Brevital Sodium

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

Tell your caregivers at once if you have any of these serious side effects:

• severe burning or swelling where the medicine was injected;
• seizure (convulsions);
• numbness or tingly feeling;
• feeling like you might pass out;
• fast heart rate;
• weak or shallow breathing; or
• confusion, anxiety, or restless feeling when coming out of anesthesia.

Less serious side effects may include:

• drowsiness;
• nausea, vomiting, stomach pain;
• chills or shivering;
• coughing, hiccups;
• muscle twitching; or
• mild skin rash or itching.

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.

You should not use this medicine if you are allergic to methohexital or other barbiturates (butabarbital, pentobarbital, phenobarbital, Luminal, Nembutal, Seconal, and others), or if you have:

• a history of porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

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

• epilepsy or other seizure disorder;

• asthma or chronic obstructive pulmonary disease (COPD);

• liver disease;

• kidney disease;

• anemia (lack of red blood cells);

• an endocrine disorder;

• high or low blood pressure;

• heart disease, congestive heart failure; or

• circulation problems.

Tell your doctor if you are pregnant.

Anesthesia medicine may affect brain development in a child under 3, or an unborn baby whose mother receives this medicine during late pregnancy. These effects may be more likely when the anesthesia is used for 3 hours or longer, or used for repeated procedures. Effects on brain development could cause learning or behavior problems later in life.

Negative brain effects from anesthesia have been seen in animal studies. However, studies in human children receiving single short uses of anesthesia have not shown a likely effect on behavior or learning. More research is needed.

In some cases, your doctor may decide to postpone a surgery or procedure based on these risks. Treatment may not be delayed in the case of life-threatening conditions, medical emergencies, or surgery needed to correct certain birth defects.

Ask your doctor for information about all medicines that will be used during your surgery or procedure. Also ask how long the procedure will last.

It is not known whether methohexital passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Since methohexital is used as a single dose, it does not have a daily dosing schedule.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

Tell your caregivers right away if you have:

• severe burning or swelling where the medicine was injected;

• fast heartbeats;

• numbness or tingly feeling;

• a light-headed feeling, like you might pass out;

• weak or shallow breathing; or

• confusion, anxiety, or restless feeling when coming out of anesthesia.

Side effects such as confusion, depression, or excitement may be more likely in older adults and those who are ill or debilitated.

Common side effects may include:

• drowsiness;

• nausea, vomiting, stomach pain;

• chills or shivering;

• coughing, hiccups;

• muscle twitching; or

• mild skin rash or itching.

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.

• If you have an allergy to methohexital or any other part of Brevital Sodium (methohexital).
• 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 porphyria.

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 Brevital Sodium with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your 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 until the effects of Brevital Sodium wear off and you feel fully awake.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this medicine.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Brevital Sodium.
• 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 this medicine during the third trimester of pregnancy. Talk with the doctor.
• Use with care in children. Talk with the doctor.
• If you are 65 or older, use Brevital Sodium with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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.
• Very bad dizziness or passing out.
• A fast heartbeat.
• Feeling confused.
• Trouble breathing, slow breathing, or shallow breathing.
• Seizures.
• Restlessness.
• Anxiety.
• This drug 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.

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:

• Upset stomach or throwing up.
• Feeling sleepy.
• Headache.
• Hiccups.
• Cough.
• Twitching.
• Belly pain.
• Drooling.
• Runny nose.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Summary of Use during Lactation

Amounts of methohexital in milk are very small. Existing data indicate that no waiting period is required before resuming breastfeeding after a single dose of methohexital. Breastfeeding can be resumed as soon as the mother has recovered sufficiently to nurse.[1] When a combination of anesthetic agents is used for a procedure, follow the recommendations for the most problematic medication used during the procedure.

Drug Levels

Maternal Levels. Nine women who were at least 1 month postpartum received between 120 and 150 mg of methohexital intravenously for induction of general anesthesia for bilateral tubal ligation. Milk samples were obtained in the recovery room after surgery, the evening of surgery and on the day after surgery. The highest milk level was found at 63 minutes after the dose in one woman. Milk levels 1 to 2 hours after the dose ranged from 100 to 407 mcg/L (n = 5); levels 2 to 4 hours after the dose ranged from 39 to 199 mcg/L (n = 4); levels 8 to 10 hours after the dose ranged from undetectable (<20 mcg/L) to 65 mcg/L (n = 9). Methohexital was not detectable in the breastmilk of any woman 24 to 48 hours after the dose. The authors estimated that the typical breastfed infant would receive a maximum single dose of 0.04 mg of methohexital in a 100 mL feeding 1 hour after the dose or between 0.1 to 0.8% of the maternal weight-adjusted dosage.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Etomidate, Propofol, Thiopental

References

1. Borgatta L, Jenny RW, Gruss L et al. Clinical significance of methohexital, meperidine, and diazepam in breast milk. J Clin Pharmacol. 1997;37:186-92. PMID: 9089420