Diastat

The dose of diazepam rectal gel will be determined for each individual according to weight and age.

For children 2 to 5 years of age, the dose is 0.5 mg per kilogram of body weight. For children 6 to 11 years of age, the dose is 0.3 mg per kilogram. For ages 12 and over, the recommended dose is 0.2 mg per kilogram.

Since the dose of diazepam rectal gel is available in fixed unit doses of 5 mg, 10 mg, 15 mg, and 20 mg only, the prescribed dose is obtained by rounding upward to the next available dose. For seniors, it is recommended that the dosage be rounded downwards.

If a single dose does not adequately treat the seizure, your doctor may wish to prescribe 2 doses of diazepam rectal gel. The second dose may be given 4 to 12 hours after the first dose if seizures continue or are known to recur, or if the patient is known to have seizures that are especially resistant to treatment.

Treatment with diazepam rectal gel should be given no more than every 5 days, and no more than 5 times per month.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

Use the preloaded diazepam rectal gel syringe exactly as prescribed by your doctor and according to package directions. Store the syringe at room temperature and away from children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each rectal delivery system of clear to slightly yellow, non-sterile gel, with a pH between 6.5 to 7.2, contains diazepam 5 mg/mL. Nonmedicinal ingredients: benzoic acid, benzyl alcohol (1.5%), ethyl alcohol (10%), hydroxypropyl methylcellulose, propylene glycol, sodium benzoate, and water.

Do not use this medication if you:

• are allergic to diazepam, any other benzodiazepines, or any ingredients of the medication

• have acute narrow-angle glaucoma

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• confusion

• diarrhea

• dizziness

• drowsiness

• euphoria (excessive feelings of happiness)

• falls

• fractures from falls

• headache

• hiccups

• lack of coordination

• muscle pain or stiffness

• weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

• symptoms of overdose:

  • confusion (continuing)

  • extreme sleepiness

  • loss of balance and coordination

  • shakiness

  • slow heartbeat

  • slow reflexes

  • slurred speech (continuing)

  • staggering

  • trouble breathing

  • weakness (severe)

• slow, weak, or shallow breathing

• thoughts of suicide or self-harm

• withdrawal symptoms

  • feeling like you cannot move or respond

  • severe confusion, shivering, irregular heart rate, and excessive sweating (delirium tremens)

  • feeling depressed

  • feeling disconnected from reality

  • hallucinations (seeing or hearing things that aren't there)

  • mania (overactive behaviour and thoughts)

  • psychosis (e.g., believing in things that aren't not true)

• worsening or new types of seizures

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

**Alcohol and other medications that cause drowsiness: **Alcohol and other medications that cause drowsiness, such as antidepressants, sleeping pills, anxiety medications, or narcotic pain relievers, should be avoided when you are taking diazepam. Combining any of these medications with diazepam can result in severe drowsiness, breathing problems, and possibly coma and death. People who have an addiction to alcohol or other medications should not take diazepam, except in rare situations under medical supervision.

Breathing problems: Diazepam can breathing problems. People with chronic lung conditions, such as bronchitis, emphysema, or asthma, may be more likely to experience increased difficulty breathing. If you have lung problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Depe****ndence and withdrawal: Physical dependence (a need to take regular doses to prevent physical symptoms) has been associated with benzodiazepines such as diazepam. Severe withdrawal symptoms may occur if the dose is significantly reduced or suddenly discontinued. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms.

Falls and fractures: Diazepam can cause drowsiness or dizziness that can affect your balance and increase your risk of falling. This can result in fractures or other injuries. Your risk of falls is increased if you drink alcohol or take sedatives while taking this medication, if you are elderly, or if you have a condition that causes weakness or frailty. ****

Drowsiness/reduced alertness: Because diazepam causes drowsiness and sedation, do not engage in activities requiring mental alertness such as driving a car or operating machinery until the sedating effects of this medication have worn off. Alcohol can increase the drowsiness effects and should be avoided.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.  ****

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. Diazepam may cause harm to the developing baby if it is used by the mother while she is pregnant. Babies born to mothers who have used diazepam regularly during late pregnancy may have breathing difficulties and show signs of withdrawal when they are first born.

Breast-feeding: Diazepam passes into breast milk. Diazepam rectal gel should not be used by women who are breast-feeding.

Children: The safety and effectiveness of diazepam rectal gel for children under 2 years of age have not been established.

Seniors: The dose of diazepam rectal gel may need to be decreased for those over 60 years of age to avoid excessive sleepiness and impaired coordination.

There may be an interaction between diazepam rectal gel and any of the following:

• alcohol

• anti-histamines (e.g., azelastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)

• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)

• apalutamide

• aprepitant

• "azole" antifungals (e.g., fluconazole, ketoconazole, voriconazole)

• barbiturates (e.g., butalbital, pentobarbital, phenobarbital)

• other benzodiazepines (e.g., alprazolam, lorazepam, temazepam)

• bosentan

• brimonidine

• buprenorphine

• buspirone

• cannabis

• chloral hydrate

• cimetidine

• clonidine

• conivaptan

• deferasirox

• dexamethasone

• diltiazem

• dronedarone

• entacapone

• efavirenz

• elagolix

• enzalutamide

• esketamine

• etravirine

• flibanserin

• fluoxetine

• general anesthetics (medications used to put people to sleep before surgery)

• grapefruit juice

• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)

• kava kava

• lemborexant

• letermovir

• lumacaftor and ivacaftor

• macrolide antibiotics (e.g., clarithromycin, erythromycin)

• melatonin

• methadone

• metoclopramide

• metronidazole

• mifepristone

• mirtazapine

• moclobemide

• modafinil

• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)

• nabilone

• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tramadol)

• pomalidomide

• pramipexole

• protein kinase inhibitors (e.g., crizotinib, imatinib, nilotinib)

• rifabutin

• rifampin

• ropinirole

• rotigotine

• St. John's wort

• sarilumab

• scopolamine

• seizure medications (e.g., clobazam, levetiracetam, phenobarbital, phenytoin, primidone, rufinamide, topiramate, valproic acid, zonisamide)

• stiripentol

• tapentadol

• thalidomide

• theophylline

• tricyclic antidepressants (e.g., clomipramine, desipramine, imipramine)

• verapamil

• yohimbine

• zolpidem

• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Diastat