Diazepam (injection)
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 {{{adverseReactions}}}.
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)
There is limited information regarding Diazepam (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
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
There is limited information regarding Diazepam (injection) Contraindications in the drug label.
Warnings
There is limited information regarding Diazepam (injection) Warnings' in the drug label.
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