Clinical Pharmacology Details


VIGABATRIN


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Indications & Dose:

Adjunctive treatment of focal seizures with or without secondary generalisation not satisfactorily controlled with other antiepileptics (under expert supervision)



Child 1–23 months: Initially 15–20 mg/kg twice daily (max. per dose 250 mg), to be increased over 2–3 weeks to usual maintenance dose, usual maintenance 30–40 mg/kg twice daily (max. per dose 75 mg/kg)


Child 2–11 years: Initially 15–20 mg/kg twice daily (max. per dose 250 mg), to be increased over 2–3 weeks to usual maintenance dose, usual maintenance 30–40 mg/kg twice daily (max. per dose 1.5 g) Child 12–17 years: Initially 250 mg twice daily, to be increased over 2–3 weeks to usual maintenance dose, usual maintenance 1–1.5 g twice daily


Adult: Initially 1 g once daily, alternatively initially 1 g daily in 2 divided doses, then increased in steps of 500 mg every week, adjusted according to response; usual dose 2–3 g daily; maximum 3 g per day

Contraindications:

Visual field defects 

Side Effects:

Cautions:

Elderly . history of behavioural problems


PREGNANCY The dose should be monitored carefully during pregnancy and after birth, and adjustments made on a clinical basis.


BREAST FEEDING Present in milk— manufacturer advises avoid.


RENAL IMPAIRMENT In adults Consider reduced dose or increased dose interval if eGFR less than 60 mL/minute/1.73m2. In children Consider reduced dose or increased dose interval if estimated glomerular filtration rate less than 60 mL/minute/1.73m2 

Precautions:

Interaction:

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

 


CNS: Abnormal magnetic resonance imaging (MRI), abnormal behavior or dreams, acute psychosis, anxiety, apathy, asthenia, attention disturbance, confusion, coordination abnormality, delirium, depression, dizziness, encephalopathy, expressive language disorder, fatigue, fever, gait disturbance, headache, hyperreflexia, hypertonia, hypoaesthesia, hyporeflexia, hypomania, hypotonia, insomnia, irritability, lethargy, malaise, malignant hyperthermia, memory loss, myoclonus, nervousness paresthesia, peripheral neuropathy,postic-tal state, seizures, sensory disturbance, somnolence, status epilepticus, suicidal ideation, thirst, tremor, vertigo


CV: Chest pain, edema, peripheral edema


EENT: Asthenopia, blurred vision, deafness, diplopia, eye pain, laryngeal edema, nasopharyngitis, nystagmus, optic neuritis, pharyngolaryngeal pain, tinnitus, toothache, vision loss (severe), visual field defect


GI: Abdominal or stomach pain, cholesta-sis, constipation, decreased liver enzymes, diarrhea, distention, dyspepsia, esophagitis, GI hemorrhage, nausea, vomiting


GU: Dysmenorrhea, erectile dysfunction, UTI


HEME: Anemia


MS: Arthralgia; back or limb pain; dysar-thria; muscle spasticity, spasms or twitching


RESP: Bronchitis, cough, pulmonary edema, respiratory failure, stridor, upper respiratory infection


SKIN: Facial edema, maculopapular rash, pruritus, Other: Angioedema, birth defects, developmental delay, influenza, multi-organ failure, weight gain 

Patient And Carer Advice: