication if you are allergic to amitriptyline (Elavil) or chlordiazepoxide (Librium), or to other benzodiazepines, such as alprazolam (Xanax), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax).

Do not use amitriptyline and chlordiazepoxide if you have taken an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

This medication can cause birth defects in an unborn baby. Do not use amitriptyline and chlordiazepoxide if you are pregnant.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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.

Do not drink alcohol while taking amitriptyline and chlordiazepoxide. Chlordiazepoxide can increase the effects of alcohol.