Carbamazepine ER (Equetro)

EQUETRO

Open Carbamazepine ER (Equetro) in the interactive console ↗

What it isCarbamazepine ER capsules (EQUETRO, 2004) — the only carbamazepine with a BIPOLAR label (acute manic and mixed episodes); same beads as Carbatrol.

Why this oneSame molecule and receptor pharmacology as the parent card — the formulation (and its label) is the difference.

What limits itClass warnings of the parent molecule apply unchanged.

FDA-approved for

bipolar disorder (acute manic/mixed) (2004)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Serious and sometimes fatal dermatologic reactions (SJS/TEN), with ~10x higher risk in patients of Asian ancestry — test for HLA-B*1502 before starting in at-risk patients and avoid if positive. Aplastic anemia and agranulocytosis can occur — obtain baseline CBC and monitor.

FDA dosing	Population	Start	Target	Max
Acute manic or mixed episodes of bipolar I disorder	Adults	200 mg BID	Adjust by 200 mg/day to optimal response	1,600 mg/day
Pain of trigeminal neuralgia	Adults	200 mg QD (day 1)	400-800 mg/day maintenance	1,200 mg/day
Epilepsy (partial with complex symptomatology, generalized tonic-clonic, mixed)	Adults and children >12 years	200 mg BID	Increase weekly by 200 mg/day to optimal response	500 mg BID (12-15 yr); 600 mg BID (15-18 yr); 800 mg BID (adults)
Epilepsy	Children <12 years	Titrate to clinical response	Usually <35 mg/kg/day	No recommendation above 35 mg/kg/day

Titration Epilepsy: increase at weekly intervals; trigeminal neuralgia: increase by up to 200 mg/day (100 mg every 12 hours) as needed

Renal Undefined

Hepatic Undefined

Instructions

Swallow capsules whole, or open and sprinkle beads over food (e.g., applesauce); do not crush or chew capsules or beads
Can be taken with or without meals
Test for HLA-B*1502 before starting in genetically at-risk patients; obtain baseline CBC and liver function
When discontinuing, reduce dose gradually to decrease seizure risk (avoid abrupt discontinuation)

Contraindications

Bone marrow depression
Known hypersensitivity to tricyclic compounds (e.g., amitriptyline, imipramine, nortriptyline)
Concomitant use of an MAOI, or within 14 days of discontinuing an MAOI (label cites serotonin syndrome)
Concomitant use of delavirdine or other NNRTIs that are CYP3A4 substrates (loss of virologic response)
Concomitant use of nefazodone

Cautions

DRESS/multiorgan hypersensitivity; hypersensitivity cross-reactivity with other anticonvulsants; HLA-A*3101 risk
Suicidal behavior and ideation (class effect for AEDs)
Embryofetal toxicity (neural tube and other malformations)
Abrupt discontinuation seizure risk; hyponatremia/SIADH; cognitive/motor impairment
Liver damage (incl. vanishing bile duct syndrome); AV heart block; hepatic porphyria; increased intraocular pressure

Adverse reactions

Dizziness
Somnolence
Nausea
Vomiting
Ataxia
Constipation
Pruritus
Dry mouth
Asthenia
Blurred vision

Pregnancy Can cause fetal harm; associated with major congenital malformations incl. neural tube defects; recommend folic acid supplementation

Lactation Carbamazepine and epoxide metabolite present in human milk; monitor breastfed infant (rare hepatitis, poor weight gain, vomiting reported)

⚠ BOXED WARNINGS