Nembutal

What is Nembutal ?

Nembutal is a prescription medicine that is used to treat sleep problems.

It is used to calm you before a procedure.

Nembutal is also used to treat seizures.

It is used to put you to sleep for surgery.

Nembutal may be given to you for other reasons. Talk to your doctor.

Description:

The barbiturates are nonselective central nervous system depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act (See “DRUG ABUSE AND DEPENDENCE” section).

The sodium salts of amobarbital, pentobarbital, phenobarbital, and secobarbital are available as sterile parenteral solutions.

Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system (CNS) activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring.

NEMBUTAL Sodium Solution (pentobarbital sodium injection) is a sterile solution for intravenous or intramuscular injection. Each mL contains pentobarbital sodium 50 mg, in a vehicle of propylene glycol, 40%, alcohol, 10% and water for injection, to volume. The pH is adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.

NEMBUTAL Sodium is a short-acting barbiturate, chemically designated as sodium 5-ethyl-5-(1-methylbutyl) barbiturate. The structural formula for pentobarbital sodium is:

The sodium salt occurs as a white, slightly bitter powder which is freely soluble in water and alcohol but practically insoluble in benzene and ether.

Before taking Nembutal, tell your doctor:

• If you are allergic to Nembutal; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had porphyria.
• If you have liver disease.

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 Nembutal with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Nembutal?

• Tell all of your health care providers that you take Nembutal. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until the effects of Nembutal wear off and you feel fully awake.
• Have your blood work checked if you are on Nembutal for a long time. Talk with your doctor.
• This medicine may be habit-forming with long-term use.
• Use Nembutal for short periods of time. If signs show up again, talk with the doctor.
• If you have been taking Nembutal on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking Nembutal all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
• Avoid drinking alcohol while taking Nembutal.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you are 65 or older, use Nembutal with care. You could have more side effects.
• Studies in young animals and children have shown that frequent or long-term use of anesthesia drugs or drugs used for sleep in children younger than 3 years of age may lead to long-term brain problems. This may also happen in unborn babies if the mother uses Nembutal during the third trimester of pregnancy. Talk with the doctor.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Nembutal.
• 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 Nembutal, call your doctor right away.
• Long-term use of Nembutal during pregnancy may cause dependence in the unborn baby or newborn. Talk with the doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Nembutal taken?

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

• It is given as a shot into a muscle or vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Nembutal that I need to call my doctor about immediately?

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:

For all uses of Nembutal:

• 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble breathing, slow breathing, or shallow breathing.
• Very bad dizziness or passing out.
• Feeling nervous and excitable.
• Feeling confused.
• Low mood (depression).

Injection (if given in the muscle):

• Pain and irritation where Nembutal goes into the body.

Injection (if given in the vein):

• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.

What are some other side effects of Nembutal?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How supplied/stored

Label

• Principal Display Panel Text for Container Label:
• NDC 76478-501-20 20 mL Sterile Solution
• Nembutal®
• Sodium Solution
• (pentobarbital sodium injection, USP)
• 50 mg/mL CII
• For Intravenous or Intramuscular Use.
• Multiple-dose Vial. LATEX-FREE
• Rx only Akorn logo