Librax

(Generic versions may still be available.)

DRUG DESCRIPTION

Librax (chlordiazepoxide and clidinium) combines in a single capsule formulation the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide, both exclusive developments of Roche research.

Each Librax (chlordiazepoxide and clidinium) capsule contains 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains corn starch, lactose and talc. Gelatin capsule shells may contain methyl and propyl parabens and potassium sorbate, with the following dye systems: D&C Yellow No. 10 and either FD&C Blue No. 1 or FD&C Green No. 3.

Chlordiazepoxide hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds.

Chlordiazepoxide hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of chlordiazepoxide hydrochloride is as follows:

Chlordiazepoxide hydrochloride Structural Formula Illustration

Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally clidinium bromide is:

What are the possible side effects of chlordiazepoxide and clidinium (Librax)?

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 of these serious side effects:

  • confusion;
  • depressed mood, thoughts of suicide or hurting yourself;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • hyperactivity, agitation, hostility;
  • hallucinations;
  • jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Librax

What are the precautions when taking chlordiazepoxide and clidinium (Librax)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to clidinium or chlordiazepoxide; 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: glaucoma, enlarged prostate, problems with urination due to a blocked urinary tract, other stomach/intestinal problems (such as slow gut, blockage, ulcerative colitis, infection, little/no stomach acid, ileostomy/colostomy patients with diarrhea), overactive thyroid, heart problems (such as coronary artery disease, angina, congestive heart failure, fast/irregular heartbeat, heart problems due...

Read All Potential Precautions of Librax


Librax Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, weakness, blurred vision, dry eyes, dry mouth, nausea, constipation, and abdominal bloating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. To relieve dry eyes, consult your pharmacist for artificial tears or other eye lubricants.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: decreased sweating, dry/hot/flushed skin, fast/irregular heartbeat, loss of coordination, slurred speech, fainting, uncontrollable/unusual muscle movements, mental/mood changes (such as confusion, agitation, unusual excitement, depression, strange thoughts), eye pain, vision changes, difficulty urinating, decreased sexual ability, slow/shallow breathing.

Tell your doctor immediately if any of these rare but serious side effects occur: signs of infection (such as fever, persistent sore throat), signs of liver problems (dark urine, persistent nausea, vomiting, stomach/abdominal pain, yellowing eyes/skin, unusual tiredness).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

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

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to clidinium or chlordiazepoxide; 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: glaucoma, enlarged prostate, problems with urination due to a blocked urinary tract, other stomach/intestinal problems (such as slow gut, blockage, ulcerative colitis, infection, little/no stomach acid, ileostomy/colostomy patients with diarrhea), overactive thyroid, heart problems (such as coronary artery disease, angina, congestive heart failure, fast/irregular heartbeat, heart problems due to severe bleeding), high blood pressure, heartburn problems (such as acid reflux, hiatal hernia, esophagus problems), a certain nervous system problem (autonomic neuropathy), myasthenia gravis, liver problems, kidney problems, breathing/lung problems, drug/alcohol abuse, mental/mood conditions (such as depression, thoughts of suicide, psychosis, schizophrenia), a certain blood disorder (porphyria).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication may make you sweat less which can increase your risk for heat stroke, a very serious condition. Avoid activities that might cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). Drink plenty of fluids, and dress lightly while in hot weather or when exercising. If you become overheated, stop exercising and promptly seek cooler shelter. Seek immediate medical attention if you develop a fever, mental/mood changes, headache, or dizziness.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, unusual excitement, memory problems, constipation, urination problems, and unsteadiness.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. If you become pregnant or think you may be pregnant while taking this medication, tell your doctor immediately.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Librax Patient Information Including Side Effects

Brand Names: Librax

Generic Name: chlordiazepoxide and clidinium (Pronunciation: klor dye az e POX ide and kli DI nee um)

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

What is chlordiazepoxide and clidinium (Librax)?

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.

Clidinium reduces stomach acid and decreases intestinal spasms.

The combination of chlordiazepoxide and clidinium is used to treat stomach ulcers, irritable bowel syndrome, and intestinal infections.

Chlordiazepoxide and clidinium may also be used for other purposes not listed in this medication guide.

What are the possible side effects of chlordiazepoxide and clidinium (Librax)?

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 of these serious side effects:

  • confusion;
  • depressed mood, thoughts of suicide or hurting yourself;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • hyperactivity, agitation, hostility;
  • hallucinations;
  • jaundice (yellowing of the skin or eyes); or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • drowsiness, tiredness;
  • swelling;
  • skin rash;
  • blurred vision;
  • dry mouth;
  • nausea, vomiting, constipation; or
  • irregular menstrual periods.

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.

What is the most important information I should know about chlordiazepoxide and clidinium (Librax)?

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

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

Before taking chlordiazepoxide and clidinium, tell your doctor if you have any breathing problems, glaucoma, porphyria, kidney or liver disease, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Do not drink alcohol while taking chlordiazepoxide and clidinium. This medication can increase the effects of alcohol.

Chlordiazepoxide and clidinium can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

This medication may be habit-forming and should be used only by the person it was prescribed for. Chlordiazepoxide and clidinium should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

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