Valium

— 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

    • Valium Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Diazepam 2mg, 5mg, 10mg; scored tabs.

    Pharmacological Class

    Benzodiazepine.

    See Also

      How Supplied

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

      Manufacturer

      Waylis Therapeutics

      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.

      Valium Indications

      Indications

      Acute alcohol withdrawal.

      Valium Dosage and Administration

      Adult

      Initially 10mg 3–4 times during the first 24hrs, then reduce to 5mg 3–4 times daily as needed.

      Children

      Not established.

      Valium Contraindications

      Contraindications

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

      Valium Boxed Warnings

      Boxed Warning

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

      Valium 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.

      Valium 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).

      Valium 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.

      Valium 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.

      Valium Clinical Trials

      See Literature

      Valium Note

      Not Applicable

      Valium Patient Counseling

      See Literature

      Valium Generic Name & Formulations

      Legal Class

      CIV

      General Description

      Diazepam 2mg, 5mg, 10mg; scored tabs.

      Pharmacological Class

      Benzodiazepine.

      See Also

      How Supplied

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

      Manufacturer

      Waylis Therapeutics

      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.

      Valium Indications

      Indications

      Anxiety.

      Valium Dosage and Administration

      Adult

      2–10mg 2–4 times daily. Elderly, debilitated: initially 2–2.5mg 1–2 times daily; increase gradually.

      Children

      <6months: See Contraindications. ≥6months: initially 1–2.5mg 3–4 times daily; increase gradually.

      Valium Contraindications

      Contraindications

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

      Valium Boxed Warnings

      Boxed Warning

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

      Valium 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.

      Valium 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).

      Valium 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.

      Valium 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.

      Valium Clinical Trials

      See Literature

      Valium Note

      Not Applicable

      Valium Patient Counseling

      See Literature

      Valium Generic Name & Formulations

      Legal Class

      CIV

      General Description

      Diazepam 2mg, 5mg, 10mg; scored tabs.

      Pharmacological Class

      Benzodiazepine.

      See Also

      How Supplied

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

      Manufacturer

      Waylis Therapeutics

      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.

      Valium Indications

      Indications

      Skeletal muscle spasm.

      Valium Dosage and Administration

      Adult

      2–10mg 3–4 times daily. Elderly, debilitated: initially 2–2.5mg 1–2 times daily; increase gradually.

      Children

      <6months: See Contraindications. ≥6months: initially 1–2.5mg 3–4 times daily; increase gradually.

      Valium Contraindications

      Contraindications

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

      Valium Boxed Warnings

      Boxed Warning

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

      Valium 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.

      Valium 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).

      Valium 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.

      Valium 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.

      Valium Clinical Trials

      See Literature

      Valium Note

      Not Applicable

      Valium Patient Counseling

      See Literature

      Valium Generic Name & Formulations

      Legal Class

      CIV

      General Description

      Diazepam 2mg, 5mg, 10mg; scored tabs.

      Pharmacological Class

      Benzodiazepine.

      See Also

      How Supplied

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

      Manufacturer

      Waylis Therapeutics

      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.

      Valium Indications

      Indications

      Adjunct in convulsive disorders.

      Valium Dosage and Administration

      Adult

      2–10mg 2–4 times daily. Elderly, debilitated: initially 2–2.5mg 1–2 times daily; increase gradually.

      Children

      <6months: See Contraindications. ≥6months: initially 1–2.5mg 3–4 times daily; increase gradually.

      Valium Contraindications

      Contraindications

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

      Valium Boxed Warnings

      Boxed Warning

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

      Valium 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.

      Valium 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).

      Valium 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.

      Valium 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.

      Valium Clinical Trials

      See Literature

      Valium Note

      Not Applicable

      Valium Patient Counseling

      See Literature

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