Side Effects of Librax (chlordiazepoxide hydrochloride and clidinium bromide)

Librax (chlordiazepoxide hydrochloride and clidinium bromide) is a combination of an anti-anxiety medication and antispasmodic used as therapy for peptic ulcer disease and irritable bowel syndrome (IBS). It also may be useful in management of acute gastroenteritis (stomach flu). It also blocks the acid secretion of the gastrointestinal tract and inhibits the action of nerves that are very active in certain diseases. 

Common side effects of Librax include

• drowsiness,
• dizziness,
• confusion,
• nausea,
• constipation, and dry mouth,
• urinary hesitancy or retention (particularly in the elderly), and
• reduced mental alertness.

Serious side effects of Librax include skin eruptions and liver abnormalities.

Drug interactions of Librax include alcohol or other central nervous system depressants because Librax has sedative effects.

Librax should not be used in people with glaucoma or urinary retention (difficulty urinating) due to benign prostatic hypertrophy (BPH) because clidinium blocks the action of choline, increasing intraocular pressure and causing difficulty urinating.

Librax is not recommended for use in pregnant women because it increases the risk of congenital malformations during the first trimester. The medications in Librax may pass into breast milk. Consult your doctor before breastfeeding. 

• Adverse reactions may include drowsiness, dizziness, and confusion. Nausea, constipation, and dry mouth may occur.
• Urinary hesitancy or retention are seen, particularly in the elderly.
• Skin eruptions and liver abnormalities are less common.
• Avoid driving or operating machinery while taking chlordiazepoxide hydrochloride/clidinium bromide because it reduces mental alertness.

No side effects or manifestations not seen with either compound alone have been reported with the administration of Librax. However, since Librax contains chlordiazepoxide hydrochloride and clidinium bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded.

When chlordiazepoxide hydrochloride has been used alone the necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients - particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported.

Other adverse reactions reported during therapy with chlordiazepoxide hydrochloride include

• isolated instances of skin eruptions,
• edema,
• minor menstrual irregularities,
• nausea and constipation,
• extrapyramidal symptoms, as well as
• increased and decreased libido.

Such side effects have been infrequent and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after chlordiazepoxide hydrochloride treatment.

Blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction have occasionally been reported during therapy with chlordiazepoxide hydrochloride. When chlordiazepoxide hydrochloride treatment is protracted, periodic blood counts and liver function tests are advisable.

Adverse effects reported with use of Librax are those typical of anticholinergic agents, i.e., dryness of the mouth, blurring of vision, urinary hesitancy and constipation. Constipation has occurred most often when Librax therapy has been combined with other spasmolytic agents and/or a low residue diet.

To report suspected adverse reactions, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Abuse And Dependence

• Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide.
• The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time.
• Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months.
• Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed.
• Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving chlordiazepoxide or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

• The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.
• Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors.
• When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.
• Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation.