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|Diastat AcuDial Gel

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Diastat AcuDial Gel

Generic Name: Diazepam Rectal Gel (AcuDial) (dye-AZ-e-pam)
Brand Name: Diastat AcuDial

Diastat AcuDial Gel is used for:

Treating episodes of increased seizure activity (cluster seizures) in certain patients with epilepsy who already take other seizure medicines.

Diastat AcuDial Gel is a benzodiazepine. It works in the brain to decrease seizures.

Do NOT use Diastat AcuDial Gel if:

you are allergic to any ingredient in Diastat AcuDial Gel
you have narrow-angle glaucoma, severe liver disease, or certain severe mental problems (eg, psychosis)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Diastat AcuDial Gel:

Some medical conditions may interact with Diastat AcuDial Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines or other substances
if you have a history of liver or kidney problems, lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD], pneumonia), myasthenia gravis, porphyria (a blood disease), or glaucoma, or you are at risk for narrow-angle glaucoma
if you have a history of depression, other mental or mood problems, suicidal thoughts or actions, or alcohol or other substance abuse or dependence

Some MEDICINES MAY INTERACT with Diastat AcuDial Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

Antidepressants (eg, amitriptyline, fluoxetine), barbiturates (eg, phenobarbital), HIV protease inhibitors (eg, ritonavir), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic medicines (eg, morphine, hydrocodone), phenothiazines (eg, chlorpromazine), valproate, or valproic acid because they may increase the risk of Diastat AcuDial Gel"s side effects, such as severe drowsiness and confusion

This may not be a complete list of all interactions that may occur. Ask your health care provider if Diastat AcuDial Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Diastat AcuDial Gel:

Use Diastat AcuDial Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Diastat AcuDial Gel. Talk to your pharmacist if you have questions about this information.
A health care provider will teach your caregiver how to use Diastat AcuDial Gel. Be sure your caregiver understands how to use Diastat AcuDial Gel. Contact your health care provider if you or your caregiver have any questions about using Diastat AcuDial Gel.
The pharmacist will set the dial to the appropriate dose before you receive Diastat AcuDial Gel. Check the syringe as soon as you pick up Diastat AcuDial Gel from the pharmacy. Make sure that you can see the dose in the display window and that the dose is correct. Make sure that you can see the green "ready" band on the syringe just below the cap. If you have questions about how to tell whether the dial is set to the correct dose or whether the syringe is ready to use, contact your doctor or pharmacist.
To use Diastat AcuDial Gel, place the patient on their side where they cannot fall. Get the syringe. Push up with your thumb and remove the cap from the syringe. Be sure the seal pin is removed with the cap. Lubricate the rectal tip with the lubricating jelly provided.
Turn the patient on their side facing you. Bend the upper leg forward and separate the buttocks to expose the rectum.
Gently insert the syringe tip into the rectum. Slowly count to 3 while gently pushing the plunger in until it stops. Slowly count to 3 before removing the syringe from the rectum. Slowly count to 3 while holding the buttocks together to prevent leakage of the medicine.
Keep the patient on their side facing you. Continue to observe the patient as directed by the patient"s doctor.
Pull on the plunger until it is completely removed from the syringe. Point the tip of the syringe over the toilet or sink. Replace the plunger into the syringe, gently pushing it in until it stops. Flush the toilet or rinse the sink with water until you can no longer see any gel.
Do not reuse the syringe or other materials. Throw away all used materials in the trash can. Keep out of the reach of children and away from pets.
Contact the patient"s doctor at once if seizures continue for 15 minutes after using Diastat AcuDial Gel, unless the patient"s doctor tells you otherwise.
Contact the doctor at once if you are alarmed by the frequency or severity of the seizures, or the color or breathing of the patient.
Contact the doctor at once if the seizures are different from the patient"s usual seizure episodes or if the patient is having unusual or serious problems.
Do NOT use Diastat AcuDial Gel more often than once every 5 days unless your doctor tells you otherwise.
Do NOT use Diastat AcuDial Gel more often than 5 times per month unless your doctor tells you otherwise.
If you miss a dose of Diastat AcuDial Gel, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Diastat AcuDial Gel.

Important safety information:

Diastat AcuDial Gel may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Diastat AcuDial Gel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Diastat AcuDial Gel; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor.
Contact the doctor at once if the patient develops new or worsening seizures.
Tell your doctor or dentist that you take Diastat AcuDial Gel before you receive any medical or dental care, emergency care, or surgery.
Use Diastat AcuDial Gel with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness or decreased coordination.
Diastat AcuDial Gel should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
Diastat AcuDial Gel should not be used in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Diastat AcuDial Gel may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Diastat AcuDial Gel while you are pregnant. Diastat AcuDial Gel is found in breast milk. Do not breast-feed while using Diastat AcuDial Gel. Discuss with your doctor how long you should wait to breast-feed after using Diastat AcuDial Gel.

Some people who use Diastat AcuDial Gel for a long time may develop a need to continue taking it. This is known as DEPENDENCE or addiction. If you are addicted to Diastat AcuDial Gel and you suddenly stop using it, you may have WITHDRAWAL symptoms. These may include feeling weak, dizzy, or lightheaded. You may also have nausea, muscle twitching, trembling of the hands and fingers, hallucinations, trouble sleeping, increased sweating, or seizures.

Possible side effects of Diastat AcuDial Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased coordination; diarrhea; dizziness; drowsiness; headache; nervousness; stomach pain; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; hallucinations; mental or mood changes; muscle spasms or twitching; new or worsened seizures; overexcitement; shortness of breath; sleep disturbances; trouble sleeping; wheezing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include coma; confusion; loss of consciousness; severe drowsiness; slow reflexes.

Proper storage of Diastat AcuDial Gel:

Store Diastat AcuDial Gel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. Keep Diastat AcuDial Gel, as well as syringes and needles, out of the reach of children and away from pets.

General information:

If you have any questions about Diastat AcuDial Gel, please talk with your doctor, pharmacist, or other health care provider.
Diastat AcuDial Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Diastat AcuDial Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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