Pronunciation:

(klor dye az e POKS ide)

U.S. Brand Names:

Synonyms:

Generic Available:

Canadian Brand Names:

Use:

Restrictions:

Pregnancy Risk Factor:

Lactation:

Contraindications:

Warnings/Precautions:

Parenteral administration should be avoided in comatose patients or shock. Adequate resuscitative equipment/personnel should be available, and appropriate monitoring should be conducted at the time of injection and for several hours following administration. The parenteral formulation should be diluted for I.M. administration with the supplied diluent only. This diluent should not be used when preparing the drug for intravenous administration.

Causes CNS depression (dose-related) resulting in sedation, dizziness, confusion, or ataxia which may impair physical and mental capabilities. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Use with caution in patients receiving other CNS depressants or psychoactive agents (lithium, phenothiazines). Effects with other sedative drugs or ethanol may be potentiated. Benzodiazepines have been associated with falls and traumatic injury and should be used with extreme caution in patients who are at risk of these events (especially the elderly).

Use caution in patients with depression, particularly if suicidal risk may be present. Use with caution in patients with a history of drug dependence. Benzodiazepines have been associated with dependence and acute withdrawal symptoms on discontinuation or reduction in dose. Acute withdrawal, including seizures, may be precipitated in patients after administration of flumazenil to patients receiving long-term benzodiazepine therapy.

Benzodiazepines have been associated with anterograde amnesia. Paradoxical reactions, including hyperactive or aggressive behavior have been reported with benzodiazepines, particularly in adolescent/pediatric or psychiatric patients. Does not have analgesic, antidepressant, or antipsychotic properties.

Adverse Reactions:

>10%:

Central nervous system: Drowsiness, fatigue, ataxia, lightheadedness, memory impairment, dysarthria, irritability

Dermatologic: Rash

Endocrine & metabolic: Decreased libido, menstrual disorders

Gastrointestinal: Xerostomia, decreased salivation, increased or decreased appetite, weight gain/loss

Genitourinary: Micturition difficulties

1% to 10%:

Cardiovascular: Hypotension

Central nervous system: Confusion, dizziness, disinhibition, akathisia, increased libido

Dermatologic: Dermatitis

Gastrointestinal: Increased salivation

Genitourinary: Sexual dysfunction, incontinence

Neuromuscular & skeletal: Rigidity, tremor, muscle cramps

Otic: Tinnitus

Respiratory: Nasal congestion

<1%: Photosensitivity

Overdosage/Toxicology:

Drug Interactions:

CNS depressants: Sedative effects and/or respiratory depression may be additive with CNS depressants; includes ethanol, barbiturates, narcotic analgesics, and other sedative agents; monitor for increased effect

CYP3A4 inducers: CYP3A4 inducers may decrease the levels/effects of chlordiazepoxide. Example inducers include aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins.

CYP3A4 inhibitors: May increase the levels/effects of chlordiazepoxide. Example inhibitors include azole antifungals, ciprofloxacin, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, and verapamil.

Levodopa: Therapeutic effects may be diminished in some patients following the addition of a benzodiazepine; limited/inconsistent data

Oral contraceptives: May decrease the clearance of some benzodiazepines (those which undergo oxidative metabolism); monitor for increased benzodiazepine effect

Theophylline: May partially antagonize some of the effects of benzodiazepines; monitor for decreased response; may require higher doses for sedation

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Food: Serum concentrations/effects may be increased with grapefruit juice, but unlikely because of high oral bioavailability of chlordiazepoxide.

Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).

Stability:

I.M. use: Reconstitute by adding 2 mL of provided diluent; agitate gently until dissolved. Provided diluent is not for I.V. use.

I.V. use: Reconstitute by adding 5 mL NS or SWFI; agitate gently until dissolved; do not administer this dilution I.M.

Compatibility:

Y-site administration: Compatible: Heparin, hydrocortisone sodium succinate, potassium chloride, vitamin B complex with C. Incompatible: Cefepime

Mechanism of Action:

Pharmacodynamics/Kinetics:

Distribution: Vd: 3.3 L/kg; crosses placenta; enters breast milk

Protein binding: 90% to 98%

Metabolism: Extensively hepatic to desmethyldiazepam (active and long-acting)

Half-life elimination: 6.6-25 hours; End-stage renal disease: 5-30 hours; Cirrhosis: 30-63 hours

Time to peak, serum: Oral: Within 2 hours; I.M.: Results in lower peak plasma levels than oral

Excretion: Urine (minimal as unchanged drug)

Dosage:

Children:

<6 years: Not recommended

>6 years: Anxiety: Oral, I.M.: 0.5 mg/kg/24 hours divided every 6-8 hours

Adults:

Anxiety:

Oral: 15-100 mg divided 3-4 times/day

I.M., I.V.: Initial: 50-100 mg followed by 25-50 mg 3-4 times/day as needed

Preoperative anxiety: I.M.: 50-100 mg prior to surgery

Ethanol withdrawal symptoms: Oral, I.V.: 50-100 mg to start, dose may be repeated in 2-4 hours as necessary to a maximum of 300 mg/24 hours

Note: Up to 300 mg may be given I.M. or I.V. during a 6-hour period, but not more than this in any 24-hour period.

Dosing adjustment in renal impairment: Clcr<10 mL/minute: Administer 50% of dose

Hemodialysis: Not dialyzable (0% to 5%)

Dosing adjustment/comments in hepatic impairment: Avoid use

Administration:

I.M.: Administer by deep I.M. injection slowly into the upper outer quadrant of the gluteus muscle; use only the diluent provided for I.M. use; solutions made with SWFI or NS cause pain with I.M. administration

I.V.: Administer slowly over at least 1 minute; do not use the diluent provided for I.M. use; air bubbles form during reconstitution

Monitoring Parameters:

Reference Range:

Patient Education:

Nursing Implications:

Additional Information:

Anesthesia and Critical Care Concerns/Other Considerations:

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Dosage Forms:

Capsule, as hydrochloride: 5 mg, 10 mg, 25 mg

Injection, powder for reconstitution, as hydrochloride: 100 mg [diluent contains benzyl alcohol, polysorbate 80, and propylene glycol]

International Brand Names: