1 Diazepam (Rectal Route): A Summary

Brand: Diastat, Diastat Pediatric

Generic: Diazepam (Rectal Route)

Brand name:

Diastat, Diastat Pediatric.

Diazepam rectal gel is a benzodiazepine used for the control of certain seizure disorders such as epilepsy.

This drug works by slowing down the nervous system. This drug requires a prescription.

2 What to Know Before Using

Before taking this drug, the risks and benefits for your body should be discussed with your healthcare provider.

Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children below 2 years of age regarding the relationship of age to the effects of diazepam rectal gel have not been performed while safety and efficacy have not been established.

This drug is contraindicated for use in infants less than 6 months of age. Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of diazepam rectal gel.

Adjustments in the dose of the elderly may be required since they are more likely to experience severe drowsiness, clumsiness, or unsteadiness.

Risks to the fetus have been reported in studies of pregnant women and animals but these may be outweighed by the benefits of therapy in a life threatening situation or a serious disease.

Harmful infant effects have been reported in studies of breastfeeding women. An alternative to this drug should be prescribed or you should stop breastfeeding while using this drug.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Alfentanil
  • Amobarbital
  • Anileridine
  • Bromazepam
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlorzoxazone
  • Cobicistat
  • Codeine
  • Dantrolene
  • Eslicarbazepine Acetate
  • Ethchlorvynol
  • Etravirine
  • Fentanyl
  • Flibanserin
  • Fosphenytoin
  • Fospropofol
  • Hydrocodone
  • Hydromorphone
  • Levorphanol
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Mirtazapine
  • Morphine
  • Morphine Sulfate Liposome
  • Orlistat
  • Oxycodone
  • Oxymorphone
  • Pentobarbital
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Propofol
  • Propoxyphene
  • Remifentanil
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Suvorexant
  • Tapentadol
  • Thiopental
  • Zolpidem
  • Amitriptyline
  • Amprenavir
  • Clarithromycin
  • Dalfopristin
  • Disulfiram
  • Erythromycin
  • Fluvoxamine
  • Ginkgo
  • Isoniazid
  • Quinupristin
  • Rifapentine
  • Roxithromycin
  • St John's Wort
  • Theophylline
  • Troleandomycin

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects.

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as alcohol abuse, drug abuse or dependence, breathing problems or lung diseases, glaucoma, Kidney disease or Liver disease.

3 Proper Usage

To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional. The dose of this drug will be variable for different patients.

The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

The dose for control of seizures in adults, teenagers, and children 2 years of age and older is based on body weight and must be determined by your healthcare professional.

Use and dose in children younger than 2 years of age must be determined by your healthcare professional.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

This drug has teratogenic potential and it is recommended to use an effective form of birth control to prevent any chance of pregnancy.

Inform your healthcare professional immediately if you think you have become pregnant while using this drug.

This drug will potentiate the effects of alcohol and other CNS depressants such as antihistamines or drug for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping drug, prescription pain drug or narcotics, barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This effect may last for a few days after you stop taking this drug. Check with your healthcare professional before taking any of the above whiles you are using this drug.

This drug may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normal.

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.

5 Potential Side Effects

Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • 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
  • the false or unusual sense of well-being
  • the feeling of warmth or heat
  • flushing or redness of the 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 the chest
  • trouble in speaking
  • trouble sleeping
  • unsteadiness
  • trembling or other problems with muscle control or coordination
  • unusual tiredness or weakness
  • wheezing
  • bladder pain
  • bloody or cloudy urine
  • difficult, burning or painful urination
  • fever or chills
  • frequent urge to urinate
  • the 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

Some side effects may occur that usually do not need medical attention. As your body adjusts to the drug, the side effects will slowly disappear.

Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional.

Report any side effects to the FDA hotline at 1-800-FDA-1088.

6 Related Clinical Trials