diazepam (Rx)

Brand and Other Names:Valium, Diastat, more...Diastat AcuDial
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet: Schedule IV

  • 2mg
  • 5mg
  • 10mg

oral solution: Schedule IV

  • 1mg/1mL
  • 5mg/mL

rectal gel: Schedule IV

  • 2.5mg
  • 10mg
  • 20mg

injectable solution: Schedule IV

  • 5mg/mL

intramuscular device: Schedule IV

  • 5mg/mL
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Anxiety

2-10 mg PO q6-12hr, OR 2-10 mg IV/IM q6-12hr; no more than 30 mg/8 hours

Alcohol Withdrawal

10 mg PO q6-8hr during first 24hr; reduce to 5 mg PO q6-8hr PRN

Initial: 10 mg IV/IM, may give additional doses of 5-10 mg IV q6-8hr as needed

Endoscopy

IV: Titrate dose to 10 mg or less immediately before procedure, not to exceed cumulative dose of 20 mg; reduce dose of narcotic by one third or omit, OR

IM: 5-10 mg 30 minutes before procedure

Preoperative Sedation

10 mg IM before surgery

Sedation in the ICU

5-10 mg IV 1-2 hours before surgery; 0.03-0.1 mg/kg q30min to 6hr

Muscle Spasm

2-10 mg PO q6-8hr PRN, OR 5-10 mg IV/IM initially; THEN q3-4hr if necessary

Seizure Disorder

2-10 mg PO q6-12hr as adjunct, OR

0.2 mg/kg PR, repeat after 4-12 hours PRN

Status Epilepticus

5-10 mg IV/IM q5-10min; not to exceed 30 mg, OR

0.5 mg/kg PR (using parenteral solution), THEN 0.25 mg/kg in 10 minutes PRN  

Dosage Modifications

Renal impairment: No dose adjustment recommended unless administered for prolonged period; decrease dose in prolonged periods

Hepatic impairment: 50% of maintenance dose

Acute Repetitive Seizures (Orphan)

Orphan indication for management of acute repetitive seizures as intranasal, buccal soluble film, or SC administration

Sponsors

  • Intranasal: Neurelis Pharmaceuticals, Inc; 1042-B N. El Camino Real, Suite 430; Encinitas, California 92024
  • SC (Diazepen [TM]): Xeris Pharmaceuticals, Inc; 3208 Red River Street, Suite 300; Austin, Texas 78705
  • Buccal soluble film: MonoSol Rx, LLC; 30 Technology Drive; Warren, New Jersey 07059

Dosage Forms & Strengths

tablet: Schedule IV

  • 2mg
  • 5mg
  • 10mg

oral solution: Schedule IV

  • 1mg/1mL
  • 5mg/mL

rectal gel: Schedule IV

  • 2.5mg
  • 10mg
  • 20mg

injectable solution: Schedule IV

  • 5mg/mL

intramuscular device: Schedule IV

  • 5mg/mL
more...

Sedative/Muscle Relaxant

Potentially toxic dose in patients <6 years: >0.5 mg/kg

<6 months: Not recommended

>12 years

  • 0.12-0.8 mg/kg/day PO divided q6-8hr, OR 
  • 0.04-0.2 mg/kg IV/IM q2-4hr; no more than 0.6 mg/kg within 8 hours

Status Epilepticus

Potentially toxic dose in patients <6 years: >0.5 mg/kg  

PR

  • 2-6 years: 0.5 mg/kg; may repeat in 4-12 hours PRN 
  • 6-12 years: 0.3 mg/kg; may repeat in 4-12 hours PRN
  • >12 years: 0.2 mg/kg; may repeat in 4-12 hours PRN

IV

  • 6 months-5 years: 0.2-0.5 mg IV initially, repeat every 2-5 minutes; do not exceed 5 mg; may repeat 2-4 hours later PRN
  • >5 years: 1 mg IV given slowly every 2-5 min; not to exceed 10 mg total dose; may repeat in 2-4 hours if necessary

2-2.5 mg PO qDay or q12hr initially; increase gradually PRN

Rectal gel: Use lower dose

Dosing Considerations

Due to long-acting metabolite, not considered a drug of choice in the elderly; associated with falls

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Interactions

Interaction Checker

and diazepam

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    Contraindicated

      Serious - Use Alternative

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          Minor

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            Adverse Effects

            1-10%

            Atax (3%)

            Euphoria (3%, rectal gel)

            Incoordination (3%, rectal gel)

            Somnolence (>1%)

            Rash (3%, rectal gel)

            Diarrhea (4%, rectal gel)

            Frequency Not Defined

            Common

            • Hypotension
            • Fatigue
            • Muscle weakness
            • Respiratory depression
            • Urinary retention
            • Depression
            • Incontinence
            • Blurred vision
            • Dysarthria
            • Headache
            • Skin rash
            • Changes in salivation

            Serious

            • Neutropenia
            • Jaundice
            • Local effects: Pain, swelling, thrombophlebitis, carpal tunnel syndrome, tissue necrosis
            • Phlebitis if too rapid IV push

            Postmarketing Reports

            Injury, poisoning and procedural complications: Falls and fractures; increased risk in those taking concomitant sedatives (including alcoholic beverages) and in the elderly, suicide attempt, suicidal ideation

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            Warnings

            Black Box Warnings

            Risks from concomitant use with opioids

            • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death
            • 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
            • Inform patients and caregivers that potentially fatal additive effects may occur if diazepam is used with opioids and that such drugs should not be used concomitantly unless supervised by a health care provider
            • Prescribers are strongly advised to take all reasonable steps to ensure that caregivers fully understand their role and obligations vis a vis the administration of diazepam rectal gel to individuals in their care
            • Prescribers should advise caregivers that they expect to be informed immediately if a patient develops any new findings which are not typical of the patient’s characteristic seizure episode

            Contraindications

            Documented hypersensitivity

            Acute alcohol intoxication

            Myasthenia gravis (allowable in limited circumstances)

            Acute narrow angle glaucoma and open angle glaucoma unless patients receiving appropriate therapy

            Severe respiratory depression

            IV use in shock, coma, depressed respiration, patients who recently received other respiratory depressants

            Sleep apnea

            Children <6 months

            Cautions

            Concomitant use of benzodiazepines, including diazepam, and opioids may result in profound sedation, respiratory depression, coma, and death; reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate; reduce opiate dose one-third when diazepam is added

            Advise both patients and caregivers about risks of respiratory depression and sedation when diazepam 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

            Use caution in COPD, sleep apnea, renal/hepatic disease, open-angle glaucoma (questionable), depression, suicide ideation, impaired gag reflex, history of drug abuse, or obese patients (prolonged action when discontinued)

            Use of benzodiazepines, including diazepam, both used alone and in combination with other CNS depressants, may lead to potentially fatal respiratory depression

            May impair ability to perform hazardous tasks

            Use with caution in patients with a history of drug abuse or acute alcoholism; tolerance, psychological, and physical dependence may occur with prolonged use (>10 days)

            Anterograde amnesia reported with benzodiazepine use

            Avoid extravasation with IV dosing

            Paradoxical reactions may occur including hallucinations, aggressive behavior, and psychoses; dinscontinue use if reactions occur

            Abrupt withdrawal may result in temporary increase of seizures

            Drug interactions overview

            • When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists; limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation
            • If rectal gel is to be combined with other psychotropic agents or other CNS depressants, careful consideration should be given to the pharmacology of agents to be employed particularly with known compounds which may potentiate the action of diazepam, such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants
            • Valproate may potentiate the CNS-depressant effects of diazepam
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            Pregnancy & Lactation

            Pregnancy category: D

            Lactation: Enters breast milk; not recommended

            Minor tranquilizers should be avoided in first trimester of pregnancy due to increased risk of congenital malformations

            Maternal use shortly before delivery is associated with floppy infant syndrome (good and consistent evidence)

            Prenatal benzodiazepine exposure slightly increased oral cleft risk (limited or inconsistent evidence)

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Modulates postsynaptic effects of GABA-A transmission, resulting in an increase in presynaptic inhibition. Appears to act on part of the limbic system, as well as on the thalamus and hypothalamus, to induce a calming effect

            Absorption

            Bioavailability: 90% (PR)

            Duration: Variable, dependent on dose and frequency (PO [hypnotic action]); 15-60 min (IV [sedative action])

            Peak plasma time: 30-90 min (PO), 5-90 min (PR)

            Peak plasma concentration: 373 ng/mL (initial at 45 min); 447 ng/mL (second peak at 70 min)

            Distribution

            Protein bound: 98%

            Vd: 0.8-1 L/kg

            Metabolism

            Metabolized by hepatic P450 enzymes CYP2C19, CYP3A4

            Metabolites: N-desmethyldiazepam, 3-hydroxdiazepam, oxazepam

            Elimination

            Half-life: 20-70 hr (active metabolite)

            Renal clearance: 20-30 mL/min

            Excretion: Urine

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            Administration

            IV Incompatibilities

            Solution: D5W(?), Ringer's(?), LR(?), NS(?) (See IV Preparation)

            Additive: Bleomycin, dobutamine, doxorubicin, floxacillin, fluorouracil, furosemide

            Syringe: Doxapram, glycopyrrolate, heparin, hydromorphone, ketorolac(?), nalbuphine(?), ranitidine(?), sufentanil

            Y-site: Amphotericin B cholesteryl SO4, atracurium, bivalirudin, cefepime, dexmedetomidine, diltiazem, fenoldopam, fluconazole, foscarnet, gatifloxacin, heparin, heparin/hydrocortisone, Hextend, hydromorphone, linezolid, meropenem, pancuronium, KCl, propofol, remifentanil(?), tirofiban, vecuronium, vitamin B/C

            Not specified: Atropine, epinephrine, hydroxyzine, lidocaine, meperidine, morphine, norepinephrine, pentobarbital, Na bicarbonate

            IV Compatibilities

            Additive: Netilmicin, verapamil

            Syringe: Cimetidine

            Y-site: Cisatracurium (may be incompatible at higher concentration), dobutamine, fentanyl, hydromorphone (may be incompatible at higher concentration), methadone, morphine sulfate, nafcillin, quinidine, remifentanil (may be incompatible at higher concentration), sufentanil

            Not specified: Aminophylline, cefazolin

            IV Preparation

            Compatibility with D5W, NS, and Ringer's controversial. If infusion is selected, adding the infusion solution to the diazepam injection (and not the other way around) may prevent precipitate formation

            IV Administration

            Administer over 3 min; no more than 5 mg/min

            Monitor respiration q5-15min and before each IV dose

            Have airway support ready until effects of IV administration are known

            Thrombosis prevention

            • Administer directly into a large vein to avoid thrombosis
            • If this is not feasible, give drug into tubing of a flowing IV solution as close as possible to vein insertion
            • Do not use small veins such as those of wrist or dorsum of hand

            Oral Administration

            Dilute oral concentrate with water/juice/carbonated beverages or mix with semisolid foods

            Rectal Administration

            Place patient on side facing you with upper leg bent forward, lubricate rectal applicator tip, gently insert syringe tip in rectum and slowly push plunger

            Rectal gel should not be used more than 5 episodes/month and no more than one episode q5days

            Storage

            Store intact vials at room temperature; protect from light

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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