Diazepam Injection

— THERAPEUTIC CATEGORIES —
  • Addiction/dependence
  • Anxiety/OCD
  • Muscle spasms
  • Seizure disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Diazepam Injection Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Diazepam 5mg/mL; soln for IM or IV use; contains propylene glycol 40%, ethyl and benzyl alcohol.

    Pharmacological Class

    Benzodiazepine.

    See Also

    How Supplied

    Tabs 2mg—100; Tabs 5mg, 10mg—100, 500; Vials (10mL)—contact supplier

    Manufacturer

    Various generic manufacturers

    Mechanism of Action

    Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects. Most of these effects are thought to result from a facilitation of the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system.

    Diazepam Injection Indications

    Indications

    Acute alcohol withdrawal.

    Diazepam Injection Dosage and Administration

    Adult

    Initially 10mg IM or IV, then 5–10mg in 3–4hrs as needed. Do not use small vein.

    Children

    Not established.

    Diazepam Injection Contraindications

    Contraindications

    Children <6months. Myasthenia gravis. Severe respiratory insufficiency. Severe hepatic insufficiency. Sleep apnea syndrome. Acute narrow-angle glaucoma. Untreated open angle glaucoma.

    Diazepam Injection Boxed Warnings

    Boxed Warning

    Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

    Diazepam Injection Warnings/Precautions

    Warnings/Precautions

    Increased risk of drug-related mortality from concomitant use with opioids. Monitor for CNS depressant effects. Discontinue if paradoxical reaction occurs. Respiratory insufficiency. Depression. Suicidal tendencies. Psychosis. May increase severity of seizures. Renal or hepatic impairment. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Reevaluate periodically. Monitor blood counts, liver function. Inj: not for use in shock, coma, acute alcohol intoxication, or obstetrical conditions. Drug or alcohol abusers. Elderly. Debilitated. Labor & delivery. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: not recommended.

    Diazepam Injection Pharmacokinetics

    See Literature

    Diazepam Injection Interactions

    Interactions

    Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Potentiates CNS depression with alcohol, other CNS depressants (eg, phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, antihistamines, barbiturates, MAOIs, other antidepressants). Potentiated by CYP3A or CYP2C19 inhibitors (eg, cimetidine, fluoxetine, fluvoxamine, ketoconazole, omeprazole). May affect or be affected by phenytoin.

    Diazepam Injection Adverse Reactions

    Adverse Reactions

    Drowsiness, fatigue, muscle weakness, ataxia, CNS effects, GI disturbances, hypotension, salivation changes, neutropenia, jaundice; paradoxical excitement. Inj: apnea, cardiac arrest, venous thrombosis, phlebitis, local irritation, swelling, tonic status epilepticus (when treating petit mal), propylene glycol toxicity, withdrawal reactions.

    Diazepam Injection Clinical Trials

    See Literature

    Diazepam Injection Note

    Not Applicable

    Diazepam Injection Patient Counseling

    See Literature

    Diazepam Injection Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Diazepam 5mg/mL; soln for IM or IV use; contains propylene glycol 40%, ethyl and benzyl alcohol.

    Pharmacological Class

    Benzodiazepine.

    See Also

    How Supplied

    Tabs 2mg—100; Tabs 5mg, 10mg—100, 500; Vials (10mL)—contact supplier

    Manufacturer

    Various generic manufacturers

    Mechanism of Action

    Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects. Most of these effects are thought to result from a facilitation of the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system.

    Diazepam Injection Indications

    Indications

    Anxiety.

    Diazepam Injection Dosage and Administration

    Adult

    Moderate: 2–5mg. Severe: 5–10mg. Both deep IM or slow IV (5mg/min). May repeat in 3–4 hours. Do not use small vein.

    Children

    Not recommended.

    Diazepam Injection Contraindications

    Contraindications

    Children <6months. Myasthenia gravis. Severe respiratory insufficiency. Severe hepatic insufficiency. Sleep apnea syndrome. Acute narrow-angle glaucoma. Untreated open angle glaucoma.

    Diazepam Injection Boxed Warnings

    Boxed Warning

    Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

    Diazepam Injection Warnings/Precautions

    Warnings/Precautions

    Increased risk of drug-related mortality from concomitant use with opioids. Monitor for CNS depressant effects. Discontinue if paradoxical reaction occurs. Respiratory insufficiency. Depression. Suicidal tendencies. Psychosis. May increase severity of seizures. Renal or hepatic impairment. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Reevaluate periodically. Monitor blood counts, liver function. Inj: not for use in shock, coma, acute alcohol intoxication, or obstetrical conditions. Drug or alcohol abusers. Elderly. Debilitated. Labor & delivery. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: not recommended.

    Diazepam Injection Pharmacokinetics

    Absorption

    Oral diazepam absorption: >90%. Mean time to peak plasma concentration: 1–1.5 hours (range: 0.25–2.5 hours). Absorption is decreased and delayed when administered with a moderate fat meal.

    Distribution

    Plasma protein bound: 98%. Volume of distribution: 0.8–1.0 L/kg.

    Metabolism

    Hepatic (CYP3A4).

    Elimination

    Renal. Terminal half-life: up to 100 hours (N-desmethyldiazepam).

    Diazepam Injection Interactions

    Interactions

    Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Potentiates CNS depression with alcohol, other CNS depressants (eg, phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, antihistamines, barbiturates, MAOIs, other antidepressants). Potentiated by CYP3A or CYP2C19 inhibitors (eg, cimetidine, fluoxetine, fluvoxamine, ketoconazole, omeprazole). May affect or be affected by phenytoin.

    Diazepam Injection Adverse Reactions

    Adverse Reactions

    Drowsiness, fatigue, muscle weakness, ataxia, CNS effects, GI disturbances, hypotension, salivation changes, neutropenia, jaundice; paradoxical excitement. Inj: apnea, cardiac arrest, venous thrombosis, phlebitis, local irritation, swelling, tonic status epilepticus (when treating petit mal), propylene glycol toxicity, withdrawal reactions.

    Diazepam Injection Clinical Trials

    See Literature

    Diazepam Injection Note

    Not Applicable

    Diazepam Injection Patient Counseling

    See Literature

    Diazepam Injection Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Diazepam 5mg/mL; soln for IM or IV use; contains propylene glycol 40%, ethyl and benzyl alcohol.

    Pharmacological Class

    Benzodiazepine.

    See Also

    How Supplied

    Tabs 2mg—100; Tabs 5mg, 10mg—100, 500; Vials (10mL)—contact supplier

    Manufacturer

    Various generic manufacturers

    Mechanism of Action

    Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects. Most of these effects are thought to result from a facilitation of the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system.

    Diazepam Injection Indications

    Indications

    Skeletal muscle spasm.

    Diazepam Injection Dosage and Administration

    Adult

    Initially 5–10mg slow IV (5mg/min) or IM. May repeat after 3–4hrs. Tetanus: may need larger dose. Do not use small vein.

    Children

    Max 0.25mg/kg over 3 minutes; if no response after 3rd dose consider adjunctive therapy. Tetanus: age <30 days: not recommended. 30 days–5yrs: 1–2mg IM or slow IV. >5yrs: 5–10mg IM or slow IV. Both: may repeat after 3–4hrs. Do not use small vein.

    Diazepam Injection Contraindications

    Contraindications

    Children <6months. Myasthenia gravis. Severe respiratory insufficiency. Severe hepatic insufficiency. Sleep apnea syndrome. Acute narrow-angle glaucoma. Untreated open angle glaucoma.

    Diazepam Injection Boxed Warnings

    Boxed Warning

    Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

    Diazepam Injection Warnings/Precautions

    Warnings/Precautions

    Increased risk of drug-related mortality from concomitant use with opioids. Monitor for CNS depressant effects. Discontinue if paradoxical reaction occurs. Respiratory insufficiency. Depression. Suicidal tendencies. Psychosis. May increase severity of seizures. Renal or hepatic impairment. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Reevaluate periodically. Monitor blood counts, liver function. Inj: not for use in shock, coma, acute alcohol intoxication, or obstetrical conditions. Drug or alcohol abusers. Elderly. Debilitated. Labor & delivery. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: not recommended.

    Diazepam Injection Pharmacokinetics

    See Literature

    Diazepam Injection Interactions

    Interactions

    Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Potentiates CNS depression with alcohol, other CNS depressants (eg, phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, antihistamines, barbiturates, MAOIs, other antidepressants). Potentiated by CYP3A or CYP2C19 inhibitors (eg, cimetidine, fluoxetine, fluvoxamine, ketoconazole, omeprazole). May affect or be affected by phenytoin.

    Diazepam Injection Adverse Reactions

    Adverse Reactions

    Drowsiness, fatigue, muscle weakness, ataxia, CNS effects, GI disturbances, hypotension, salivation changes, neutropenia, jaundice; paradoxical excitement. Inj: apnea, cardiac arrest, venous thrombosis, phlebitis, local irritation, swelling, tonic status epilepticus (when treating petit mal), propylene glycol toxicity, withdrawal reactions.

    Diazepam Injection Clinical Trials

    See Literature

    Diazepam Injection Note

    Not Applicable

    Diazepam Injection Patient Counseling

    See Literature

    Diazepam Injection Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Diazepam 5mg/mL; soln for IM or IV use; contains propylene glycol 40%, ethyl and benzyl alcohol.

    Pharmacological Class

    Benzodiazepine.

    See Also

    How Supplied

    Tabs 2mg—100; Tabs 5mg, 10mg—100, 500; Vials (10mL)—contact supplier

    Manufacturer

    Various generic manufacturers

    Mechanism of Action

    Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects. Most of these effects are thought to result from a facilitation of the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system.

    Diazepam Injection Indications

    Indications

    Adjunct in status epilepticus and recurrent seizures.

    Diazepam Injection Dosage and Administration

    Adult

    Initially 5–10mg slow IV (5mg/min). May repeat every 10–15 minutes; max 30mg. Repeat in 2–4 hours if needed. Do not dilute. May give IM if IV impossible. Do not use small vein.

    Children

    Max 0.25mg/kg over 3 minutes; if no response after 3rd dose consider adjunctive therapy. Age <30 days: not recommended. 30 days–5yrs: 0.2–0.5mg slow IV every 2–5 minutes; max 5mg. >5yrs: 1mg slow IV every 2–5 minutes; max 10mg. Repeat in 2–4 hours if needed. Do not use small vein.

    Diazepam Injection Contraindications

    Contraindications

    Children <6months. Myasthenia gravis. Severe respiratory insufficiency. Severe hepatic insufficiency. Sleep apnea syndrome. Acute narrow-angle glaucoma. Untreated open angle glaucoma.

    Diazepam Injection Boxed Warnings

    Boxed Warning

    Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

    Diazepam Injection Warnings/Precautions

    Warnings/Precautions

    Increased risk of drug-related mortality from concomitant use with opioids. Monitor for CNS depressant effects. Discontinue if paradoxical reaction occurs. Respiratory insufficiency. Depression. Suicidal tendencies. Psychosis. May increase severity of seizures. Renal or hepatic impairment. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Reevaluate periodically. Monitor blood counts, liver function. Inj: not for use in shock, coma, acute alcohol intoxication, or obstetrical conditions. Drug or alcohol abusers. Elderly. Debilitated. Labor & delivery. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: not recommended.

    Diazepam Injection Pharmacokinetics

    Absorption

    Oral diazepam absorption: >90%. Mean time to peak plasma concentration: 1–1.5 hours (range: 0.25–2.5 hours). Absorption is decreased and delayed when administered with a moderate fat meal.

    Distribution

    Plasma protein bound: 98%. Volume of distribution: 0.8–1.0 L/kg.

    Metabolism

    Hepatic (CYP3A4).

    Elimination

    Renal. Terminal half-life: up to 100 hours (N-desmethyldiazepam).

    Diazepam Injection Interactions

    Interactions

    Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Potentiates CNS depression with alcohol, other CNS depressants (eg, phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, antihistamines, barbiturates, MAOIs, other antidepressants). Potentiated by CYP3A or CYP2C19 inhibitors (eg, cimetidine, fluoxetine, fluvoxamine, ketoconazole, omeprazole). May affect or be affected by phenytoin.

    Diazepam Injection Adverse Reactions

    Adverse Reactions

    Drowsiness, fatigue, muscle weakness, ataxia, CNS effects, GI disturbances, hypotension, salivation changes, neutropenia, jaundice; paradoxical excitement. Inj: apnea, cardiac arrest, venous thrombosis, phlebitis, local irritation, swelling, tonic status epilepticus (when treating petit mal), propylene glycol toxicity, withdrawal reactions.

    Diazepam Injection Clinical Trials

    See Literature

    Diazepam Injection Note

    Not Applicable

    Diazepam Injection Patient Counseling

    See Literature

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