Adults were dosed at four and 12 hours after the first dose and were observed for a total of 24 hours. Primary outcomes for this study were seizure frequency during the period of observation and a global assessment that took into account the severity and nature of the seizures as well as their frequency. The median seizure frequency for the Diazepam Rectal Gel treated group was zero seizures per hour, compared to a median seizure frequency of 0. Analysis of response by gender and age revealed no substantial differences between treatment in either of these subgroups.
Analysis of response by race was considered unreliable, due to the small percentage of non-Caucasians. A second double-blind study compared single doses of Diazepam Rectal Gel and placebo in patients 53 children, 61 adults. The dose was given at the onset of the identified episode and patients were observed for a total of 12 hours. The primary outcome in this study was seizure frequency.
The median seizure frequency for the Diazepam Rectal Gel-treated group was zero seizures per 12 hours, compared to a median seizure frequency of 2.
An analysis of response by gender revealed a statistically significant difference between treatments in females but not in males in this study, and the difference between the 2 genders in response to the treatments reached borderline statistical significance.
Indications and Usage for Diazepam Rectal Gel 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. 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. 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 but is contraindicated in acute narrow angle glaucoma. CNS Depression Because Diazepam Rectal Gel produces CNS depression, patients receiving this drug who are otherwise capable and qualified to do so should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle until they have completely returned to their level of baseline functioning.
Prolonged CNS depression has been observed in neonates treated with diazepam. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers such as codeine, hydrocodone , alcohol, marijuana , drugs for sleep or anxiety such as alprazolam , lorazepam , zolpidem , muscle relaxants such as carisoprodol , cyclobenzaprine , or antihistamines such as cetirizine , diphenhydramine.
Check the labels on all your medicines such as allergy or cough -and-cold products because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Should I avoid certain foods while taking Diazepam Kit? Overdose This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing , call Otherwise, call a poison control center right away. US residents can call their local poison control center at Canada residents can call a provincial poison control center.
Symptoms of overdose may include: Notes Do not share this medication with others. It is against the law. Missed Dose Not applicable. The reports suggesting an elevated incidence of birth defects in children of drug treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship.
There are intrinsic methodologic problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors, e. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.
In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even mild seizures do not pose some hazards to the developing embryo or fetus.
General Concerns About Benzodiazepines: An increased risk of congenital malformations associated with the use of benzodiazepine drugs has been suggested in several studies.
There may also be non-teratogenic risks associated with the use of benzodiazepines during pregnancy. In addition, children born to mothers receiving benzodiazepines on a regular basis late in pregnancy may be at some risk of experiencing withdrawal symptoms during the postnatal period. In general, the use of diazepam rectal gel in women of childbearing potential, and more specifically during known pregnancy, should be considered only when the clinical situation warrants the risk to the fetus.
The specific considerations addressed above regarding the use of anticonvulsants in epileptic women of childbearing potential should be weighed in treating or counseling these women. Because of experience with other members of the benzodiazepine class, diazepam rectal gel is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Patients should also be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug. If Diazepam rectal gel is to be combined with other psychotropic agents or other CNS depressants, careful consideration should be given to the pharmacology of the agents to be employed particularly with known compounds which may potentiate the action of diazepam, such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants.
The clearance of diazepam and certain other benzodiazepines can be delayed in association with cimetidine administration. The clinical significance of this is unclear. Valproate may potentiate the CNS-depressant effects of diazepam. Effect of Other Drugs on Diazepam Metabolism: In vitro studies using human liver preparations suggest that CYP2C19 and CYP3A4 are the principal isozymes involved in the initial oxidative metabolism of diazepam.
Potential inhibitors of CYP2C19 e. That means two things: Studies show a risk of adverse effects to the fetus when the mother takes the drug. The benefits of taking the drug during pregnancy may outweigh the potential risks in certain cases.
Taking this drug during pregnancy may cause babies to be born with deformities, muscle weakness, breathing and eating problems, low body temperatures, and withdrawal symptoms. Diazepam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Women who are breast-feeding Diazepam passes into breast milk and can cause serious effects in a child who is breastfed.
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