Diazepam Rectal gel

What is this medicine?

DIAZEPAM (dye AZ e pam) is a benzodiazepine. It is used to treat certain types of seizures.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions

• an alcohol or drug abuse problem
• bipolar disorder, depression, psychosis or other mental health condition
• glaucoma
• kidney disease
• liver disease
• lung or breathing disease
• myasthenia gravis
• Parkinson's disease
• seizures or a history of seizures
• suicidal thoughts
• an unusual or allergic reaction to diazepam, other benzodiazepines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Patients and caregivers should thoroughly read and understand how to use medicine. Follow the directions given to you by your doctor or health care professional. If an AcuDial syringe is being used and you have any questions about the medicine, you may call 1-877-361-2719. This medicine should be used to treat no more than five episodes per month and no more than one episode every five days.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

What if I miss a dose?

This does not apply; this medicine is not for regular use.

What may interact with this medicine?

• cimetidine
• clotrimazole
• cyclosporine
• dexamethasone
• grapefruit juice
• herbal or dietary supplements such as kava kava, melatonin, St. John's Wort or valerian
• ketoconazole
• medicines for anxiety or sleeping problems, such as alprazolam, lorazepam or triazolam
• medicines for depression, mental problems or psychiatric disturbances
• medicines for HIV infection or AIDS
• omeprazole
• paclitaxel
• prescription pain medicines
• propranolol
• rifampin, rifapentine, or rifabutin
• some medicines for seizures like carbamazepine, phenobarbital, phenytoin, or primidone
• theophylline
• troleandomycin
• valproic acid
• warfarin

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce the risk of dizzy and fainting spells, do not stand or sit up quickly, especially if you are an older patient. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• angry, confused, depressed, other mood changes
• breathing problems
• feeling faint or lightheaded, falls
• muscle cramps
• restlessness
• tremors
• trouble passing urine or change in the amount of urine
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• difficulty sleeping, nightmares
• dizziness, drowsiness, clumsiness, or unsteadiness, a hangover effect
• headache
• nausea, vomiting
• problems with balance, talking, walking

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Protect from light. Throw away any unused medicine after the expiration date.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.