Sabril
vigabatrin
(vye-gah-bat-rin) vigabatrin,Sabril
(trade name)Classification
Therapeutic: anticonvulsantsIndications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (anticonvulsant effect)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
PO | unknown | 1 hr† | 12 hr‡ |
Contraindications/Precautions
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
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
Availability
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.