Diastat

DRUG DESCRIPTION

Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/mL diazepam, propylene glycol, ethyl alcohol (10%), hydroxypropyl methylcellulose, sodium benzoate, benzyl alcohol (1.5%), benzoic acid and water. Diazepam rectal gel is clear to slightly yellow and has a pH between 6.5 -7.2.

Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1 -methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. The structural formula is as follows:

Diastat (diazepam) structural formula illustration

What are the possible side effects of diazepam rectal (Diastat AcuDial, Diastat Pediatric)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the person receiving this medication has any of these serious side effects:

  • worsening seizures, or seizures that seem different from the patient's other seizures;
  • pale or discolored skin;
  • confusion, unusual thoughts or behavior;
  • unusual risk-using behavior, decreased...

Read All Potential Side Effects and See Pictures of Diastat

What are the precautions when taking diazepam rectal gel (Diastat)?

Before using this product, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., oxazepam, temazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain eye problem (narrow-angle glaucoma), a certain muscle disease (myasthenia gravis), breathing trouble during sleep (sleep apnea).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, pneumonia), brain problems that could...

Read All Potential Precautions of Diastat


Diastat Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, diarrhea, and unsteadiness may occur. If these persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication stays in the body for a long time. Be sure to watch for reactions for at least 4 hours after giving the medication.

Seek immediate medical attention if any of these unlikely but very serious side effects occur: slow/shallow/difficult breathing, mental/mood changes (e.g., anxiety, restlessness, hallucinations, sleep problems), slurred speech, trouble walking.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., oxazepam, temazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain eye problem (narrow-angle glaucoma), a certain muscle disease (myasthenia gravis), breathing trouble during sleep (sleep apnea).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, pneumonia), brain problems that could affect breathing (e.g., decreased consciousness, head injury), a certain eye problem (wide-angle glaucoma), kidney disease, liver disease, history of drug/alcohol abuse.

This drug may make you dizzy or drowsy. Do not drive, use machinery, ride a bicycle, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of this drug, especially the drowsiness effect.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy.

This drug may pass into breast milk. Because of the possible harm to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Diastat Patient Information Including Side Effects

Brand Names: Diastat AcuDial, Diastat Pediatric

Generic Name: diazepam rectal (Pronunciation: dye AZ e pam)

  • What is diazepam rectal (Diastat)?
  • What are the possible side effects of diazepam rectal (Diastat)?
  • What is the most important information I should know about diazepam rectal (Diastat)?
  • What should I discuss with my healthcare provider before using diazepam rectal (Diastat)?
  • How should I use diazepam rectal (Diastat)?
  • What happens if I miss a dose (Diastat)?
  • What happens if I overdose (Diastat)?
  • What should I avoid while using diazepam rectal (Diastat)?
  • What other drugs will affect diazepam rectal (Diastat)?
  • Where can I get more information?

What is diazepam rectal (Diastat)?

Diazepam rectal is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Diazepam rectal affects chemicals in the brain that may become unbalanced and cause seizure.

Diazepam rectal is used to treat occasionally increased seizures in people with epilepsy who also routinely take other anti-convulsants. Diazepam rectal is not for long-term daily use to prevent seizures.

Diazepam rectal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of diazepam rectal (Diastat)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the person receiving this medication has any of these serious side effects:

  • worsening seizures, or seizures that seem different from the patient's other seizures;
  • pale or discolored skin;
  • confusion, unusual thoughts or behavior;
  • unusual risk-using behavior, decreased inhibitions, no fear of danger;
  • depressed mood, thoughts of suicide or hurting yourself;
  • hyperactivity, agitation, hostility;
  • hallucinations;
  • feeling light-headed, fainting; or
  • pain or burning with urination.

Less serious side effects may include:

  • drowsiness, tiredness;
  • blurred vision;
  • sleep problems (insomnia);
  • muscle weakness, lack of balance or coordination;
  • slurred speech;
  • nausea, vomiting, stomach pain, diarrhea;
  • headache;
  • skin rash; or
  • runny nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about diazepam rectal (Diastat)?

Do not use this medication if you are allergic to diazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), lorazepam (Ativan), or oxazepam (Serax).

This medication can cause birth defects in an unborn baby. Do not use diazepam rectal if you are pregnant.

Before using diazepam rectal, tell your doctor if you have any breathing problems, glaucoma, kidney or liver disease, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Avoid using other medicines that make you sleepy. They can add to sleepiness caused by diazepam rectal.

Diazepam may be habit-forming and this medication should be used only by the person it was prescribed for. Diazepam rectal should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

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