Diazepam (Page 5 of 6)

OVERDOSAGE

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS: Abuse, Misuse, and Addiction). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage.

In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway maintenance. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency. The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage. See the flumazenil injection Prescribing Information.

Consider contacting the Poison Help line (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.

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 6 — 11 Years 12+ Years
0.5 mg/kg 0.3 mg/kg 0.2 mg/kg
Weight Dose Weight Dose Weight Dose
(kg) (mg) (kg) (mg) (kg) (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 rectal delivery system 10 mg syringe is available with a 4.4 cm tip and the diazepam rectal gel rectal delivery system 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.

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