DIAZEPAM 10mg. Tablets.
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Description
Diazepam 10mg.
BOXED WARNING
As with other benzodiazepines, diazepam should be used with caution in patients with pulmonary disease. Additionally, avoid coadministration with other CNS depressants, especially opioids, unless no other alternatives are available as coadministration significantly increases the risk for respiratory depression, low blood pressure, and death. Oral diazepam tablets are contraindicated for use in those with severe respiratory insufficiency or sleep apnea syndrome. Diazepam should be used with caution in other pulmonary diseases as well including severe chronic obstructive pulmonary disease (COPD), sleep apnea, asthma, or pneumonia because the drug can exacerbate ventilatory failure. Lower doses are recommended in patients with chronic respiratory insufficiency.
DEA CLASS
Rx, schedule IV
DESCRIPTION
Oral, parenteral, or rectal long-acting benzodiazepine
Used for anxiety, acute alcohol withdrawal, skeletal muscle spasm, and seizure disorders
Long-term use not well studied
COMMON BRAND NAMES
Diastat, Dizac, Valium
HOW SUPPLIED
Diastat/Diazepam Rectal Gel: 1mL, 5mg
Diazepam Oral Sol: 1mL, 5mg, 5mL
Diazepam/Dizac/Valium Intramuscular Inj Sol: 1mL, 5mg
Diazepam/Dizac/Valium Intramuscular Sol: 1mL, 5mg
Diazepam/Dizac/Valium Intravenous Inj Sol: 1mL, 5mg
Diazepam/Dizac/Valium Intravenous Sol: 1mL, 5mg
Diazepam/Valium Oral Tab: 2mg, 5mg, 10mg
DOSAGE & INDICATIONS
2 to 10 mg PO 2 to 4 times per day depending upon the severity of the symptoms. Use lower initial adult doses for the debilitated adult patient. A maximum daily dosage has not been defined by the manufacturer, but commonly implied limit is 40 mg/day in divided doses for ambulatory use.
2 to 2.5 mg PO 1 to 2 times per day, increasing the dose according to response and patient tolerability. A maximum daily dosage has not been defined, but commonly the adult limits are 40 mg/day in divided doses for ambulatory use. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of anxiolytics in long-term care facility (LTCF) residents. Max: 5 mg/day PO in residents meeting the criteria for treatment, except when documentation is provided showing that higher doses are necessary to maintain or improve the resident’s functional status. In addition, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines.
Initially, 1 to 2.5 mg PO 3 to 4 times per day. The dose may be increased as needed and tolerated.
2 to 5 mg IM or IV for moderate anxiety disorders and symptoms of anxiety; repeat in 3 to 4 hours if necessary. For severe anxiety disorders and symptoms of anxiety, 5 to 10 mg IM or IV; repeat in 3 to 4 hours if necessary.
Until it is known how the patient will respond, a dose of 10 mg IV initially, followed by 5 to 10 mg IV every 3 to 4 hours as needed. Doses of 5 to 10 mg IV may be given every hour if required. Some patients may require massive doses of benzodiazepines during the acute phase of ethanol withdrawal. Intravenous doses of 270 mg over 45 minutes and 2,335 mg over a period of 4 days have been reported.
2 to 10 mg PO 3 to 4 times per day.
2 to 2.5 mg PO 1 to 2 times per day, increasing the dose according to response and patient tolerability.
Initially, 1 to 2.5 mg PO 3 to 4 times per day. The dose may be increased as needed and tolerated.
5 to 10 mg IM or IV initially, repeated every 3 to 4 hours as needed. For tetanus, larger doses may be required.
5 to 10 mg IM or IV every 3 to 4 hours as needed.
1 to 2 mg IM or IV every 3 to 4 hours as needed.
NOTE: Many clinicians now prefer IV lorazepam over IV diazepam for the acute treatment of seizures.
5—10 mg IV initially, repeated at 10—15 minute intervals to a maximum dosage of 30 mg. The dosage may be repeated in 2—4 hours if needed.
1 mg IV every 2—5 minutes to a maximum of 10 mg. The dose may be repeated in 2—4 hours.
0.2—0.5 mg IV every 2—5 minutes to a maximum dose of 5 mg. Repeat in 2—4 hours as needed.
Initial doses of 0.1—0.15 mg/kg IV repeated as needed every 10 minutes were administered to pediatric patients as young as 2 weeks of age in a retrospective study. The mean dose of total diazepam required to control status epilepticus was 0.38 mg/kg IV (range 0.09—0.71 mg/kg IV) and it was successful in terminating seizures in 11 of 16 patients (69%). NOTE: Not recommended as a first-line agent due to sodium benzoate and benzoic acid in the injection (see Precautions and How Supplied).
2 to 10 mg PO 2 to 4 times per day. The manufacturer, however, notes that diazepam is not useful as sole therapy and may not be effective as adjunctive therapy for longer than 4 months.
2 to 2.5 mg PO 1 to 2 times per day, increasing the dose according to response and patient tolerability.
Initially, 1 to 2.5 mg PO 3 to 4 times per day. The dose may be increased as needed and tolerated.
NOTE: It is recommended that rectal diazepam be used to treat no more than five episodes per month and no more than one episode every five days.
NOTE: The Diastat 2.5 mg dose may also be used as a partial replacement dose for patients who expel a portion of the first dose.
0.2 mg/kg PR. Doses should be rounded upward to the next available dosage strength. A second dose, if needed, may be given 4 to 12 hours after the first dose.
0.2 mg/kg PR. Doses should be rounded downward to reduce the likelihood of ataxia or oversedation. A second dose, if needed, may be given 4 to 12 hours after the first dose.
0.3 mg/kg PR. Doses should be rounded upward to the next available dosage strength. A second dose, if needed, may be given 4 to 12 hours after the first dose.
0.5 mg/kg PR. Doses should be rounded upward to the next available dosage strength. A second dose, if needed, may be given 4 to 12 hours after the first dose.
5—15 mg IV 5—10 minutes before the procedure.
Dose may be titrated up to 20 mg IV, depending on response and patient tolerability.
0.05—0.1 mg/kg IV initially, titrate slowly to a maximum dose of 0.25 mg/kg IV.
10 mg PO 45—60 minutes prior to procedure.
0.2—0.4 mg/kg PO 45—60 minutes prior to procedure. Maximum dose is 20 mg PO.
Because benzodiazepine withdrawal is more pronounced with shorter-acting agents, diazepam has been proposed as the benzodiazepine of choice for managing withdrawal. Diazepam-equivalent doses have been established for some other benzodiazepines. Diazepam should be tapered off in increments of 0.5 to 2 mg per week over a period of 4 to 16 weeks.
Children ranging in age from 6 months to 5 years and who had at least one febrile seizure were randomized to receive oral diazepam 0.33 mg/kg PO every 8 hours during each episode of fever until the child was afebrile for at least 24 hours or placebo. An 82% reduction in the rate of recurrent febrile seizures was observed in the diazepam group. Although diazepam is effective in preventing recurrent febrile seizures, due to the risk of adverse events and the lack of long term complications from simple febrile seizures, the American Academy of Pediatrics does not recommend routine use of intermittent diazepam for febrile seizure prophylaxis.
Single doses of 2 to 5 mg IV or PO have been recommended. Repeat doses should be based on clinical response.
Eleven cases of acute chloroquine overdose (total ingested dose ranged 5 to 12 g) were treated with diazepam 2 mg/kg IV over 30 minutes in combination with IV epinephrine, general anesthesia with thiopental, and FiO2 40%. Diazepam was continued at a dose of 1 to 2 mg/kg/day IV for 2 to 4 additional days. Other vasopressors and/or inotropic agents were used as necessary. Ten of 11 patients were discharged alive from the hospital. The one patient who died had ingested the largest total dose (15 g) of chloroquine.
2 to 10 mg PO at bedtime has been used ; dosage must be titrated and individualized according to patient response.
See adult dose. Use is not recommended as a hypnotic due to the long half-life of diazepam, the availability of safer sleep agents, and the increased sensitivity to benzodiazepines (e.g., ataxia, psychomotor impairment, syncope, falls) within the geriatric population.
†Indicates off-label use
MAXIMUM DOSAGE
Dosage must be individualized. Suggested maximum doses: 40 mg/day PO in divided doses for chronic ambulatory uses. A maximum dose has not been specifically defined by the manufacturer for emergent conditions.
Dosage must be individualized. Suggested maximum dose: 40 mg/day PO in divided doses for many chronic ambulatory uses. A maximum dose has not been specifically defined by the manufacturer for emergent conditions.
Dosage must be individualized. Suggested maximum dose: 0.6 mg/kg IV in 8 hour period for acute anxiety.
Dosage must be individualized. Suggested maximum dose: 0.6 mg/kg IV in 8 hour period for acute anxiety.
Maximum dosage not established.
Maximum dosage not established.
DOSING CONSIDERATIONS
Dosage should be modified depending on clinical response and degree of hepatic impairment, but no quantitative recommendations are available.
Dosage should be modified depending on clinical response and degree of renal impairment, but no quantitative recommendations are available; active and inactive diazepam metabolites are excreted by the kidney.
ADMINISTRATION
The dose of the oral concentrate solution should be added to 30 ml or more of liquid (e.g., water, juices, carbonated, soda-like beverages) or to semi-solid foods (e.g., applesauce, pudding) prior to administration.
Strict aseptic technique must always be maintained during handling of parenteral products. Diazepam injectable emulsion (Dizac) contains no antimicrobial preservatives and can support rapid growth of microorganisms.
Following parenteral administration, patients should be kept under observation for a period of 3 to 8 hours or longer, based on the patient’s clinical response and rate of recovery.
Replace parenteral therapy with oral therapy as soon as possible.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Diazepam injection solution:
No dilution necessary. Dilution may cause precipitation.
Diazepam emulsified injection:
For intravenous administration only. Diazepam emulsified injection should be prepared for single patient use only.
Diazepam emulsified injection should be prepared for use just prior to initiation of each individual treatment procedure.
The injection emulsion should be drawn into sterile syringes immediately after ampules are opened. The syringe(s) should be labeled with appropriate information including the date and time the ampule was opened.
Administration should commence promptly and be completed within 6 hours after the ampules have been opened.
Any unused portion of diazepam emulsified injection reservoirs, dedicated administration tubing and/or solutions containing diazepam emulsified injection must be discarded after the end of parenteral treatment or at 6 hours, whichever occurs sooner.
The IV line should be flushed every 6 hours and at the end of treatment procedure to remove residual diazepam emulsified injection. Do not use if there is evidence of separation of the phases of the emulsion.
Intravenous injection:
Do not administer rapidly because respiratory depression or hypotension may develop. Monitor heart rate, respiratory rate, and blood pressure during IV use.
A large vein should be used to avoid thrombosis. If a large vein is not available, inject into the tubing of a flowing IV solution as close as possible to the vein insertion.
Do not add diazepam emulsified injection to infusion sets containing PVC. Do not administer diazepam emulsified injection through filters with a pore size less than 5 microns because this could restrict the flow of the emulsion and/or cause the breakdown of the emulsion.
Adults: inject IV slowly at a rate not exceeding 5 mg/minute.
Infants and children: inject IV slowly at a rate not exceeding 1—2 mg/minute.
Intramuscular injection (Diazepam injection solution only):
This route is usually not recommended due to slow and erratic absorption.
Inject deeply into a large muscle mass. Aspirate prior to injection to avoid injection into a blood vessel.
Patients/Caregivers should thoroughly read and understand the administration steps for diazepam rectal gel.
NOTE: Inspect product before preparation and administration. Small cracks have been noted at the base of the plastic tip of the applicators with resultant leakage of the medication when the plunger is depressed, preventing full dosing and potentially resulting in a sub-optimal therapeutic response. If a cracked syringe is noted, notify your dispensing pharmacist to inspect the product. U.S. Pharmacists should contact Rx Hope at 1—800—511—2120 for replacement product.
Diastat AcuDial is available in the following delivery system units: 2.5 mg, 10 mg, and 20 mg. The available doses from the 20 mg delivery system are 10 mg, 12.5 mg, 15 mg, 17.5 mg, and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg, and 10 mg. The 2.5 mg dose may also be used as a partial replacement dose for patients who may expel a portion of the first dose.
Diastat AcuDial preparation:
NOTE: A pharmacist must Dial in the Dose and Lock the rectal syringe prior to dispensing the product to the patient. It is ready when the “Green Ready Band” in clearly visible.
Hold barrel of the syringe with the cap pointed downward. Grasp cap with the other hand and turn to adjust dose. The prescribed dose should appear in the window. Grasp and push the locking ring upward to lock both sides of the ring.
If the ring is locked at an incorrect dose, call 1—877—361—2719.
Administration steps:
Put person on their side where they can not fall.
Get the medicine and the syringe. To remove protective cover from syringe, push up with thumb and pull. Ensure that both the cap and seal pin are removed.
If an AcuDial syringe is being used, confirm the correct dose by looking at the dose shown on the syringe display window. Also, the green ‘ready’ band should be visible.
Lubricate rectal tip with lubricating jelly.
Turn person on side facing you and bend upper leg forward to expose rectum. Separate buttocks to expose rectum.
Gently insert syringe tip into rectum (rim should be snug against rectal opening) and slowly count to 3 while gently pushing the plunger in until it stops. Slowly count to 3 before removing the syringe from the rectum.
Slowly count to 3 while holding the buttocks together to prevent leakage.
Keep person on the side facing you, note time given and continue to observe.
If an AcuDial syringe was used, pull the plunger out and then replace and push in to expel any remaining drug into the sink or toilet.
STORAGE
Generic:
– Discard opened bottle after 90 days
– Protect from light
– Store at controlled room temperature (between 68 and 77 degrees F)
Diastat:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Dizac:
– Protect from light
– Store at controlled room temperature (between 68 and 77 degrees F)
Valium:
– Store at controlled room temperature (between 68 and 77 degrees F)
CONTRAINDICATIONS / PRECAUTIONS
Diazepam is contraindicated in any patient with a known or suspected hypersensitivity to diazepam or with sensitivity to any component of the formulation. Patients with a benzodiazepine hypersensitivity to other benzodiazepines may experience a cross-sensitivity to diazepam.
Intravenous diazepam should be injected slowly to reduce the possibility of local reactions; avoid intraarterial administration or extravasation. Do not dilute diazepam injection with other solutions or drugs. If direct IV access is not feasible, inject slowly via infusion tubing as close as possible to the vein insertion.
Although diazepam is occasionally beneficial for patients with major depression, the drug should be administered cautiously to patients with suicidal ideation. Large quantities of benzodiazepines should not be prescribed for patients with known suicidal ideation or a history of suicide attempt. In addition, worsening of depressive symptoms may occur during diazepam administration. Suicidal thoughts and actions, including completed suicides, have been reported in association with the use of sedative/hypnotics. Benzodiazepines should be used cautiously in patients with bipolar disorder because mania and hypomania have been reported in conjunction with the use of benzodiazepines in depressive disorders. The manufacturer states that diazepam has no use in psychosis and should not be used in lieu of appropriate therapy.
Diazepam can cause physical and psychological dependence, and should be used with extreme caution in patients with known, suspected or a history of substance abuse. Generally, benzodiazepines should be prescribed for short periods (2—4 weeks) with continued reevaluation of the need for treatment. Tolerance (or tachyphylaxis) may develop to the sedative effects of benzodiazepines. Patients should be questioned about the need for escalating doses, and the clinician may need to intervene to prevent further tolerance or increased risk for addiction. Abrupt discontinuation of diazepam after prolonged use should be avoided. Abrupt discontinuation of benzodiazepine therapy has been reported to cause withdrawal symptoms, especially following high dose or prolonged therapy. It should be noted that withdrawal symptoms may be seen in some individuals following cessation of treatment after 1—2 weeks; however this is more likely to occur with short-acting benzodiazepines. Patients with a history of a epilepsy or who are taking other drugs that lower the seizure threshold (i.e., TCAs, phenothiazines) should not be withdrawn abruptly from benzodiazepines due to the risk of precipitating a seizure. Benzodiazepines should be withdrawn slowly, using a gradual dosage-tapering schedule. During withdrawal, the greatest risk of seizure appears to be during the first 24 to 72 hours.
The use of diazepam in controlling seizure activity is relatively short-lived, and clinicians should be prepared to re administer IV diazepam if needed. Tonic status epilepticus has been precipitated in patients treated with IV diazepam for petit mal status or petit mal variant status. Most clinicians now prefer the use of IV lorazepam over IV diazepam for treatment of acute seizure activity. A longer acting anticonvulsant should be selected for maintenance treatment of seizure activity. When oral diazepam is used as an adjunct for a seizure disorder, there is the possibility of worsened seizures requiring higher dosages of standard anticonvulsant medications. In addition, abrupt discontinuation following maintenance treatment of seizures may result in a temporary increase in the frequency and/or severity of seizures. Clinicians should ensure that the caregivers of patients with refractory seizures can adequately administer diazepam rectal gel, if this route and dosage form are to be used. Additionally, the caregiver should be able to identify the correct seizure clusters for which the gel is to be used, adequately monitor the patient after administration and know when to refer for immediate medical attention. Prescribers should regularly discuss the caregiver administration instructions (found in the package insert) with the caregiver and patient. Diazepam rectal gel is not recommended for chronic, daily use.
Diazepam and other benzodiazepines should be administered cautiously in patients with CNS depression. Ambulatory patients receiving diazepam should be warned of the hazards of driving or operating machinery, and should avoid engaging in these activities until the full effect of the drug has dissipated. There is a potential for synergistic CNS-depressant effects if benzodiazepines are administered concomitantly with alcohol, barbiturates, or other CNS depressants. If opiate agonists are used concomitantly, the dose of the opiate should be reduced by at least one-third. Except as indicated for acute alcohol withdrawal, diazepam should not be administered parenterally to patients with acute ethanol intoxication, shock, or coma because the drug can worsen CNS depression.
Due to the potential for prolonged CNS depression, oral diazepam is contraindicated in neonates and infants less than 6 months old, and parenteral diazepam is not recommended for use in neonates under one month of age. Safety and efficacy of diazepam rectal gel has not been established in children less than 2 years of age. Further, the response of children to benzodiazepine therapy can be unpredictable. In general the pediatric population is more sensitive to the effects of the benzodiazepines. Initially, children should receive the lowest dose of diazepam, with increases made according to response. When using parenteral diazepam, age and size appropriate resuscitative equipment and trained personnel should be readily available.
All diazepam formulations are contraindicated in patients with closed-angle glaucoma. The mechanistic rational for this contraindication has been questioned, as benzodiazepines do not have antimuscarinic activity and do not raise intraocular pressure. Benzodiazepines may be used in patients with open-angle glaucoma who are receiving appropriate therapy.
As with other benzodiazepines, diazepam should be used with caution in patients with pulmonary disease. Additionally, avoid coadministration with other CNS depressants, especially opioids, unless no other alternatives are available as coadministration significantly increases the risk for respiratory depression, low blood pressure, and death. Oral diazepam tablets are contraindicated for use in those with severe respiratory insufficiency or sleep apnea syndrome. Diazepam should be used with caution in other pulmonary diseases as well including severe chronic obstructive pulmonary disease (COPD), sleep apnea, asthma, or pneumonia because the drug can exacerbate ventilatory failure. Lower doses are recommended in patients with chronic respiratory insufficiency.
Consider diazepam use during pregnancy only when the clinical situation warrants the risk to the fetus. If diazepam is to be used during pregnancy or the patient becomes pregnant while taking diazepam, apprise the patient of the potential hazard to the fetus. Consider the possibility that a woman of childbearing age may be pregnant when initiating therapy with diazepam. Advise patients who become pregnant or intend to become pregnant while taking diazepam to discuss the possibility of discontinuing the drug with their physician. Diazepam crosses the placental barrier. An increased risk of congenital malformations and other developmental abnormalities is associated with benzodiazepine use in the first trimester. Diazepam is associated with teratogenic effects in animals. Diazepam injection should not be given to pregnant women except in serious or life-threatening situations (e.g., status epilepticus). Diazepam is not recommended for use in obstetrical procedures, labor, or obstetric delivery, including cesarean section. Neonatal flaccidity has been reported in an infant whose mother was using benzodiazepines during pregnancy. High single doses administered during labor and delivery can cause an irregular fetal heart rate, hypotonia, poor sucking, hypothermia, and respiratory depression in the neonate.
Diazepam passes into breast milk and can cause sedation, feeding difficulties, and weight loss in the nursing infant. Diazepam use during breast-feeding is not recommended. Diazepam concentrations were assessed in 3 breast-feeding mothers receiving diazepam 30 mg daily for 6 days after delivery. The mean concentration of diazepam and its metabolite in the mothers’ sera, the breast milk, and the infants’ sera at 4 days were 831 ng/mL, 79 ng/mL, and 415 ng/mL and at 6 days were 1,084 ng/mL, 130 ng/mL, and 105 ng/mL, respectively. The infants’ mean serum concentration decrease from days 4 to 6 may be due to decreases in the amount of milk consumed or the onset of elimination mechanisms. None of the infants showed signs of lethargy or hypoventilation. One infant exposed to diazepam 30 mg daily at 5 days postpartum experienced weight loss, lethargy, and electroencephalogram (EEG) findings consistent with a sedative medication. A small series of 9 infants exposed to diazepam at unspecified doses through breast milk found the only adverse event was mild jaundice in 3 of the infants. Previous American Academy of Pediatrics recommendations considered diazepam as a drug whose effect on the breast-feeding infant is not known but may be of concern, particularly with prolonged exposure. If occasional maternal therapy with a benzodiazepine is required, lorazepam or oxazepam may be reasonable alternatives for some patients. Some experts suggest that occasional maternal treatment with usual doses of lorazepam or oxazepam would pose little risk to a breast-feeding infant. If any benzodiazepine is used by a breast-feeding mother, monitor the infant for adverse effects, such as sedation.
According to the manufacturer, oral diazepam tablets are contraindicated in those with severe hepatic disease. In general, all forms of diazepam should be administered cautiously to patients with mild to moderate hepatic disease, cirrhosis, hepatic fibrosis, and acute or chronic hepatitis, because its elimination half-life can be prolonged, possibly resulting in toxicity. Diazepam is metabolized to an active metabolite, and patients with hepatic disease are more likely to experience adverse CNS reactions and should receive reduced initial dosages. Elevated hepatic enzymes (e.g., transaminases, alkaline phosphatase) have been reported during diazepam administration. The manufacturer recommends obtaining periodic liver function tests during chronic treatment due to rare reports of jaundice.
The manufacturer recommends obtaining periodic blood counts during chronic treatment with diazepam due to rare reports of neutropenia.
Patients with renal impairment (including renal failure) should be carefully monitored during prolonged treatment with diazepam to avoid the adverse reactions that may occur from drug accumulation. The active metabolites of diazepam are excreted by the kidney.
According to the manufacturer, oral diazepam tablets are contraindicated for use in patients with myasthenia gravis. In general, diazepam should be used with caution in patients with a neuromuscular disease, such as muscular dystrophy, myasthenia gravis, or myotonia as these conditions can be exacerbated. Patients with late stage Parkinson’s disease may experience worsening of their psychosis or impaired cognition with administration of benzodiazepines. Benzodiazepines may also cause incoordination or paradoxical reactions that may worsen symptoms of Parkinson’s disease.
Use diazepam with caution in the geriatric adult, especially for chronic treatment. Significant accumulation of diazepam and its major metabolite, desmethyldiazepam, has been noted in elderly subjects receiving prolonged, routine therapy. Decreased elimination may also occur in some elderly patients due to a decline in renal function and can either intensify or prolong the adverse reactions of the drug. The impairment of cognitive and motor function may be more marked in this patient group. Benzodiazepines have also been associated with falls in the elderly. Due to its long half-life and the availability of safer alternatives, diazepam is not recommended for the treatment of insomnia in the elderly. In geriatric and debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation, and that close monitoring be employed. Use caution when administering IV diazepam to the elderly due to the risk of apnea and/or cardiac instability. According to the Beers Criteria, benzodiazepines are considered potentially inappropriate medications (PIMs) for use in geriatric patients and avoidance is generally recommended, although some agents from this class may be appropriate for seizure disorders, rapid eye movement sleep disorders, benzodiazepine withdrawal, severe generalized anxiety disorder, peri-procedural anesthesia, and end of life care. Older adults have an increased sensitivity to benzodiazepines and slower metabolism of long-acting agents, which increases their risk of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents. The Panel recommends avoiding benzodiazepines in geriatric patients with the following disease states or symptoms due to the potential for exacerbation of the condition or increased risk of adverse effects: delirium (possible new-onset or worsening delirium), dementia (adverse CNS effects), and history of falls/fractures (ataxia, impaired psychomotor function, syncope, and additional falls). If a benzodiazepine must be used in a patient with a history of falls or fractures, consider reducing use of other CNS-active medications that increase the risk of falls and fractures and implement other strategies to reduce fall risk. The federal Omnibus Budget Reconciliation Act (OBRA) regulates medication use in residents of long-term care facilities (LTCFs). Specific criteria for anxiolytics must be met, including 1) limiting use to indications specified in the OBRA guidelines (e.g., generalized anxiety disorder, panic disorder, significant anxiety to a situational trigger, alcohol withdrawal) which meet the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for the indication, and 2) evidence exists that other possible reasons for the individual’s distress have been considered, and 3) use results in maintenance or improvement in mental, physical, and psychosocial well-being as reflected on the Minimum Data Set (MDS) or other assessment tool. Anxiolytics should be used for delirium, dementia, or other cognitive disorders only when there are associated behaviors that are 1) quantitatively and objectively documented, and 2) are persistent, and 3) are not due to preventable or correctable reasons, and 4) constitute clinically significant distress or dysfunction to the LTCF resident or represent a danger to the resident or others. There are exceptions that may warrant the use of an anxiolytic such as a long-acting benzodiazepine for withdrawal from a short-acting benzodiazepine, use for neuromuscular syndromes (e.g., tardive dyskinesia, restless legs syndrome, seizure disorder, cerebral palsy), or end of life care. The need for indefinite continuation of diazepam (e.g., seizure disorder) should be based on confirmation of the condition being treated and its potential cause(s). It should be noted that benzodiazepines may increase the risk of confusion, sedation, and falls. OBRA provides dosing guidance for diazepam as an anxiolytic. When a medication is used to manage behavior, stabilize mood, or treat a psychiatric disorder, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines.
Tobacco smoking does not affect the metabolism of the parent drug diazepam, but does accelerate the metabolism of its major active metabolite, N-desmethyldiazepam, by up to 3-fold. Conversely, because the effect on hepatic microsomal enzymes is not related to the nicotine component of tobacco, sudden smoking cessation may result in a reduced clearance of this diazepam metabolite, despite the initiation of nicotine replacement. No specific dosage adjustment recommendations are available, but monitor patients for the desired clinical effects when changes in tobacco smoking status occur.
Additional information
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