Sabril


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Related to Sabril: Rivotril

vigabatrin

(vye-gah-bat-rin) ,

Sabril

(trade name)

Classification

Therapeutic: anticonvulsants
Pregnancy Category: C

Indications

Management (adjunctive) of refractory complex partial seizures in patients who have responded inadequately to several alternative treatments (and where potential benefit outweighs risk of vision loss); not a first-line treatment.Management of infantile spasms (IS).

Action

Acts an irreversible inhibitor of γ-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous system.

Therapeutic effects

Decreased incidence and severity of refractory complex partial seizures.

Pharmacokinetics

Absorption: Completely absorbed following oral administration.
Distribution: Enters breast milk, remainder of distribution unknown.
Protein Binding: None.
Metabolism and Excretion: Minimal metabolism, mostly eliminated unchanged in urine.
Half-life: 7.5 hr.

Time/action profile (anticonvulsant effect)

ROUTEONSETPEAKDURATION
POunknown1 hr†12 hr‡
†blood level‡clinical benefit should be seen in 2–4 week for IS or within 3 mo for complex partial seizures

Contraindications/Precautions

Contraindicated in: History or high risk of other types of irreversible vision loss unless benefits of treatment clearly outweigh risks; Obstetric: Use only if the potential benefit justifies the potential risk to the fetus (may cause fetal harm); Lactation: Enters breast milk; breast feeding should be avoided.
Use Cautiously in: Renal impairment (dose modification recommended for CCr <50 mL/min);History of suicidal ideation; Geriatric: Consider age-related ↓ in renal function adjust dose accordingly (↑ risk of sedation/confusion); Pediatric: Abnormal MRI signal changes have been seen in infants.

Adverse Reactions/Side Effects

Central nervous system

  • suicidal thoughts (life-threatening)
  • confusional state (most frequent)
  • memory impairment (most frequent)
  • drowsiness (most frequent)
  • fatigue (most frequent)

Cardiovascular

  • edema

Dermatologic

  • stevens-johnson syndrome (life-threatening)
  • toxic epidermal necrolysis (life-threatening)

Ear, Eye, Nose, Throat

  • blurred vision (most frequent)
  • nystagmus (most frequent)
  • vision loss (most frequent)

Hematologic

  • anemia

Metabolic

  • weight gain (most frequent)

Musculoskeletal

  • arthralgia (most frequent)

Neurologic

  • abnormal coordination (most frequent)
  • tremor (most frequent)
  • peripheral neuropathy

Interactions

Drug-Drug interaction

Should not be used concurrently with other drugs having adverse ocular effects ; ↑ risk of additive toxicity.May ↓ phenytoin levels and effectiveness.

Route/Dosage

Refractory Complex Partial Seizures

Oral (Adults and Children >16 yr) 500 mg twice daily initially, may be ↑ in 500 mg increments every 7 days depending on response up to 1500 mg twice daily
Oral (Children 10–16 yr and >60 kg) 500 mg twice daily initially, may be ↑ in 500 mg increments every 7 days depending on response up to 1500 mg twice daily
Oral (Children 10–16 yr and 25–60 kg) 250 mg twice daily initially, may be ↑ every 7 days depending on response up to 1000 mg twice daily

Renal Impairment

Oral (Adults and Children ≥10 yr and ≥25 kg) CCr >50–80 mL/min—↓ dose by 25%; CCr >30–50 mL/min—↓ dose by 50%; CCr >10–30 mL/min—↓ dose by 75%

Infantile Spasms

Oral (Children 1 mo–2 yr) 50 mg/kg/day given in 2 divided doses initially, ↑ by 25-50 mg/kg/day increments every 3 days up to a maximum of 150 mg/kg/day; dosage adjustments are necessary for renal impairment.

Availability

Tablets: 500 mg
Powder packets for oral solution: 500 mg/packet

Nursing implications

Nursing assessment

  • Assess location, duration, and characteristics of seizure activity. Institute seizure precautions. Assess response to and continued need for vigabatrin periodically during therapy.
  • Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
  • Test vision at baseline (no later than 4 wks after starting), at least every 3 months during, and 3–6 months after discontinuation of therapy.
  • Assess for signs and symptoms of peripheral neuropathy (numbness or tingling or toes or feet, reduced lower limb vibration or position sensation, progressive loss of reflexes, starting at ankles).
  • Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
  • Lab Test Considerations: Monitor CBC periodically during therapy. May cause anemia.
    • May cause ↓ AST and ALT levels precluding use to detect hepatic injury.
    • May ↑ amino acids in urine causing false positive results of genetic metabolic diseases.

Potential Nursing Diagnoses

Risk for injury (Indications)
Disturbed sensory perception (Adverse Reactions)

Implementation

  • Available only through SHARE program of restricted distribution. Only prescribers and pharmacies registered in the program and patients enrolled in the program have access. Patients receive vigabatrin from a specialty pharmacy. Contact SHARE program at 1-888-45-SHARE.
  • Oral: Administer twice daily without regard to food.
    • Mix oral solution for babies by mixing the powder in each packet with 10 mL of water; may be cold or room temperature. Follow manufacturer's instruction for mixing oral solution. Oral solution may be administered at the same time as food, but should only be mixed with water.

Patient/Family Teaching

  • Enroll patient in SHARE Program. Instruct patient to take vigabatrin around the clock, as directed. Discuss with health care professional what to do if a dose is missed. Medication should be gradually discontinued to prevent seizures. Advise patient to read the Medication Guide before starting therapy and with each Rx refill in case of changes.
  • Educate patient on risks of vigabatrin. Inform patient of the risk of permanent vision loss, particularly loss of peripheral vision, and that vision loss may not be detected before it is severe and is irreversible. Emphasize the importance of monitoring vision every 3 months. Advise patient to notify health care professional immediately if changes in vision (not seeing as well as before starting therapy, tripping, bumping into things, more clumsy than usual, surprised by people or things coming in front of you that seem to come out of nowhere) or changes in infant's vision are suspected.
  • May cause drowsiness, ataxia, fatigue and confusion. Caution patient to avoid driving or other activities requiring alertness until response to medication is known. Tell patient not to resume driving until physician gives clearance based on control of seizure disorder.
  • Inform patients and families of risk of suicidal thoughts and behavior and advise that behavioral changes, emergency or worsening signs and symptoms of depression, unusual changes in mood, or emergence of suicidal thoughts, behavior, or thoughts of self-harm or rash should be reported to health care professional immediately.
  • Advise patient to notify health care professional if an increase in seizures, weight gain, or edema occurs or if sleepiness, ear infection, or irritability occurs in an infant.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken, to consult health care professional before taking any new medications and to avoid taking alcohol or other CNS depressants concurrently with lacosamide.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding. Encourage pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334; information is available at www.aedpregnancyregistry.org.

Evaluation/Desired Outcomes

  • Decreased seizure activity. If no substantial clinical benefit within 3 months of initiation, discontinue vigabatrin.
  • Decreased in infantile spasms. If no substantial clinical benefit within 2–4 wk of initiation, discontinue vigabatrin.

Sabril

A brand name for VIGABATRIN.
References in periodicals archive ?
Public health agency The US Food and Drug Administration on Monday announced the approval of the first generic version of Sabril (vigabatrin) in 500mg tablets for treating complex partial seizures, also called focal seizures, in patients ten years and older.
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Lundbeck's product pipeline includes therapies such as Cipralex/Lexapro, for depression; Ebixa, for Alzheimer's disease; Azilect, for Parkinson's disease; Sabril, for epilepsy; and Sycrest, for bipolar disorder.
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The only other FDA-approved treatment for infantile spasms is vigabatrin, sold under the brand name Sabril by Danish drugmaker H.
Sales of product Sabril (vigabatrin) for the treatment of epilepsy were DKK37m.
The animal data for vigabatrin (Sabril; C), an equal mixture of active and inactive enantiomers, suggest risk, as do the human data.
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Key: SLE = Systemic lupus erythematosus Generic Name Trade Name Indication Toxic retinopathy Plaquenil Hydroxychloroquine Rheumatoid arthritis, SLE Tamoxyfen Nolvadex Breast cancer Vigabatrin Sabril Epilepsy anti-convulsant Chlorpromazine Largactil Anti-psychotic Desferrioxamine Desferal Anaemia Toxic optic neuropathy Ethambutol Isoniazid Rifina- Tuberculosis treatment Generic Name Visual side effect Toxic retinopathy Plaquenil Bull's eye maculopathy - blurred vision, altered colour Tamoxyfen Crystalline maculopathy - vision impaired if severe Vigabatrin Field restriction Chlorpromazine Blurred vision, abnormal colour (brownish tinge) Desferrioxamine Acuity reduction, scotomata, photopsia, metamorphopsia Toxic optic neuropathy Ethambutol Isoniazid Acuity and field loss, colourdefect-
Sabril Sarioglu then hit the base of Reina's right-hand post with a curling free-kick that neither Hakan Sukur or Umit Karan could convert on the rebound, while at the other end Kuyt also struck the woodwork with Gerrard's follow-up striking the prone Mondragon on the leg.
Clinical trials for the treatment of addiction with GVG--known as Sabril in Europe--are now underway in this country.
The controversial drug is also known as Sabril and has been available in the UK since 1989.