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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: chlordiazepoxide and clidinium (klor dye az e POX ide and kli DI nee um)
Brand name(s): LIBRAX
GENERIC: not available FAMILIES: Other Gastrointestinal Drugs , Benzodiazepines, Anticholinergics
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

Safety Warnings For This Drug [top]

WARNING

INDICATIONS AND USAGE

Based on a review of this drug by the National Academy of Sciences — National Research Council and/or other information, the FDA has classified the indications as follows:

"Possibly" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

Final classification of the less-than-effective indications requires further investigation.

FDA BLACK-BOX WARNING

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Product Warnings

Ask a doctor or pharmacist before use if you are taking antibiotics.

When using this product, tiredness, drowsiness or dizziness may occur. Be careful driving or operating machinery.

Stop using and ask a doctor if symptoms get worse, diarrhea lasts more than two days or you get abdominal swelling or bulging. These may be signs of a serious condition.

If pregnant or breast-feeding, ask a health care professional before use.

Older adults are especially sensitive to the harmful anticholinergic effects of this drug. Drugs in this family should not be used unless absolutely necessary.

Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention.

Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma.

If you are currently taking zolpidem and develop complex sleep behaviors, discontinue the drug immediately and seek medical help.

Otherwise, if you have been taking zolpidem for awhile, do not stop taking this drug suddenly because it may cause drug-induced dependence. Instead, work with your doctor to create a schedule to stop it gradually to avoid withdrawal reactions (including stomach cramps, vomiting, nervousness and panic attacks).

The FDA has concluded that this drug lacks evidence of effectiveness.

Facts About This Drug [top]

This combination of clidinium and chlordiazepoxide is approved by the Food and Drug Administration (FDA) to treat symptoms associated with stomach and duodenal ulcers, irritable bowel syndrome and acute enterocolitis in combination with other treatments. It is said to relieve abdominal discomfort from cramping (spasms), reduce the amount of stomach acid and relax the digestive system. However, it is an irrational and ineffective mixture of drugs that older adults should not use. In...

This combination of clidinium and chlordiazepoxide is approved by the Food and Drug Administration (FDA) to treat symptoms associated with stomach and duodenal ulcers, irritable bowel syndrome and acute enterocolitis in combination with other treatments. It is said to relieve abdominal discomfort from cramping (spasms), reduce the amount of stomach acid and relax the digestive system. However, it is an irrational and ineffective mixture of drugs that older adults should not use. In particular, the FDA has determined that this drug does not have evidence of effectiveness;[1] such drugs are supposed to be removed from the market, but the FDA has failed to do so.

One ingredient in this combination is clidinium, an antispasmodic drug. Clidinium alone has such severe adverse effects that older adults should not use it (see box above). Even if you are taking only the usual adult dose, you may suffer excitement, restlessness, drowsiness or confusion.[2] Clidinium can also reduce the amount of saliva. Because saliva fights bacteria in the mouth, a decrease in the amount of saliva leads to erosion of the gums and teeth, and later to dental or denture problems such as tooth decay.

The second ingredient in this combination, chlordiazepoxide (sold by itself as LIBRIUM), is a benzodiazepine tranquilizer. Because of this ingredient, the resulting product is addictive. Withdrawal reactions include sweating, vomiting, tremor, abdominal pain and seizures.

Benzodiazepines can cause confusion, lack of muscle coordination leading to falls and hip fractures and drowsiness in older adults. Public Citizen’s Health Research Group designated all benzodiazepines — except for alprazolam (XANAX), which should only be used to treat panic disorder — as Do Not Use drugs. These drugs should not be used to treat digestive problems.

If you are taking this combination of chlordiazepoxide and clidinium, ask your doctor to prescribe another drug. If you have used the drug continuously for several weeks or longer, ask for a dosing schedule that lowers your dose gradually.

Regulatory Actions

2016: The FDA added a boxed warning, the strongest warning from the FDA, to opioid and benzodiazepine drugs stating that serious side effects have occurred when these medications are used together.[3]

2023: The FDA updated the drug product label of benzodiazepines to warn that the drug can cause sedation and withdrawal symptoms in newborns when used during late pregnancy. [3283]

last reviewed September 30, 2023