General MedicationsRECTALBlack Box

Diazepam

DIAZEPAM

Standard Dose

DOSAGE AND ADMINISTRATION (see also Patient/Caregiver Package Insert) This section is intended primarily for the prescriber; however, the prescriber should also be aware of the dosing information and directions for use provided in the patient package insert. A decision to prescribe diazepam rectal gel involves more than the diagnosis and the selection of the correct dose for the patient. First, the prescriber must be convinced from historical reports and/or personal observations that the patient exhibits the characteristic identifiable seizure cluster that can be distinguished from the patient's usual seizure activity by the caregiver who will be responsible for administering diazepam rectal gel. Second, because diazepam rectal gel is only intended for adjunctive use, the prescriber must ensure that the patient is receiving an optimal regimen of standard anti-epileptic drug treatment and is, nevertheless, continuing to experience these characteristic episodes. Third, because a non-health professional will be obliged to identify episodes suitable for treatment, make the decision to administer treatment upon that identification, administer the drug, monitor the patient, and assess the adequacy of the response to treatment, a major component of the prescribing process involves the necessary instruction of this individual. Fourth, the prescriber and caregiver must have a common understanding of what is and is not an episode of seizures that is appropriate for treatment, the timing of administration in relation to the onset of the episode, the mechanics of administering the drug, how and what to observe following administration, and what would constitute an outcome requiring immediate and direct medical attention. Calculating Prescribed Dose The diazepam rectal gel dose should be individualized for maximum beneficial effect. The recommended dose of diazepam rectal gel is 0.2-0.5 mg/kg depending on age. See the dosing table for specific recommendations. Age (years) Recommended Dose 2 through 5 0.5 mg/kg 6 through 11 0.3 mg/kg 12 and older 0.2 mg/kg Because diazepam rectal gel is provided as unit doses of 2.5, 5, 7.5, 10, 12.5, 15, 17.5, and 20 mg, the prescribed dose is obtained by rounding upward to the next available dose. The following table provides acceptable weight ranges for each dose and age category, such that patients will receive between 90% and 180% of the calculated recommended dose. The safety of this strategy has been established in clinical trials. 2 - 5 Years 0.5 mg/kg 6 - 11 Years 0.3 mg/kg 12+ Years 0.2 mg/kg Weight (kg) Dose (mg) Weight (kg) Dose (mg) Weight (kg) Dose (mg) 6 to 10 5 10 to 16 5 14 to 25 5 11 to 15 7.5 17 to 25 7.5 26 to 37 7.5 16 to 20 10 26 to 33 10 38 to 50 10 21 to 25 12.5 34 to 41 12.5 51 to 62 12.5 26 to 30 15 42 to 50 15 63 to 75 15 31 to 35 17.5 51 to 58 17.5 76 to 87 17.5 36 to 44 20 59 to 74 20 88 to 111 20 The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths. The Diazepam Rectal Gel 10 mg syringe is available with a 4.4 cm tip and the Diazepam Rectal Gel 20 mg syringe is available with a 6.0 cm tip. Diazepam Rectal Gel 2.5 mg is also available with a 4.4 cm tip. In elderly and debilitated patients, it is recommended that the dosage be adjusted downward to reduce the likelihood of ataxia or oversedation. The prescribed dose of diazepam rectal gel should be adjusted by the physician periodically to reflect changes in the patient's age or weight. The diazepam rectal gel 2.5 mg dose may also be used as a partial replacement dose for patients who may expel a portion of the first dose. Additional Dose The prescriber may wish to prescribe a second dose of diazepam rectal gel. A second dose, when required, may be given 4-12 hours after the first dose. Treatment Frequency It is recommended that diazepam rectal gel be used to treat no more than five episodes per month and no more than one episode every five days. _______________________________________________________________________________________________________________ Pharmacist Instructions Image Image Image

Max Dose

See official label

Primary Use

INDICATIONS AND USAGE Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older.

Summary

Dosage and administration DOSAGE AND ADMINISTRATION (see also Patient/Caregiver Package Insert) This section is intended primarily for the prescriber; however, the prescriber should also be aware of the dosing information and directions for use provided in the patient package insert.

Structured Monograph

Clinical summary

Indications and usage INDICATIONS AND USAGE Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older. Dosage and administration DOSAGE AND ADMINISTRATION (see also Patient/Caregiver Package Insert) This section is intended primarily for the prescriber; however, the prescriber should also be aware of the dosing information and directions for use provided in the patient package insert. A decision to prescribe diazepam rectal gel involves more than the diagnosis and the selection of the correct dose for the patient. First, the prescriber must be convinced from historical reports and/or personal observations that the patient exhibits the characteristic identifiable seizure cluster that can be distinguished from the patient's usual seizure activity by the caregiver who will be responsible for administering diazepam rectal gel. Second, because diazepam rectal gel is only intended for adjunctive use, the prescriber must ensure that the patient is receiving an optimal regimen of standard anti-epileptic drug treatment and is, nevertheless, continuing to experience these characteristic episodes. Third, because a non-health professional will be obliged to identify episodes suitable for treatment, make the decision to administer treatment upon that identification, administer the drug, monitor the patient, and assess the adequacy of the response to treatment, a major component of the prescribing process involves the necessary instruction of this individual. Fourth, the prescriber and caregiver must have a common understanding of what is and is not an episode of seizures that is appropriate for treatment, the timing of administration in relation to the onset of the episode, the mechanics of administering the drug, how and what to observe following administration, and what would constitute an outcome requiring immediate and direct medical attention. Calculating Prescribed Dose The diazepam rectal gel dose should be individualized for maximum beneficial effect. The recommended dose of diazepam rectal gel is 0.2-0.5 mg/kg depending on age. See the dosing table for specific recommendations. Age (years) Recommended Dose 2 through 5 0.5 mg/kg 6 through 11 0.3 mg/kg 12 and older 0.2 mg/kg Because diazepam rectal gel is provided as unit doses of 2.5, 5, 7.5, 10, 12.5, 15, 17.5, and 20 mg, the prescribed dose is obtained by rounding upward to the next available dose. The following table provides acceptable weight ranges for each dose and age category, such that patients will receive between 90% and 180% of the calculated recommended dose. The safety of this strategy has been established in clinical trials. 2 - 5 Years 0.5 mg/kg 6 - 11 Years 0.3 mg/kg 12+ Years 0.2 mg/kg Weight (kg) Dose (mg) Weight (kg) Dose (mg) Weight (kg) Dose (mg) 6 to 10 5 10 to 16 5 14 to 25 5 11 to 15 7.5 17 to 25 7.5 26 to 37 7.5 16 to 20 10 26 to 33 10 38 to 50 10 21 to 25 12.5 34 to 41 12.5 51 to 62 12.5 26 to 30 15 42 to 50 15 63 to 75 15 31 to 35 17.5 51 to 58 17.5 76 to 87 17.5 36 to 44 20 59 to 74 20 88 to 111 20 The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths. The Diazepam Rectal Gel 10 mg syringe is available with a 4.4 cm tip and the Diazepam Rectal Gel 20 mg syringe is available with a 6.0 cm tip. Diazepam Rectal Gel 2.5 mg is also available with a 4.4 cm tip. In elderly and debilitated patients, it is recommended that the dosage be adjusted downward to reduce the likelihood of ataxia or oversedation. The prescribed dose of diazepam rectal gel should be adjusted by the physician periodically to reflect changes in the patient's age or weight. The diazepam rectal gel 2.5 mg dose may also be used as a partial replacement dose for patients who may expel a portion of the first dose. Additional Dose The prescriber may wish to prescribe a second dose of diazepam rectal gel. A second dose, when required, may be given 4-12 hours after the first dose. Treatment Frequency It is recommended that diazepam rectal gel be used to treat no more than five episodes per month and no more than one episode every five days. _______________________________________________________________________________________________________________ Pharmacist Instructions Image Image Image Warnings and cautions WARNINGS General Diazepam rectal gel should only be administered by caregivers who in the opinion of the prescribing physician 1) are able to distinguish the distinct cluster of seizures (and/or the events presumed to herald their onset) from the patient's ordinary seizure activity, 2) have been instructed and judged to be competent to administer the treatment rectally, 3) understand explicitly which seizure manifestations may or may not be treated with diazepam rectal gel, and 4) are able t

Boxed Warning

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation ( see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including Diazepam Rectal Gel, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing Diazepam Rectal Gel and throughout treatment, assess each patient's risk for abuse, misuse, and addiction ( see WARNINGS ). The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although Diazepam Rectal Gel is indicated only for intermittent use ( see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION ), if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of Diazepam Rectal Gel may precipitate acute withdrawal reactions, which can be life-threatening. For patients using Diazepam Rectal Gel more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue Diazepam Rectal Gel (see WARNINGS ).

Monitoring

• WARNINGS General Diazepam rectal gel should only be administered by caregivers who in the opinion of the prescribing physician 1) are able to distinguish the distinct cluster of seizures (and/or the events presumed to herald their onset) from the patient's ordinary seizure activity, 2) have been instructed and judged to be competent to administer the treatment rectally, 3) understand explicitly which seizure manifestations may or may not be treated with diazepam rectal gel, and 4) are able to monitor the clinical response and recognize when that response is such that immediate professional medical evaluation is required.
• Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including Diazepam Rectal Gel, and opioids may result in profound sedation, respiratory depression, coma, and death.
• Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for patients for whom alternative treatment options are inadequate.
• Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.

Interaction Notes

• Drug Interactions There have been no clinical studies or reports in literature to evaluate the interaction of rectally administered diazepam with other drugs.
• As with all drugs, the potential for interaction by a variety of mechanisms is a possibility.
• Effect of Concomitant Use of Benzodiazepines and Opioids: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.
• Benzodiazepines interact at GABA A sites, and opioids interact primarily at mu receptors.