Description
Phenobarbital injection is used to treat seizures in babies. Phenobarbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.
This medicine is to be given only by or under the direct supervision of a doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of phenobarbital injection in term and preterm infants. Safety and efficacy have been established.
Geriatric
No information is available on the relationship of age to the effects of phenobarbital injection in geriatric patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Atazanavir
- Boceprevir
- Cabotegravir
- Cobicistat
- Darunavir
- Dasabuvir
- Delamanid
- Doravirine
- Elvitegravir
- Lonafarnib
- Maraviroc
- Mavacamten
- Nirmatrelvir
- Ombitasvir
- Paritaprevir
- Ranolazine
- Rilpivirine
- Ritonavir
- Rivaroxaban
- Telaprevir
- Tenofovir Alafenamide
- Voriconazole
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abemaciclib
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Abrocitinib
- Acalabrutinib
- Acenocoumarol
- Acepromazine
- Alfentanil
- Alfuzosin
- Alprazolam
- Amiodarone
- Amisulpride
- Amlodipine
- Amobarbital
- Amprenavir
- Anagrelide
- Anileridine
- Anisindione
- Apalutamide
- Apixaban
- Apomorphine
- Aprepitant
- Aprobarbital
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atogepant
- Atorvastatin
- Avacopan
- Avanafil
- Avapritinib
- Avatrombopag
- Axitinib
- Azithromycin
- Baclofen
- Bedaquiline
- Belumosudil
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Betamethasone
- Bexarotene
- Cortisone
- Digitoxin
- Ethosuximide
- Ginkgo
- Griseofulvin
- Leucovorin
- Levomethadyl
- Methylprednisolone
- Metoprolol
- Ospemifene
- Prednisone
- Rufinamide
- Theophylline
- Tiagabine
- Topiramate
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart or blood vessel disease (eg, heart failure, angina) or
- Heart rhythm problems (eg, QT prolongation, torsade de pointes) or
- Lung or breathing problems (eg, respiratory depression) or
- Porphyria (enzyme problem) or
- Stroke—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you or your child this medicine in a hospital. It is given through a needle that is placed in one of your veins. This medicine must be injected slowly, so your IV tube will need to stay in place for 15 minutes.
Precautions
It is very important that your doctor check your or your child's progress at regular visits, to make sure the medicine is working properly. Blood tests may be needed to check for any unwanted effects.
Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not suddenly stop using this medicine without checking first with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.
Signs of an overdose include: difficult or labored breathing, irregular, fast, slow, or shallow breathing, or pale or blue lips, fingernails, or skin.
Serious skin reactions (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis) can occur while using this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness with this medicine.
Tell your doctor right away if you or your child develop a fever, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, unusual bleeding or bruising, or yellow eyes or skin after using this medicine. These may be symptoms of a serious and life-threatening condition called drug reaction with eosinophilia and systemic symptoms (DRESS).
This medicine may cause serious allergic reactions, including rash, fever, face or limb edema, and lymphadenopathy. Check with your doctor right away if you have swelling or puffiness of the face, swollen, painful, or tender lymph glands in the neck, armpit, or groin.
Check with your doctor right away if you have chest pain or discomfort, irregular heartbeat recurrent, fainting, or trouble breathing. These may be symptoms of QT prolongation.
If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Some of the changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Phenobarbital may cause confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine 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 or nurse immediately if any of the following side effects occur:
More common
- Blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- relaxed and calm
- sleepiness
- sweating
- unusual tiredness or weakness
Less common
- Chest pain or discomfort
- chills
- coma
- confusion
- decreased urine output
- headache
- fever
- increased thirst
- muscle pain or cramps
- nausea or vomiting
- slow or irregular heartbeat
- swelling of the face, ankles, or hands
- trouble breathing
Incidence not known
- Black, tarry stools
- blistering, peeling, or loosening of the skin
- changes in behavior
- cough
- diarrhea
- dry, red, hot, or irritated skin
- itching
- joint or muscle
- loss of strength or energy
- muscle pain or weakness
- pale or blue lips, fingernails, or skin
- painful or difficult urination
- red irritated eyes
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- swelling of the face, throat, or tongue
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- thoughts of killing oneself
- unusual bleeding or bruising
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Change in consciousness
- changes in patterns and rhythms of speech
- confusion
- difficult or trouble breathing
- drowsiness
- hallucinations
- irregular, fast or slow, or shallow breathing
- loss of consciousness
- loss of strength or energy
- muscle pain or weakness
- pale or blue lips, fingernails, or skin
- shakiness and unsteady walk
- slurred speech
- trouble in speaking
- trouble sleeping
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual excitement, nervousness, restlessness, or irritability nightmares
- unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
- unusual weak feeling
Some side effects 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:
Incidence not known
- Skin rash, encrusted, scaly and oozing
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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