DIAZEPAM Gel Ref.[10558] Active ingredients: Diazepam

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

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

How Supplied

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:

Diazepam Rectal Gel Rectal Tip Size NDC
2.5 mg Twin Pack 4.4 cm 68682-650-20
Diazepam Rectal Gel Rectal Tip Size NDC
10 mg Delivery 4.4 cm 68682-652-20
System Twin Pack
20 mg Delivery 6.0 cm 68682-655-20
System Twin Pack

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. Diazepam Rectal Gel delivery system is also packed with Instructions for Caregivers upon receipt from pharmacy.

Diazepam Rectal Gel 10 mg delivery system and 20 mg delivery system:

INSTRUCTIONS FOR CAREGIVERS UPON RECEIPT FROM PHARMACY

  • Remove the syringe from the case.
  • Confirm the dose prescribed by your doctor is visible and if known, is correct.

FOR EACH SYRINGE:

  • Confirm that the prescribed dose is visible in the dose display window.
  • Confirm that the green “READY” band is visible.
  • Return the syringe to the case.

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.

Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, USA

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215, USA
 
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