DIAZEPAM Gel (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Oceanside Pharmaceuticals

Λέξεις κλειδιά

68682-652 68682-655 68682-650

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BOXED WARNING SECTION

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and PRECAUTIONS). ...

1. 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 ...

2. Clinical Pharmacology

Mechanism of Action Although the precise mechanism by which diazepam exerts its antiseizure effects is unknown, animal and in vitro studies suggest that diazepam acts to suppress seizures through an interaction ...

3. Indications and Usage

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 ...

4. Contraindications

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 ...

5. Warnings

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 ...

6. Precautions

Information to Be Communicated by the Prescriber to Patients and Caregivers Risks from Concomitant Use with Opioids: Inform patients and caregivers that potentially fatal additive effects may occur ...

6.4. Drug Interactions

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 ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of rectal diazepam has not been evaluated. In studies in which mice and rats were administered diazepam in the diet at a dose of 75 mg/kg/day (approximately six and 12 times, ...

6.7. Pregnancy

(see WARNINGS) 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, ...

6.9. 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 ...

6.10. Pediatric Use

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 ...

6.11. Geriatric Use

In elderly patients diazepam rectal gel should be used with caution due to an increase in half-life with a corresponding decrease in the clearance of free diazepam. It is also recommended that the dosage ...

7. Adverse Reactions

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 ...

8. Drug Abuse and Dependence

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 ...

9. Overdosage

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 ...

10. Dosage and Administration

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 ...

11. 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 ...

13. Clinical Studies

The effectiveness of diazepam rectal gel has been established in two adequate and well controlled clinical studies in children and adults exhibiting the seizure pattern described below under INDICATIONS ...

14. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].