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diazepam rectal

Pronunciation

Generic Name: diazepam rectal (dye AZ e pam)
Brand Name: Diastat AcuDial, Diastat Pediatric

What is diazepam rectal?

Diazepam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). Diazepam affects chemicals in the brain that may become unbalanced and cause seizure.

Diazepam rectal is used to treat occasionally increased seizures (cluster seizures) in people with epilepsy who also routinely take other anti-convulsants. Diazepam rectal is not for long-term daily use to prevent seizures.

Diazepam rectal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about diazepam rectal?

You should not receive this medication if you have untreated or uncontrolled narrow-angle glaucoma.

Not all types of seizures can be treated with diazepam rectal. If you are a patient 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.

Slideshow: Flashback: FDA Drug Approvals 2013

Do not start or stop using any of your seizure medications during pregnancy without your doctor's advice.

What should I discuss with my healthcare provider before using diazepam rectal?

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

To make sure diazepam is safe for you, tell your doctor if you have:

  • glaucoma;

  • asthma, pneumonia, emphysema, bronchitis, chronic obstructive pulmonary disease (COPD), or other breathing disorder;

  • liver or kidney disease;

  • a history of depression or suicidal thoughts or behavior;

  • a history of drug or alcohol addiction; or

  • if you are allergic to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), lorazepam (Ativan), or oxazepam (Serax).

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

Diazepam can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

The sedative effects of diazepam rectal may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are using diazepam rectal.

Do not give this medication to a child younger than 6 months old.

How should I use diazepam rectal?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

This medication is usually given by a caregiver to the person who is having a seizure. If you are a patient caregiver, make sure you know and understand all instructions for giving diazepam rectal.

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.

After giving diazepam rectal to another person, stay with the person for at least 4 hours and watch for changes in his or her breathing, and any side effects from the medicine.

Get emergency medical help if:

  • the seizure has not stopped within 15 minutes after giving diazepam rectal;

  • the seizure seems to be different from the person's usual seizures;

  • the seizures seems to be closer together or more severe than the person's usual seizures; or

  • the person has breathing problems, pale or blue-colored skin, or any other serious or unusual problems.

Diazepam rectal is used in combination with other seizure medications. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Diazepam rectal is not for long-term daily use to prevent seizures. Using diazepam rectal daily over long periods can actually make your seizures more frequent or more severe. You may also have withdrawal symptoms when you stop using diazepam rectal.

Diazepam may be habit forming. Never share diazepam with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Do not use this medication for longer than 5 days in a row without a doctor's advice. Contact your doctor if this medicine seems to stop working as well in treating your symptoms.

Store at room temperature away from moisture, heat, and light.

After giving a dose of diazepam rectal, empty any leftover medicine from the syringe into a toilet and flush, or into a sink and rinse down the drain. Throw the empty syringe away where children and pets cannot get to it. Do not reuse a diazepam rectal syringe.

What happens if I miss a dose?

Since diazepam rectal is used on an as needed basis, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include extreme drowsiness, loss of balance or coordination, limp or weak muscles, or fainting.

What should I avoid while using diazepam rectal?

Diazepam may impair your thinking or reactions. Do not drive, operate machinery, or perform other hazardous activities until you are alert and awake and you no longer feel drowsy from this medicine.

Do not drink alcohol while using diazepam. This medication can increase the effects of alcohol.

Grapefruit and grapefruit juice may interact with diazepam and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Diazepam rectal side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the person receiving this medication has:

  • worsening seizures, or seizures that seem different from the patient's other seizures;

  • pale or discolored skin, feeling like you might pass out;

  • confusion, hallucinations, unusual thoughts or behavior, unusual risk-taking behavior, decreased inhibitions, no fear of danger; or

  • hyperactivity, agitation, hostility, depressed mood, thoughts of suicide or hurting yourself.

Common side effects may include:

  • drowsiness, dizziness, headache, nervous feeling;

  • stomach pain, diarrhea;

  • flushing (warmth, redness, or tingly feeling);

  • weakness, loss of coordination; or

  • runny nose, sneezing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Diazepam rectal dosing information

Usual Adult Dose for Anxiety:

Oral: 2 to 10 mg 2 to 4 times a day.
IM or IV: 2 to 5 mg (moderate anxiety) or 5 to 10 mg (severe anxiety) for one dose. May repeat in 3 to 4 hours, if necessary.

Usual Adult Dose for Alcohol Withdrawal:

Oral: 10 mg 3 to 4 times during the first 24 hours, then 5 mg 3 to 4 times a day as needed.
IM or IV: 5 to 10 mg one time. May repeat in 3 to 4 hours, if necessary.

Usual Adult Dose for ICU Agitation:

Initial dose: 0.02 to 0.08 mg/kg IV over 2 to 5 minutes every 0.5 to 2 hours to control acute agitation.
Maintenance dose: 0.4 to 0.2 mg/kg/hr by continuous IV infusion.

Usual Adult Dose for Muscle Spasm:

Oral: 2 to 10 mg 3 to 4 times a day.
IM or IV: 5 to 10 mg initially, then 5 to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.

Usual Adult Dose for Seizures:

Oral: 2 to 10 mg 2 to 4 times a day.
Rectal gel: 0.2 mg/kg, rounded up to the nearest available unit dose. A supplemental dose of 2.5 mg may be added for more precise titration or if a portion of the first dose is expelled. May repeat in 4 to 12 hours. Maximum of 1 episode every 5 days, or 5 episodes per month.

Usual Adult Dose for Endoscopy or Radiology Premedication:

IV: 10 mg or less is usually adequate; however up to 20 mg may be necessary to produce the desired sedation in some patients.
IM: If IV cannot be used, 5 to 10 mg 30 minutes prior to the procedure.
Dosage of narcotics should be reduced by at least a third and in some cases may be omitted.

Usual Adult Dose for Status Epilepticus:

IV or IM: 5 to 10 mg initially (IV preferred).
May be repeated at 10 to 15 minute intervals up to a maximum dose of 30 mg.
If necessary, may be repeated again in 2 to 4 hours.

Usual Adult Dose for Light Anesthesia:

Premedication for Anesthesia:
10 mg, IM (preferred route), 1 to 2 hours before surgery.

Usual Pediatric Dose for Seizures:

Rectal gel:
Infants less than 6 months old: Not recommended; product contains benzoic acid, benzyl alcohol, ethanol 10%, propylene glycol, and sodium benzoate. Prolonged CNS depression has been reported in neonates receiving diazepam.
Infants and Children 6 months to 2 years: Dose not established
2 to 5 years: 0.5 mg/kg, rounded up to the nearest available unit dose.
6 to 11 years: 0.3 mg/kg, rounded up to the nearest available unit dose.
12 years or greater: 0.2 mg/kg, rounded up to the nearest available unit dose.
A supplemental dose of 2.5 mg may be added in 10 minutes for more precise titration or if a portion of the first dose is expelled. May repeat in 4 to 12 hours. Maximum of 1 episode every 5 days, or 5 episodes per month.

Usual Pediatric Dose for Status Epilepticus:

Neonates: IV: (This is not recommended as a first line agent because the injection contains benzoic acid, benzyl alcohol, and sodium benzoate): 0.1 to 0.3 mg/kg/dose given over 3 to 5 minutes, every 15 to 30 minutes to a maximum total dose of 2 mg.

Infants greater than 30 days old and Children: IV: 0.1 to 0.3 mg/kg dose given over 3 to 5 minutes, every 5 to 10 minutes (maximum of 10 mg/dose).

Manufacturer recommendation:

Infants greater than 30 days old and Children less than 5 years: IV: 0.2 to 0.5 mg slow IV every 2 to 5 minutes up to a maximum total dose of 5 mg. Repeat in 2 to 4 hours if needed.

Children greater than or equal to 5 years: IV: 1 mg slow IV every 2 to 5 minutes up to a maximum of 10 mg. Repeat in 2 to 4 hours if needed.

Usual Pediatric Dose for Anxiety:

1 to 12 years:
Oral: 0.12 to 0.8 mg/kg/day in divided doses every 6 to 8 hours as needed.

IM: 0.04 to 0.3 mg/kg every 2 to 4 hours as needed, up to a maximum of 0.6 mg/kg in 8 hours.

Febrile seizure prophylaxis in children: Oral: 1 mg/kg/day orally in divided doses every 8 hours. Initiate therapy at first sign of fever and continue for 24 hours after fever resolves.

Usual Pediatric Dose for Muscle Spasm:

1 to 12 years:
Oral: 0.12 to 0.8 mg/kg/day in divided doses every 6 to 8 hours as needed.

IM: 0.04 to 0.3 mg/kg every 2 to 4 hours as needed, up to a maximum of 0.6 mg/kg in 8 hours.

Febrile seizure prophylaxis in children: Oral: 1 mg/kg/day orally in divided doses every 8 hours. Initiate therapy at first sign of fever and continue for 24 hours after fever resolves.

Usual Pediatric Dose for Seizure Prophylaxis:

1 to 12 years:
Oral: 0.12 to 0.8 mg/kg/day in divided doses every 6 to 8 hours as needed.

IM: 0.04 to 0.3 mg/kg every 2 to 4 hours as needed, up to a maximum of 0.6 mg/kg in 8 hours.

Febrile seizure prophylaxis in children: Oral: 1 mg/kg/day orally in divided doses every 8 hours. Initiate therapy at first sign of fever and continue for 24 hours after fever resolves.

Usual Pediatric Dose for Light Sedation:

Conscious sedation for procedures:
Oral:
1 to 12 years: 0.2 to 0.3 mg/kg orally 45 to 60 minutes before procedure, up to a maximum of 10 mg
13 to 18 years: 5 mg orally 45 to 60 minutes before procedure, may repeat with 2.5 mg dose.

Sedation:
1 to 12 years:
Oral: 0.02 to 0.3 mg/kg every 6 to 8 hours as needed.
IM: 0.04 to 0.3 mg/kg IM every 2 to 4 hours as needed, up to a maximum of 0.6 mg/kg in 8 hours.

13 to 18 years:
Oral: 2 to 10 mg 2 to 4 times a day as needed.
IM or IV: 2 to 10 mg 2 to 4 times a day as needed.

Usual Pediatric Dose for Tetanus:

Less than 1 month: 0.83 to 1.67 mg/kg/hour by continuous IV infusion, or 1.67 to 3.33 mg/kg IV, slowly, every 2 hours (20 to 40 mg/kg/day). Diazepam injection is not recommended as the drug of choice for neonates due to its benzyl alcohol and propylene glycol content.

1 month to 5 years: 1 to 2 mg IM or IV, slowly, repeated every 3 to 4 hours as necessary, or 15 mg/kg/day in divided doses every 2 hours.

Greater than 5 years: 5 to 10 mg IM or IV, slowly, repeated every 3 to 4 hours as necessary.

What other drugs will affect diazepam rectal?

Using diazepam with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using diazepam with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with diazepam rectal, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about diazepam rectal.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.01. Revision Date: 2014-05-01, 10:42:49 AM.

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