In the U.S.—

• Antianxiety agent–antidepressant

Chlordiazepoxide and amitriptyline (klor-dy-az-e-POX-ide and a-mee-TRIP-ti-leen ) 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 the following dosage form:

Oral
• Tablets (U.S.)

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 chlordiazepoxide and amitriptyline combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to chlordiazepoxide (e.g., Librium) or other benzodiazepines (such as alprazolam [e.g., Xanax], bromazepam [e.g., Lectopam], clonazepam [e.g., Klonopin], clorazepate [e.g., Tranxene], diazepam [e.g., Valium], estazolam [e.g., ProSom], flurazepam [e.g., Dalmane], halazepam [e.g., Paxipam], ketazolam [e.g., Loftran], lorazepam [e.g., Ativan], midazolam [e.g., Versed], nitrazepam [e.g., Mogadon], oxazepam [e.g., Serax], prazepam [e.g., Centrax], quazepam [e.g., Doral], temazepam [e.g., Restoril], triazolam [e.g., Halcion]) or to amitriptyline (e.g., Elavil) or other tricyclic antidepressants (such as amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]).

Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—

• Chlordiazepoxide: Chlordiazepoxide has been reported to increase the chance of birth defects when used during the first 3 months of pregnancy.In addition, overuse of chlordiazepoxide during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects in the baby after birth.Use of chlordiazepoxide during pregnancy, especially during the last weeks, may cause drowsiness, slow heartbeat, shortness of breath, or troubled breathing in the newborn baby. Chlordiazepoxide given just before or during labor may cause weakness in the newborn baby.
• Amitriptyline: Studies with amitriptyline have not been done in pregnant women. However, studies in animals have shown amitriptyline to cause birth defects when used in doses many times the human dose. Also, there have been reports of newborns suffering from muscle spasms and heart, breathing, and urinary problems when their mothers had taken tricyclic antidepressants (such as amitriptyline) immediately before delivery.

Breast-feeding—Chlordiazepoxide may pass into the breast milk and cause drowsiness, slow heartbeat, shortness of breath, or troubled breathing in babies of mothers taking this medicine. Although amitriptyline has also been found in breast milk, it has not been reported to cause problems in nursing babies.

Children—Children may be especially sensitive to the effects of chlordiazepoxide and amitriptyline combination. This may increase the chance of side effects during treatment.

Older adults—Elderly people are especially sensitive to the effects of chlordiazepoxide and amitriptyline combination. This may increase the chance of side effects during treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases 2 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 chlordiazepoxide and amitriptyline combination, it is especially important that your health care professional know if you are taking any of the following:

• Alcohol or
• Central nervous system (CNS) depressants (medicines that cause drowsiness)—Using these medicines with chlordiazepoxide and amitriptyline combination may increase the CNS depressant effects

• Amphetamines or
• Appetite suppressants (diet pills) or
• Medicine for asthma or other breathing problems or
• Medicine for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays)—Using these medicines with chlordiazepoxide and amitriptyline combination may increase the risk of serious effects on your heart

• Antacids—Taking these medicines with chlordiazepoxide and amitriptyline combination may delay the combination medicine's effects

• Antihypertensives (high blood pressure medicine)—Taking these medicines with chlordiazepoxide and amitriptyline combination may increase the chance of low blood pressure (hypotension)

• Antithyroid agents (medicine for overactive thyroid) or
• Cimetidine (e.g., Tagamet)—Taking these medicines with chlordiazepoxide and amitriptyline combination may increase the chance of serious side effects

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking chlordiazepoxide and amitriptyline combination while you are taking or within 2 weeks of taking monoamine oxidase (MAO) inhibitors may cause sudden very high body temperature, extremely high blood pressure, and severe convulsions; however, sometimes certain of these medicines may be used with this combination medicine under close supervision by your doctor

• 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

• 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

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 chlordiazepoxide and amitriptyline combination 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 chlordiazepoxide and amitriptyline combination. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets 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 taking chlordiazepoxide and amitriptyline combination.

• For oral dosage forms (tablets):
  • Adults and adolescents: To start, 5 milligrams of chlordiazepoxide and 12.5 milligrams of amitriptyline or 10 milligrams of chlordiazepoxide and 25 milligrams 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 milligrams of chlordiazepoxide and 25 milligrams of amitriptyline taken six times a day.
  • Children up to 12 years of age: Dose must be determined by the 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—

To store this medicine:

• Keep out of the reach of children. Overdose of this medicine is very dangerous in young children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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

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.

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:

• Less common
  • 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 
  
  

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

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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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

• Less common
  • Diarrhea;  nausea or vomiting;  unusual tiredness or weakness 
  
  

After you stop using this medicine, your body may need time to adjust. If you took this medicine in high doses or for a long time, this may take up to 2 weeks. During this time check with your doctor if you notice any of the following side effects:

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

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.