Medication Audit Criteria and Guidelines

Carbamazepine (Tegretol®) PEFC Approved: January 2021

Indications ● Bipolar I disorder, acute manic or mixed episodes ● Trigeminal neuralgia ● Bipolar major depression ● Maintenance treatment for bipolar disorder

Black Box Warning ● Serious dermatologic reactions (including Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis); Screen for HLA-B*1502 allele prior to initiating therapy in patients of Asian ancestry ● Aplastic anemia and agranulocytosis; Obtain complete pretreatment hematological testing

Contraindications ● Bone marrow depression or history of bone marrow depression ● Hypersensitivity to carbamazepine ● Hypersensitivity to tricyclic compounds ● Concomitant use of delavirdine or other non-nucleoside reverse transcriptase inhibitors that are substrates for CYP3A4 ● Concomitant use of MAOIs or within 14 days of discontinuing MAOIs ● Concomitant use of nefazodone

Warnings and Precautions ● Serious dermatologic reactions (including SJS/TEN) ● Variant HLA-B*1502 allele or HLA-A*3101 allele ● Aplastic anemia and agranulocytosis ● Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) ● Suicidal behavioral and ideation ● Pregnancy ● Breastfeeding ● Abrupt discontinuation and risk of seizure

1 Texas Health and Human Services ● hhs.texas.gov Carbamazepine (Tegretol®)

● Hyponatremia ● Cognitive and motor impairment ● Loss of virologic response to Non-nucleoside Reverse Transcriptase Inhibitors that are substrates for CYP3A4 with concomitant use ● History of cardiac damage or conduction disturbances, including AV heart block ● Hepatic porphyria ● Increased intraocular pressure ● Mixed seizure disorder that includes atypical absence seizures ● Hepatic damage ● Renal damage ● Adverse hematologic or hypersensitivity reaction to other drugs, including reactions to other anticonvulsants ● Interrupted courses of therapy with carbamazepine

Adverse Reactions

Side Effects Which Require Medical Attention ● Dermatologic reactions/rash ● Sore throat or fever ● Worsening confusion or disorientation ● Nausea, vomiting, diarrhea or abdominal discomfort ● Drowsiness, lethargy ● Bone or joint pain ● Suicidal ideation ● Myalgia, body weakness, malaise ● Blurred or double vision

Pregnancy and Breastfeeding ● Review product-specific labeling. Consider risks/benefits in reviewing medication-specific labeling.

Drug Interactions of Major Significance

See: Indiana Univ Drug Interaction Table

See: Lexicomp or Micromedex

2 Texas Health and Human Services ● hhs.texas.gov Carbamazepine (Tegretol®)

Special Populations

Age-Specific Considerations ● Pediatrics/Adolescents: See “Psychotropic Medication Utilization Parameters for Children and Youth in Texas Public Behavioral Health (6th Version)” for specific details. ● Geriatric: Start at the low end of dosing range. ● Renal: No dose adjustments necessary for oral formulation in mild to severe impairment. ● Hepatic: Use with caution in hepatic impairment. ● Hemodialysis: No dosage adjustment necessary. Dose may be administered without regard to timing of dialysis on dialysis days.

Patient Monitoring Parameters ● Prior to initiation of carbamazepine  Presence of HLA-B*1502 in patients with Asian ancestry (required)  Presence of HLA-A*3101 in patients with ancestry in genetically at-risk populations (considered, not required) ● CBC with differential baseline, 1 to 2 weeks after each dose increase, annually, and as clinically indicated ● Electrolytes baseline, 1 to 2 weeks after each dose increase, annually, and as clinically indicated ● Hepatic function baseline, monthly for the first 3 months, annually, and as clinically indicated ● Pregnancy test baseline and as clinically indicated ● Serum carbamazepine levels 1 week after start, 3-4 weeks after dose change, and as clinically indicated ● Monitor for the emergence of suicidal ideation or behavior

Dosing ● See HHSC Psychiatric Drug Formulary for dosage guidelines. ● Exceptions to maximum dosage must be justified as per medication rule.

3 Texas Health and Human Services ● hhs.texas.gov