Loading…
PHENOBARBITAL PHARMVIT is a brand name for Phenobarbital (also known as Phenobarbitone). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For all forms of epilepsy except absence seizures.
Verbatim from this product's MHRA label. Tap a section to expand.
Adults and the elderly: 60 - 180 mg daily at night. Children: 5 - 8 mg per kg bodyweight daily.
Elderly:
Phenobarbital clearance diminishes in the elderly. Therefore the dose of phenobarbital is usually lower in elderly patients. The dose of phenobarbital should be adjusted to meet the needs of individual patients. This usually requires plasma concentration of 15 to 40 micrograms/ml (65 to 170 micromoles/litre).
Caution must be exercised in the treatment of elderly patients with careful monitoring of their condition.
Administration:
Oral; the tablets should be swallowed with water.
• Blood and the lymphatic system disorders: megaloblastic anaemia (due to folate deficiency), agranulocytosis, thrombocytopenia. • Metabolism and nutritional disorders: osteomalacia have been associated with barbiturate administration, rickets.
There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with phenobarbital. The mechanism by which phenobarbital affects bone metabolism has not been identified.
• Psychiatric disorders: paradoxical reaction (unusual excitement), hallucinations, restlessness and confusion in the elderly, mental depression, memory and cognitive impairment, drowsiness, lethargy. • Nervous system disorders: hyperactivity, behavioural disturbances in children, ataxia, nystagmus.
• Cardiac disorders: hypotension. • Respiratory disorders: respiratory depression. • Hepato-bilary: hepatitis, cholestasis. • Skin and subcutaneous tissue disorders: allergic skin reactions (maculopapular morbilliform or scarlatiniform rashes), other skin reactions such as exfoliative dermatitis, erythema multiforme and toxic epidermal necrolysis are extremely rare.
4). Frequency: very rare • General disorders and administration site conditions: antiepileptic hypersensitivity syndrome (features include fever, rash, lymphadenopathy, lymphocytosis, eosinophilia, haematological abnormalities, hepatic and other organ involvement including renal and pulmonary systems which may become life threatening).
Phenobarbital should be used with caution in the young, debilitated or senile patients and those with renal impairment, existing liver disease or respiratory depression (should be avoided if severe). Prolonged use may result in the dependence of the alcohol-barbiturate type and particular care should be taken in treating patients with a history of drug abuse or alcoholism.
Avoid sudden withdrawal to prevent rebound seizures. Suicidal ideation and behaviour have been reported in patients treated with anti- epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Phenobarbital. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Steven-Johnson syndrome and toxic epidermal necrolysis Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of phenobarbital.
Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. g. progressive skin rash often with blisters or mucosal lesions) are present, Phenobarbital treatment should be discontinued.
The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of phenobarbital, phenobarbital must not be re-started in this patient at any time.
1. Known hypersensitivity to barbiturates. 2. Hypersensitivity to any of the ingredients in this medicine. 3. Acute intermittent porphyria. 4. Severe respiratory depression. 5. Severe impairment of renal and hepatic function.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Phenobarbital in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Phenobarbital may interfere with some laboratory tests including metyrapone test, phenlolamine tests and serum bilirubin estimation Care should be used in the following situations: • Patients with the rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose – galactose malabsorption should not take this medicine • Respiratory depression (avoid if severe) • Young, debilitated or senile patients • Renal impairment • Existing liver disease • Sudden withdrawal should be avoided as severe withdrawal syndrome (rebound insomnia, anxiety, tremor, dizziness, nausea, fits and delirium) may be precipitated • Acute chronic pain – paradoxical excitement may be induced or important symptoms masked.
• Prolonged use may result in dependence of the alcohol-barbiturate type. Care should be taken in treating patients with a history of drug abuse or alcoholism.