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warnings and cautions
5 WARNINGS AND PRECAUTIONS RE Chlordiazepoxide/Clidinium Capsules may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery. Use caution when prescribing RE Chlordiazepoxide/Clidinium Capsules concurrently with psychotropic agents, especially those that include MAO inhibitors and phenothiazines. Patients with impaired renal or hepatic function should be observed, along with patients being treated for anxiety or depression. Paradoxical reactions to chlordiazepoxide hydrochloride, e.g. excitement, stimulation and acute rage have been reported in psychiatric patients and should be considered during RE Chlordiazepoxide/Clidinium Capsules therapy.
6 ADVERSE REACTIONS: When chlordiazepoxide hydrochloride has been used alone, drowsiness, ataxia and confusion have been reported in some patients, particularly the elderly and debilitated. These effects can be avoided in almost all instances by adjusting the dosage, and have occasionally been observed at the lower dosage ranges. In a few instances, syncope has been reported. Also reported are isolated instances of skin eruptions, edema, nausea and constipation, extrapyramidal symptoms, minor menstrual irregularities, 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 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. Typical of anlichalinergic agents, adverse effects reported with use of RE Chlordiazepoxide/Clidinium Capsules may include dry mouth, blurred vision, urinary hesitancy and constipation. Constipation occurred most often when combined with other spasinolytic agents and/or a restrictive, low residue diet. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.