ady taking chlordiazepoxide, prescribe a lower initial dose of the opioid and titrate based upon clinical response. advise both patients and caregivers about the risks of respiratory depression and sedation when chlordiazepoxide is used with opioids. advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see precautions: drug interactions ). abuse, misuse, and addiction: the use of benzodiazepines, including chlordiazepoxide, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see drug abuse and dependence: abuse ). before prescribing chlordiazepoxide and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). use of chlordiazepoxide, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of chlordiazepoxide along with monitoring for signs and symptoms of abuse, misuse, and addiction. prescribe the lowest effective dosage; avoid or minimize concomitant use of cns depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. if a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. dependence and withdrawal reactions: to reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide or reduce the dosage (a patient-specific plan should be used to taper the dose) (see dosage and administration: discontinuation or dosage reduction of chlordiazepoxide ). patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages and those who have had longer durations of use. acute withdrawal reactions the continued use of benzodiazepines, including chlordiazepoxide, may lead to clinically significant physical dependence. abrupt discontinuation or rapid dosage reduction of chlordiazepoxide after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see drug abuse and dependence: dependence ). protracted withdrawal syndrome in some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see drug abuse and dependence: dependence ). chlordiazepoxide hydrochloride may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. similarly, it may impair mental alertness in children. the concomitant use of alcohol or other central nervous system depressants may have an additive effect. patients should be warned accordingly. neonatal sedation and withdrawal syndrome use of chlordiazepoxide hydrochloride late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate ( see precautions, pregnancy ). monitor neonates exposed to chlordiazepoxide hydrochloride during pregnancy or labor for signs of sedation and monitor neonates exposed to chlordiazepoxide hydrochloride during pregnancy for signs of withdrawal; manage these infants accordingly.

rs of age is limited, the use of the drug in this age group is not recommended. 5 mg, 2 to 4 times daily (may be increased in some pediatric patients to 10 mg, 2 to 3 times daily) for the relief of withdrawal symptoms of acute alcoholism, the parenteral form* is usually used initially. if the drug is administered orally, the suggested initial dose is 50 to 100 mg, to be followed by repeated doses as needed until agitation is controlled - up to 300 mg per day. dosage should then be reduced to maintenance levels. *see package insert for injectable chlordiazepoxide hydrochloride discontinuation or dosage reduction of chlordiazepoxide to reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide or reduce the dosage. if a patient develops withdrawal reactions, consider pausing the taper or increase the dosage to the previous tapered dosage level. subsequently decrease the dosage more slowly (see warnings: dependence and withdrawal reactions and drug abuse and dependence: dependence ).

iazepoxide treatment is protracted, periodic blood counts and liver function tests are advisable. to report suspected adverse reactions, contact chartwell rx, llc. at 1-845-232-1683 or fda at 1- 800-fda-1088 or www.fda.gov/medwatch.

ct of chlordiazepoxide hydrochloride was further demonstrated in rats made vicious by lesions in the septal area of the brain. the drug dosage which effectively blocked the vicious reaction was well below the dose which caused sedation in these animals. the ld 50 of parenterally administered chlordiazepoxide hydrochloride was determined in mice (72 hours) and rats (5 days), and calculated according to the method of miller and tainter, with the following results: mice, iv, 123±12mg/kg; mice, im, 366±7mg/kg; rats, iv, 120±7 mg/kg; rats, im, >160 mg/kg. effects on reproduction reproduction studies in rats fed 10, 20 and 80 mg/kg daily and bred through one or two matings showed no congenital anomalies, nor were there adverse effects on lactation of the dams or growth of the newborn. however, in another study at 100 mg/kg daily there was noted a significant decrease in the fertilization rate and a marked decrease in the viability and body weight of offspring which may be attributable to sedative activity, thus resulting in lack of interest in mating and lessened maternal nursing and care of the young. one neonate in each of the first and second matings in the rat reproduction study at the 100 mg/kg dose exhibited major skeletal defects. further studies are in progress to determine the significance of these findings.

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