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Vigabatrin Brand Names
- Sabril
- VIGADRONE
What is Vigabatrin
Vigabatrin, an oral anticonvulsant, was synthesized in 1974 as a structural analog of gamma-aminobutyric acid (GABA) and was designed to inhibit the metabolism of GABA. Decreased concentrations of GABA have been associated with certain forms of epilepsy.
Vigabatrin has been investigated for the treatment of many seizure types but appears to be most effective in treating complex partial seizures and infantile spasms, particularly those associated with tuberous sclerosis complex (TSC).
Vigabatrin was the first drug to be FDA-approved for the treatment of infantile spasms, and it was the first real pharmacologic advancement in the treatment of this refractory seizure type since the introduction of ACTH in the late 1950s.
It has been used to treat patients with infantile spasms and refractory complex partial seizures in other countries for over 20 years and is available in over 50 countries worldwide.
The approval for the use of vigabatrin in the United States was delayed due to the FDA’s request for additional research on the visual field defects that are associated with vigabatrin use.
Due to the risk of permanent vision loss, vigabatrin is only available through a restricted distribution program.
Only prescribers and pharmacies registered with the program may prescribe and dispense vigabatrin.
Indications & Dosage
- infantile spasms
- partial seizures
For use as monotherapy in the treatment of infantile spasms in pediatric patients for whom the potential benefits outweigh the potential risk of vision loss
Side Effects
- abdominal pain
- abnormal magnetic resonance imaging (MRI) signal changes
- acne vulgaris
- agitation
- alopecia
- anemia
- angioedema
- anorexia
- anxiety
- appetite stimulation
- arthralgia
- asthenia
- back pain
- blurred vision
- candidiasis
- chest pain (unspecified)
- cholestasis
- confusion
- conjunctivitis
- constipation
- cough
- delirium
- dental pain
- depression
- diarrhea
- diplopia
- dizziness
- drowsiness
- dysarthria
- dyskinesia
- dysmenorrhea
- dyspepsia
- dystonic reaction
- edema
- encephalopathy
- esophagitis
- fatigue
- fever
- GI bleeding
- hallucinations
- headache
- hearing loss
- hepatitis
- hyperkinesis
- hyperreflexia
- hypertonia
- hypoesthesia
- hyporeflexia
- hypotonia
- impotence (erectile dysfunction)
- infection
- influenza
- insomnia
- irritability
- laryngeal edema
- lethargy
- maculopapular rash
- malaise
- malignant hyperthermia
- memory impairment
- muscle cramps
- myalgia
- myoclonia
- nasal congestion
- nausea
- nystagmus
- ocular pain
- optic neuritis
- paresthesias
- peripheral edema
- peripheral neuropathy
- pharyngitis
- polydipsia
- pruritus
- psychosis
- pulmonary embolism
- rash
- respiratory depression
- seizures
- sinusitis
- Stevens-Johnson syndrome
- suicidal ideation
- tinnitus
- toxic epidermal necrolysis
- tremor
- vertigo
- visual impairment
- vomiting
- weight gain
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- abrupt discontinuation
- breast-feeding
- children
- depression
- driving or operating machinery
- geriatric
- hepatic decompensation
- hepatic disease
- infants
- laboratory test interference
- neonates
- pregnancy
- renal impairment
- requires an experienced clinician
- substance abuse
- suicidal ideation
- visual impairment
Interactions
- Acetaminophen; Butalbital
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine; Dihydrocodeine
- Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
- Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
- Acetaminophen; Codeine
- Acetaminophen; Dextromethorphan; Doxylamine
- Acetaminophen; Dichloralphenazone; Isometheptene
- Acetaminophen; Diphenhydramine
- Acetaminophen; Hydrocodone
- Acetaminophen; Oxycodone
- Acetaminophen; Pentazocine
- Acetaminophen; Propoxyphene
- Acetaminophen; Tramadol
- Acrivastine; Pseudoephedrine
- Alfentanil
- Alprazolam
- Amitriptyline; Chlordiazepoxide
- Amobarbital
- Amphetamines
- Anxiolytics; Sedatives; and Hypnotics
- Aspirin, ASA; Butalbital; Caffeine
- Aspirin, ASA; Butalbital; Caffeine; Codeine
- Aspirin, ASA; Caffeine; Dihydrocodeine
- Aspirin, ASA; Carisoprodol; Codeine
- Aspirin, ASA; Oxycodone
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Azathioprine
- Azelastine; Fluticasone
- Barbiturates
- Beclomethasone
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Belladonna; Opium
- Benzhydrocodone; Acetaminophen
- Benzodiazepines
- Betamethasone
- Brompheniramine
- Brompheniramine; Carbetapentane; Phenylephrine
- Brompheniramine; Dextromethorphan; Guaifenesin
- Brompheniramine; Guaifenesin; Hydrocodone
- Brompheniramine; Hydrocodone; Pseudoephedrine
- Brompheniramine; Pseudoephedrine
- Budesonide
- Budesonide; Formoterol
- Buprenorphine
- Buprenorphine; Naloxone
- Bupropion
- Bupropion; Naltrexone
- Buspirone
- Butabarbital
- Butorphanol
- Cannabidiol
- Carbetapentane; Chlorpheniramine
- Carbetapentane; Chlorpheniramine; Phenylephrine
- Carbetapentane; Diphenhydramine; Phenylephrine
- Carbetapentane; Phenylephrine; Pyrilamine
- Carbetapentane; Pyrilamine
- Carbinoxamine
- Carbinoxamine; Dextromethorphan; Pseudoephedrine
- Carbinoxamine; Hydrocodone; Phenylephrine
- Carbinoxamine; Hydrocodone; Pseudoephedrine
- Carbinoxamine; Phenylephrine
- Carbinoxamine; Pseudoephedrine
- Chlophedianol; Dexbrompheniramine
- Chlophedianol; Dexchlorpheniramine; Pseudoephedrine
- Chloral Hydrate
- Chlorcyclizine
- Chlordiazepoxide
- Chlordiazepoxide; Clidinium
- Chloroquine
- Chlorpheniramine
- Chlorpheniramine; Codeine
- Chlorpheniramine; Dextromethorphan
- Chlorpheniramine; Dextromethorphan; Phenylephrine
- Chlorpheniramine; Dihydrocodeine; Phenylephrine
- Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
- Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
- Chlorpheniramine; Hydrocodone
- Chlorpheniramine; Hydrocodone; Phenylephrine
- Chlorpheniramine; Hydrocodone; Pseudoephedrine
- Chlorpheniramine; Phenylephrine
- Chlorpheniramine; Pseudoephedrine
- Ciclesonide
- Clemastine
- Clonazepam
- Clorazepate
- Codeine
- Codeine; Guaifenesin
- Codeine; Phenylephrine; Promethazine
- Codeine; Promethazine
- Corticosteroids
- Corticotropin, ACTH
- Cortisone
- Cyclizine
- Cyproheptadine
- Deferoxamine
- Deflazacort
- Deutetrabenazine
- Dexamethasone
- Dexchlorpheniramine
- Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine
- Dextromethorphan; Diphenhydramine; Phenylephrine
- Diazepam
- Diclofenac
- Diclofenac; Misoprostol
- Dihydrocodeine; Guaifenesin; Pseudoephedrine
- Dimenhydrinate
- Diphenhydramine
- Diphenhydramine; Hydrocodone; Phenylephrine
- Diphenhydramine; Ibuprofen
- Diphenhydramine; Naproxen
- Diphenhydramine; Phenylephrine
- Doxylamine
- Doxylamine; Pyridoxine
- Dronabinol
- Droperidol
- Esomeprazole; Naproxen
- Estazolam
- Eszopiclone
- Ethambutol
- Fentanyl
- Fludrocortisone
- Flunisolide
- Flurazepam
- Fluticasone
- Fluticasone; Salmeterol
- Fluticasone; Umeclidinium; Vilanterol
- Fluticasone; Vilanterol
- Formoterol; Mometasone
- Fosphenytoin
- Guaifenesin; Hydrocodone
- Guaifenesin; Hydrocodone; Pseudoephedrine
- Homatropine; Hydrocodone
- Hydrochlorothiazide, HCTZ; Losartan
- Hydrocodone
- Hydrocodone; Ibuprofen
- Hydrocodone; Phenylephrine
- Hydrocodone; Potassium Guaiacolsulfonate
- Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
- Hydrocodone; Pseudoephedrine
- Hydrocortisone
- Hydromorphone
- Hydroxychloroquine
- Hydroxyzine
- Ibuprofen; Oxycodone
- Interferons
- Lansoprazole; Naproxen
- Levorphanol
- Lorazepam
- Losartan
- Loxapine
- Maprotiline
- Mecasermin rinfabate
- Mecasermin, Recombinant, rh-IGF-1
- Meclizine
- Mefloquine
- Meloxicam
- Meperidine
- Meperidine; Promethazine
- Mephobarbital
- Meprobamate
- Methadone
- Methohexital
- Methylprednisolone
- Midazolam
- Mirtazapine
- Molindone
- Mometasone
- Morphine
- Morphine; Naltrexone
- Nabilone
- Nalbuphine
- Naproxen
- Naproxen; Pseudoephedrine
- Naproxen; Sumatriptan
- Nateglinide
- Opiate Agonists
- Oxazepam
- Oxycodone
- Oxymorphone
- Pemoline
- Pentazocine
- Pentazocine; Naloxone
- Pentobarbital
- Pentostatin
- Phenobarbital
- Phenothiazines
- Phenytoin
- Phosphodiesterase inhibitors
- Prednisolone
- Prednisone
- Primidone
- Propoxyphene
- Quazepam
- Ramelteon
- Remifentanil
- Secobarbital
- Sedating H1-blockers
- Sufentanil
- Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
- Temazepam
- Thiopental
- Thiothixene
- Tramadol
- Triamcinolone
- Triazolam
- Tricyclic antidepressants
- Triprolidine
- Warfarin
- Zaleplon
- Zolpidem