Drugs List

Therapeutic Indications

Uses

Epilepsy - partial seizures
Epilepsy - tonic-clonic seizures

Contraindications

Neonates under 1 month
Within 2 weeks of discontinuing MAOIs
Atrioventricular block
History of myelosuppression
Porphyria

Precautions and Warnings

East Asian ancestry
Elderly
Breastfeeding
Cardiac impairment
Glaucoma
Haematological disorder
Hepatic impairment
History of drug induced haematological reactions
Pregnancy
Renal impairment
Urinary retention

Advise impaired alertness may affect ability to drive or operate machinery
Confirm HLA-B 1502 status in Han Chinese & Thai patients before initiating
Cross sensitivity can occur with other antiepileptics
Folic acid 5mg daily required pre-conception to end of 1st trimester
Increased risk of osteomalacia; consider vitamin D supplement
Prescribe by manufacturer's product to ensure seizure control maintenance
Increase in seizures may occur during switch from oral to suppositories
Short term (7 day) replacement for oral forms when oral route not available
Blood counts should be performed before and periodically during treatment
Monitor hepatic function before treatment and regularly during treatment
Perform urine analysis before and periodically during treatment
Breastfeeding: Monitor infant for systemic effects of treating the mother
Monitor patients at risk of glaucoma for increases in intraocular pressure
Monitor plasma sodium in patients at risk of hyponatraemia
Monitor renal function
Monitor serum biochemistry regularly
Monitor thyroid function regularly
Plasma level monitoring may be useful: refer to local guidelines
Refer women considering pregnancy for specialist advice and monitoring
Advise patient to seek medical advice if severe skin reaction occurs
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Advise patients/carers to seek medical advice if suicidal intent develops
Consult Dr.at once if rash, sore throat, mouth ulcers, bruising,fever occur
May cause activation of latent psychosis
May cause agitation and confusion in the elderly
Avoid abrupt withdrawal
Discontinue if epilepsy is exacerbated
Discontinue if evidence of significant bone marrow depression
Discontinue if hypersensitivity reactions occur
Discontinue if severe skin reaction occurs
Discontinue if significant leucopenia occurs
Discontinue if significant/persistent hepatic function abnormalities occur
Bioavailability differs with preparations;caution on changing formulations
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise patient grapefruit products may increase plasma level
May affect spermatogenesis
Female: Non-hormonal contraception or minimum 50mcg oestrogen advised
Neonate exposed in utero: Administer vitamin K at birth
Pregnancy: Administer vitamin K in the last few weeks of pregnancy

Severe dermatological reactions
Severe dermatological reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome have been rarely reported during treatment with carbamazepine. These reactions usually appear within the first few months of treatment. The HLA-B*1502 allele has been strongly associated with risk of developing Stevens-Johnson syndrome. Genetic screening of patients who are of Han Chinese or Thai origin should be considered as the HLA-B*1502 allele is more prevalent in these populations (approximately 10%). If patient tests positive for this allele carbamazepine treatment should not be initiated unless there is no other therapeutic option.

Severe dermatological reactions have also been associated with the HLA-A*3101 allele in European and Japanese populations. There is currently there is insufficient data to support genetic testing for this allele, although if a patient is known to be positive for the allele, the use of carbamazepine may be considered if the benefits are thought to outweigh the risk.

Milder reactions (macular and maculopapular exanthema) may also occur and may dissipate upon dose reduction or continued treatment; these patients should be monitored closely for potential immediate withdrawal on worsening reaction.

Antiepileptic drug hypersensitivity
Patients usually present with fever, rash, lymphadenopathy and other organ system involvement. Other possible symptoms include liver dysfunction, haematological, renal and pulmonary abnormalities, vasculitis and multi-organ failure. If signs or symptoms of hypersensitivity syndrome occur, the drug should be withdrawn immediately and expert advice sought.

Suicidal ideation
Antiepileptic treatment is associated with a small increased risk of suicidal thoughts and behaviour, available data suggest that the increased risk applies to all antiepileptics and is seen as early as one week after starting treatment. Patients (and carers of patients) should be alert to any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment. They should be advised to seek medical advice if they develop such thoughts or behaviour, and should be referred for appropriate treatment if necessary.
The available evidence does not define whether the risk of suicidal thoughts and behaviour differs between antiepileptics. Patients should not stop or switch treatment on the basis of this information and without speaking to a healthcare professional.

Pregnancy and Lactation

Pregnancy

Use carbamazepine with caution in pregnancy.

Use minimum effective doses cautiously in pregnancy, with monitoring of plasma concentrations.

Women of child bearing potential wherever possible should be prescribed monotherapy. The incidence of congenital abnormalities is less in the offspring of monotherapy patients. There is an increased risk of teratogenicity during pregnancy, particularly if the woman is being treated with a combination of antiepileptic drugs.

Folic acid deficiency is known to occur during pregnancy. Antiepileptic medication is known to aggravate this deficiency. It is recommend that folic acid 5 mg daily should be prescribed to all women with epilepsy who are taking antiepileptic drugs, prior to conception and continued until the 12th week of pregnancy.

Use of carbamazepine in pregnancy is associated with an increase in both minor and major malformations. There are reports of developmental disorders and malformations, including spina bifida, and also other congenital anomalies e.g. craniofacial defects, cardiovascular malformations, hypospadias and anomalies involving various body systems. However, developmental disorders including malformations have occurred in the offspring of mothers with untreated epilepsy. Patients should be counselled regarding the possibility of increased risk of malformations and given the opportunity of antenatal screening.

Adjusting or stopping any anti-epileptic medication during pregnancy should not be done without specialist advice, and the relative benefits and risks should be discussed carefully first. The risk of inadequate seizure control may be more detrimental to the foetus than the use of antiepileptic drugs. Pregnancy in epileptic women is associated with a higher risk of congenital abnormalities, which are mainly associated with the use of anti-epileptic drugs rather than the disease itself. This risk is increased when multiple drugs are used. Routine monitoring of antiepileptic drugs is not recommended, but may be useful in cases where seizures have increased or are likely to, in order to plan the extent of dose adjustment needed.

Maternal use of carbamazepine with a concurrent second antiepileptic has in some cases resulted in neonatal seizures and/or respiratory depression. Neonatal vomiting, diarrhoea and/or decreased feeding have also been reported. These reactions may represent a neonatal withdrawal syndrome. Vitamin K1 should be given to the mother during the later stages of pregnancy as well as to the newborn to prevent bleeding disorders in the infant.

Animal studies in mice, rats and rabbits found an increased embryo mortality when administered during organogenesis at maternally toxic doses (20 times the usual human dosage). Rat foetuses also showed growth retardation at maternally toxic doses.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use carbamazepine with caution in breastfeeding.

Carbamazepine passes into breast milk (about 25 to 60% of the plasma concentrations).

The benefits of breast feeding should be weighed against the remote possibility of adverse events happening in the infant.
Mothers treated with carbamazepine may breast feed their infants provided the infant is monitored for adverse reactions such as vomiting, sedation, poor sucking, withdrawal reactions and hepatic dysfunction. If these occur, the concentration of carbamazepine in the infant's serum should be measured, and liver values also measured in suspicious cases.

Monitor the infant for jaundice, drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsant or psychotropic drugs.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acne
Acute intermittent porphyria
Aggravation of coronary artery disease
Aggression
Agitation
Agranulocytosis
Allergic skin reactions
Anaphylactic reaction
Angioedema
Aplastic anaemia
Arrhythmias
Arthralgia
Aseptic meningitis
Atrioventricular block
Bradycardia
Changes of blood pressure
CNS disturbances
Confusion
Congestive cardiac failure
Decrease in plasma calcium
Decreased appetite
Delayed hypersensitivity reactions
Depression
Dyspnoea
Elevation of liver enzymes
Eosinophilia
Erythema multiforme
Erythema nodosum
Erythroderma
Exfoliative dermatitis
Fever
Fluid retention
Folic acid deficiency
Galactorrhoea
Gastro-intestinal symptoms
Glossitis
Gynaecomastia
Haemolytic anaemia
Hair loss
Hallucinations
Hearing disturbances
Hepatic failure
Hepatitis
Hepatosplenomegaly
Hirsutism
Hypersensitivity reactions
Hypogammaglobulinaemia
Hyponatraemia
Impaired renal function
Increase in plasma cholesterol
Increased intra-ocular pressure
Increased prolactin
Interference with spermatogenesis
Interstitial nephritis
Involuntary movement disorders
Jaundice
Leucocytosis
Leucopenia
Lymphadenopathy
Lymphoma-like disorder
Megaloblastic anaemia
Muscle weakness
Muscular cramps
Neuroleptic malignant syndrome
Osteomalacia
Pancreatitis
Paraesthesia
Paretic symptoms
Peripheral neuropathy
Photosensitivity
Pneumonia
Pneumonitis
Possible alteration of thyroid function tests
Proteinuria
Pruritus
Psychosis
Purpura
Rectal irritation
Red cell aplasia
Renal failure
Reticulocytosis
Sexual disturbances
Skin pigmentation changes
Speech disturbances
Stevens-Johnson syndrome
Stomatitis
Sweating
Syncope
Systemic lupus erythematosus
Taste disturbances
Thrombocytopenia
Thromboembolism
Thrombophlebitis
Toxic epidermal necrolysis
Urinary frequency
Urinary retention
Urticaria
Vanishing bile duct syndrome
Visual disturbances
Weight gain

Presentation

Suppositories containing carbamazepine

Drugs List

Therapeutic Indications

Uses

Epilepsy - partial seizures
Epilepsy - tonic-clonic seizures

Dosage

Dose adjustment should always depend on the clinical response in the individual patient. Monitoring of plasma levels may be useful in certain conditions.

The suppositories are intended for short term use (7 days of less) in patients where the oral route is temporarily not available, for example post-operatively or in unconscious subjects.

Adults

Elderly

Children

Additional Dosage Information

Therapeutic Drug Monitoring

Refer to local therapeutic drug monitoring service for specific local carbamazepine guidelines.

Monitoring of plasma levels may be useful in certain conditions: dramatic increase in seizure frequency, verification of patient compliance, during pregnancy, when treating children or adolescents, possible absorption disorders and in suspected toxicity when more than one drug is being used.

Steady state plasma concentrations vary inter-individually, but are usually achieved within a period of 1 to 2 weeks. The recommended therapeutic plasma concentration range is between 4 to 12 microgram per ml (17 to 50 micromoles per litre).

Using AUC calculations the total bioavailability of carbamazepine suppositories is approximately 25% less than oral formulations.
For doses up to 300 mg approximately 75% of the total amount absorbed reaches the general circulation within 6 hours of application.
Consequently the maximum dosage per day is 1000 mg (equivalent of 800 mg oral formulation).
Clinical trials have shown plasma levels using suppositories are within the range 5 to 8 micrograms/ml (19 to 34 micromol/litre).

To avoid reduced effect or risk of breakthrough seizures or excessive side effects, it may be prudent to avoid changing the formulation. Bioavailability is unaffected by food regardless of formulation. Increased frequency of seizures may occur during switchover from oral formulation to suppositories.

Owing to enhanced carbamazepine elimination, children may require higher doses of carbamazepine (in mg/kg) than adults to maintain therapeutic concentrations.

Carbamazepine is 70 to 80% bound to serum protein.

Carbamazepine induces its own metabolism and the half life falls with repeated dosing. The elimination half-life of unchanged drug in the plasma averages 36 hours following a single dose. After repeated dosing (which leads to auto-induction of the hepatic enzymes) the half-life falls to approximately 16 to 24 hours. In patients receiving concomitant enzyme-inducing medications (phenobarbitone, phenytoin) the half life may be further reduced to 9 to 10 hours.

Contraindications

Neonates under 1 month
Within 2 weeks of discontinuing MAOIs
Atrioventricular block
History of myelosuppression
Porphyria

Precautions and Warnings

East Asian ancestry
Elderly
Breastfeeding
Cardiac impairment
Glaucoma
Haematological disorder
Hepatic impairment
History of drug induced haematological reactions
Pregnancy
Renal impairment
Urinary retention

Advise impaired alertness may affect ability to drive or operate machinery
Confirm HLA-B 1502 status in Han Chinese & Thai patients before initiating
Cross sensitivity can occur with other antiepileptics
Folic acid 5mg daily required pre-conception to end of 1st trimester
Increased risk of osteomalacia; consider vitamin D supplement
Prescribe by manufacturer's product to ensure seizure control maintenance
Increase in seizures may occur during switch from oral to suppositories
Short term (7 day) replacement for oral forms when oral route not available
Blood counts should be performed before and periodically during treatment
Monitor hepatic function before treatment and regularly during treatment
Perform urine analysis before and periodically during treatment
Breastfeeding: Monitor infant for systemic effects of treating the mother
Monitor patients at risk of glaucoma for increases in intraocular pressure
Monitor plasma sodium in patients at risk of hyponatraemia
Monitor renal function
Monitor serum biochemistry regularly
Monitor thyroid function regularly
Plasma level monitoring may be useful: refer to local guidelines
Refer women considering pregnancy for specialist advice and monitoring
Advise patient to seek medical advice if severe skin reaction occurs
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Advise patients/carers to seek medical advice if suicidal intent develops
Consult Dr.at once if rash, sore throat, mouth ulcers, bruising,fever occur
May cause activation of latent psychosis
May cause agitation and confusion in the elderly
Avoid abrupt withdrawal
Discontinue if epilepsy is exacerbated
Discontinue if evidence of significant bone marrow depression
Discontinue if hypersensitivity reactions occur
Discontinue if severe skin reaction occurs
Discontinue if significant leucopenia occurs
Discontinue if significant/persistent hepatic function abnormalities occur
Bioavailability differs with preparations;caution on changing formulations
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise patient grapefruit products may increase plasma level
May affect spermatogenesis
Female: Non-hormonal contraception or minimum 50mcg oestrogen advised
Neonate exposed in utero: Administer vitamin K at birth
Pregnancy: Administer vitamin K in the last few weeks of pregnancy

Severe dermatological reactions
Severe dermatological reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome have been rarely reported during treatment with carbamazepine. These reactions usually appear within the first few months of treatment. The HLA-B*1502 allele has been strongly associated with risk of developing Stevens-Johnson syndrome. Genetic screening of patients who are of Han Chinese or Thai origin should be considered as the HLA-B*1502 allele is more prevalent in these populations (approximately 10%). If patient tests positive for this allele carbamazepine treatment should not be initiated unless there is no other therapeutic option.

Severe dermatological reactions have also been associated with the HLA-A*3101 allele in European and Japanese populations. There is currently there is insufficient data to support genetic testing for this allele, although if a patient is known to be positive for the allele, the use of carbamazepine may be considered if the benefits are thought to outweigh the risk.

Milder reactions (macular and maculopapular exanthema) may also occur and may dissipate upon dose reduction or continued treatment; these patients should be monitored closely for potential immediate withdrawal on worsening reaction.

Antiepileptic drug hypersensitivity
Patients usually present with fever, rash, lymphadenopathy and other organ system involvement. Other possible symptoms include liver dysfunction, haematological, renal and pulmonary abnormalities, vasculitis and multi-organ failure. If signs or symptoms of hypersensitivity syndrome occur, the drug should be withdrawn immediately and expert advice sought.

Suicidal ideation
Antiepileptic treatment is associated with a small increased risk of suicidal thoughts and behaviour, available data suggest that the increased risk applies to all antiepileptics and is seen as early as one week after starting treatment. Patients (and carers of patients) should be alert to any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment. They should be advised to seek medical advice if they develop such thoughts or behaviour, and should be referred for appropriate treatment if necessary.
The available evidence does not define whether the risk of suicidal thoughts and behaviour differs between antiepileptics. Patients should not stop or switch treatment on the basis of this information and without speaking to a healthcare professional.

Pregnancy and Lactation

Pregnancy

Use carbamazepine with caution in pregnancy.

Use minimum effective doses cautiously in pregnancy, with monitoring of plasma concentrations.

Women of child bearing potential wherever possible should be prescribed monotherapy. The incidence of congenital abnormalities is less in the offspring of monotherapy patients. There is an increased risk of teratogenicity during pregnancy, particularly if the woman is being treated with a combination of antiepileptic drugs.

Folic acid deficiency is known to occur during pregnancy. Antiepileptic medication is known to aggravate this deficiency. It is recommend that folic acid 5 mg daily should be prescribed to all women with epilepsy who are taking antiepileptic drugs, prior to conception and continued until the 12th week of pregnancy.

Use of carbamazepine in pregnancy is associated with an increase in both minor and major malformations. There are reports of developmental disorders and malformations, including spina bifida, and also other congenital anomalies e.g. craniofacial defects, cardiovascular malformations, hypospadias and anomalies involving various body systems. However, developmental disorders including malformations have occurred in the offspring of mothers with untreated epilepsy. Patients should be counselled regarding the possibility of increased risk of malformations and given the opportunity of antenatal screening.

Adjusting or stopping any anti-epileptic medication during pregnancy should not be done without specialist advice, and the relative benefits and risks should be discussed carefully first. The risk of inadequate seizure control may be more detrimental to the foetus than the use of antiepileptic drugs. Pregnancy in epileptic women is associated with a higher risk of congenital abnormalities, which are mainly associated with the use of anti-epileptic drugs rather than the disease itself. This risk is increased when multiple drugs are used. Routine monitoring of antiepileptic drugs is not recommended, but may be useful in cases where seizures have increased or are likely to, in order to plan the extent of dose adjustment needed.

Maternal use of carbamazepine with a concurrent second antiepileptic has in some cases resulted in neonatal seizures and/or respiratory depression. Neonatal vomiting, diarrhoea and/or decreased feeding have also been reported. These reactions may represent a neonatal withdrawal syndrome. Vitamin K1 should be given to the mother during the later stages of pregnancy as well as to the newborn to prevent bleeding disorders in the infant.

Animal studies in mice, rats and rabbits found an increased embryo mortality when administered during organogenesis at maternally toxic doses (20 times the usual human dosage). Rat foetuses also showed growth retardation at maternally toxic doses.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use carbamazepine with caution in breastfeeding.

Carbamazepine passes into breast milk (about 25 to 60% of the plasma concentrations).

The benefits of breast feeding should be weighed against the remote possibility of adverse events happening in the infant.
Mothers treated with carbamazepine may breast feed their infants provided the infant is monitored for adverse reactions such as vomiting, sedation, poor sucking, withdrawal reactions and hepatic dysfunction. If these occur, the concentration of carbamazepine in the infant's serum should be measured, and liver values also measured in suspicious cases.

Monitor the infant for jaundice, drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsant or psychotropic drugs.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Advise patients to seek immediate medical advice if reactions such as fever, sore throat, rash, ulcers in the mouth, easy bruising, petechial or purpuric haemorrhage occur. Advise patients that their ability to drive and operate machinery may be impaired by treatment. Women of child-bearing age should be informed of the potential risks and benefits of continuing anti-epileptic treatment throughout pregnancy. Patients should be advised to consult their physician if they are planning a pregnancy, and consider taking folic acid 5mg daily before conception. Patients should be counselled regarding the possibility of increased risk of malformations and given the opportunity of antenatal screening. Advise patients to refrain from alcohol consumption as tolerance of alcohol is reduced.Advise patient to avoid grapefruit products. Advise patient not to use products containing St John's wort with carbamazepine. Patients and caregivers should be aware of the need to monitor for the emergence of suicidal thoughts and behaviour, and the need to seek medical advice immediately if they present.

Side Effects

Acne
Acute intermittent porphyria
Aggravation of coronary artery disease
Aggression
Agitation
Agranulocytosis
Allergic skin reactions
Anaphylactic reaction
Angioedema
Aplastic anaemia
Arrhythmias
Arthralgia
Aseptic meningitis
Atrioventricular block
Bradycardia
Changes of blood pressure
CNS disturbances
Confusion
Congestive cardiac failure
Decrease in plasma calcium
Decreased appetite
Delayed hypersensitivity reactions
Depression
Dyspnoea
Elevation of liver enzymes
Eosinophilia
Erythema multiforme
Erythema nodosum
Erythroderma
Exfoliative dermatitis
Fever
Fluid retention
Folic acid deficiency
Galactorrhoea
Gastro-intestinal symptoms
Glossitis
Gynaecomastia
Haemolytic anaemia
Hair loss
Hallucinations
Hearing disturbances
Hepatic failure
Hepatitis
Hepatosplenomegaly
Hirsutism
Hypersensitivity reactions
Hypogammaglobulinaemia
Hyponatraemia
Impaired renal function
Increase in plasma cholesterol
Increased intra-ocular pressure
Increased prolactin
Interference with spermatogenesis
Interstitial nephritis
Involuntary movement disorders
Jaundice
Leucocytosis
Leucopenia
Lymphadenopathy
Lymphoma-like disorder
Megaloblastic anaemia
Muscle weakness
Muscular cramps
Neuroleptic malignant syndrome
Osteomalacia
Pancreatitis
Paraesthesia
Paretic symptoms
Peripheral neuropathy
Photosensitivity
Pneumonia
Pneumonitis
Possible alteration of thyroid function tests
Proteinuria
Pruritus
Psychosis
Purpura
Rectal irritation
Red cell aplasia
Renal failure
Reticulocytosis
Sexual disturbances
Skin pigmentation changes
Speech disturbances
Stevens-Johnson syndrome
Stomatitis
Sweating
Syncope
Systemic lupus erythematosus
Taste disturbances
Thrombocytopenia
Thromboembolism
Thrombophlebitis
Toxic epidermal necrolysis
Urinary frequency
Urinary retention
Urticaria
Vanishing bile duct syndrome
Visual disturbances
Weight gain

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: March 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com [Accessed on [March 12, 2014]].

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Paediatric Formulary Committee. BNF for Children 2013-2014. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2013. Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com [Accessed on [March 12, 2014].

Summary of Product Characteristics: Tegretol Suppositories. Novartis Pharmaceuticals UK Ltd. Revised January 2014.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/
Last accessed: March 12, 2014

Clinical Knowledge Summaries - Pre-conception - advice and management - Management
Available at: https://cks.nice.org.uk/pre-conception-advice-and-management#azTab
Last accessed: March 12, 2014

Clinical Knowledge Summaries - Epilepsy - Management
Available at: https://cks.nice.org.uk/epilepsy#azTab
Last accessed: March 12, 2014

NICE clinical guideline 137 - The epilepsies, January 2012
Available at: https://www.nice.org.uk/nicemedia/live/13635/57779/57779.pdf
Last accessed: March 12, 2014

MHRA Drug Safety Update Vol 2, Issue 1, August 2008
Antiepileptics: risk of suicidal thoughts and behaviour
Available at: www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON023078
Last accessed: March 12, 2014

MHRA Drug Safety Update Vol 2, Issue 9, April 2009
Antiepileptics: adverse effects on bone
Available at: https://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON043809
Last accessed: March 12, 2014