Diastat AcuDial

Diastat® AcuDial™

INSTRUCTIONS FOR CAREGIVERS UPON RECEIPT FROM PHARMACY

• Remove the syringe from the case.
• Confirm the dose prescribed by your doctor is visible and if known, is correct.

FOR EACH SYRINGE:

• Confirm that the prescribed dose is visible in the dose display window.
• Confirm that the green “READY” band is visible.
• Return the syringe to the case.

SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.

The instructions are also available on the bottom of each drug product package.

CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.

ADMINISTRATION AND DISPOSAL INSTRUCTIONS

Read first before using

To the caregiver using Diastat®:

Please do not give DIASTAT® until:

You have thoroughly read these instructions

• Reviewed administration steps with the doctor
• Understand the directions

To the caregiver using Diastat® AcuDial™:

Please do not give DIASTAT® AcuDial™ until:

1. You have confirmed:

• Prescribed dose is visible and if known, is correct
• green “READY” band is visible

2. You have thoroughly read these instructions

3. Reviewed administration steps with the doctor

4. Understand the directions

Please do not administer DIASTAT until you feel comfortable with how to use DIASTAT. The doctor will tell you exactly when to use DIASTAT. When you use DIASTAT correctly and safely you will help bring seizures under control. Be sure to discuss every aspect of your role with the doctor. If you are not comfortable, then discuss your role with the doctor again.

To help the person with seizures:

• You must be able to tell the difference between cluster and ordinary seizures.
• You must be comfortable and satisfied that you are able to give DIASTAT.
• You need to agree with the doctor on the exact conditions when to treat with DIASTAT.
• You must know how and for how long you should check the person after giving DIASTAT.

To know what responses to expect:

• You need to know how soon seizures should stop or decrease in frequency after giving DIASTAT.
• You need to know what you should do if the seizures do not stop or there is a change in the person's breathing, behavior or condition that alarms you.
• If you have any questions or feel unsure about using the treatment, CALL THE DOCTOR before using DIASTAT.

When to treat. Based on the doctor's directions or prescription. Your doctor may prescribe a second dose of Diazepam rectal gel. If a second dose is needed, give it 4 hours to 12 hours after the first dose.

Special considerations.

DIASTAT should be used with caution:

• In people with respiratory (breathing) difficulties (e.g., asthma or pneumonia)
• In the elderly
• In women of child bearing potential, pregnancy and nursing mothers

Discuss beforehand with the doctor any additional steps you may need to take if there is leakage of DIASTAT or a bowel movement.

Patient's DIASTAT dosage is: ________mg

Patient's resting breathing rate ________ Patient's current weight ________

Confirm current weight is still the same as when DIASTAT was prescribed __________________________

Check expiration date and always remove cap before using. Be sure seal pin is removed with the cap.

Treatment 1

Things to do after treatment with DIASTAT.

Stay with the person for 4 hours and make notes on the following:

• Changes in resting breathing rate _____________________
• Changes in color _________________________________
• Possible side effects from treatment___________________
• Your doctor may prescribe a second dose of Diazepam rectal gel. If a second dose is needed, give it 4 hours to 12 hours after the first dose.

Treatment 2

Things to do after treatment with DIASTAT.

Stay with the person for 4 hours and make notes on the following:

• Changes in resting breathing rate________________________
• Changes in color ___________________________________
• Possible side effects from treatment

HOW TO ADMINISTER AND DISPOSAL

You should not receive this medication if you are allergic to diazepam (Valium), or if you have untreated or uncontrolled narrow-angle glaucoma.

Before using diazepam rectal, tell your doctor if you have glaucoma, liver or kidney disease, asthma, pneumonia, other breathing problems, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol. Also tell your doctor if you are allergic to other benzodiazepines (alprazolam, Ativan, lorazepam, Klonopin, Restoril, Tranxene, Xanax, and others).

This medication is usually given by a caregiver to the person who is having a seizure. Not all types of seizures can be treated with diazepam rectal. If you are the caregiver, do not give this medication unless you know how to recognize the symptoms of a seizure episode that should be treated with diazepam rectal.

Diazepam rectal may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor right away if you become pregnant while using diazepam rectal for seizures. Do not start or stop using any of your seizure medications during pregnancy without your doctor's advice.

There are many other drugs that can interact with diazepam rectal. Tell your doctor about all medications you use.

Diazepam may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

• If you have an allergy to diazepam or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Breathing problems, glaucoma, liver disease, myasthenia gravis, or sleep apnea.
• If you have psychosis.
• If you have recently drunk a lot of alcohol or taken a big amount of drugs that may slow your actions like phenobarbital or some pain drugs like oxycodone.
• If you are breast-feeding. Do not breast-feed while you take Diastat AcuDial. You may also need to avoid breast-feeding for some time after your last dose. Talk with your doctor to see if you need to avoid breast-feeding after your last dose.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Diastat AcuDial with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• Shortness of breath.
• Change in balance.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Memory problems or loss.
• Very bad dizziness or passing out.
• Feeling very tired or weak.
• If seizures are worse or not the same after starting Diastat AcuDial.
• Muscle spasm.
• Twitching.
• Not able to sleep.
• Change in eyesight.

Applies to diazepam: oral capsule extended release, oral solution, oral tablet

Other dosage forms:

• injection emulsion, injection solution
• rectal gel/jelly, rectal kit

Along with its needed effects, diazepam (the active ingredient contained in Diastat AcuDial) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking diazepam:

• Shakiness and unsteady walk
• unsteadiness, trembling, or other problems with muscle control or coordination

• Abdominal or stomach pain
• agitation
• black, tarry stools
• blistering, flaking, or peeling of the skin
• blurred vision
• changes in patterns and rhythms of speech
• chills
• confusion
• cough
• dark urine
• decrease in the frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• discouragement
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• false beliefs that cannot be changed by facts
• fast heartbeat
• fast or irregular breathing
• feeling sad or empty
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• feeling, seeing, or hearing things that are not there
• fever
• headache
• hyperexcitability
• increased muscle spasms or tone
• irritability
• itching or rash
• lack of memory of what takes place after a certain event
• loss of appetite
• loss of bladder control
• loss of interest or pleasure
• lower back or side pain
• nausea
• nightmares
• outbursts of anger
• painful or difficult urination
• pale skin
• restlessness
• seizures
• slurred speech
• sore throat
• sweating
• trouble concentrating
• trouble sleeping
• trouble speaking
• ulcers, sores, or white spots in the mouth
• unpleasant breath odor
• unusual behavior
• unusual bleeding or bruising
• unusual feeling of excitement
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking diazepam:

• Change in consciousness
• difficult or troubled breathing
• irregular, fast or slow, or shallow breathing
• lack of coordination
• loss of consciousness
• loss of strength or energy
• muscle pain or weakness
• pale or blue lips, fingernails, or skin
• sleepiness
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects of diazepam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• decreased interest in sexual intercourse
• diarrhea
• difficulty with swallowing
• double vision
• dry mouth
• feeling of constant movement of self or surroundings
• inability to have or keep an erection
• increase in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• increased watering of the mouth
• indigestion
• loss of sexual ability, desire, drive, or performance
• passing of gas
• seeing double
• sensation of spinning

ORAL:
-Initial dose: 10 mg orally 3 to 4 times a day for the first 24 hours
-Maintenance dose: 5 mg orally 3 to 4 times a day as needed

PARENTERAL:
10 mg IM or IV once, then 5 to 10 mg IM or IV in 3 to 4 hours if necessary

Use: Symptomatic relief of acute agitation, tremor, impending/acute delirium tremens, and hallucinations in acute alcohol withdrawal

PARENTERAL:
-Initial dose: 5 to 10 mg IV once, repeated at 10 to 15 minute intervals to a maximum dose of 30 mg if necessary

Comments:
-The IV route is preferred; however, the IM route may be used if IV administration is impossible.
-Treatment may be repeated every 2 to 4 hours, but active metabolites may persist during readministration.
-Patients with chronic lung disease or unstable cardiovascular conditions should be given this drug with extreme caution.

Use: Adjunct to status epilepticus and severe recurrent convulsive seizures

ORAL:
-Initial dose: 2 to 2.5 mg orally once to 2 times a day

PARENTERAL:
-Initial dose: 2 to 5 mg IM or IV, repeated in 3 to 4 hours if necessary

Comments:
-Doses may be increased gradually as needed and tolerated, but should be limited to the smallest effective amount.
-Maintenance doses should be determined by clinical need and patient tolerance.

Uses:
-Management of anxiety disorders and short-term relief of anxiety symptoms
-Symptomatic relief of acute agitation, tremor, impending/acute delirium tremens, and hallucinations in acute alcohol withdrawal
-Adjunctive treatment for the relief of skeletal muscle spasm due to reflex spasm to local pathology, spasticity caused by upper motor neuron disorders, athetosis, and stiff-man syndrome (e.g., inflammation of the muscles/joints secondary to trauma, cerebral palsy, paraplegia)

ORAL:
-Initial dose: 2 to 2.5 mg orally once to 2 times a day

PARENTERAL:
-Initial dose: 2 to 5 mg IM or IV, repeated in 3 to 4 hours if necessary

Comments:
-Doses may be increased gradually as needed and tolerated, but should be limited to the smallest effective amount.
-Maintenance doses should be determined by clinical need and patient tolerance.

Uses:
-Management of anxiety disorders and short-term relief of anxiety symptoms
-Symptomatic relief of acute agitation, tremor, impending/acute delirium tremens, and hallucinations in acute alcohol withdrawal
-Adjunctive treatment for the relief of skeletal muscle spasm due to reflex spasm to local pathology, spasticity caused by upper motor neuron disorders, athetosis, and stiff-man syndrome (e.g., inflammation of the muscles/joints secondary to trauma, cerebral palsy, paraplegia)

Renal impairment: Use with caution (parenteral and rectal formulations); data not available (oral formulations)