Diastat AcuDial

Diastat AcuDial is a rectal gel used to treat seizures in people with epilepsy. Diastat AcuDial contains the medication diazepam, which belongs to a class of drugs called benzodiazepine anticonvulsant medications.

Diastat AcuDial works by reducing the excitability of nerve cells or neurons in the brain. It does this by helping a neurotransmitter called gamma-aminobutyric acid (GABA) work. GABA is a chemical messenger that blocks impulses between nerve cells.

Diastat AcuDial is given via a rectal delivery system. The rectal delivery system combines a pre-filled syringe with a plastic applicator with a flexible, molded tip which is used to deliver the medication into the rectum. The syringe has a window on it that displays the dose and a green band that confirms when the dose is ready to be given.

Diastat AcuDial contains the same gel formulation of diazepam as Diastat, which uses an older rectal delivery system that doesn't have a window displaying the dose of the medication.

Diastat was approved by the US Food and Drug Administration (FDA) in 1997. When the new delivery system - Diastat AcuDial - was approved in 2005, only the lowest strength pre-filled syringe of Diastat (containing diazepam 2.5mg/0.5ml) remained on the market. The higher strength versions of Diastat were discontinued at that time.

• Afinitor
• Carbamazepine
• Divalproex sodium
• Dilantin
• Lamictal
• Lamotrigine
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Sabril
• Tegretol
• Topamax
• Topiramate
• Valproic acid
• Zonegran
• Aptiom
• Neurontin
• Briviact
• Onfi
• Sympazan

Suddenly stopping or reducing the dose of Diastat AcuDial very quickly may precipitate acute withdrawal reactions, which can be life-threatening. In some cases, patients have developed withdrawal symptoms lasting weeks to more than 12 months, including but not limited to:

• anxiety
• difficulty thinking
• mental changes
• depression
• insomnia
• abnormal skin sensations
• muscle weakness
• tremors
• twitching
• ringing in your ears
• burning or prickling feeling in your hands, arms, or feet

The most frequent side effect reported for Diastat AcuDial in clinical studies was somnolence (sleepiness or drowsiness).

Other side effects included dizziness, headache, pain, abdominal pain, nervousness, vasodilation (increase in diameter of blood vessel), diarrhea, ataxia/incoordination (lack of coordination), euphoria (feeling of great happiness or well-being), asthma, rhinitis (irritation of the nose similar to an allergy or a cold), and rash.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also contact Bausch Health Customer Service at 1-800-321-4576.

For the caregiver giving Diastat AcuDial

• Read the Instructions for Use that come with Diastat AcuDial before using it.
• Use Diastat AcuDial exactly as your healthcare provider tells you to.
• Step-by-step instructions
  • Lie the person down and put them on their side where they can't fall.
  • Get the Diastat AcuDial.
  • Get the syringe, check the dose and green "ready" band is visible.
  • To remove the cap from the syringe push up with your thumb and pull the cap with your. other hand. Make sure the Seal Pin is removed with the cap.
  • Lubricate the rectal tip with lubricating jelly.
  • Turn the person on their side facing you. Pull there pants down below their bottom.
  • Bend their upper leg forward to expose their rectum.
  • Separate the buttock to expose their rectum.
  • Gently insert the Diastat AcuDial syringe into the rectum so that the rim of the syringe fits snuggly against the rectal opening.
  • 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 the gel from leaking out.
  • Keep the person on their side facing you and note the time Diastat AcuDial was administered while continuing to watch them.
  • Watch the person for 4 hours and take note of any changes in the resting breathing rate or color. Also watch for possible side effects.
  • Based on the doctor's directions or prescription a second dose of Diastat AcuDial may be required. If a second dose is needed, give it 4 to 12 hours after the first dose.

Call for help if any of the following occur when using Diastat AcuDial

• Seizure(s) continues 15 minutes after giving Diastat AcuDial or as per doctor's instructions.
• Seizure behavior is different from other episodes.
• You are alarmed by the frequency or severity of the seizure(s).
• You are alarmed by the color or breathing of the person.
• The person is having unusual or serious problems.

The recommended dose of Diastat AcuDial depends on the age of the person:

• 2-5 years of age: 0.5 mg/kg
• 6-11 years of age: 0.3 mg/kg
• 12 years of age and older: 0.2 mg/kg

The following tables provide acceptable weight ranges for each dose and age category

• See the full prescribing information for additional information about dosing
• Some people may need to round their dose of Diastat AcuDial up or down. Check with your doctor about what is right for you
• Diastat AcuDial 10 mg syringe comes with a 4.4 cm tip
• Diastat AcuDial 20 mg syringe comes with a 6.0 cm tip
• Diastat 2.5 mg comes with a 4.4 cm tip

立即寻求紧急医疗救助。

• Store Diastat AcuDial at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
• To dispose of Diastat AcuDial:
  • Pull on plunger until it is completely removed from the syringe body.
  • Point the tip of the syringe over sink or toilet.
  • Replace the plunger into the syringe body and gently push the plunger in until it stops.
  • Flush the toilet or rinse the sink with water until gel is no longer visible.
  • Discard all used materials in the garbage can
  • Do not reuse
• To dispose of Diastat 2.5 mg
  • Discard all used materials in the garbage can
  • Do not reuse

Keep out of reach of children.