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Uses

Anxiety Disorders

Management of anxiety disorders and short-term relief of anxiety or anxiety associated with depressive symptoms.

Surgery

Relief of anxiety and provision of sedation, light anesthesia, and anterograde amnesia prior to endoscopy, cardioversion, and minor surgical procedures.

Seizure Disorders

A drug of choice for termination of status epilepticus or acute seizure episodes resulting from drug overdosage and poisons.

Rectal administration may be useful for out-of-hospital management (e.g., at home or school, during transport to an emergency room) of status attacks and acute repetitive seizures (i.e., serial, cyclic, cluster, breakthrough, or crescendo seizures).

Has been used as adjunct to other anticonvulsants for prophylaxis of epileptic seizures; however, tolerance to anticonvulsant effects often develops after short time. (See Seizure Disorders under Cautions.)

Alcohol Withdrawal

Relief of agitation and tremor and prevention or symptomatic relief of delirium tremens and hallucinations associated with acute alcohol withdrawal.

Skeletal Muscle Spasticity

Adjunct to rest, physical activity, analgesics, and other measures for relief of discomfort associated with acute, painful musculoskeletal conditions.

Short- and long-term management of skeletal muscle spasticity such as reflex spasm secondary to local pathology (e.g., trauma, inflammation), spasticity caused by upper motor neuron disorders (e.g., cerebral palsy, paraplegia), athetosis, stiff-man syndrome, strychnine poisoning, and tetanus.

Sedation in Critical-Care Settings

Sedation of intubated and mechanically ventilated patients during treatment in a critical-care setting†. One of several benzodiazepines recommended for sedation of acutely agitated patients because of its rapid onset and short duration of action when given in single doses.

Night Terrors

Has been used effectively to prevent night terrors†.

Labor and Delivery

Is used as an adjunct to local anesthetics and systemic analgesics during labor and delivery† to reduce requirements for opiate analgesics and to produce anterograde amnesia, although nor recommended by manufacturer.

Myocardial Infarction

Has been used to relieve anxiety associated with AMI; however, AHA and ACC state that routine anxiolytic use is neither necessary not recommended.

Drug-Induced Cardiovascular Emergencies

Adjunct in the management of certain drug-induced cardiovascular emergencies† (e.g., drug-induced hemodynamically significant tachycardia†, hypertensive emergency†, or acute coronary syndrome†) when standard emergency cardiovascular care (ECC) guidelines may not be optimal or appropriate. Adjunct in the initial treatment of cocaine-induced acute coronary syndrome†.

Neonatal Opiate Withdrawal

Relief of agitation in the management of neonatal opiate withdrawal†.

Dosage and Administration

General

• Use the smallest effective dosage to avoid oversedation.
• Consider long half-life of diazepam and its metabolites when making dosage adjustments (see Half-life under Pharmacokinetics).
• In patients who have received prolonged (e.g., for several months) therapy, avoid abrupt discontinuance, since manifestations of withdrawal can be precipitated; gradually taper dosage.

Anxiety

• Periodically reassess usefulness for treatment of anxiety. Administer for the shortest period of time; frequent dosage adjustments may be required.

Seizure Disorders

• Do not discontinue diazepam abruptly in patients with a history of a seizure disorder, since seizures may be precipitated.

Administration

Administer orally, by IM or IV injection, or rectally.

Oral Administration

Initially, administer orally in 3 or 4 doses daily for the treatment of anxiety disorders or skeletal muscle spasticity. When dosage is stabilized, may administer orally in 1 or 2 doses daily, with all or most of the dosage given at bedtime to minimize daytime sedation.

Dilute oral concentrate solution (e.g., with water, juice, carbonated beverages) or mix with semisolid foods (e.g., applesauce, pudding) just prior to administration.

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

For IV injection, administer dose directly into a large vein; if this is not possible, inject the drug into the tubing of a flowing IV solution as close as possible to the vein insertion site.

Take care to avoid intra-arterial administration or extravasation.

Switch patient to oral therapy as soon as possible.

Dilution

Some clinicians recommend IV administration of a dilute solution to avoid extravasation; however, manufacturers do not recommend this method of administration, since precipitation may occur.

Rate of Administration

Adults: Inject dose slowly at rate of ≤5 mg per minute.

Children and infants ≥30 days of age: Administer dose slowly over 3 minutes.

IM Administration

May be administered as deep IM injection; however, absorption may be slow and erratic. IM route is rarely justified.

Rectal Administration

Administer rectally as the commercially available gel via the delivery device (a plastic applicator with a flexible molded tip) provided by the manufacturer. Consult the manufacturer’s labeling for specific instructions for administration of the rectal gel.

Alternatively, administer as the parenteral solution† via a syringe and rectally inserted tubing or via lubricated tuberculin syringe (without a needle) inserted 4–5 cm into the rectum.

Commercially available gel is provided in prefilled syringe applicators containing 2.5, 10, or 20 mg of diazepam.

Dose to be delivered by the AcuDial^® applicator is locked into the device prior to dispensing. If necessary, use 2 applicators to administer the prescribed dose.

The 2.5-mg unit-dose applicator also may be used as a partial replacement dose (supplemental dose) for patients who partially expel the recommended dose within 5 minutes after administration.

Prescribing

Prescription should indicate the appropriate dose to be locked into the applicator, the appropriate rectal tip size, and the number of packages (2 applicators per package) to be dispensed.

Dispensing

Pharmacist must dial in and lock the correct dose to be administered prior to dispensing Diastat^® AcuDial^®.

While holding the barrel of the applicator in one hand, turn the cap of the applicator to select the dose. After confirming that the dose visible in the display window is correct, lock the dose by grasping the locking ring and pushing upward to lock both sides of the ring. A green “ready” band becomes visible at the base of the applicator once the dose-locking ring is engaged.

Repeat the process for each applicator to be dispensed.

Administration to Patient

Prior to administering the dose, check the diazepam gel expiration date, verify that the green “ready” band on the Diastat^® AcuDial^® applicator is visible, and verify the dose displayed in the AcuDial^® display window.

Remove the protective cap from the syringe and ensure that the seal pin is removed with the cap.

Lubricate the rectal applicator tip with the water-soluble lubricant (jelly) provided by the manufacturer.

Turn the patient so that they are resting on their side facing the caregiver; the patient’s upper leg should be bent forward and the buttocks separated to expose the rectum. Insert the lubricated applicator tip into the rectum until the rim of the syringe is snug against the rectal opening; slowly push the plunger (counting aloud slowly to 3) until it stops (i.e., until the entire dose of the applicator has been expelled into the rectum). Count aloud slowly to 3 before removing the syringe from the rectum; to prevent leakage of the administered dose from the rectum, hold the buttocks together while again counting aloud slowly to 3.

Leave the patient on their side facing the caregiver, note the time the dose was given, and observe the patient.

If bowel leakage occurs, a supplemental dose may be required. (See Rectal Administration under Dosage and Administration.)

Disposal

Discard Diastat^® and Diastat^® AcuDial^® rectal delivery systems and all unused materials in the garbage in a safe place away from children; do not reuse.

Prior to discarding AcuDial^® applicator in the garbage, dispose of any gel remaining in the applicator. With the applicator tip pointed over the sink or toilet, pull back and remove the plunger from the barrel; then, replace the plunger in the barrel and gently depress the plunger until it stops, forcing gel from the applicator. Flush toilet or rinse sink with water until gel is no longer visible.

Inspection for Cracks in Applicator Tip

Formation of cracks at the base of the plastic tip of Diastat^® AcuDial^® applicators has been reported. (See Manufacturing Problem with Diazepam Rectal Gel [Diastat^® AcuDial^®] Applicators under Cautions.) Until the problem is resolved, Diastat^® AcuDial^® applicators should be inspected for cracks at the base of the applicator tip, without removal of the applicator cap, prior to dispensing and frequently (i.e., monthly) thereafter.

Obtain detailed instructions for inspecting syringe applicator from the manufacturer at 877-361-2719 or http://www.diastat.com.

Instruct patients and/or their caregivers to return any cracked applicators to the pharmacy for immediate replacement.

Pharmacists should contact RxHope at 800-511-2120 or http://www.rxhope.com to obtain replacements for damaged products.

Dosage

Pediatric Patients

Anxiety Disorders

Oral

Children ≥6 months of age: Initially, 1–2.5 mg 3 or 4 times daily. Alternatively, 0.12–0.8 mg/kg or 3.5–24 mg/m² in 3 or 4 divided doses daily. Increase dosage gradually as needed and tolerated.

IV

0.04–0.2 mg/kg; may repeat in 3–4 hours. Total dose should not exceed 0.6 mg/kg in an 8-hour period.

Surgery

IM

Children >2 years of age: 0.4 mg/kg has been administered 1–2 hours before surgery.

Seizure Disorders

Oral

6–15 mg daily (occasionally up to 30 mg daily) in divided doses has been used.

IV or IM

Children 30 days to 5 years of age: Initially, 0.1–0.5 mg; may repeat every 2–5 minutes to a maximum total dose of 5–10 mg. May repeat dose in 2–4 hours.

Children ≥5 years of age: Initially, 1 mg; may repeat every 2–5 minutes to a maximum total dose of 10 mg. May repeat dose in 2–4 hours.

Rectal

Children 2–5 years of age: Initially, 0.5 mg/kg as rectal gel, rounded up to the next available dose (i.e., the next multiple of 2.5 mg). If necessary, repeat initial dose in 4–12 hours. Administration of a third dose is not recommended by the manufacturer.

Children 6–11 years of age: Initially, 0.3 mg/kg as rectal gel, rounded up to the next available dose (i.e., the next multiple of 2.5 mg). If necessary, repeat initial dose in 4–12 hours. Administration of a third dose is not recommended by the manufacturer.

Children ≥12 years of age: Initially, 0.2 mg/kg as rectal gel, rounded up to the next available dose (i.e., the next multiple of 2.5 mg). If necessary, repeat initial dose in 4–12 hours. Administration of a third dose is not recommended by the manufacturer.

Usual dosage of parenteral solutions† administered rectally in children: 0.5 mg/kg (not to exceed 20 mg).

Skeletal Muscle Spasticity

Oral

0.12–0.8 mg/kg in 3 or 4 divided doses daily.

IV

0.04–0.3 mg/kg has been administered every 2–4 hours, not to exceed 0.6 mg/kg in an 8-hour period.

Tetanus

IV or IM

Children >30 days to 5 years of age: 1–2 mg. May repeat dose every 3–4 hours as needed.

Children >5 years of age: 5–10 mg. May repeat dose every 3–4 hours as needed.

Sedation in Critical-Care Settings

IV

Children >12 years of age: 0.03–0.1 mg/kg as an intermittent injection every 0.5–6 hours; more frequent administration may be required for the management of acutely agitated patients.†

Neonatal Opiate Withdrawal

IM

0.5–2 mg has been administered every 8 hours, followed by gradual dosage reduction.†

Adults

Anxiety Disorders

Oral

2–10 mg 2–4 times daily, depending on the severity of the symptoms.

IV

Initially, 2–5 mg for moderate or 5–10 mg for severe acute anxiety; may repeat in 3–4 hours.

Surgery

Preoperative Sedation

IV or IM

10 mg 1–2 hours before surgery; some clinicians recommend doses up to 20 mg.

Cardioversion

IV

5–15 mg 5–10 minutes before the procedure.

Endoscopy

IV

Titrate dosage to obtain desired sedative response (e.g., slurring of speech). Initially, 10 mg, but up to 20 mg may be required, especially if opiates are not given concomitantly.

IM

5–10 mg approximately 30 minutes prior to endoscopy.

Alcohol Withdrawal

Oral

10 mg 3 or 4 times during the first 24 hours, followed by 5 mg 3 or 4 times daily as needed.

IV

Initially, 10 mg (some clinicians recommend up to 20 mg), then 5–10 mg every hour if necessary, although an interval of 3–4 hours may be satisfactory.

Alternatively, some clinicians recommend 10 mg initially, followed by 10 mg at 20–30 minutes intervals until patient is calm.

Seizure Disorders

Oral

2–10 mg 2–4 times daily.

IV or IM

Initially, 5–10 mg. May repeat at 10- to 15-minute intervals, to a maximum total dose of 30 mg. May repeat dose in 2–4 hours.

Rectal

Initially, 0.2 mg/kg as rectal gel, rounded up to next available dose (i.e., the next multiple of 2.5 mg). If necessary, repeat initial dose in 4–12 hours. Administration of a third dose is not recommended by the manufacturer.

For rectal administration of parenteral solutions†, 0.5 mg/kg (not to exceed 20 mg).

Skeletal Muscle Spasticity

Oral

2–10 mg 2–4 times daily.

IV

Initially, 5–10 mg; may repeat in 3–4 hours if necessary.

Tetanus

IV

Doses up to 20 mg have been given every 2–8 hours.

Sedation in Critical-Care Settings

IV

0.03–0.1 mg/kg as an intermittent injection every 0.5–6 hours; more frequent administration may be required for the management of acutely agitated patients.†

Night Terrors

Oral

Dosages of 5–20 mg at bedtime have been used.†

Labor and Delivery

IV

10–20 mg.†

Prescribing Limits

Pediatric Patients

IV

Maximum 0.25 mg/kg as a single initial dose, repeated at 15- to 30-minute intervals to a maximum total dose of 0.75 mg/kg.

Seizure Disorders

Rectal

Maximum recommended frequency for administration by caregivers outside hospital is 1 treatment course every 5 days and 5 treatment courses per month.

Adults

Anxiety Disorders

IV

Some clinicians recommend maximum dosage of 30 mg in an 8-hour period.

Seizure Disorders

Rectal

Maximum recommended frequency for administration by caregivers outside hospital is 1 treatment course every 5 days and 5 treatment courses per month.

Special Populations

Dosage in Hepatic Impairment

Reduce dosage; use the smallest effective dose to avoid oversedation.

Dosage in Renal Impairment

Use the smallest effective dose to avoid oversedation.

Geriatric Patients

Oral

Initially, 2–2.5 mg once or twice daily. Increase dosage gradually as needed and tolerated.

IV

Initially, 2–5 mg as a single dose. Increase dosage gradually as needed and tolerated.

Rectal

Dosage to be administered should be adjusted downward for the commercially available prefilled applicators of rectal gel.

Other Populations

Use the smallest effective dosage in debilitated patient and patients with low serum albumin concentrations. In debilitated patients, observe maximum geriatric dosages. (See Geriatric Patients under Dosage and Administration.)