diazepam (Diastat)

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Trade Name: Diastat

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Bausch Health US, LLC

Presentation: GEL, HUMAN PRESCRIPTION DRUG

Strength: 2.5 mg/.5mL

Storage and handling

DIAZEPAM Benzodiazepine [EPC],Benzodiazepines [CS]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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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, benzoic acid, benzyl alcohol (1.5%), ethyl alcohol (10%), hydroxypropyl methylcellulose, propylene glycol, purified water, and sodium benzoate. 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:

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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 ) 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.

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.

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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.

Diazepam is a Schedule IV controlled substance and can produce drug dependence. It is recommended that patients be treated with diazepam rectal gel no more frequently than every five days and no more than five times per month.
Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving diazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence.
Abrupt discontinuation of diazepam following chronic regular use has resulted in withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating). The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuation of benzodiazepines taken continuously at therapeutic levels for several months.

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.

(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 patientu2019s 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.

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 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
DIASTATACUDIALu2122n- INSTRUCTIONS FOR CAREGIVERS FROM PHARMACY
FOR 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:
Manufactured by:
u00ae/u2122 are trademarks of Bausch Health Companies Inc. or its affiliates.
u00a9 2019 Bausch Health Companies Inc. or its affiliates
9435003u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Rev. 10/19

Arrayn- ADMINISTRATION AND DISPOSAL INSTRUCTIONS
I M P O R T A N T
Read first before using
To the caregiver using DIASTAT:
Please do not give DIASTAT until:
To the caregiver using DIASTAT ACUDIALu2122:
Please do not give DIASTAT ACUDIALu2122 until:
Please do not administer DIASTAT until you feel comfortable with how to use DIASTAT. The doctor will tell you exactly when to use DIASTAT. When you use DIASTAT correctly and safely you will help bring seizures under control. Be sure to discuss every aspect of your role with the doctor. If you are not comfortable, then discuss your role with the doctor again.
To help the person with seizures:
To know what responses to expect:
If you have any questions or feel unsure about using the treatment, before using DIASTAT.
When to treat.n- Based on the doctoru2019s directions or prescription.
________________________________________________________
________________________________________________________
Special considerations.
DIASTAT should be used with caution:
Discuss beforehand with the doctor any additional steps you may need to take if there is leakage of DIASTAT or a bowel movement.
Patientu2019s DIASTAT dosage is:
Patientu2019s resting breathing rateu00a0_________u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Patientu2019s current weightu00a0____________
Confirm current weight is still the same as when DIASTAT was prescribedu00a0____________
Check expiration date and always remove cap before using. Be sure seal pin is removed with the cap.
T R E A T M E N T 1n- ------------------------------------------------------------------------------------------------------------
Important things to tell the doctor:
Things to do after treatment with DIASTAT:
Stay with the person for 4 hours and make notes on the following:
T R E A T M E N T 2
------------------------------------------------------------------------------------------------------------
Important things to tell the doctor:
Things to do after treatment with DIASTAT:
Stay with the person for 4 hours and make notes on the following:
ADMINISTRATION AND DISPOSAL INSTRUCTIONS
Manufactured for:n
Manufactured by:n
u00ae/u2122 are trademarks of Bausch Health Companies Inc. or its affiliates.
u00a92019 Bausch Health Companies Inc. or its affiliates
9435003u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Rev. 10/19

NDC
Rx Only
2.5 mg
For Rectal n- Administration Only
Dian
Rectal Delivery System
TWIN PACKn- Contains two pre-filled, unit dose, rectal delivery systemswith lubricating jelly and instructions for use
BAUSCH

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of diazepam (Diastat) which is also known as Diastat and Manufactured by Bausch Health US, LLC. It is available in strength of 2.5 mg/.5mL.

diazepam (Diastat) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.