cenobamate

Contraindicated in:

Hypersensitivity;
Familial short QT syndrome;
End-stage renal disease on hemodialysis;
Severe hepatic impairment.

Use Cautiously in:

All patients (may ↑ risk of suicidal thoughts/behaviors);
Mild, moderate, or severe renal impairment (consider ↓ dose);
Mild or moderate hepatic impairment;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.
Geri: Start with lowest dose in older adults due to age-related renal and/or hepatic impairment.

Adv. Reactions/Side Effects ⬆ ⬇

CV: QT INTERVAL SHORTENING, palpitations

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), pruritus, rash

EENT: diplopia, blurred vision, nystagmus, pharyngitis, vertigo, visual impairment

F and E: hyperkalemia

GI: ↑liver enzymes, abdominal pain, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, nausea, vomiting

GU: dysmenorrhea, pain, urinary tract infection

Metab: ↓appetite, ↓weight

Neuro: dizziness, headache, somnolence, amnesia, aphasia, ataxia, attention disturbance, confusion, disorientation, dysarthria, euphoria, irritability, memory impairment, slowness of thoughts, SUICIDAL THOUGHTS/BEHAVIORS, tremor

Resp: dyspnea, hiccups

Misc: fatigue, physical dependence

Interactions ⬆ ⬇

Drug-drug:

QT interval shortening medications may enhance QT shortening which can ↑ risk of ventricular arrhythmias and sudden cardiac death; use concurrently with caution.
May ↓ levels and effectiveness of carbamazepine and lamotrigine; ↑ lamotrigine and carbamazepine doses.
May ↑ levels and risk of toxicity of phenytoin; ↓ phenytoin by up to 50%.
May ↑ levels and risk of toxicity of phenobarbital and clobazam; ↓ phenobarbital and clobazam doses as clinically appropriate.
May ↓ levels and effectiveness of CYP2B6 substrates and CYP3A substrates; ↑ dose of CYP2B6 or CYP3A substrate as clinically appropriate.
May ↓ levels and effectiveness of oral hormonal contraceptives; advise women of reproductive potential to use additional or alternative non-hormonal contraceptive method.
May ↑ levels and risk of toxicity of CYP2C19 substrates; ↓ dose of CYP2C19 substrate as clinically appropriate.
Use with other CNS depressants, including benzodiazepines, sedative/hypnotics, anxiolytics, opioids, or alcohol may cause profound sedation.

Availability ⬆ ⬇

Tablets: 12.5 mg; 25 mg; 50 mg; 100 mg; 150 mg; 200 mg

Route/Dosage ⬆ ⬇

PO (Adults ): 12.5 mg once daily for 2 wk, then 25 mg once daily for 2 wk, then 50 mg once daily for 2 wk, then 100 mg once daily for 2 wk, then 150 mg once daily for 2 wk, then 200 mg once daily. If needed based on clinical response, may ↑ in increments of 50 mg every 2 wk to max dose of 400 mg once daily.

Hepatic Impairment

PO (Adults ): Mild or moderate hepatic impairment: Not to exceed 200 mg once daily.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits voltage-gated sodium channels, reducing repetitive neuronal firing. Also acts as a positive allosteric modulator of GABA_A ion channels.

Therapeutic effects:

Decreased incidence of seizures.

Classifications ⬆ ⬇

Therapeutic Classification: anticonvulsants

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed (≥88%) following oral administration.

Distribution: Well distributed to extravascular tissues.

Metabolism/Excretion: Primarily metabolized by liver by glucuronidation (via UGT2B7 and UGT2B4) and oxidation (via CYP2E1, CYP2A6, CYP2B6, CYP2C19, and CYP3A4/5). Primarily excreted in urine (88%; <10% as unchanged drug) and feces (5%).

Half-Life: 50–60 hr.

Contr. Subst. Schedule ⬆ ⬇

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1–4 hr	24 hr

Patient/Family Teaching ⬆ ⬇

Instruct patient to take cenobamate as directed. Do not stop abruptly; dose should be gradually decreased over 2 wk. Advise patient to read the Medication Guide prior to starting therapy and with each Rx refill in case of changes.
May cause dizziness and somnolence. Caution patient to avoid driving or activities requiring alertness until response to medication is known. Do not resume driving until physician gives clearance based on control of seizure disorder.
Advise patient to notify health care professional if signs and symptoms of DRESS, QT shortening (prolonged heart palpitations, loss of consciousness) or neurological adverse reactions occur.
Advise patient and family to notify health care professional if thoughts about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood or if skin rash occur.
Instruct patient to consult with health care professional before drinking alcohol.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Instruct patient to notify health care professional of medication regimen prior to treatment or surgery.
Rep: Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding. Advise women of reproductive potential using oral contraceptives to use additional or alternative non-hormonal birth control. Encourage pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334; information is available at www.aedpregnancyregistry.org.
Advise patient to carry identification describing disease process and medication regimen at all times.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

42765- Metrochem API Private Limited
- 42765-071-
  - 42765-071-15- 15 kg in 1 DRUM (42765-071-15)

59651- Aurobindo Pharma Limited
- 59651-881-
  - 59651-881-37- 50 kg in 1 DRUM (59651-881-37)

60240- Joyochem Co.,Ltd
- 60240-0272-
  - 60240-0272-1- 1 BAG in 1 DRUM (60240-0272-1) / 5 kg in 1 BAG (60240-0272-2)

60240- Joyochem Co.,Ltd
- 60240-0272-
  60240-0272-3- 1 BAG in 1 DRUM (60240-0272-3) / 10 kg in 1 BAG (60240-0272-4)

60240- Joyochem Co.,Ltd
- 60240-0272-
  60240-0272-5- 1 BAG in 1 DRUM (60240-0272-5) / 25 kg in 1 BAG (60240-0272-6)

71699- SK Life Science, Inc.
- 71699-025- Xcopri
  71699-025-30- 30 TABLET, FILM COATED in 1 BOTTLE (71699-025-30)

71699- SK Life Science, Inc.
- 71699-050- Xcopri
  - 71699-050-30- 30 TABLET, FILM COATED in 1 BOTTLE (71699-050-30)

71699- SK Life Science, Inc.
- 71699-050- Xcopri
  - 71699-050-99- 30 TABLET, FILM COATED in 1 BOTTLE (71699-050-99)

71699- SK Life Science, Inc.
- 71699-100- Xcopri
  - 71699-100-30- 30 TABLET, FILM COATED in 1 BOTTLE (71699-100-30)

71699- SK Life Science, Inc.
- 71699-103- Xcopri Maintenance Pack
  - 71699-103-56- 1 KIT in 1 CARTON (71699-103-56) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK

71699- SK Life Science, Inc.
- 71699-104- Xcopri Maintenance Pack
  - 71699-104-56- 1 KIT in 1 CARTON (71699-104-56) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK

71699- SK Life Science, Inc.
- 71699-150- Xcopri
  - 71699-150-30- 30 TABLET, FILM COATED in 1 BOTTLE (71699-150-30)

71699- SK Life Science, Inc.
- 71699-200- Xcopri
  - 71699-200-30- 30 TABLET, FILM COATED in 1 BOTTLE (71699-200-30)

71699- SK Life Science, Inc.
- 71699-201- Xcopri Titration Pack
  - 71699-201-28- 1 KIT in 1 CARTON (71699-201-28) * 1 TABLET in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK

71699- SK Life Science, Inc.
- 71699-202- Xcopri Titration Pack
  - 71699-202-28- 1 KIT in 1 CARTON (71699-202-28) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK

71699- SK Life Science, Inc.
- 71699-203- Xcopri Titration Pack
  - 71699-203-28- 1 KIT in 1 CARTON (71699-203-28) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK

73435- Biophore India Pharmaceuticals Pvt. Ltd
- 73435-036-
  - 73435-036-11- 60 kg in 1 DRUM (73435-036-11)

74436- SK BIOTEK
- 74436-0223-
  74436-0223-6- 30 kg in 1 DRUM (74436-0223-6)

81666- APICHEM Laboratories Private Limited
- 81666-005-
  81666-005-01- 65 kg in 1 DRUM (81666-005-01)

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Indications ⬇

Contraind./Precautions ⬆ ⬇