Diazepam (injection)

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Diazepam (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Overview

Diazepam (injection) is a general anesthetic that is FDA approved for the {{{indicationType}}} of alcohol withdrawal syndrome, anxiety, sedation, premedication before surgery, endoscopic procedures and cardioversion, seizure, refractory, increased frequency, seizure adjunct, skeletal muscle spasm; adjunct, skeletal muscle spasm - tetanus, status epilepticus.. Common adverse reactions include cardiovascular: hypotension, dermatologic: rash (3%, rectal gel ), gastrointestinal: diarrhea (4%, rectal gel ), musculoskeletal: muscle weakness, neurologic: ataxia, incoordination (3%, rectal gel ), somnolence, psychiatric: euphoria (3%, rectal gel )respiratory: respiratory depression, other: fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Alcohol withdrawal syndrome: initial, 10 mg IM or IV; may give 5 to 10 mg in 3 to 4 hr if necessary.
  • Alcohol withdrawal syndrome: initial, 10 mg ORALLY 3 to 4 times in first 24 hr, then 5 mg ORALLY 3 to 4 times daily as needed.
  • Anxiety: 2 to 10 mg ORALLY 2 to 4 times a day depending on symptom severity.
  • Anxiety: 2 to 10 mg IM or IV every 3 to 4 hr if needed depending on symptom severity.
  • Sedation, Premedication before surgery, endoscopic procedures and cardioversion: preoperative medication, 10 mg IM before surgery [2]

Sedation, Premedication before surgery, endoscopic procedures and cardioversion: endoscopic procedure, 10 mg or less IV immediately prior to procedure; MAX 20 mg OR 5 to 10 mg IM 30 min prior to procedure.

  • Sedation, Premedication before surgery, endoscopic procedures and cardioversion: cardioversion, 5 to 15 mg IV 5 to 10 min prior to procedure.
  • Sedation for a mechanically ventilated patient, Intensive care unit: 0.03 to 0.1 mg/kg every 0.5 to 6 hr IV as needed.
  • Seizure, Refractory, increased frequency: 0.2 mg/kg gel RECTALLY, may repeat in 4 to 12 hr if necessary; may use for up to 1 episode/5 days or 5 episodes/mo.
  • Seizure; Adjunct: 2 to 10 mg ORALLY 2 to 4 times daily.
  • Seizure; Adjunct: severe, recurrent; initial, 5 to 10 mg IV every 10 to 15 min as necessary up to a MAX dose of 30 mg; may repeat in 2 to 4 hr if needed.
  • Seizure; Adjunct: initial, 0.2 mg/kg RECTALLY (rounded up to available rectal dose available available), may repeat in 4 to 12 hours, no more than 1 episode every 5 days, and 5 episodes per month.
  • Skeletal muscle spasm; Adjunct: 2 to 10 mg ORALLY 3 to 4 times a day.
  • Skeletal muscle spasm; Adjunct: initial, 5 to 10 mg IM or IV, then repeat in 3 to 4 hr if needed.
  • Skeletal muscle spasm - Tetanus: initial, 5 to 10 mg IM or IV, then repeat in 3 to 4 hr if needed; larger doses may be required for tetanus.
  • Status epilepticus: initial, 5 to 10 mg IV every 10 to 15 min up to a MAX dose of 30 mg; may repeat in 2 to 4 hr if needed.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

  • Anesthesia; Adjunct.
  • Benzodiazepine withdrawal.
  • Sedation for a mechanically ventilated patient, Intensive care unit.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Diazepam in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • Safety and effectiveness not established in children less than 6 months of age.
  • Anxiety: initial, 1 to 2.5 mg ORALLY 3 to 4 times daily; increase gradually as needed.
  • Seizure, Refractory, increased frequency: 2 to 5 yr, 0.5 mg/kg gel RECTALLY, may repeat in 4 to 12 hr if necessary; may use for up to 1 episode/5 days or 5 episodes/mo.
  • Seizure, Refractory, increased frequency: 6 to 11 yr, 0.3 mg/kg gel RECTALLY, may repeat in 4 to 12 hr if necessary; may use for up to 1 episode/5 days or 5 episodes/mo.
  • Seizure, Refractory, increased frequency: 12 yr and older, 0.2 mg/kg gel RECTALLY, may repeat in 4 to 12 hr if necessary; may use for up to 1 episode/5 days or 5 episodes/mo.
  • Seizure; Adjunct: 6 mo or older, initial, 1 to 2.5 mg ORALLY 3 to 4 times daily, may increase gradually as needed.
  • Seizure; Adjunct: severe, recurrent; 30 days to 5 yr of age, 0.2 to 0.5 mg IV slowly (preferred) OR IM every 2 to 5 min up to a MAX of 5 mg.
  • Seizure; Adjunct: severe, recurrent; 5 yr and older, 1 mg IV slowly (preferred) OR IM every 2 to 5 min up to MAX of 10 mg; repeat in 2 to 4 hr if necessary.
  • Seizure; Adjunct: 2 to 5 years, initial, 0.5 mg/kg RECTALLY (rounded up to the manufactured unit dose available), may repeat in 4 to 12 hours, no more than 1 episode every 5 days, and 5 episodes per month.
  • Seizure; Adjunct: 6 to 11 years, initial, 0.3 mg/kg RECTALLY (rounded up to the manufactured unit dose available), may repeat in 4 to 12 hours, no more than 1 episode every 5 days, and 5 episodes per month.
  • Seizure; Adjunct: 12 years and older, initial, 0.2 mg/kg RECTALLY (rounded up to the manufactured unit dose available), may repeat in 4 to 12 hours, no more than 1 episode every 5 days, and 5 episodes per month.
  • Skeletal muscle spasm; Adjunct: 6 mo or older, initial, 1 to 2.5 mg ORALLY 3 to 4 times daily, may increase gradually as needed.
  • Skeletal muscle spasm - Tetanus: spasms due to tetanus, over 30 days to 5 yr, 1 to 2 mg IM OR IV, repeat every 3 to 4 hr as necessary.
  • Skeletal muscle spasm - Tetanus: spasms due to tetanus, 5 yr and older, 5 to 10 mg IM OR IV, repeat every 3 to 4 hr as necessary.
  • Status epilepticus: 30 days to 5 yr of age, 0.2 to 0.5 mg IV slowly (preferred) OR IM every 2 to 5 min up to a MAX of 5 mg.
  • Status epilepticus: 5 yr and older, 1 mg IV slowly (preferred) OR IM every 2 to 5 min up to MAX of 10 mg; repeat in 2 to 4 hr if necessary.
  • Status epilepticus: infants and children, 0.1 mg/kg up to a MAX of 0.3 mg/kg IV every 2 min; do not exceed a total dose of 5 mg in children aged 30 days to 5 yr OR a total dose of 10 mg in children aged 5 yr or older.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Diazepam in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Diazepam in pediatric patients.

Contraindications

Valium is contraindicated in patients with a known hypersensitivity to diazepam and, because of lack of sufficient clinical experience, in pediatric patients under 6 months of age. Valium is also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome. It may be used in patients with open-angle glaucoma who are receiving appropriate therapy, but is contraindicated in acute narrow-angle glaucoma.

Warnings

Valium is not recommended in the treatment of psychotic patients and should not be employed instead of appropriate treatment.

Since Valium has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during Valium therapy.

As with other agents that have anticonvulsant activity, when Valium is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the dosage of standard anticonvulsant medication. Abrupt withdrawal of Valium in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Diazepam (injection) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Diazepam (injection) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Diazepam (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Diazepam (injection) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Diazepam (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Diazepam (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Diazepam (injection) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Diazepam (injection) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Diazepam (injection) in geriatric settings.

Gender

There is no FDA guidance on the use of Diazepam (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Diazepam (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Diazepam (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Diazepam (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Diazepam (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Diazepam (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Diazepam (injection) Administration in the drug label.

Monitoring

There is limited information regarding Diazepam (injection) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Diazepam (injection) and IV administrations.

Overdosage

There is limited information regarding Diazepam (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Diazepam (injection) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Diazepam (injection) Mechanism of Action in the drug label.

Structure

There is limited information regarding Diazepam (injection) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Diazepam (injection) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Diazepam (injection) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Diazepam (injection) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Diazepam (injection) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Diazepam (injection) How Supplied in the drug label.

Storage

There is limited information regarding Diazepam (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Diazepam (injection) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Diazepam interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Diazepam (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Diazepam (injection) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Synonyms / Brand Names: DAP, Methyldiazepinone, Alboral, Aliseum, Alupram, Amiprol, An-Ding, Ansiolin, Ansiolisina, Apaurin, Apo-Diazepam, Apozepam, Armonil, Assival, Atensine, Atilen, Bensedin, Bialzepam, Calmocitene, Calmpose, Cercine, Ceregulart, Condition, Diacepan, Dialag, Dialar, Diapam, Diastat, Diazemuls, Diazemulus, Diazepam Intensol, Diazepan, Diazetard, Dienpax, Dipam, Dipezona, Dizac, Domalium, Duksen, Duxen, E-Pam, Eridan, Eurosan, Evacalm, Faustan, Faustan, Freudal, Frustan, Gewacalm, Gihitan, Kabivitrum, Kiatrium, LA III, La-Iii, Lamra, Lembrol, Levium, Liberetas, Mandrozep, Morosan, Neurolytril, Noan, Novazam, Novo-Dipam, Paceum, Pacitran, Paranten, Paxate, Paxel, Plidan, Pms-Diazepam, Pro-Pam, Q-Pam, Q-Pam Relanium, Quetinil, Quiatril, Quievita, Relaminal, Relanium, Renborin, Ruhsitus, Saromet, Sedapam, Sedipam, Seduksen, Seduxen, Serenack, Serenamin, Serenzin, Servizepam, Setonil, Sibazon, Sibazone, Solis, Sonacon, Stesolid, Stesolin, Tensopam, Tranimul, Tranqdyn, Tranquase, Tranquirit, Tranquo-Puren, Tranquo-Tablinen, Umbrium, Unisedil, Usempax Ap, Valaxona, Valeo, Valiquid, Valitran, Valium, Valrelease, Vatran, Velium, Vival, Vivol, Zetran, Zipan