Applies to chlordiazepoxide / clidinium: oral capsule.
Warning
Oral route (Capsule)
Warning: Risks From Concomitant Use With Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal ReactionsConcomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.The use of benzodiazepines, include chlordiazepoxide hydrochloride, a component of Librax®, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing chlordiazepoxide hydrochloride/clidinium bromide and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.The continued use of benzodiazepines, including chlordiazepoxide hydrochloride/clidinium bromide, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of chlordiazepoxide hydrochloride/clidinium bromide after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risks of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride/clidinium bromide or reduce the dosage.
Serious side effects
Along with its needed effects, chlordiazepoxide / clidinium may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking chlordiazepoxide / clidinium:
Incidence not known
- Chills
- clay-colored stools
- confusion
- cough or hoarseness
- dark urine
- difficulty with speaking
- dizziness
- drooling
- drowsiness
- fever with or without chills
- general feeling of tiredness or weakness
- headache
- itching or rash
- loss of appetite
- loss of balance control
- lower back or side pain
- muscle trembling, jerking, or stiffness
- nausea
- painful or difficult urination
- pale skin
- restlessness
- shakiness and unsteady walk
- shuffling walk
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stiffness of the limbs
- stomach pain
- swelling
- twisting movements of the body
- uncontrolled movements, especially of the face, neck, and back
- unpleasant breath odor
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bruising or bleeding
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking chlordiazepoxide / clidinium:
Symptoms of overdose
- Agitation
- blurred vision
- change in consciousness
- changes in patterns and rhythms of speech
- confusion
- difficulty having a bowel movement (stool)
- dry mouth
- lack of coordination
- loss of consciousness
- loss of strength or energy
- nightmares
- shakiness and unsteady walk
- sleepiness or unusual drowsiness
- slurred speech
- talkativeness
- trouble speaking
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusual excitement, nervousness, restlessness, or irritability
- unusual paleness
Other side effects
Some side effects of chlordiazepoxide / clidinium may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Inability to have or keep an erection
- increase or loss in sexual ability, desire, drive, or performance
- increased or decreased interest in sexual intercourse
- menstrual changes
- skin blisters
For Healthcare Professionals
Applies to chlordiazepoxide / clidinium: oral capsule.
General
The most commonly reported side effects included anticholinergic effects (e.g., blurred vision, constipation, dry mouth, urinary hesitancy).[Ref]
Psychiatric
The elderly and debilitated may be more susceptible to confusion; this side effect has occasionally been reported at the lower dosage ranges.[Ref]
Uncommon (0.1% to 1%): Decreased libido, increased libido
Rare (0.01% to 0.1%): Confusion[Ref]
Gastrointestinal
Constipation most commonly occurred when patients took spasmolytic agents concurrently and/or with a low residue diet.[Ref]
Uncommon (0.1% to 1%): Constipation, nausea
Frequency not reported: Dry mouth[Ref]
Hepatic
Uncommon (0.1% to 1%): Jaundice, liver dysfunction[Ref]
Hematologic
Uncommon (0.1% to 1%): Agranulocytosis, blood dyscrasias[Ref]
Nervous system
Uncommon (0.1% to 1%): Extrapyramidal symptoms
Rare (0.01% to 0.1%): Drowsiness
Very rare (less than 0.01%): Syncope
Frequency not reported: Anticholinergic effects, changes in EEG patterns (low-voltage fast activity)[Ref]
The elderly and debilitated may be more susceptible to drowsiness and syncope; the side effects have occasionally been reported at the lower dosage ranges.[Ref]
Genitourinary
Uncommon (0.1% to 1%): Minor menstrual irregularities
Frequency not reported: Urinary hesitancy[Ref]
Cardiovascular
Uncommon (0.1% to 1%): Edema[Ref]
Dermatologic
Uncommon (0.1% to 1%): Skin eruptions[Ref]
Other
The elderly and debilitated may be more susceptible to ataxia; this side effect has occasionally been reported at the lower dosage ranges.[Ref]
Rare (0.01% to 0.1%): Ataxia[Ref]
Ocular
Frequency not reported: Blurred vision[Ref]
