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Carbamazepine

 

Indications and Dose for Carbamazepine

Seizures (Epilepsy)

Focal and Secondary Generalized Tonic-Clonic Seizures; Primary Generalized Tonic-Clonic Seizures:

  • Adults: Start with 100-200 mg once or twice daily, increased by 100-200 mg every 2 weeks. Usual dose is 800-1200 mg daily in divided doses, with a possible increase up to 1600-2000 mg daily.
  • Elderly: Reduced initial dose.
  • By Rectum: Up to 1000 mg daily in 4 divided doses for up to 7 days when oral administration is not possible.

Trigeminal Neuralgia

  • Adults: Start with 100 mg once or twice daily. Some may require a higher initial dose. Gradually increase based on response; usual dose is 200 mg 3-4 times daily, with a possible increase up to 1600 mg daily.

Bipolar Disorder (Unresponsive to Lithium)

  • Adults: Start with 400 mg daily in divided doses, increased until symptoms are controlled. Usual dose is 400-600 mg daily, with a maximum of 1600 mg per day.

Acute Alcohol Withdrawal (Adjunct)

  • Adults: Start with 800 mg daily in divided doses, then reduce to 200 mg daily for a typical treatment duration of 7-10 days. Gradually reduce the dose over 5 days.

Diabetic Neuropathy

  • Adults: Start with 100 mg 1-2 times a day, gradually increased based on response. Usual dose is 200 mg 3-4 times a day, with a possible increase up to 1600 mg daily.

Pediatric Dosing for Seizures

  • 1 month-11 years:Start with 5 mg/kg once daily at night or 2.5 mg/kg twice daily, then increase by 2.5-5 mg/kg every 3-7 days as needed; maintenance dose is 5 mg/kg 2-3 times a day, up to 20 mg/kg daily.
  • 12-17 years:Start with 100-200 mg 1-2 times a day, then increase to 200-400 mg 2-3 times a day, up to 1800 mg daily, with slow dose adjustments.

CARBAGEN® SR – Dosage Guidelines

Focal and Secondary Generalized Tonic-Clonic Seizures | Primary Generalized Tonic-Clonic Seizures

  • By Mouth:
    • Adult: Initially 100–400 mg daily in 1–2 divided doses. Increase in steps of 100–200 mg every 2 weeks, slowly. Usual dose is 800–1200 mg daily in 1–2 divided doses. If necessary, increase up to 1600–2000 mg daily.
    • Elderly: Reduce initial dose.

Trigeminal Neuralgia

  • By Mouth:
    • Adult: Start with 100–200 mg daily in 1–2 divided doses. Some patients may require a higher initial dose. Increase gradually according to response. Usual dose is 600–800 mg daily in 1–2 divided doses. If necessary, increase up to 1600 mg daily.

Prophylaxis of Bipolar Disorder Unresponsive to Lithium

  • By Mouth:
    • Adult: Start with 400 mg daily in 1–2 divided doses. Increase until symptoms are controlled. Usual dose is 400–600 mg daily in 1–2 divided doses, with a maximum of 1600 mg per day.

Pediatric Dosing for Focal and Generalized Tonic-Clonic Seizures | Prophylaxis of Bipolar Disorder

  • By Mouth:
    • Children 5–11 years: Start with 5 mg/kg daily in 1–2 divided doses. Increase in steps of 2.5–5 mg/kg every 3–7 days as required. Dose should be increased slowly. Maintenance dose is 10–15 mg/kg daily in 1–2 divided doses. If necessary, increase up to 20 mg/kg daily.
    • Children 12–17 years: Initially 100–400 mg daily in 1–2 divided doses. Then increase to 400–1200 mg daily in 1–2 divided doses. If necessary, increase up to 1800 mg daily. Dose should be increased slowly.

TEGRETOL® PROLONGED RELEASE – Dosage Guidelines

Focal and Secondary Generalized Tonic-Clonic Seizures | Primary Generalized Tonic-Clonic Seizures

  • By Mouth:
    • Adult: Start with 100–400 mg daily in 2 divided doses. Increase in steps of 100–200 mg every 2 weeks, slowly. Usual dose is 800–1200 mg daily in 2 divided doses. If necessary, increase up to 1600–2000 mg daily.
    • Elderly: Reduce initial dose.

Pediatric Dosing for Focal and Generalized Tonic-Clonic Seizures | Prophylaxis of Bipolar Disorder

  • By Mouth:
    • Children 5–11 years: Start with 5 mg/kg daily in 2 divided doses. Increase in steps of 2.5–5 mg/kg every 3–7 days as required. Maintenance dose is 10–15 mg/kg daily in 2 divided doses. If necessary, increase up to 20 mg/kg daily.
    • Children 12–17 years: Initially 100–400 mg daily in 2 divided doses, slowly increase. Maintenance is 400–1200 mg daily in 2 divided doses. If necessary, increase up to 1800 mg daily.

Trigeminal Neuralgia

  • By Mouth:
    • Adult: Start with 100–200 mg daily in 2 divided doses, some patients may require a higher initial dose. Increase gradually according to response. Usual dose is 600–800 mg daily in 2 divided doses. If necessary, increase up to 1600 mg daily.

Prophylaxis of Bipolar Disorder Unresponsive to Lithium

  • By Mouth:
    • Adult: Start with 400 mg daily in 2 divided doses, increased until symptoms are controlled. Usual dose is 400–600 mg daily in 2 divided doses. Maximum dose is 1600 mg per day.

CONTRAINDICATIONS

  • Conduction Abnormalities (unless paced)
  • History of Bone Marrow Depression
  • Cardiac Disease
  • History of Hematological Reactions to other drugs

CAUTIONS

  • Presence of HLA-B1502 or HLA-A3101 Allele
  • Seizures (may be exacerbated)
  • Skin Reactions
  • Susceptibility to Angle-Closure Glaucoma

FURTHER INFORMATION

  • The MHRA advises consideration of vitamin D supplementation in patients who are immobilized for long periods or who have inadequate sun exposure or dietary intake of calcium.

Blood, Hepatic, or Skin Disorders

  • Carbamazepine should be withdrawn immediately in cases of aggravated liver dysfunction or acute liver disease.
  • Leucopenia that is severe, progressive, or associated with clinical symptoms requires withdrawal (if necessary under cover of a suitable alternative).

HLA Allele

  • HLA-B*1502: Strongly associated with an increased risk of Stevens-Johnson syndrome, particularly in individuals of Han Chinese or Thai origin. Pre-treatment screening noted.
  • HLA-A*3101: Associated with an increased risk of cutaneous adverse reactions, particularly in individuals of European or Japanese origin. Insufficient data to support pre-treatment screening, but consider use if potential benefit outweighs risk.

Seizure Exacerbation

  • Carbamazepine may exacerbate seizures in patients with:
    • Absence or Myoclonic Seizures (including Juvenile Myoclonic Epilepsy)
    • Tonic or Atonic Seizures
    • Dravet Syndrome
    • Lennox-Gastaut Syndrome
    • Myoclonic-Atonic Seizures

SIDE EFFECTS

  • Common or Very Common:
    • Dizziness, drowsiness, dry mouth, eosinophilia, fatigue, fluid imbalance, gastrointestinal discomfort, headache, hyponatremia, leucopenia, movement disorders, nausea, oedema, skin reactions, thrombocytopenia, vision disorders, vomiting, weight increase.
  • Uncommon:
    • Constipation, diarrhoea, eye disorders, tic, tremor.
  • Rare or Very Rare:
    • Aggression, agranulocytosis, albuminuria, alopecia, anaemia, angioedema, anxiety, appetite decreased, arrhythmias, arthralgia, azotaemia, bone disorders, bone marrow disorders, cardiac conduction disorders, circulatory collapse, confusion, congestive heart failure, conjunctivitis, coronary artery disease aggravated, depression, dyspnoea, embolism and thrombosis, erythema nodosum, fever, folate deficiency, galactorrhoea, gynaecomastia, haematuria, haemolytic anaemia, hallucinations, hearing impairment, hepatic disorders, hirsutism, hyperacusia, hyperhidrosis, hypersensitivity, hypertension, hypogammaglobulinaemia, hypotension, lens opacity, leucocytosis, lymphadenopathy, meningitis aseptic, muscle complaints, muscle weakness, nephritis tubulointerstitial, nervous system disorder, neuroleptic malignant syndrome, oral disorders, pancreatitis, paraesthesia, paresis, peripheral neuropathy, photosensitivity reaction, pneumonia, pneumonitis, pseudolymphoma, psychosis, red blood cell abnormalities, renal impairment, severe cutaneous adverse reactions (SCARs), sexual dysfunction, speech impairment, spermatogenesis abnormal, syncope, systemic lupus erythematosus (SLE), taste altered, tinnitus, urinary disorders, vanishing bile duct syndrome, vasculitis.
  • Frequency Not Known:
    • Bone fracture, colitis, human herpesvirus 6 infection reactivation, memory loss, nail loss, suicidal behaviors.

SIDE-EFFECTS, FURTHER INFORMATION

  • Some side effects such as headache, ataxia, drowsiness, nausea, vomiting, blurring of vision, dizziness, and allergic skin reactions are dose-related and may limit dosage increases. These side effects are more common at the start of treatment and among the elderly.

ALLERGY AND CROSS-SENSITIVITY

  • Antiepileptic Hypersensitivity Syndrome: Associated with Carbamazepine.
  • Cross-Sensitivity: Reported with oxcarbazepine, phenytoin, primidone, and phenobarbital.

PREGNANCY

  • An increased risk of major congenital malformations associated with Carbamazepine.

MONITORING

  • Plasma-Drug Concentration: Should be monitored and maintained on the lower side of the therapeutic range to ensure seizure control.
  • Breastfeeding: The amount in breast milk is likely too small to be harmful. Monitor infants for possible adverse reactions.
  • Hepatic Impairment: Use with caution and close monitoring; no detailed information available.
  • Renal Impairment: Use with caution.
  • Pre-Treatment Screening: Test for HLA-B*1502 allele in individuals of Han Chinese or Thai origin and consider testing in other at-risk Asian populations.
  • Monitoring Requirements: Plasma concentration for optimum response is 4–12 mg/litre (20–50 micromol/litre) measured after 1–2 weeks. Blood counts, hepatic, and renal function tests are recommended, though the practical value is uncertain.

TREATMENT CESSATION

  • When stopping Carbamazepine for bipolar disorder, reduce the dose gradually over at least 4 weeks.

DIRECTIONS FOR ADMINISTRATION

  • In Children: Oral liquid can be used rectally and should be retained for at least 2 hours, although it may have a laxative effect.
  • TEGRETOL® PROLONGED RELEASE: Tablets can be halved but should not be chewed.

PRESCRIBING AND DISPENSING INFORMATION

  • Switching between different formulations can vary in bioavailability. For epilepsy treatment, maintain patients on a specific manufacturer’s product.

PATIENT AND CARER ADVICE

  • Recognize signs of blood, liver, or skin disorders and seek immediate medical attention if symptoms such as fever, rash, mouth ulcers, bruising, or bleeding develop.

PROFESSION SPECIFIC INFORMATION

  • Dental Practitioners’ Formulary: Carbamazepine tablets may be prescribed.

MEDICINAL FORMS

There can be variations in the licensing of different medicines containing the same drug. The forms available include:

  • Oral Suspension
  • Oral Solution
  • Modified-Release Tablet
  • Tablet
  • Suppository

SPECIFIC PRODUCTS AND FORMULATIONS

  • Curatil Prolonged Release (Tillomed Laboratories Ltd): Carbamazepine 200 mg in prolonged release tablets.
  • Tegretol Retard (Novartis Pharmaceuticals UK Ltd): Carbamazepine available in 200 mg and 400 mg prolonged release tablets.
  • Carbamazepine (Non-proprietary): Available in 100 mg, 200 mg tablets, and 125 mg, 250 mg suppositories.
  • Tegretol (Novartis Pharmaceuticals UK Ltd): Available in 100 mg, 200 mg, and 400 mg tablets.
  • Carbamazepine Oral Suspension (Non-proprietary): 20 mg per 1 ml, available in a sugar-free formulation.
  • Tegretol Oral Solution (Novartis Pharmaceuticals UK Ltd): 20 mg per 1 ml in a sugar-free liquid formulation.

 

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