FDA label 6eaff581-29dc-35e3-e053-2991aa0a64f2

INDICATIONS AND USAGE Based on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows: "Possibly" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Final classification of the less-than-effective indications requires further investigation.

WARNINGS As in the case of other preparations containing CNS-acting drugs, patients receiving chlordiazepoxide hydrochloride and clidinium bromide 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. Pregnancy Usage in Pregnancy An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, 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. As with all anticholinergic drugs, an inhibiting effect on lactation may occur (see Animal Pharmacology ).

ADVERSE REACTIONS No side effects or manifestation not seen with either compound alone have been reported with the administration of Chlordiazepoxide Hydrochloride/Clidinium Bromide. However, since the capsule 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 Chlordiazepoxide Hydrochloride/Clidinium Bromide 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 Chlordiazepoxide Hydrochloride/Clidinium Bromide therapy has been combined with other spasmolytic agents and/or low residue diet. To report suspected adverse reactions, contact Virtus Pharmaceuticals OPCO II, LLC at 1-855-255-6076 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.