"Eluxadoline (Viberzi, Allergan), a drug used to treat irritable bowel syndrome (IBS) with diarrhea, should not be used in patients who do not have a gallbladder, the US Food and Drug Administration (FDA) said today.
(Generic versions may still be available.)
As in the case of other preparations containing CNS-acting drugs, patients receiving Librax should be cautioned about possible combined effects with alcohol and other CNS depressants. For the same reason, they should be cautioned against hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle.
Usage In Pregnancy
An Increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.
In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion (not more than 2 Librax capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Librax and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed - particularly when the known potentiating compounds such as the MAO inhibitors and phenothiazines are to be used. The usual precautions in treating patients with impaired renal or hepatic function should be observed.
Paradoxical reactions to chlordiazepoxide hydrochloride, eg, excitement, stimulation and acute rage, have been reported in psychiatric patients and should be watched for during Librax therapy. The usual precautions are indicated when chlordiazepoxide hydrochloride is used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary. Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide hydrochloride.
Safety and effectiveness in pediatric patients have not been established.
Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Librax. These effects can usually be avoided with proper dosage adjustment, although they have occasionally been observed even at the lower dosage ranges. Dosing in geriatric subjects should be initiated cautiously (no more than 2 capsules per day) and increased gradually if needed and tolerated (see DOSAGE AND ADMINISTRATION). Librax is contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction (see CONTRAINDICATIONS).This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/27/2017
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