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diazepam

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Overview

What is Diastat?

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-2-1,4-benzodiazepin-2-one. The structural formula is as follows:



What does Diastat look like?



What are the available doses of Diastat?

Sorry No records found.

What should I talk to my health care provider before I take Diastat?

Sorry No records found

How should I use Diastat?

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 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.

(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.


What interacts with Diastat?

Diazepam rectal gel is contraindicated in patients with a known hypersensitivity to diazepam. Diazepam rectal gel may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.



What are the warnings of Diastat?

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

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CNS Depression

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Pregnancy Risks

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Withdrawal Symptoms

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of regular use of benzodiazepines (see section).

Chronic Use

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.

Use in Patients with Petit Mal Status

Tonic has been precipitated in patients treated with IV diazepam for petit mal status or petit mal variant status.


What are the precautions of Diastat?

Information to Be Communicated by the Prescriber to Patients and Caregivers

Array

Caution in Renally Impaired Patients

Metabolites of Diazepam rectal gel are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function.

Caution in Hepatically Impaired Patients

Concomitant liver disease is known to decrease the clearance of diazepam (see ). Therefore, Diazepam rectal gel should be used with caution in patients with liver disease.

Use in Pediatrics

The controlled trials demonstrating the effectiveness of Diazepam rectal gel included children two years of age and older. Clinical studies have not been conducted to establish the efficacy and safety of Diazepam rectal gel in children under two years of age.

Use in Patients with Compromised Respiratory Function

Diazepam rectal gel should be used with caution in patients with compromised respiratory function related to a concurrent disease process (e.g., asthma, pneumonia) or neurologic damage.

Use in Elderly

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Concomitant Medication

Although Diazepam rectal gel is indicated for use solely on an intermittent basis, the potential or 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.

Drug Interactions

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Carcinogenesis, Mutagenesis, Impairment of Fertility

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Pregnancy

Category D (see section)

Labor and Delivery

In humans, measurable amounts of diazepam have been found in maternal and cord blood, indicating placental transfer of the drug. Until additional information is available, Diazepam rectal gel is not recommended for obstetrical use.

Nursing Mothers

Because diazepam and its metabolites may be present in human breast milk for prolonged periods of time after acute use of Diazepam rectal gel, patients should be advised not to breast-feed for an appropriate period of time after receiving treatment with Diazepam rectal gel.


What are the side effects of Diastat?

Diazepam rectal gel adverse event data were collected from double-blind, placebo-controlled studies and open-label studies. The majority of adverse events were mild to moderate in severity and transient in nature.

Two patients who received Diazepam rectal gel died seven to 15 weeks following treatment; neither of these deaths was deemed related to Diazepam rectal gel.

The most frequent adverse event reported to be related to Diazepam rectal gel in the two double-blind, placebo-controlled studies was somnolence (23%). Less frequent adverse events were dizziness, headache, pain, abdominal pain, nervousness, vasodilatation, diarrhea, ataxia, euphoria, incoordination, asthma, rhinitis, and rash, which occurred in approximately 2-5% of patients.

Approximately 1.4% of the 573 patients who received Diazepam rectal gel in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse event most frequently associated with discontinuation (occurring in three patients) was somnolence. Other adverse events most commonly associated with discontinuation and occurring in two patients were hypoventilation and rash. Adverse events occurring in one patient were asthenia, hyperkinesia, incoordination, vasodilatation and urticaria. These events were judged to be related to diazepam rectal gel.

In the two domestic double-blind, placebo-controlled, parallel-group studies, the proportion of patients who discontinued treatment because of adverse events was 2% for the group treated with Diazepam rectal gel, versus 2% for the placebo group. In the Diazepam rectal gel group, the adverse events considered the primary reason for discontinuation were different in the two patients who discontinued treatment; one discontinued due to rash and one discontinued due to lethargy. The primary reason for discontinuation in the patients treated with placebo was lack of effect.

Adverse Event Incidence in Controlled Clinical Trials

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TABLE 1: Treatment-Emergent Signs And Symptoms That Occurred In > 1% Of Patients Enrolled In Parallel-Group, Placebo-Controlled Trials And Were Numerically More Common In The Diazepam rectal gel Group
Body As A WholeHeadache5%4%
CardiovascularVasodilatation2%0%
DigestiveDiarrhea4%
NervousAtaxia3%
Dizziness3%2%
Euphoria3%0%
Incoordination3%0%
Somnolence23%8%
RespiratoryAsthma2%0%
Skin and AppendagesRash3%0%


Other Adverse Events Observed During All Clinical Trials:

Array


What should I look out for while using Diastat?

Diazepam rectal gel is contraindicated in patients with a known hypersensitivity to diazepam. Diazepam rectal gel may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.


What might happen if I take too much Diastat?

Two patients in the clinical studies received more than twice the target dose; no adverse events were reported.

Previous reports of diazepam overdosage have shown that manifestations of diazepam overdosage include somnolence, confusion, coma, and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol. Dialysis is of limited value.

Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment. The complete flumazenil package insert, including and, should be consulted prior to use.


How should I store and handle Diastat?

Storage: Store Naftifine Hydrochloride Cream USP, 2% at ° [see USP Controlled Room Temperature].Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].DiastatAcuDial™INSTRUCTIONS FOR CAREGIVERS FROM PHARMACYFOR EACH SYRINGE:SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.The instructions are also available on the bottom of each drug product package.CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.Manufactured for:By:All other product/brand names are trademarks of their respective owners.9435002Rev. 12/16


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Although the precise mechanism by which diazepam exerts its antiseizure effects is unknown, animal and studies suggest that diazepam acts to suppress seizures through an interaction with γ-aminobutyric acid (GABA) receptors of the A-type (GABA). GABA, the major inhibitory neurotransmitter in the central nervous system, acts at this receptor to open the membrane channel allowing chloride ions to flow into neurons. Entry of chloride ions causes an inhibitory potential that reduces the ability of neurons to depolarize to the threshold potential necessary to produce action potentials. Excessive depolarization of neurons is implicated in the generation and spread of seizures. It is believed that diazepam enhances the actions of GABA by causing GABA to bind more tightly to the GABA receptor.

Non-Clinical Toxicology
Diazepam rectal gel is contraindicated in patients with a known hypersensitivity to diazepam. Diazepam rectal gel may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.

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:

opioids increases the risk of respiratory depression because of actions at different receptor sites in the

CNS that control respiration. Benzodiazepines interact at GABAA sites, and opioids interact primarily at

mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to

significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of

concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression

and sedation.

Other Psychotropic Agents or Other CNS Depressants:

Cimetidine:

with cimetidine administration. The clinical significance of this is unclear.

Valproate:







Effect of Diazepam on the Metabolism of Other Drugs:

Risks from Concomitant Use with Opioids:

Inform patients and caregivers that potentially fatal additive effects may occur if Diastat or Diastat AcuDial is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider (see and ).

Administration: Prescribers are strongly advised to take all reasonable steps to ensure that caregiversfully understand their role and obligations vis a vis the administration of Diazepam rectal gel toindividuals in their care. Prescribers should routinely discuss the steps in the Patient/Caregiver PackageInsert (see Patient/Caregiver Insert printed at the end of the product labeling and also included in the product carton). The successful and safe use of Diazepam rectal gel depends in large measure on thecompetence and performance of the caregiver.

Prescribers should advise caregivers that they expect to be informed immediately if a patient develops anynew findings which are not typical of the patient’s characteristic seizure episode.

Diazepam rectal gel adverse event data were collected from double-blind, placebo-controlled studies and open-label studies. The majority of adverse events were mild to moderate in severity and transient in nature.

Two patients who received Diazepam rectal gel died seven to 15 weeks following treatment; neither of these deaths was deemed related to Diazepam rectal gel.

The most frequent adverse event reported to be related to Diazepam rectal gel in the two double-blind, placebo-controlled studies was somnolence (23%). Less frequent adverse events were dizziness, headache, pain, abdominal pain, nervousness, vasodilatation, diarrhea, ataxia, euphoria, incoordination, asthma, rhinitis, and rash, which occurred in approximately 2-5% of patients.

Approximately 1.4% of the 573 patients who received Diazepam rectal gel in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse event most frequently associated with discontinuation (occurring in three patients) was somnolence. Other adverse events most commonly associated with discontinuation and occurring in two patients were hypoventilation and rash. Adverse events occurring in one patient were asthenia, hyperkinesia, incoordination, vasodilatation and urticaria. These events were judged to be related to diazepam rectal gel.

In the two domestic double-blind, placebo-controlled, parallel-group studies, the proportion of patients who discontinued treatment because of adverse events was 2% for the group treated with Diazepam rectal gel, versus 2% for the placebo group. In the Diazepam rectal gel group, the adverse events considered the primary reason for discontinuation were different in the two patients who discontinued treatment; one discontinued due to rash and one discontinued due to lethargy. The primary reason for discontinuation in the patients treated with placebo was lack of effect.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).