Diastat
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Questions & Answers
Side Effects & Adverse Reactions
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.
Because diazepam rectal gel produces CNS depression, patients receiving this drug who are otherwise capable and qualified to do so should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle until they have completely returned to their level of baseline functioning.
Although diazepam rectal gel is indicated for use solely on an intermittent basis, the potential for a synergistic CNS-depressant effect when used simultaneously with alcohol or other CNS depressants must be considered by the prescribing physician, and appropriate recommendations made to the patient and/or caregiver.
Prolonged CNS depression has been observed in neonates treated with diazepam. Therefore, diazepam rectal gel is not recommended for use in children under six months of age.
No clinical studies have been conducted with diazepam rectal gel in pregnant women. Data from several sources raise concerns about the use of diazepam during pregnancy.
Animal Findings: Diazepam has been shown to be teratogenic in mice and hamsters when given orally at single doses of 100 mg/kg or greater (approximately eight times the maximum recommended human dose [MRHD=1 mg/kg/day] or greater on a mg/m2 basis). Cleft palate and exencephaly are the most common and consistently reported malformations produced in these species by administration of high, maternally-toxic doses of diazepam during organogenesis. Rodent studies have indicated that prenatal exposure to diazepam doses similar to those used clinically can produce longterm changes in cellular immune responses, brain neurochemistry, and behavior.
General Concerns and Considerations About Anticonvulsants: Reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to phenytoin and phenobarbital, but a smaller number of systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.
The reports suggesting an elevated incidence of birth defects in children of drug treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship. There are intrinsic methodologic problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors, e.g., genetic factors or the epileptic condition itself, may be more important than drug therapy in leading to birth defects. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even mild seizures do not pose some hazards to the developing embryo or fetus.
General Concerns About Benzodiazepines: An increased risk of congenital malformations associated with the use of benzodiazepine drugs has been suggested in several studies.
There may also be non-teratogenic risks associated with the use of benzodiazepines during pregnancy. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy. In addition, children born to mothers receiving benzodiazepines on a regular basis late in pregnancy may be at some risk of experiencing withdrawal symptoms during the postnatal period.
Advice Regarding the Use of Diazepam rectal gel in Women of Childbearing Potential: In general, the use of Diazepam rectal gel in women of childbearing potential, and more specifically during known pregnancy, should be considered only when the clinical situation warrants the risk to the fetus.
The specific considerations addressed above regarding the use of anticonvulsants in epileptic women of childbearing potential should be weighed in treating or counseling these women.
Because of experience with other members of the benzodiazepine class, Diazepam rectal gel is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should also be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug.
Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of regular use of benzodiazepines (see DRUG ABUSE AND DEPENDENCE section).
Diazepam rectal gel is not recommended for chronic, daily use as an anticonvulsant because of the potential for development of tolerance to diazepam. Chronic daily use of diazepam may increase the frequency and/or severity of tonic clonic seizures, requiring an increase in the dosage of standard anticonvulsant medication. In such cases, abrupt withdrawal of chronic diazepam may also be associated with a temporary increase in the frequency and/or severity of seizures.
Tonic status epilepticus has been precipitated in patients treated with IV diazepam for petit mal status or petit mal variant status.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Diazepam rectal gel is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity.
Evidence to support the use of diazepam rectal gel was adduced in two controlled trials (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES subsection) that enrolled patients with partial onset or generalized convulsive seizures who were identified jointly by their caregivers and physicians as suffering intermittent and periodic episodes of markedly increased seizure activity, sometimes heralded by nonconvulsive symptoms, that for the individual patient were characteristic and were deemed by the prescriber to be of a kind for which a benzodiazepine would ordinarily be administered acutely. Although these clusters or bouts of seizures differed among patients, for any individual patient the clusters of seizure activity were not only stereotypic but were judged by those conducting and participating in these studies to be distinguishable from other seizures suffered by that patient. The conclusion that a patient experienced such unique episodes of seizure activity was based on historical information.
History
There is currently no drug history available for this drug.
Other Information
Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/mL diazepam, propylene glycol, ethyl alcohol (10%), hydroxypropyl methylcellulose, sodium benzoate, benzyl alcohol (1.5%), benzoic acid and water. Diazepam rectal gel is clear to slightly yellow and has a pH between 6.5 -7.2.
Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. The structural formula is as follows:
Sources
Diastat Manufacturers
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Valeant Pharmaceuticals North America Llc
![Diastat (Diazepam) Gel [Valeant Pharmaceuticals North America Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Diastat | Valeant Pharmaceuticals North America Llc
(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 patient¹s 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 DoseThe 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/kgBecause 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 20The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths. The Diastat® AcuDial™ 10-mg syringe is available with a 4.4 cm tip and the Diastat® AcuDial™ 20 mg syringe is available with a 6.0 cm tip. Diastat® 2.5 mg is also available with a 4.4cm 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 patient¹s age or weight.
The Diastat® 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 DoseThe 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 FrequencyIt 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 -
Valeant Pharmaceuticals North America
Diastat | Valeant Pharmaceuticals North America Llc
(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 patient¹s 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 DoseThe 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/kgBecause 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 20The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths. The Diastat® AcuDial™ 10-mg syringe is available with a 4.4 cm tip and the Diastat® AcuDial™ 20 mg syringe is available with a 6.0 cm tip. Diastat® 2.5mg 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 patient¹s age or weight.
The Diastat® 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 DoseThe 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 FrequencyIt 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
![Diastat (Diazepam) Gel [Valeant Pharmaceuticals North America]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=88e0f275-dd7b-447d-b9d3-316a06da934f&name=diastat-2pt5mg-label.jpg)
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