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PHENOBARBITAL THORNTON & ROSS 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: As an anticonvulsant in the treatment of all forms of epilepsy except absence seizures.
Verbatim from this product's MHRA label. Tap a section to expand.
Oral RECOMMENDED DOSE AND DOSAGE SCHEDULE Usual adult daily dose: 60-200mg phenobarbital taken in 2 or 3 divided portions. Children: initially 3-6mg per kg body weight per day taken in 2 or 3 divided portions. Label states: for use as directed by the practitioner
The following adverse effects have been associated with use of phenobarbital. The most frequent adverse effect is sedation. Blood and lymphatic system disorders Agranulocytosis, macrocytic anaemia, megaloblastic anaemia, hypoprothrombinaemia, thrombocytopenia.
Methaemoglobinaemia in infants nursed by mothers receiving phenobarbital. 5). 4), vitamin K deficiency. Psychiatric disorders Abnormal behaviour, aggression and hyperactivity (particularly in children), agitation, confusional state, delirium, dependence.
4), withdrawal syndrome. Nervous system disorders Ataxia, cognitive impairment, dizziness, drowsiness, Grand Mal convulsion. headache, irritability, lethargy, memory impairment, nystagmus, sedation. Vascular disorders Hypotension. Respiratory, thoracic and mediastinal disorders Respiratory depression.
Hepato-biliary disorders Cholestasis, abnormal hepatic function, hepatitis. Skin and subcutaneous tissue disorders Exfoliative dermatitis, drug eruption, erythema multiforme, macropapular rash, mobilliform rash, photosensitivity, purpura, scarlatiniform rash, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Musculoskeletal, connective tissue and bone disorders Bone metabolism disorder, Dupuytren’s contracture, frozen shoulder, Ledderhose’s syndrome, Peyronie’s disease, fibromas, general joint pain, 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. Pregnancy, puerperium and perinatal conditions Neonatal sedation, neonatal drug dependence and withdrawal syndrome, neonatal bleeding due to vitamin K deficiency.
Congenital and familial/genetic disorders Cleft lip and palate, congenital anomaly General disorders and administration site conditions Antiepileptic hypersensitivity syndrome (including fever, rash, lymphadenopathy, lymphocytosis, eosinophilia, liver and other organ involvement).
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 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 Elixir. 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. Barbiturates are frequently used in suicidal attempts. In the presence of severe pain, barbiturates may fail to exert their hypnotic action and may cause wakefulness, excitement and delirium unless accompanied by an analgesic.
Phenobarbital should be used with caution in the young, the elderly, debilitated patients, those with depressive disorders, 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. There is still some debate on the effects of antiepileptics, including Phenobarbital, on bone metabolism.
It is therefore recommended that Vitamin D supplementation is considered in patients who are immobilised for long periods or who have inadequate sun exposure or dietary intake of Vitamin D or calcium. e. up to 21g based on a 65ml dose).
e. up to 501ml beer or 208ml wine based on a 65ml dose). The alcohol in this preparation is likely to effect children. These effects include feeling sleepy and change in behaviour. It may also affect patient’s ability to concentrate and take part in physical activities.
Contra-indicated in patients with known hypersensitivity to barbiturates or any other ingredient, with severe respiratory depression, with severely impaired hepatic or renal function, and in cases of acute intermittent porphyria. Also in hyperkinetic children
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.
Symptoms generally occur between 1 and 8 weeks after first exposure, or within 1 day of rechallenge in sensitised individuals, with potential cross reactivity to other antiepileptics. 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. uk/yellowcard.
The amount of alcohol in this medicine can affect patient ability to drive or use machines. The amount of alcohol in this medicine may alter the effects of other medicines. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
85mg/100ml. Care should be taken when giving to neonates as regular dosing could result in alcohol toxicity. Patients are advised to avoid other sources of alcohol while using this medicine. 5). 1mg benzyl alcohol in each 65ml dose which may cause allergic reactions.
Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called gasping syndrome) in young children. Do not use for more than a week in young children (less than 3 years old) increased risk due to accumulation.
High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment, or during pregnancy or breast feeding, because of the risk of accumulation and toxicity (metabolic acidosis). The medicine contains a large proportion of glycerol.
This may cause headache, stomach upset and diarrhoea. This medicine also contains tartrazine (E102) and sunset yellow FCF (E110) colours, which may cause allergic reactions. 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 her 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 her doctor immediately if she becomes pregnant or thinks she may be pregnant while on treatment with phenobarbital.