Diastat

• Valeant Pharmaceuticals North America LLC

• Xcel Pharmaceuticals

Diastat is part of the drug class:

• Anxiolytic Benzodiazepine

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.

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.

• It is used to help control certain kinds of seizures.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Diastat affects you.
• Avoid drinking alcohol while taking this medicine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you are 65 or older, use Diastat with care. You could have more side effects.
• This medicine is not meant for regular, daily use. Talk with the doctor.
• Use with care in children. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

Use Diastat as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to use as you have been told by the doctor or read the package insert.
• Do not use more than 5 times in a month or more than once every 5 days.
• Check to make sure the right dose is locked in. You will see a green ready band.
• Call the doctor right away if you keep having seizures for 15 minutes after you give this medicine, unless your doctor has told you to do something else.

What do I do if I miss a dose?

• Get medical help right away.

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.
• Muscle spasm.
• Twitching.
• Not able to sleep.
• Change in eyesight.

Diazepam rectal gel is contraindicated in patients with a known hypersensitivity to diazepam. Diazepam rectal gel may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.

General

Diazepam rectal gel should only be administered by caregivers who in the opinion of the prescribing physician 1) are able to distinguish the distinct cluster of seizures (and/or the events presumed to herald their onset) from the patient’s ordinary seizure activity, 2) have been instructed and judged to be competent to administer the treatment rectally, 3) understand explicitly which seizure manifestations may or may not be treated with diazepam rectal gel, and 4) are able to monitor the clinical response and recognize when that response is such that immediate professional medical evaluation is required.

Risks from Concomitant Use with Opioids

Concomitant use of benzodiazepines, including Diastat and Diastat AcuDial, and opioids may result in

profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant

prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are

inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines

increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to

prescribe Diastat or Diastat AcuDial concomitantly with opioids, prescribe the lowest effective dosages

and minimum durations of concomitant use, and follow patients closely for signs and symptoms of

respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory

depression and sedation when Diastat or Diastat AcuDial is used with opioids (see PRECAUTIONS

section).

CNS Depression

Because diazepam rectal gel produces CNS depression, patients receiving this drug who are otherwise capable and qualified to do so should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle until they have completely returned to their level of baseline functioning.

Although diazepam rectal gel is indicated for use solely on an intermittent basis, the potential for a synergistic CNS-depressant effect when used simultaneously with alcohol or other CNS depressants must be considered by the prescribing physician, and appropriate recommendations made to the patient and/or caregiver.

Prolonged CNS depression has been observed in neonates treated with diazepam. Therefore, diazepam rectal gel is not recommended for use in children under six months of age.

Pregnancy Risks

No clinical studies have been conducted with diazepam rectal gel in pregnant women. Data from several sources raise concerns about the use of diazepam during pregnancy.

Animal Findings: Diazepam has been shown to be teratogenic in mice and hamsters when given orally at single doses of 100 mg/kg or greater (approximately eight times the maximum recommended human dose [MRHD=1 mg/kg/day] or greater on a mg/m2 basis). Cleft palate and exencephaly are the most common and consistently reported malformations produced in these species by administration of high, maternally-toxic doses of diazepam during organogenesis. Rodent studies have indicated that prenatal exposure to diazepam doses similar to those used clinically can produce longterm changes in cellular immune responses, brain neurochemistry, and behavior.

General Concerns and Considerations About Anticonvulsants: Reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to phenytoin and phenobarbital, but a smaller number of systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.

The reports suggesting an elevated incidence of birth defects in children of drug treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship. There are intrinsic methodologic problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors, e.g., genetic factors or the epileptic condition itself, may be more important than drug therapy in leading to birth defects. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even mild seizures do not pose some hazards to the developing embryo or fetus.

General Concerns About Benzodiazepines: An increased risk of congenital malformations associated with the use of benzodiazepine drugs has been suggested in several studies.

There may also be non-teratogenic risks associated with the use of benzodiazepines during pregnancy. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy. In addition, children born to mothers receiving benzodiazepines on a regular basis late in pregnancy may be at some risk of experiencing withdrawal symptoms during the postnatal period.

Advice Regarding the Use of Diazepam rectal gel in Women of Childbearing Potential: In general, the use of Diazepam rectal gel in women of childbearing potential, and more specifically during known pregnancy, should be considered only when the clinical situation warrants the risk to the fetus.

The specific considerations addressed above regarding the use of anticonvulsants in epileptic women of childbearing potential should be weighed in treating or counseling these women.

Because of experience with other members of the benzodiazepine class, Diazepam rectal gel is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should also be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug.

Withdrawal Symptoms

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of regular use of benzodiazepines (see DRUG ABUSE AND DEPENDENCE section).

Chronic Use

Diazepam rectal gel is not recommended for chronic, daily use as an anticonvulsant because of the potential for development of tolerance to diazepam. Chronic daily use of diazepam may increase the frequency and/or severity of tonic clonic seizures, requiring an increase in the dosage of standard anticonvulsant medication. In such cases, abrupt withdrawal of chronic diazepam may also be associated with a temporary increase in the frequency and/or severity of seizures.

Use in Patients with Petit Mal Status

Tonic status epilepticus has been precipitated in patients treated with IV diazepam for petit mal status or petit mal variant status.

Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:

Diastat®	Rectal Tip Size	NDC
2.5 mg Twin Pack	4.4 cm	NDC 66490-650-20
Diastat®AcuDial™	Rectal Tip Size	NDC
10 mg Delivery	4.4 cm	NDC 0187-0658-20
System Twin Pack
20 mg Delivery	6.0 cm	NDC 0187-0659-20
System Twin Pack

Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat® AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature].

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.

Manufactured for:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

By:
DPT Laboratories, Ltd.
San Antonio, TX 78215 USA

All other product/brand names are trademarks of their respective owners.

9435002

Rev. 12/16

Diastat® C-IV
(diazepam rectal gel)

Diastat® AcuDial™ C-IV
(diazepam rectal gel)

ADMINISTRATION AND DISPOSAL INSTRUCTIONS

IMPORTANT

Read first before using

To the caregiver using Diastat®:

Please do not give Diastat® until:

1. You have thoroughly read these instructions 2. Reviewed administration steps with the doctor 3. Understand the directions

To the caregiver using Diastat® AcuDialTM:

Please do not give Diastat® AcuDial™ until:

1. You have confirmed: 2. Prescribed dose is visible and if known, is correct 3. green “READY” band is visible

4. You have thoroughly read these instructions 5. Reviewed administration steps with the doctor 6. 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 data and always remove cap before using. Be sure seal pin is removed with the cap.

TREATMENT 1
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Important things to tell the doctor.

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

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Important things to tell the doctor

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

®/™ are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

Manufactured for:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
By:
DPT Laboratories, Ltd.
San Antonio, TX 78215 USA

9435002

Rev. 12/16