Phenobarbital (Intravenous route)

Pronunciation:

fee-noe-BAR-bi-tal SOE-dee-um

Dosage Forms:

Powder for Solution

Warnings:

Intravenous route(Powder for Solution)

Risks from Concomitant Use with OpioidsConcomitant use of phenobarbital products including phenobarbital sodium powder for solution, and opioids, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients whom alternative treatment options are inadequate. If a decision is made for concomitant use of these drugs, limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression and sedation.Dependence and Withdrawal Reactions After Use of Phenobarbital Sodium Powder for Solution for a Longer Duration than RecommendedThe continued use of phenobarbital may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although phenobarbital sodium powder for solution is indicated only for short-term use, if used for a longer duration than recommended, abrupt discontinuation or rapid dosage reduction of phenobarbital sodium powder for solution may precipitate acute withdrawal reactions, which can be life-threatening. For patients receiving phenobarbital sodium powder for solution for longer duration than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue phenobarbital sodium powder for solution.Abuse, Misuse, and Addiction with Unapproved Use in Adolescents and AdultsPhenobarbital sodium powder for solution is not approved for use in adolescent or adults. The unapproved use of phenobarbital sodium powder for solution, in adolescents and adults exposes them to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of phenobarbital commonly involve concomitant use of other drugs, alcohol, and/or illicit substances, which is associated with and increased frequency of serious adverse outcomes .

Classifications:

Therapeutic—

Anticonvulsant

Pharmacologic—

Phenobarbital

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

No information is available on the relationship of age to the effects of phenobarbital injection in geriatric patients.

Breast-feeding—

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.

Other medicines—

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
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
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
Benperidol
Benzhydrocodone
Bepridil
Bictegravir
Bosutinib
Brigatinib
Bromazepam
Bromocriptine
Bromopride
Budesonide
Buprenorphine
Bupropion
Buserelin
Buspirone
Butabarbital
Butalbital
Butorphanol
Cabozantinib
Calcifediol
Calcium Oxybate
Cannabidiol
Cannabis
Capivasertib
Capmatinib
Carbamazepine
Carbinoxamine
Carisoprodol
Carmustine
Carphenazine
Carvedilol
Celecoxib
Cenobamate
Ceritinib
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chloroquine
Chlorpromazine
Chlorzoxazone
Cilostazol
Ciprofloxacin
Cisapride
Citalopram
Clarithromycin
Clindamycin
Clobazam
Clofazimine
Clonazepam
Clopidogrel
Clorazepate
Clozapine
Cobimetinib
Codeine
Colchicine
Conivaptan
Copanlisib
Crizotinib
Cyclobenzaprine
Cyclophosphamide
Cyclosporine
Dabigatran Etexilate
Dabrafenib
Daclatasvir
Dantrolene
Daridorexant
Darifenacin
Darolutamide
Dasatinib
Deferasirox
Deflazacort
Degarelix
Delavirdine
Deslorelin
Desogestrel
Deutetrabenazine
Dexamethasone
Dexmedetomidine
Diacetylmorphine
Diazepam
Dichloralphenazone
Dicumarol
Dienogest
Difenoxin
Dihydrocodeine
Dihydroergotamine
Diltiazem
Diphenhydramine
Diphenoxylate
Disopyramide
Disulfiram
Ditiocarb Sodium
Docetaxel
Dofetilide
Dolasetron
Dolutegravir
Domperidone
Donepezil
Doxorubicin
Doxorubicin Hydrochloride Liposome
Doxylamine
Dronedarone
Droperidol
Drospirenone
Duvelisib
Ebastine
Edoxaban
Efavirenz
Elacestrant
Elagolix
Elbasvir
Eletriptan
Elexacaftor
Encorafenib
Enflurane
Entrectinib
Enzalutamide
Eplerenone
Eravacycline
Erdafitinib
Ergotamine
Eribulin
Erlotinib
Escitalopram
Esketamine
Eslicarbazepine Acetate
Esomeprazole
Estazolam
Estetrol
Estradiol
Eszopiclone
Ethchlorvynol
Ethinyl Estradiol
Ethopropazine
Ethylmorphine
Ethynodiol
Etonogestrel
Etravirine
Everolimus
Famotidine
Fedratinib
Felbamate
Felodipine
Fentanyl
Fexinidazole
Finerenone
Fingolimod
Flecainide
Fluconazole
Flunitrazepam
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluticasone
Fluvastatin
Fluvoxamine
Formoterol
Fosamprenavir
Fosaprepitant
Foscarnet
Fosnetupitant
Fosphenytoin
Fospropofol
Fostamatinib
Fostemsavir
Fruquintinib
Gabapentin
Gabapentin Enacarbil
Galantamine
Gatifloxacin
Gemifloxacin
Gestodene
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Gonadorelin
Goserelin
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Hemin
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Hydroxyzine
Ibrexafungerp
Ibrutinib
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Idelalisib
Ifosfamide
Iloperidone
Imatinib
Indinavir
Infigratinib
Inotuzumab Ozogamicin
Irbesartan
Irinotecan
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Isoflurane
Istradefylline
Itraconazole
Ivabradine
Ivacaftor
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Ixazomib
Ketamine
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Ketobemidone
Ketoconazole
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Lapatinib
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Lorazepam
Lorlatinib
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Losartan
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Loxapine
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Lurasidone
Macimorelin
Magnesium Oxybate
Maribavir
Meclizine
Medazepam
Medroxyprogesterone
Mefloquine
Melperone
Meperidine
Mephenesin
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Mestranol
Metaxalone
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Methdilazine
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Methohexital
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Methylene Blue
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Mitapivat
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Mobocertinib
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Moricizine
Morphine
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Naldemedine
Naloxegol
Nateglinide
Nelfinavir
Neratinib
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Nifedipine
Nilotinib
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Nintedanib
Nirogacestat
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Nitisinone
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Nitrous Oxide
Nomegestrol
Norelgestromin
Norethindrone
Norfloxacin
Norgestimate
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Octreotide
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Oliceridine
Olutasidenib
Omaveloxolone
Omeprazole
Ondansetron
Opium
Opium Alkaloids
Orlistat
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Osilodrostat
Osimertinib
Oxaliplatin
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Oxcarbazepine
Oxycodone
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Ozanimod
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Panobinostat
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Papaveretum
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Paregoric
Paroxetine
Pasireotide
Pazopanib
Pemigatinib
Pentamidine
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Pentobarbital
Perampanel
Perazine
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Perphenazine
Phenindione
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Pirtobrutinib
Pitolisant
Ponesimod
Posaconazole
Potassium Oxybate
Pralsetinib
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Praziquantel
Pregabalin
Pretomanid
Primidone
Probenecid
Probucol
Procainamide
Procarbazine
Prochlorperazine
Progesterone
Promazine
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Propafenone
Propofol
Quazepam
Quercetin
Quetiapine
Quinidine
Quinine
Quizartinib
Ramelteon
Reboxetine
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Remimazolam
Remoxipride
Repaglinide
Repotrectinib
Ribociclib
Rifabutin
Rifampin
Rimegepant
Ripretinib
Risperidone
Roflumilast
Rolapitant
Ropeginterferon Alfa-2b-njft
Rosiglitazone
Salmeterol
Samidorphan
Saquinavir
Saxagliptin
Scopolamine
Secobarbital
Segesterone
Selexipag
Selpercatinib
Selumetinib
Sertindole
Sertraline
Sevoflurane
Sildenafil
Simeprevir
Simvastatin
Siponimod
Sirolimus
Sodium Oxybate
Sodium Phosphate
Sodium Phosphate, Dibasic
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Solifenacin
Sonidegib
Sorafenib
Sotalol
Sparfloxacin
St John's Wort
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Sunitinib
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Tacrolimus
Tamoxifen
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Tapentadol
Tazemetostat
Telavancin
Telithromycin
Temazepam
Temsirolimus
Teniposide
Tepotinib
Terfenadine
Tetrabenazine
Tezacaftor
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Thiotepa
Ticagrelor
Ticlopidine
Tilidine
Tipranavir
Tivozanib
Tizanidine
Tolbutamide
Tolonium Chloride
Tolterodine
Tolvaptan
Toremifene
Torsemide
Trabectedin
Tramadol
Trazodone
Triazolam
Triclabendazole
Trifluoperazine
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Triflupromazine
Trimeprazine
Triptorelin
Tucatinib
Ubrogepant
Ulipristal
Upadacitinib
Valproic Acid
Vandetanib
Vardenafil
Velpatasvir
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Venetoclax
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Verapamil
Vilanterol
Vinblastine
Vincristine
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Vinflunine
Vinorelbine
Voclosporin
Vonoprazan
Vorapaxar
Vorinostat
Voxelotor
Voxilaprevir
Warfarin
Zaleplon
Zanubrutinib
Ziprasidone
Zolpidem
Zopiclone
Zotepine
Zuclopenthixol
Zuranolone

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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.

Last Updated: 4/24/2024

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