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|Diastat Gel

Diastat Gel

Diastat Gel is used for:

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

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

Do NOT use Diastat Gel if:

• you are allergic to any ingredient in Diastat 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 Gel:

Some medical conditions may interact with Diastat 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 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 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 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 Gel:

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

• An extra patient leaflet is available with Diastat Gel. Talk to your pharmacist if you have questions about this information.
• A health care provider will teach your caregiver how to use Diastat Gel. Be sure your caregiver understands how to use Diastat Gel. Contact your health care provider if you or your caregiver have any questions about using Diastat Gel.
• To use Diastat 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.
• 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 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 Gel more often than once every 5 days unless your doctor tells you otherwise.
• Do NOT use Diastat Gel more often than 5 times per month unless your doctor tells you otherwise.
• If you miss a dose of Diastat Gel, contact your doctor right away.

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

Important safety information:

• Diastat Gel may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Diastat 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 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 Gel before you receive any medical or dental care, emergency care, or surgery.
• Use Diastat Gel with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness or decreased coordination.
• Diastat 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 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 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 Gel while you are pregnant. Diastat Gel is found in breast milk. Do not breast-feed while using Diastat Gel. Discuss with your doctor how long you should wait to breast-feed after using Diastat Gel.

Some people who use Diastat 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 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 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.

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.

Store Diastat 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 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 Gel, please talk with your doctor, pharmacist, or other health care provider.
• Diastat 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 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.