Diazepam Oral Solution

— THERAPEUTIC CATEGORIES —
  • 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 Oral Solution Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Diazepam 5mg; per 5mL; wintergreen-spice flavor.

    Pharmacological Class

    Benzodiazepine.

    See Also

    How Supplied

    Soln—473mL; Intensol—30mL (w. dropper)

    Manufacturer

    Hikma Pharmaceuticals

    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 Oral Solution Indications

    Indications

    Anxiety.

    Diazepam Oral Solution Dosage and Administration

    Adult

    Intensol: Mix with liquid or semi-solid food. 2–10mg 2–4 times daily. Elderly, debilitated: initially 2–2.5mg 1–2 times daily; increase gradually.

    Children

    Intensol: mix with liquid or semi-solid food. <6months: see Contraindications. >6months: 1–2.5mg 3–4 times daily; increase gradually.

    Diazepam Oral Solution Contraindications

    Contraindications

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

    Diazepam Oral Solution Boxed Warnings

    Boxed Warning

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

    Diazepam Oral Solution 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. 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 Oral Solution Pharmacokinetics

    Absorption

    >90% of oral diazepam is absorbed. 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.

    Diazepam Oral Solution 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 Oral Solution Adverse Reactions

    Adverse Reactions

    Drowsiness, fatigue, muscle weakness, ataxia, CNS effects, GI disturbances, hypotension, salivation changes, neutropenia, jaundice; paradoxical excitement, withdrawal reactions.

    Diazepam Oral Solution Clinical Trials

    See Literature

    Diazepam Oral Solution Note

    Not Applicable

    Diazepam Oral Solution Patient Counseling

    See Literature

    Diazepam Oral Solution Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Diazepam 5mg; per 5mL; wintergreen-spice flavor.

    Pharmacological Class

    Benzodiazepine.

    See Also

    How Supplied

    Soln—473mL; Intensol—30mL (w. dropper)

    Manufacturer

    Hikma Pharmaceuticals

    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 Oral Solution Indications

    Indications

    Adjunct for skeletal muscle spasm.

    Diazepam Oral Solution Dosage and Administration

    Adult

    Intensol: Mix with liquid or semi-solid food. 2–10mg 3–4 times daily. Elderly, debilitated: initially 2–2.5mg 1–2 times daily; increase gradually.

    Children

    Intensol: mix with liquid or semi-solid food. <6months: see Contraindications. >6months: 1–2.5mg 3–4 times daily; increase gradually.

    Diazepam Oral Solution Contraindications

    Contraindications

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

    Diazepam Oral Solution Boxed Warnings

    Boxed Warning

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

    Diazepam Oral Solution 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. 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 Oral Solution Pharmacokinetics

    Absorption

    >90% of oral diazepam is absorbed. 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.

    Diazepam Oral Solution 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 Oral Solution Adverse Reactions

    Adverse Reactions

    Drowsiness, fatigue, muscle weakness, ataxia, CNS effects, GI disturbances, hypotension, salivation changes, neutropenia, jaundice; paradoxical excitement, withdrawal reactions.

    Diazepam Oral Solution Clinical Trials

    See Literature

    Diazepam Oral Solution Note

    Not Applicable

    Diazepam Oral Solution Patient Counseling

    See Literature

    Diazepam Oral Solution Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Diazepam 5mg; per 5mL; wintergreen-spice flavor.

    Pharmacological Class

    Benzodiazepine.

    See Also

    How Supplied

    Soln—473mL; Intensol—30mL (w. dropper)

    Manufacturer

    Hikma Pharmaceuticals

    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 Oral Solution Indications

    Indications

    Adjunct in convulsive disorders.

    Diazepam Oral Solution Dosage and Administration

    Adult

    Intensol: Mix with liquid or semi-solid food. 2–10mg 2–4 times daily. Elderly, debilitated: initially 2–2.5mg 1–2 times daily; increase gradually.

    Children

    Intensol: mix with liquid or semi-solid food. <6months: see Contraindications. >6months: 1–2.5mg 3–4 times daily; increase gradually.

    Diazepam Oral Solution Contraindications

    Contraindications

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

    Diazepam Oral Solution Boxed Warnings

    Boxed Warning

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

    Diazepam Oral Solution 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. 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 Oral Solution Pharmacokinetics

    Absorption

    >90% of oral diazepam is absorbed. 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.

    Diazepam Oral Solution 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 Oral Solution Adverse Reactions

    Adverse Reactions

    Drowsiness, fatigue, muscle weakness, ataxia, CNS effects, GI disturbances, hypotension, salivation changes, neutropenia, jaundice; paradoxical excitement, withdrawal reactions.

    Diazepam Oral Solution Clinical Trials

    See Literature

    Diazepam Oral Solution Note

    Not Applicable

    Diazepam Oral Solution Patient Counseling

    See Literature

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