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PHENOBARBITAL SODIUM 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: An anti-convulsant for the treatment all forms of epilepsy except absence seizures.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults 50 - 200mg as a single dose by intramuscular, subcutaneous or, after dilution 1 in 10 with Water for Injection, by intravenous injection, repeated, if necessary, after 6 hours. Paediatric population 3 - 5mg per kg body weight as a single dose by intramuscular injection.
Method of administration Intramuscular, subcutaneous or intravenous injection
Antiepileptic hypersensitivity syndrome may occur. Symptoms include fever, rash, lymphadenopathy and hepatitis. Blood and the lymphatic system disorders: megaloblastic anaemia (due to folate deficiency), agranulocytosis, thrombocytopenia.
Metabolism and nutritional disorders: osteomalacia, rickets. 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.
4) very rarely.
Musculoskeletal, connective tissue and bone disorders:
Frequency not known: Dupuytren's contracture, frozen shoulder, arthralgia, osteomalacia, 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.
Reproductive system and breast disorders Frequency not known:
Peyronie's disease. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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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 Sodium. 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.
Phenobarbital should be used with caution in the young, elderly, senile or debilitated patient and those with renal impairment, existing liver disease or respiratory depression, (should be avoided if severe) pregnancy, breastfeeding and porphyria.
Prolonged use may result in dependence of the alcohol-barbiturate type and care must be taken in treating patients with a history of drug abuse or alcoholism. 2. Subcutaneous injection can cause tissue necrosis. Sudden withdrawal should be avoided as severe withdrawal syndrome (rebound insomnia, anxiety, tremor, dizziness, nausea, fits and delirium) may be precipitated.
1. Severe respiratory depression. Acute intermittent porphyria. Severe impairment of renal or hepatic function.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Phenobarbital in United Kingdom.
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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.
Acute chronic pain – paradoxical excitement may be induced or important symptoms masked. Herbal preparations containing St John’s wort (Hypericum perforatum) should not be used while taking phenobarbital due to the risk of decreased plasma concentrations and reduced clinical effects of phenobarbital Women of childbearing potential Phenobarbital may cause foetal harm when administered to a pregnant woman.
6). Phenobarbital should not be used in women of childbearing potential unless the potential benefit is judged to outweigh the risks following consideration of other suitable treatment options. Women of childbearing potential should be fully informed of the potential risk to the foetus if they take phenobarbital during pregnancy.
A pregnancy test to rule out pregnancy should be considered prior to commencing treatment with phenobarbital in women of childbearing potential. Women of childbearing potential should use highly effective contraception during treatment and for 2 months after the last dose.
Due to enzyme induction, phenobarbital may result in a failure of the therapeutic effect of oral contraceptive drugs containing oestrogen and/or progesterone. 6). Women planning a pregnancy should be advised to consult in advance with their physician so that adequate counselling can be provided and appropriate other treatment options can be discussed prior to conception and before contraception is discontinued.
Women of childbearing potential should be counselled to contact their doctor immediately if they become pregnant or think they might be pregnant while on treatment with phenobarbital. 9g of propylene glycol per ml of undiluted product.
Propylene glycol in high doses may cause central nervous system side-effects, lactic acidosis, kidney and liver toxicity, increase in plasma osmolarity, and haemolytic reactions.