DIAZEPAM gel DIAZEPAM gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIAZEPAM (UNII: Q3JTX2Q7TU) (DIAZEPAM - UNII:Q3JTX2Q7TU)

Available from:

Oceanside Pharmaceuticals

INN (International Name):

DIAZEPAM

Composition:

DIAZEPAM 10 mg in 2 mL

Administration route:

RECTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older. 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. Controlled Substance: Diazepam rectal gel contains diazepam, a Schedule IV controlled substance. Abuse : Diazepam rectal gel is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see WARNINGS, Abuse, Misuse, and Addiction ). The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol). Dependence: Physical Dependence After Use of Diazepam Rectal Gel More Frequently Than Recommended Diazepam rectal gel may produce physical dependence if used more frequently than recommended. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Although diazepam rectal gel is indicated only for intermittent use (see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION ) , if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see WARNINGS, Dependence and Withdrawal Reactions ). For patients using diazepam rectal gel more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam rectal gel (see WARNINGS, Dependence and Withdrawal Reactions ). Acute Withdrawal Signs and Symptoms Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. Protracted Withdrawal Syndrome Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. Tolerance Tolerance to diazepam rectal gel may develop after use more frequently than recommended. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of benzodiazepines may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Product summary:

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 Delivery System 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 rectal delivery system is also packed with Instructions for Caregivers upon receipt from pharmacy. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Diazepam Rectal Gel Rectal Delivery System INSTRUCTIONS FOR CAREGIVERS UPON RECEIPT 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. 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 © 2023 Bausch Health Companies Inc. or its affiliates 9570805                                                               Rev. 07/2023

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DIAZEPAM- DIAZEPAM GEL
OCEANSIDE PHARMACEUTICALS
----------
DIAZEPAM RECTAL GEL C-IV
RECTAL DELIVERY SYSTEM
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS;
ABUSE, MISUSE, AND ADDICTION; AND
DEPENDENCE AND WITHDRAWAL REACTIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF THESE DRUGS FOR PATIENTS FOR WHOM
ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. LIMIT DOSAGES AND
DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS AND
SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION
(SEEWARNINGSANDPRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING DIAZEPAM RECTAL GEL, EXPOSES
USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO
OVERDOSE OR DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY
INVOLVE CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING DIAZEPAM RECTAL GEL
AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND ADDICTION (SEEWARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES MAY LEAD TO CLINICALLY
SIGNIFICANT
PHYSICAL DEPENDENCE. THE RISKS OF DEPENDENCE AND WITHDRAWAL
INCREASE WITH LONGER TREATMENT DURATION AND HIGHER DAILY DOSE.
ALTHOUGH DIAZEPAM RECTAL GEL IS INDICATED ONLY FOR INTERMITTENT USE
(SEEINDICATIONS AND USAGEANDDOSAGE AND ADMINISTRATION), IF
USED MORE FREQUENTLY THAN RECOMMENDED, ABRUPT DISCONTINUATION OR
RAPID DOSAGE REDUCTION OF DIAZEPAM RECTAL GEL MAY PRECIPITATE ACUTE
WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING. FOR PATIENTS
USING DIAZEPAM RECTAL GEL MORE FREQUENTLY THAN RECOMMENDED, TO
REDUCE THE RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO
DISCONTINUE DIAZEPAM RECTAL GEL (SEE WARNINGS).
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%), e