What happens if I overdose Trazep?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include clumsiness; confusion; deep sleep; fainting; loss of consciousness; severe drowsiness; slow or shallow breathing; slow reflexes.
Proper storage of Trazep Intensol concentrate:
Store Trazep Intensol concentrate at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Trazep Intensol concentrate out of the reach of children and away from pets.
Overdose of Trazep in details
Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Trazep is seldom life-threatening if Trazep is taken alone, but may lead to areflexia, apnea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease.
Benzodiazepines increase the effects of other central nervous system (CNS) depressants, including alcohol.
Treatment: Monitor the patient's vital signs and institute supportive measures as indicated by the patient's clinical state. In particular, patients may require symptomatic treatment for cardio respiratory effects or CNS effects.
Further absorption should be prevented using an appropriate method eg, treatment within 1-2 hrs with activated charcoal. If activated charcoal is used, airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure.
If CNS depression is severe consider the use of flumazenil (Anexate), a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short t½ (about an hour) therefore, patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (eg, tricyclic antidepressants). Refer to the prescribing information for flumazenil (Anexate), for further information on the correct use of Trazep.
What should I avoid while taking Trazep?
Trazep may impair your thinking or reactions. Do not drive, operate machinery, or perform other hazardous activities until you are alert and awake and you no longer feel drowsy from this medicine.
Do not drink alcohol while using Trazep. This medication can increase the effects of alcohol.
Grapefruit and grapefruit juice may interact with Trazep and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.
Trazep warnings
General
Trazep 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 to herald their onset) from the patient’s ordinary seizure activity, 2) have been instructed and judged to be competent to administer the treatment rectally, 3) understand explicitly which seizure manifestations may or may not be treated with Trazep Rectal Gel, and 4) are able to monitor the clinical response and recognize when that response is such that immediate professional medical evaluation is required.
CNS Depression
Because Trazep 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.
Although Trazep Rectal Gel is indicated for use solely on an intermittent basis, the potential for a synergistic CNS-depressant effect when used simultaneously with alcohol or other CNS depressants must be considered by the prescribing physician, and appropriate recommendations made to the patient and/or caregiver.
Prolonged CNS depression has been observed in neonates treated with Trazep. Therefore, Trazep Rectal Gel is not recommended for use in children under six months of age.
Pregnancy Risks
No clinical studies have been conducted with Trazep Rectal Gel in pregnant women. Data from several sources raise concerns about the use of Trazep during pregnancy.
Animal Findings: Trazep has been shown to be teratogenic in mice and hamsters when given orally at single doses of 100 mg/kg or greater (approximately eight times the maximum recommended human dose [MRHD=1 mg/kg/day] or greater on a mg/m2 basis). Cleft palate and exencephaly are the most common and consistently reported malformations produced in these species by administration of high, maternally-toxic doses of Trazep during organogenesis. Rodent studies have indicated that prenatal exposure to Trazep doses similar to those used clinically can produce longterm changes in cellular immune responses, brain neurochemistry, and behavior.
General Concerns and Considerations About Anticonvulsants: Reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to phenytoin and phenobarbital, but a smaller number of systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.
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.g., genetic factors or the epileptic condition itself, may be more important than drug therapy in leading to birth defects. 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. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in 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.
Advice Regarding the Use of Trazep Rectal Gel in Women of Childbearing Potential: In general, the use of Trazep 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, Trazep 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.
Withdrawal Symptoms
Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of regular use of benzodiazepines.
Chronic Use
Trazep Rectal Gel is not recommended for chronic, daily use as an anticonvulsant because of the potential for development of tolerance to Trazep. Chronic daily use of Trazep may increase the frequency and/or severity of tonic clonic seizures, requiring an increase in the dosage of standard anticonvulsant medication. In such cases, abrupt withdrawal of chronic Trazep may also be associated with a temporary increase in the frequency and/or severity of seizures.
Use in Patients with Petit Mal Status
Tonic status epilepticus has been precipitated in patients treated with IV Trazep for petit mal status or petit mal variant status.
What should I discuss with my healthcare provider before taking Trazep?
You should not use this medication if you are allergic to Trazep or similar drugs (Ativan, Klonopin, Restoril, Xanax, and others), or if you have:
- myasthenia gravis (a muscle weakness disorder);
- severe liver disease;
- narrow-angle glaucoma;
- a severe breathing problem; or
- sleep apnea (breathing stops during sleep).
To make sure Trazep is safe for you, tell your doctor if you have any of these conditions:
- open-angle glaucoma;
- asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
- kidney or liver disease;
- epilepsy or other seizure disorder;
- a history of mental illness, depression, or suicidal thoughts or behavior; or
- a history of drug or alcohol addiction.
Trazep may be habit forming. Never share Trazep with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
FDA pregnancy category D. Do not use Trazep if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Trazep may cause low blood pressure, breathing problems, or addiction and withdrawal symptoms in a newborn if the mother takes the medication during pregnancy.
Do not start or stop taking Trazep during pregnancy without your doctor's advice. Trazep may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor right away if you become pregnant while taking Trazep for seizures.
Trazep can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
Do not give this medication to a child younger than 6 months old.
The sedative effects of Trazep may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking Trazep.
Trazep precautions
Caution In Renally Impaired Patients
Metabolites of Trazep rectal gel are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function.
Caution In Hepatically Impaired Patients
Concomitant liver disease is known to decrease the clearance of Trazep. Therefore, Trazep rectal gel should be used with caution in patients with liver disease.
Use In Pediatrics
The controlled trials demonstrating the effectiveness of Trazep rectal gel included children two years of age and older. Clinical studies have not been conducted to establish the efficacy and safety of Trazep rectal gel in children under two years of age.
Use In Patients With Compromised Respiratory Function
Trazep rectal gel should be used with caution in patients with compromised respiratory function related to a concurrent disease process (e.g., asthma, pneumonia) or neurologic damage.
Use In Elderly
In elderly patients Trazep rectal gel should be used with caution due to an increase in halflife with a corresponding decrease in the clearance of free Trazep. It is also recommended that the dosage be decreased to reduce the likelihood of ataxia or oversedation.
Information To Be Communicated By The Prescriber To The Caregiver
Prescribers are strongly advised to take all reasonable steps to ensure that caregivers fully understand their role and obligations vis a vis the administration of Trazep rectal gel to individuals in their care. Prescribers should routinely discuss the steps in the Patient/Caregiver Package Insert. The successful and safe use of Trazep rectal gel depends in large measure on the competence and performance of the caregiver.
Prescribers should advise caregivers that they expect to be informed immediately if a patient develops any new findings which are not typical of the patient's characteristic seizure episode.
Interference With Cognitive and Motor Performance: Because benzodiazepines have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Trazep rectal gel therapy does not affect them adversely.
Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with Trazep rectal gel.
Nursing: Because Trazep and its metabolites may be present in human breast milk for prolonged periods of time after acute use of Trazep rectal gel, patients should be advised not to breast-feed for an appropriate period of time after receiving treatment with Trazep rectal gel.
Concomitant Medication
Although Trazep rectal gel is indicated for use solely on an intermittent basis, the potential for a synergistic CNS-depressant effect when used simultaneously with alcohol or other CNS-depressants must be considered by the prescribing physician, and appropriate recommendations made to the patient and/or caregiver.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
The carcinogenic potential of rectal Trazep has not been evaluated. In studies in which mice and rats were administered Trazep in the diet at a dose of 75 mg/kg/day (approximately six and 12 times, respectively, the maximum recommended human dose [MRHD=1 mg/kg/day] on a mg/m² basis) for 80 and 104 weeks, respectively, an increased incidence of liver tumors was observed in males of both species.
The data currently available are inadequate to determine the mutagenic potential of Trazep.
Reproduction studies in rats showed decreases in the number of pregnancies and in the number of surviving offspring following administration of an oral dose of 100 mg/kg/day (approximately 16 times the MRHD on a mg/m² basis) prior to and during mating and throughout gestation and lactation. No adverse effects on fertility or offspring viability were noted at a dose of 80 mg/kg/day (approximately 13 times the MRHD on a mg/m² basis).
Pregnancy
Category D
Labor And Delivery
In humans, measurable amounts of Trazep have been found in maternal and cord blood, indicating placental transfer of the drug. Until additional information is available, Trazep rectal gel is not recommended for obstetrical use.
Nursing Mothers
Because Trazep and its metabolites may be present in human breast milk for prolonged periods of time after acute use of Trazep rectal gel, patients should be advised not to breast-feed for an appropriate period of time after receiving treatment with Trazep rectal gel.
What happens if I miss a dose of Trazep?
Because you will receive Trazep in a clinical setting, you are not likely to miss a dose.
References
- DailyMed. "DIAZEPAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "diazepam". http://www.drugbank.ca/drugs/DB00829 (accessed September 17, 2018).
- MeSH. "Hypnotics and Sedatives". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
