Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Diastat
  2. Diastat Pediatric

Descriptions


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.

This product is available in the following dosage forms:

  • Gel/Jelly
  • Kit

Before Using

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.

Pediatric

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.

Geriatric

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

Information about this diazepam-rectal-route
Pregnancy Category Explanation
All Trimesters D Studies 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.

Breastfeeding

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.

Drug Interactions

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
  • Codeine
  • Dabrafenib
  • Dantrolene
  • Eslicarbazepine Acetate
  • Ethchlorvynol
  • Etravirine
  • Fentanyl
  • Fospropofol
  • Hydrocodone
  • Hydromorphone
  • Itraconazole
  • Ketorolac
  • Levorphanol
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methocarbamol
  • Methohexital
  • Morphine
  • Morphine Sulfate Liposome
  • Orlistat
  • Oxycodone
  • Oxymorphone
  • Pentobarbital
  • Phenobarbital
  • Primidone
  • Propoxyphene
  • Remifentanil
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • 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
  • Fosphenytoin
  • Ginkgo
  • Isoniazid
  • Mirtazapine
  • Perampanel
  • Phenytoin
  • 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

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

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

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

  1. Anxiety
  2. blurred vision
  3. changes in patterns and rhythms of speech
  4. confusion
  5. cough
  6. crying
  7. delusions
  8. dementia
  9. depersonalization
  10. difficulty breathing
  11. difficulty in speaking
  12. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  13. dry mouth
  14. dysphoria
  15. euphoria
  16. false or unusual sense of well-being
  17. feeling of warmth or heat
  18. flushing or redness of skin, especially on face and neck
  19. headache
  20. hyperventilation
  21. irregular heartbeats
  22. irritability
  23. lack of coordination
  24. mental depression
  25. mood or mental changes
  26. nervousness
  27. noisy breathing
  28. paranoia
  29. quick to react or overreact emotionally
  30. rapidly changing moods
  31. restlessness
  32. seizures
  33. shakiness and unsteady walk
  34. shortness of breath
  35. slurred speech
  36. sweating
  37. tightness in chest
  38. trouble in speaking
  39. trouble sleeping
  40. unsteadiness, trembling, or other problems with muscle control or coordination
  41. unusual tiredness or weakness
  42. wheezing

Rare

  1. Bladder pain
  2. bloody or cloudy urine
  3. difficult, burning, or painful urination
  4. fever or chills
  5. frequent urge to urinate
  6. increase in body movements
  7. lower back or side pain
  8. painful or difficult urination
  9. pale skin
  10. swollen, painful, or tender lymph glands in neck, armpit, or groin
  11. 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

  1. Sleepiness or unusual drowsiness

Less common

  1. Diarrhea
  2. feeling of constant movement of self or surroundings
  3. hiccups
  4. lack or loss of strength
  5. rash
  6. runny nose
  7. sensation of spinning
  8. sneezing
  9. stuffy nose

Rare

  1. Bigger, dilated, or enlarged pupils (black part of eye)
  2. increased sensitivity of eyes to light
  3. itching skin
  4. loss of appetite
  5. vomiting
  6. 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.