Adult Dosing

Grand mal or psychomotor seizures

• Initial dose: 1 g or less, PO divided in 4-6 doses, increase gradually over a period of several days to meet the individuals need
• Usual maintenance dose: 2-3 g/day PO in divided doses

Note:

• In tonic-clonic (grand mal) seizures, it may be beneficial to use with phenobarbital

Pediatric Dosing

Grand mal or psychomotor seizures

• Initial dose: 750 mg/day PO divided in 4-6 doses
• Usual maintenance dose: 500 mg-1 g/day PO in divided doses
• May increase to 2-3 g rarely

Note:

• In tonic-clonic (grand mal) seizures, it may be beneficial to use with phenobarbital

[Outline]

• Adult Dosing
• Pediatric Dosing

• Management of tonic-clonic (grand mal) and complex partial (psychomotor) seizures

• Hypersensitivities to any of the ingredients of the product
• Hepatic abnormalities
• Hematologic disorders

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Contraindicated

See Supplemental Patient Information

• Increase in suicidal thoughts or behavior has been observed in a week time after starting the antiepileptic drugs, monitor the patients for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior
• Ethotoin causes fetal harm when administered to a pregnancy, hence should be used in women of childbearing potential only if essential in the management of their seizures and if the patient becomes pregnant during the treatment, she should be apprised of the potential hazard to the fetus
• Do not discontinue treatment in pregnant patients in whom the drug is administered to prevent major seizures because of the possibility of precipitating status epilepticus with hypoxia and risk to both the mother and fetus
• Ethotoin causes blood dyscrasias, monitor the patients for general malaise, sore throat, petechiae, epistaxis and other symptoms indicative of possible blood dyscrasia
• If clinical evidence suggests the possibility of hepatic dysfunction, perform liver function test, and discontinue the drug if any sign of liver damage
• Perform CBC and urinalyses before starting the therapy and at monthly interval thereafter
• Lymphadenopathy and systemic lupus erythematosus have been reported in patient receiving ethotoin therapy, temporary withdraw the therapy if a lymphoma-like syndrome develops, and monitor the patients closely for regression of signs and symptoms before resuming the treatment

Cautions: Use cautiously in

• Concomitant use of anticoagulant
• Elderly patients

Supplemental Patient Information

• Alert patient's caregivers and families about the increased risk of suicidal thoughts or behavior with the therapy and should be advised to consult the health care professional if there is any sign of emergence or worsening of symptoms of depression, any unusual changes in mood or behavior
• Patients should be advised to inform their physician if they become pregnant or intend to become pregnant during therapy and encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant

Pregnancy Category:D

Breastfeeding: Ethotoin is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from ethotoin, either discontinues the drug or the breastfeeding based on the importance of the drug to the mother.

• CNS: Increase in suicidal thoughts or behavior, ataxia, dizziness, headache, insomnia, fatigue, numbness
• CV: Chest pain
• HEMA: Lymphadenopathy, blood dyscrasias
• GI: Vomiting, nausea, gum hypertrophy, diarrhea
• EENT: Nystagmus, diplopia
• DERM: Skin rash, Stevens-Johnson syndrome
• MISC: Fever, systemic lupus erythematosus

• Anticonvulsant; acts at motor cortex, inhibits nerve impulses by lowering sodium ion influx, limiting tetanic stimulation. It stabilize the normal seizure threshold and prevent the spread of seizure activity
• Metabolized by liver to N-deethyl and p-hydroxyl-ethotoin, the major metabolites
• Excreted via urine and feces
• Half-life: 3-9 hrs

US Trade Name(s)

• Peganone

US Availability

Peganone

• TABS: 250 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Neurologic

Anticonvulsants

Hydantoins

Pricing data from www.DrugStore.com in U.S.A.

• Peganone 250 MG TABS [Bottle] (LUNDBECK)
  120 mg = $163.98
  360 mg = $489.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Peganone 250 MG Oral Tablet

Ingredient(s): Ethotoin

Imprint: OV;61

Color(s): White

Shape: Round

Size (mm): 10.00

Score: 1

Inactive Ingredient(s): acacia / lactose / carboxymethylcellulose sodium / stearic acid / talc

Drug Label Author:
Lundbeck Inc.

DEA Schedule:
Non-Scheduled