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:

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.