Usual Adult Dose for Anxiety

ORAL: 2 to 10 mg orally 2 to 4 times a day

PARENTERAL:
Moderate Anxiety Disorders and Symptoms: 2 to 5 mg IM or IV, repeated in 3 to 4 hours if necessary
Severe Anxiety Disorders and Symptoms: 5 to 10 mg IM or IV, repeated in 3 to 4 hours if necessary

Comments:

• Oral doses should be determined by the severity of symptoms.
• Anxiety associated with the stress of everyday life usually does not require treatment with this drug.

Use: Management of anxiety disorders and short-term relief of anxiety symptoms

Usual Adult Dose for Alcohol Withdrawal

ORAL:

• Initial dose: 10 mg orally 3 to 4 times a day for the first 24 hours
• Maintenance dose: 5 mg orally 3 to 4 times a day as needed

PARENTERAL: 10 mg IM or IV once, then 5 to 10 mg IM or IV in 3 to 4 hours if necessary

Use: Symptomatic relief of acute agitation, tremor, impending/acute delirium tremens, and hallucinations in acute alcohol withdrawal

Usual Adult Dose for Muscle Spasm

ORAL: 2 to 10 mg orally 3 to 4 times a day

PARENTERAL: 5 to 10 mg IM or IV, then 5 to 10 mg IM or IV in 3 to 4 hours if necessary

Comment: Larger parenteral doses may be necessary for patients with tetanus.

Use: Adjunctive treatment for the relief of skeletal muscle spasm due to reflex spasm to local pathology, spasticity caused by upper motor neuron disorders, athetosis, and stiff-man syndrome (e.g., inflammation of the muscles/joints secondary to trauma, cerebral palsy, paraplegia)

Usual Adult Dose for Seizures

ORAL: 2 to 10 mg orally 2 to 4 times a day

RECTAL:

• Initial dose: 0.2 mg/kg rectally, rounded upward to the next available dose. A 2.5 mg rectal dose may be given as a partial replacement if patients expel a portion of the initial dose
• If necessary, a second dose of 0.2 mg/kg may be given rectally 4 to 12 hours after the first dose.
• Maximum Frequency: May be used to treat up to 1 seizure episode every 5 days, and no more than 5 episodes/month

Uses:

• Management of selected, refractory patients with epilepsy on stable regimens of antiepileptic drugs who require intermittent use of this drug to control bouts of increased seizure activity
• Adjunctive treatment for convulsive disorders

Usual Adult Dose for Endoscopy or Radiology Premedication

PARENTERAL:
Cardioversion: 5 to 15 mg IV once 5 to 10 minutes before the procedure

Endoscopic Procedures:
IV: Usually less than 10 mg, but some patients require up to 20 mg IV, especially when narcotics are omitted

• IV titration: The IV dose should be titrated to desired sedative response (e.g., slurring of speech) with slow administration immediately before the procedure.

IM: 5 to 10 mg IM once 30 minutes prior to the procedure

Comments:

• Narcotic dosing should be reduced by approximately 33%, and may be omitted in some patients.
• The IV route is preferred, but IM administration may be used if IV administration is not possible.

Uses:

• Adjunct prior to endoscopic procedures if apprehension, anxiety, or acute stress reactions are present and to diminish recall of the procedures
• Prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure

Usual Adult Dose for Status Epilepticus

PARENTERAL:

• Initial dose: 5 to 10 mg IV once, repeated at 10 to 15 minute intervals to a maximum dose of 30 mg if necessary

Comments:

• The IV route is preferred; however, the IM route may be used if IV administration is impossible.
• Treatment may be repeated every 2 to 4 hours, but active metabolites may persist during readministration.
• Patients with chronic lung disease or unstable cardiovascular conditions should be given this drug with extreme caution.

Use: Adjunct to status epilepticus and severe recurrent convulsive seizures

Usual Adult Dose for Light Anesthesia

PARENTERAL:
Preoperative Medication: 10 mg IM once before surgery

Comments:

• The IM route is preferred when given as a preoperative medication.
• Atropine, scopolamine, and other premedications should be administered in separate syringes.

Use: Premedication for the relief of anxiety and tension in patients undergoing surgical procedures

Usual Geriatric Dose for Seizures

ORAL:

• Initial dose: 2 to 2.5 mg orally once to 2 times a day

RECTAL:

• Initial dose: 0.2 mg/kg rectally, rounded downward to the next available dose. A 2.5 mg rectal dose may be given as a partial replacement if patients expel a portion of the initial dose
• If necessary, a second dose of 0.2 mg/kg may be given rectally 4 to 12 hours after the first dose.
• Maximum Frequency: May be used to treat up to 1 seizure episode every 5 days, and no more than 5 episodes/month

Comment: Oral doses may be increased gradually as needed and tolerated, but should be limited to the smallest effective amount

Uses:

• Management of selected, refractory patients with epilepsy on stable regimens of antiepileptic drugs who require intermittent use of this drug to control bouts of increased seizure activity
• Adjunctive treatment in convulsive disorders

Usual Geriatric Dose for Alcohol Withdrawal

ORAL:

• Initial dose: 2 to 2.5 mg orally once to 2 times a day

PARENTERAL:

• Initial dose: 2 to 5 mg IM or IV, repeated in 3 to 4 hours if necessary

Comments:

• Doses may be increased gradually as needed and tolerated, but should be limited to the smallest effective amount.
• Maintenance doses should be determined by clinical need and patient tolerance.

Uses:

• Management of anxiety disorders and short-term relief of anxiety symptoms
• Symptomatic relief of acute agitation, tremor, impending/acute delirium tremens, and hallucinations in acute alcohol withdrawal
• Adjunctive treatment for the relief of skeletal muscle spasm due to reflex spasm to local pathology, spasticity caused by upper motor neuron disorders, athetosis, and stiff-man syndrome (e.g., inflammation of the muscles/joints secondary to trauma, cerebral palsy, paraplegia)

Usual Geriatric Dose for Anxiety

ORAL:

• Initial dose: 2 to 2.5 mg orally once to 2 times a day

PARENTERAL:

• Initial dose: 2 to 5 mg IM or IV, repeated in 3 to 4 hours if necessary

Comments:

• Doses may be increased gradually as needed and tolerated, but should be limited to the smallest effective amount.
• Maintenance doses should be determined by clinical need and patient tolerance.

Uses:

• Management of anxiety disorders and short-term relief of anxiety symptoms
• Symptomatic relief of acute agitation, tremor, impending/acute delirium tremens, and hallucinations in acute alcohol withdrawal
• Adjunctive treatment for the relief of skeletal muscle spasm due to reflex spasm to local pathology, spasticity caused by upper motor neuron disorders, athetosis, and stiff-man syndrome (e.g., inflammation of the muscles/joints secondary to trauma, cerebral palsy, paraplegia)

Usual Geriatric Dose for Muscle Spasm

ORAL:

• Initial dose: 2 to 2.5 mg orally once to 2 times a day

PARENTERAL:

• Initial dose: 2 to 5 mg IM or IV, repeated in 3 to 4 hours if necessary

Comments:

• Doses may be increased gradually as needed and tolerated, but should be limited to the smallest effective amount.
• Maintenance doses should be determined by clinical need and patient tolerance.

Uses:

• Management of anxiety disorders and short-term relief of anxiety symptoms
• Symptomatic relief of acute agitation, tremor, impending/acute delirium tremens, and hallucinations in acute alcohol withdrawal
• Adjunctive treatment for the relief of skeletal muscle spasm due to reflex spasm to local pathology, spasticity caused by upper motor neuron disorders, athetosis, and stiff-man syndrome (e.g., inflammation of the muscles/joints secondary to trauma, cerebral palsy, paraplegia)

Usual Pediatric Dose for Seizures

ORAL:
6 months and older:

• Initial dose: 1 to 2.5 mg orally 3 to 4 times a day

RECTAL:
2 to 5 years:

• Initial dose: 0.5 mg/kg rectally, rounded upward to the next available dose. A 2.5 mg rectal dose may be given as a partial replacement if patients expel a portion of the initial dose
• If necessary, a second dose of 0.5 mg/kg may be given rectally 4 to 12 hours after the first dose.
• Maximum Frequency: 1 episode every 5 days, and no more than 5 episodes/month

6 to 11 years:

• Initial dose: 0.3 mg/kg rectally, rounded upward to the next available dose. A 2.5 mg rectal dose may be given as a partial replacement if patients expel a portion of the initial dose
• If necessary, a second dose of 0.3 mg/kg may be given rectally 4 to 12 hours after the first dose.
• Maximum Frequency: 1 episode every 5 days, and no more than 5 episodes/month

12 years and older:

• Initial dose: 0.2 mg/kg rectally, rounded upward to the next available dose. A 2.5 mg rectal dose may be given as a partial replacement if patients expel a portion of the initial dose
• If necessary, a second dose of 0.2 mg/kg may be given rectally 4 to 12 hours after the first dose.
• Maximum Frequency: May be used to treat up to 1 seizure episode every 5 days, and no more than 5 episodes/month

Comment: Oral doses may be increased gradually as needed and tolerated, but should be limited to the smallest effective amount.

Uses:

• Management of selected, refractory patients with epilepsy on stable regimens of antiepileptic drugs who require intermittent use of this drug to control bouts of increased seizure activity
• Adjunctive treatment in convulsive disorders

Usual Pediatric Dose for Status Epilepticus

PARENTERAL:
IV Injection:
30 days to less than 5 years: 0.2 to 0.5 mg slow IV injection every 2 to 5 minutes, up to a maximum dose of 5 mg. Repeat in 2 to 4 hours if needed.

5 years and older: 1 mg slow IV injection every 2 to 5 minutes, up to a maximum dose of 10 mg. Repeat in 2 to 4 hours if needed.

Comment: EEG monitoring may be helpful to monitor seizure activity.

Use: Adjunct in status epilepticus and severe recurrent convulsive seizures

Usual Pediatric Dose for Anxiety

ORAL:
6 months and older:

• Initial dose: 1 to 2.5 mg orally 3 to 4 times a day

Comments:

• Doses may be increased gradually as needed and tolerated, but should be limited to the smallest effective amount.
• Maintenance doses should be determined by clinical need and patient tolerance.

Uses:

• Management of anxiety disorders and short-term relief of anxiety symptoms
• Symptomatic relief of acute agitation, tremor, impending/acute delirium tremens, and hallucinations in acute alcohol withdrawal
• Adjunctive treatment for the relief of skeletal muscle spasm due to reflex spasm to local pathology, spasticity caused by upper motor neuron disorders, athetosis, and stiff-man syndrome (e.g., inflammation of the muscles/joints secondary to trauma, cerebral palsy, paraplegia)

Usual Pediatric Dose for Muscle Spasm

ORAL:
6 months and older:

• Initial dose: 1 to 2.5 mg orally 3 to 4 times a day

Comments:

• Doses may be increased gradually as needed and tolerated, but should be limited to the smallest effective amount.
• Maintenance doses should be determined by clinical need and patient tolerance.

Uses:

• Management of anxiety disorders and short-term relief of anxiety symptoms
• Symptomatic relief of acute agitation, tremor, impending/acute delirium tremens, and hallucinations in acute alcohol withdrawal
• Adjunctive treatment for the relief of skeletal muscle spasm due to reflex spasm to local pathology, spasticity caused by upper motor neuron disorders, athetosis, and stiff-man syndrome (e.g., inflammation of the muscles/joints secondary to trauma, cerebral palsy, paraplegia)

Usual Pediatric Dose for Seizure Prophylaxis

ORAL:
6 months and older:

• Initial dose: 1 to 2.5 mg orally 3 to 4 times a day

Comments:

• Doses may be increased gradually as needed and tolerated, but should be limited to the smallest effective amount.
• Maintenance doses should be determined by clinical need and patient tolerance.

Uses:

• Management of anxiety disorders and short-term relief of anxiety symptoms
• Symptomatic relief of acute agitation, tremor, impending/acute delirium tremens, and hallucinations in acute alcohol withdrawal
• Adjunctive treatment for the relief of skeletal muscle spasm due to reflex spasm to local pathology, spasticity caused by upper motor neuron disorders, athetosis, and stiff-man syndrome (e.g., inflammation of the muscles/joints secondary to trauma, cerebral palsy, paraplegia)

Usual Pediatric Dose for Tetanus

PARENTERAL:
30 days to 5 years: 1 to 2 mg IM or slow IV injection, repeated every 3 to 4 hours as necessary

5 years and older: 5 to 10 mg IM or slow IV injection, repeated every 3 to 4 hours as necessary to control spasms

Comment: Respiratory assistance should be available for patients.

Use: Tetanus

Renal Dose Adjustments

Renal dysfunction:

• Oral formulations: Data not available
• Parenteral and rectal formulations: Use with caution

Liver Dose Adjustments

Patients with liver disease: Use with caution (parenteral and rectal formulations)
Mild to moderate hepatic insufficiency: Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended. (oral formulations)
Severe hepatic insufficiency: Contraindicated (oral formulations)

Dose Adjustments

Debilitated patients:
Oral:

• Initial dose: 2 to 2.5 mg orally once or 2 times a day

Parenteral:

• Initial dose: 2 to 5 mg once a day

Rectal:

• Initial dose: 0.2 mg/kg rectally, rounded downward to the next available dose. A 2.5 mg rectal dose may be given as a partial replacement if patients expel a portion of the initial dose
• If necessary, a second dose of 0.2 mg/kg may be given rectally 4 to 12 hours after the first dose.
• Maximum Frequency: May be used to treat up to 1 seizure episode every 5 days, and no more than 5 episodes/month

Precautions

US BOXED WARNINGS:
RISKS FROM CONCOMITANT USE WITH OPIOIDS:

• Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
• Because of these risks, reserve concomitant prescribing of these drugs for use 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.
• Advise both patients and caregivers about the risks of respiratory depression and sedation when this drug is used with opioids.

Safety and efficacy have not been established in patients younger than 30 days (parenteral formulations), 6 months (oral formulations), and 2 years (rectal formulations).

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

Administration advice:

• IV administration: This drug should be injected slowly (at a rate of at least 1 minute for every 5 mg OR 1 mL/min), avoiding small veins. If direct IV injection is not possible, treatment should be injected slowly through infusion tubing as close as possible to vein insertion.
• Pediatric IV administration: The IV should be given slowly, over a 3-minute period at a rate of 0.25 mg/kg or slower. After 15 to 30 minutes, the initial dosage may be repeated. The use of emulsion for injection formulations should be carefully considered in pediatric patient populations.
• IM administration: This drug should be injected deeply into the muscle.
• Rectal formulations: Patients and caregivers should review administration steps included in the manufacturer product information.

Storage requirements:

• Emulsion for injection: When used as a continuous infusion, the mixed product should be used within 6 hours. When used as an injection, the dose should be drawn into a syringe immediately before administration.
• Oral concentrated solution: Once mixed into food/liquid, the solution should not be stored for future use.

Reconstitution/preparation techniques:

• Emulsion for injection: When used for continuous infusion, the emulsion may be added to dextrose 5% or 10% to make a solution with a concentration of 0.1 to 0.4 mg/mL.
• Oral concentrated solution: The concentrated solution should be dosed with the included calibrated dropper and mixed into liquids or semi-soft foods. Once the solution is added to the liquid/food, it should be mixed for a few seconds; patients should immediately consume the entire dose.
• Solution for injection: When used for continuous infusion, the solution should be used immediately after mixing with infusion fluid.

IV compatibility:

• Emulsion for Injection: When used as a continuous infusion, the emulsion may be mixed with intralipid 10% or 20%, but mixture with saline solutions should be avoided. Adsorption into plastic infusion equipment may occur, but may be less than with other formulations.
• Solution for Injection: When used as a continuous infusion, this formulation should be mixed with at least 200 mL of sodium chloride or dextrose in glass bottles. Adsorption into plastic bags may occur.

General:

• Rectal solution formulations are recommended in patients who require rapid treatment, but cannot receive IV formulations.
• Efficacy of long-term use (e.g., longer than 4 months) of the oral solution has not been established. Patients should be regularly reassessed for continued need of treatment, especially when they are symptom-free.
• Patients should receive the lowest effective dose for the shortest amount of time.
• If a third IV dose does not relieve symptoms in pediatric patients, adjunctive therapy appropriate to the condition should be used.

Monitoring:

• Renal function, especially in elderly patients with decreased renal function
• Periodic blood counts, especially in patients on long-term therapy
• Periodic liver function tests, especially in patients on long-term therapy
• Sedation, especially within 1 hour of administration AND when given a parenteral formulation

Patient advice:

• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
• Inform patients that this drug may cause drowsiness, and they should avoid driving or operating machinery until the full effects of the drug are seen.
• Patients and their caregivers should be told to report any signs/symptoms of respiratory depression or profound sedation.