Side Effects of Librax (chlordiazepoxide hydrochloride and clidinium bromide)

Librax(chlordiazepoxide hydrochloride and clidinium bromide) is a combination of an anti-anxiety药物和抗痉挛治疗peptic ulcerdisease andirritable bowel syndrome(IBS). It also may be useful in management of acutegastroenteritis(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, anddry mouth,
• urinary hesitancy or retention (particularly in the elderly), and
• reduced mental alertness.

Serious side effects of Librax include skin eruptions andliverabnormalities.

Drug interactionsof Librax includealcoholor other central nervous system depressants because Librax has sedative effects.

Libraxshould not be used in people withglaucomaorurinary retention(difficulty urinating) due tobenign prostatic hypertrophy(BPH) because clidinium blocks the action of choline, increasingintraocular pressureand causing difficulty urinating.

Libraxis not recommended for use inpregnantwomen because it increases the risk ofcongenital malformationsduring thefirst trimester. The medications in Librax may pass intobreast milk. Consult your doctor beforebreastfeeding.

• Adverse reactions may include drowsiness,dizziness, and confusion.Nausea,constipation, anddry mouthmay 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 takingchlordiazepoxidehydrochloride/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,ataxiaand 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 instancessyncopehas been reported.

Other adverse reactions reported during therapy with chlordiazepoxide hydrochloride include

• isolated instances of skin eruptions,
• edema,
• minor menstrual irregularities,
• nausea andconstipation,
• extrapyramidal symptoms, as well as
• increased and decreasedlibido.

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

Blood dyscrasias, includingagranulocytosis,jaundiceand hepatic dysfunction have occasionally been reported during therapy with chlordiazepoxide hydrochloride. When chlordiazepoxide hydrochloride treatment is protracted, periodic blood counts andliver functiontests are advisable.

Adverse effects reported with use of Librax are those typical ofanticholinergicagents, 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 residuediet.

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 withbarbituratesand alcohol (convulsions,tremor, abdominal andmuscle cramps,vomitingandsweating), 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.,dysphoriaandinsomnia) have been reported following abrupt discontinuance ofbenzodiazepines不断在治疗列弗els for several months.
• Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed.
• Addiction-proneindividuals (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 ofbenzodiazepinesand opioids increases the risk ofrespiratory depressionbecause of actions at different receptor sites in the CNS that controlrespiration.
• Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors.
• When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsenopioid-related respiratorydepressionexists.
• Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratorydepressionand sedation.