Skip to main content

Diazepam (Rectal route)

Pronunciation:

dye-AZ-e-pam

Brand Names:

  • Diastat
  • Diastat Pediatric

Dosage Forms:

  • Gel/Jelly
  • Kit

Classifications:

Therapeutic—

Anticonvulsant

Pharmacologic—

Benzodiazepine, Long Acting

Uses of This Medicine:

Diazepam rectal gel is used to control certain seizure disorders such as epilepsy.

Diazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of diazepam rectal gel in children below 2 years of age. Safety and efficacy have not been established.

Use is not recommended in infants under 6 months of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diazepam rectal gel in the elderly. However, severe drowsiness, clumsiness, or unsteadiness are more likely to occur in the elderly, which may require an adjustment in the dose for patients receiving diazepam rectal gel.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Amobarbital
  • Anileridine
  • Aprobarbital
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlorzoxazone
  • Cobicistat
  • Codeine
  • Dantrolene
  • Eslicarbazepine Acetate
  • Ethchlorvynol
  • Etravirine
  • Fentanyl
  • Fosphenytoin
  • Fospropofol
  • Hydrocodone
  • Hydromorphone
  • Itraconazole
  • Ketorolac
  • Levorphanol
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Mirtazapine
  • Morphine
  • Morphine Sulfate Liposome
  • Orlistat
  • Oxycodone
  • Oxymorphone
  • Pentobarbital
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Propoxyphene
  • Remifentanil
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Suvorexant
  • Tapentadol
  • Thiopental
  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amitriptyline
  • Amprenavir
  • Clarithromycin
  • Dalfopristin
  • Disulfiram
  • Erythromycin
  • Fluvoxamine
  • Ginkgo
  • Isoniazid
  • Perampanel
  • Quinupristin
  • Rifapentine
  • Roxithromycin
  • St John's Wort
  • Theophylline
  • Troleandomycin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, or history of, or
  • Drug abuse or dependence, or history of—Dependence on diazepam may develop.
  • Breathing problems or lung diseases (e.g., asthma, pneumonia)—Use with caution. May make this condition worse.
  • Glaucoma, acute narrow angle—Should not be used in patients with this condition.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

This medicine is not for daily use. After you use the medicine, it is best to wait at least 5 days before using it again. Do not use this medicine more than 5 times per month, unless your doctor tells you to.

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.

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, teenagers, and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor.
      • 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.

Destroy any medicine that you do not need by flushing it down the toilet.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), 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 you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to diazepam before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

Side Effects of This Medicine:

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
confusion
cough
crying
delusions
dementia
depersonalization
difficulty breathing
difficulty in speaking
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
dry mouth
dysphoria
euphoria
false or unusual sense of well-being
feeling of warmth or heat
flushing or redness of skin, especially on face and neck
headache
hyperventilation
irregular heartbeats
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
shortness of breath
slurred speech
sweating
tightness in chest
trouble in speaking
trouble sleeping
unsteadiness, trembling, or other problems with muscle control or coordination
unusual tiredness or weakness
wheezing
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 neck, armpit, or groin
unusual bleeding or bruising

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 health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Sleepiness or unusual drowsiness
Less common
Diarrhea
feeling of constant movement of self or surroundings
hiccups
lack or loss of strength
rash
runny nose
sensation of spinning
sneezing
stuffy nose
Rare
Bigger, dilated, or enlarged pupils (black part of eye)
increased sensitivity of 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.


Last Updated: 11/4/2014

Copyright © 1984- Thomson Micromedex. All rights reserved.

Thomson & A.D.A.M