Diastat Pediatric (Rectal)

Diazepam rectal gel is used to control seizures (for example, seizure clusters, acute repetitive seizures) in patients with epilepsy. Diazepam is a benzodiazepine. Benzodiazepines are a type of medicine known as central nervous system (CNS) depressants, which slow down the nervous system.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly and to monitor for any unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during later pregnancy may cause problems in your newborn baby (for example, sedation or withdrawal symptoms). Inform your doctor right away if your baby has an unusual sleep pattern, diarrhea, feeding issues, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, difficulty breathing, weight loss, vomiting, or does not gain weight. If you think you might be pregnant while using this medicine, tell your doctor immediately.

This medicine will enhance the effects of alcohol and other CNS depressants (medications that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants include antihistamines or medications for hay fever, other allergies, or colds, sedatives, tranquilizers, sleeping medications, prescription pain medications or narcotics, barbiturates (used for seizures), muscle relaxants, or anesthetics (numbing medications), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while using this medicine.

Do not change your dose or stop taking this medicine without first consulting your doctor. Your doctor may want you or your child to gradually decrease the amount being used before stopping it completely. This may help prevent worsening of your seizures and reduce the risk of withdrawal symptoms, which can include hallucinations, stomach or muscle cramps, sweating, tremors, or unusual behavior.

Symptoms of an overdose include: change or loss of consciousness, confusion, lack of coordination, or sleepiness or unusual drowsiness. Call your doctor immediately if you notice any of these symptoms.

This medicine may cause some people, especially older individuals, to feel drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than usual. Make sure you understand how you react to diazepam before you drive, operate machinery, or engage in any activities that could be dangerous if you are not alert or able to think or see well.

Call your doctor right away:

• If your seizures continue after using this medicine.
• If your seizures are different from your previous episodes.
• If you are concerned about the number or severity of your seizure episodes.
• If you are worried about the color or breathing of the patient.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not take more than your prescribed dose. Call your doctor for guidance.

Do not take other medications unless you have discussed them with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications, as well as herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking it must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

The dose of this medicine can vary between patients. Follow your doctor's instructions or the directions on the label. The information below includes only average doses of this medicine. If your prescribed dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on its strength. Additionally, the number of doses you take each day, the time allowed between doses, and how long you take the medicine depend on the medical issue you are treating.

Pediatric

Studies have not been done to determine how diazepam rectal gel affects children under 2 years of age. Safety and effectiveness have not been established for this age group.

Geriatric

Studies so far have not shown any specific problems in elderly patients that would limit the use of diazepam rectal gel in older adults. However, older patients are more likely to experience side effects such as severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness, which may require caution and possibly a dose adjustment.

Breast Feeding

There is not enough research to determine the risk to infants when women use this medication while breastfeeding. Weigh the potential benefits against any risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there is a chance of interaction. In these situations, your doctor may want to adjust the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily a complete list.

Using this medicine with any of the following is not recommended. Your doctor may decide not to use this medication for you or may change some of the other medicines you are taking.

• Flumazenil

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Abametapir
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprepitant
• Aripiprazole
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Cetirizine
• Chloral Hydrate
• Chlorzoxazone
• Clobazam
• Clonazepam
• Cobicistat
• Codeine
• Conivaptan
• Dabrafenib
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Diacetylmorphine
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Doxylamine
• Esketamine
• Eslicarbazepine Acetate
• Ethchlorvynol
• Ethylmorphine
• Etravirine
• Fedratinib
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Fluvoxamine
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Hydrocodone
• Hydromorphone
• Itraconazole
• Ivacaftor
• Ketamine
• Ketobemidone
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Loxapine
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Metoclopramide
• Midazolam
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Netupitant
• Nicomorphine
• Olanzapine
• Omaveloxolone
• Omeprazole
• Opium
• Opium Alkaloids
• Orlistat
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Phenytoin
• Piritramide
• Potassium Oxybate
• Pregabalin
• Primidone
• Propofol
• Remifentanil
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• Sparsentan
• Sufentanil
• Tapentadol
• Thiopental
• Tilidine
• Tocilizumab
• Topiramate
• Tramadol
• Trazodone
• Zolpidem
• Zuranolone

Using this medicine with any of the following may increase the risk of certain side effects, but using both medicines may be the best option for you. If both are prescribed, your doctor may adjust the dose or frequency of use for one or both medicines.

• Amitriptyline
• Amprenavir
• Clarithromycin
• Dalfopristin
• Desogestrel
• Dienogest
• Disulfiram
• Drospirenone
• Erythromycin
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Fluoxetine
• Gestodene
• Ginkgo
• Isoniazid
• Levonorgestrel
• Mestranol
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Quinupristin
• Rifapentine
• Roxithromycin
• St John's Wort
• Theophylline
• Troleandomycin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as food or certain types of food since interactions can happen. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. The following interactions have been chosen based on their potential importance and are not necessarily a complete list.

Using this medicine with any of the following may increase the risk of certain side effects, but may be necessary in some cases. If used together, your doctor may adjust the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Grapefruit Juice

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to inform your doctor about any other medical conditions, especially:

• Alcohol and drug abuse or dependence, or a history of—Dependence on diazepam may develop.

• Glaucoma, acute narrow angle—Should not be used in patients with this condition.

• Glaucoma, open angle or
• Lung or breathing problems (e.g., asthma, pneumonia)—Use with caution. It may worsen these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Anxiety
• blurred vision
• changes in patterns and rhythms of speech
• chest tightness
• confusion
• cough
• crying
• delusions
• dementia
• depersonalization
• difficulty breathing
• difficulty in speaking
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• dysphoria
• false or unusual sense of well-being
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• headache
• irregular heartbeat
• irritability
• lack of coordination
• mental depression
• mood or mental changes
• nervousness
• noisy breathing
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods
• restlessness
• seizures
• shakiness and unsteady walk
• slurred speech
• sweating
• trouble breathing
• trouble in speaking
• trouble sleeping
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual tiredness or weakness

Rare

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• fever or chills
• frequent urge to urinate
• increase in body movements
• lower back or side pain
• painful or difficult urination
• pale skin
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation
• change or loss of consciousness
• changes in patterns and rhythms of speech
• confusion
• excitement
• irritability
• loss of strength or energy
• muscle pain or weakness
• restlessness
• shakiness and unsteady walk
• sleepiness or unusual drowsiness
• slurred speech
• talkativeness
• trouble in speaking
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual weak feeling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Diarrhea
• feeling of constant movement of self or surroundings
• hiccups
• lack or loss of strength
• rash
• runny or stuffy nose
• sensation of spinning
• sneezing

Rare

• Bigger, dilated, or enlarged pupils (black part of eye)
• increased sensitivity of the eyes to light
• itching skin
• loss of appetite
• vomiting
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Diastat
• Diastat Pediatric

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Benzodiazepine, Long Acting

Apply this medicine only as directed by your doctor. Do not apply more of it, do not apply it more often, and do not apply it for a longer time than your doctor ordered. Never take rectal medicine by mouth. If too much of this medicine is used for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

This medicine is not to be used every day. Do not use this medicine for more than 1 episode every 5 days or more than 5 episodes per month.

If a second dose is needed, use it at least 4 to 12 hours after the first dose..

This medicine will need to be given to you while you are having a seizure. A family member or other caregiver will give the medicine to you since you will most likely be unable to give it to yourself.

For caregivers administering this medicine:

• Discuss with the patient's medical doctor exactly when and how to use diazepam rectal gel.
• Discuss with the patient's medical doctor when you should call for emergency help.
• Read the instructions that you received with the medicine before you need to use it.
• Stay with the patient after administering diazepam rectal gel to check his or her condition as instructed by the doctor.

This medicine comes in a prefilled plastic applicator. Remove the cap from the prefilled applicator before inserting it. To make the applicator easier to insert, use the lubricating gel that came with the medicine.

Before using the Diastat® Acudial™ syringe, make sure you can see the prescribed dose in the dose display window and that it is correct. Also, look for the green "ready" band on the syringe before inserting it. If the dose is not correct, or if the green band is not on the syringe, call your doctor or pharmacist right away.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For rectal dosage form (gel):For control of seizures: Adults and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. Adults and children 12 years of age and older—The dose is usually 0.2 milligram (mg) per kilogram (kg) body weight. Weighing 88 to 111 kilograms (kg)—20 milligrams (mg) once a day. Weighing 76 to 87 kg—17.5 mg once a day. Weighing 63 to 75 kg—15 mg once a day. Weighing 51 to 62 kg—12.5 mg once a day. Weighing 38 to 50 kg—10 mg once a day. Weighing 26 to 37 kg—7.5 mg once a day. Weighing 14 to 25 kg—5 mg once a day. Children 6 to 11 years of age—The dose is usually 0.3 milligram (mg) per kilogram (kg) body weight. Weighing 59 to 74 kilograms (kg)—20 milligrams (mg) once a day. Weighing 51 to 58 kg—17.5 mg once a day. Weighing 42 to 50 kg—15 mg once a day. Weighing 34 to 41 kg—12.5 mg once a day. Weighing 26 to 33 kg—10 mg once a day. Weighing 17 to 25 kg—7.5 mg once a day. Weighing 10 to 16 kg—5 mg once a day. Children 2 to 5 years of age—The dose is usually 0.5 milligram (mg) per kilogram (kg) body weight. Weighing 36 to 44 kilograms (kg)—20 milligrams (mg) once a day. Weighing 31 to 35 kg—17.5 mg once a day. Weighing 26 to 30 kg—15 mg once a day. Weighing 21 to 25 kg—12.5 mg once a day. Weighing 16 to 20 kg—10 mg once a day. Weighing 11 to 15 kg—7.5 mg once a day. Weighing 6 to 10 kg—5 mg once a day. Children younger than 2 years of age—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm