Diastat

Diastat is a prescription medication used in emergency situations to manage seizures. Diastat belongs to a group of drugs called benzodiazepines. These work to treat seizures by increasing the effects of GABA, a neurotransmitter responsible for inhibiting activity within the nervous system.

This medication comes in gel form and is administered rectally by a healthcare professional or a caregiver at the onset of seizures. A second dose of Diastat is sometimes required and given 4-12 hours after the first dose.

Common side effects of Diastat include drowsiness, headache, and abdominal pain.

Diastat can also cause dizziness. Do not drive or operate heavy machinery until you know how Diastat affects you.

Diastat is a prescription medication used in emergency situations to manage patients with epilepsy, on stable regimens of antiepileptics, who require intermittent use of diazepam to control bouts of increased seizure activity or breakthrough seizures. 

This medicine may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Valeant Pharmaceuticals North America LLC

• Xcel Pharmaceuticals

Serious side effects have been reported with Diastat. See the “Diastat Precautions” section.

Common side effects of Diastat include the following:

• drowsiness
• headache
• stomach pain
• nervousness 
• vasodilation (increase in diameter of blood vessel)
• diarrhea
• lack of coordination
• euphoria (feeling of great happiness or well-being)
• asthma
• rhinitis (irritation of the nose similar to an allergy or a cold)
• rash

This is not a complete list of Diastat side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Alcohol
• CNS depressants
• Cimetidine
• Valproate
• Antidepressants such as imipramine (Tofranil)
• Monnoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• St. John's Wort
• medications that use the protein CYP2C19 such as omeprazole and propranolol
• medications that use the protein CYP3A4 such as cyclosporine, paclitaxel, terfenadine, theophylline, and warfarin

This is not a complete list of Diastat drug interactions. Talk to your doctor for more information.

Serious side effects have been reported with Diastat including the following:

Withdrawal symptoms. If abruptly discontinued after regular use, withdrawal symptoms of tremors, seizures, rapid heart rate, sweating, and/or general ill-feeling (malaise) may develop. Do not abruptly discontinue Diastat after regular use. Consult with your physician if you wish to discontinue treatment and your physician will instruct you on how to safely discontinue use.

Diastat is a Schedule IV controlled substance and can produce drug dependence. It is recommended that patients be treated with Diastat rectal gel no more frequently than every five days and no more than five times per month.

Diastat is not recommended to be used every day, because of the potential for development of tolerance to Diastat. 

Do not use Diastat if you:

• are allergic to Diastat or to any of its ingredients 
• have acute narrow-angle glaucoma

Diastat can also cause drowsiness and/or dizziness. Do not drive or operate heavy machinery until you know how Diastat affects you

Grapefruit and grapefruit juice may interact with Diastat and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Diastat, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Diastat or to any of its ingredients
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have sleep apnea
• drink alcohol or use other sedative medications
• are over the age of 65 years
• have liver disease
• have kidney disease
• have a history of alcohol or drug addiction
• have glaucoma
• have lung disease (asthma, emphysema, bronchitis, or COPD)
• have heart disease
• have a history of mental illness, depression, or suicidal thoughts or behavior

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Diastat has been shown to be teratogenic in animal studies. There are no well-controlled studies that have been done in pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

Diastat has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Diastat, a choice should be made whether to stop nursing or to stop use of this medication. Women should not breast-feed for an appropriate period of time after receiving treatment with Diazepam rectal gel.

Use Diastat exactly as prescribed.

Diastat is available in a rectal gel form and is typically given by a healthcare professional or a caregiver at the onset of seizure. A second dose of Diastat is sometimes required and given 4-12 hours after the first dose.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on age weight: 

• Ages 2-5 years: 0.5 mg per kilogram of body weight 
• Ages 6-11 years: 0.3 mg per kilogram of body weight
• Ages 12 years and older: 0.2 mg per kilogram of body weight

Diastat rectal gel is provided as unit doses of 2.5, 5, 7.5, 10, 12.5, 15, 17.5, and 20 mg, so the prescribed dose is obtained by rounding upward to the next available dose. 

Diastat AcuDial is available in a 10-mg syringe and in a 20 mg syringe. 

A second dose of Diastat is sometimes required and given 4-12 hours after the first dose.

If you administer too much Diastat, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Diastat is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.