ESLICARBAZEPINE ACETATE- eslicarbazepine acetate tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ESLICARBAZEPINE ACETATE (UNII: BEA68ZVB2K) (ESLICARBAZEPINE - UNII:S5VXA428R4)

Disponível em:

Camber Pharmaceuticals, Inc.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Eslicarbazepine acetate tablets are contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see Warnings and Precautions ( 5.2, 5.3, and 5.4)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as eslicarbazepine acetate, during pregnancy. Encourage women who are taking eslicarbazepine acetate during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. Risk Summary Limited available data with eslicarbazepine acetate use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In oral studies conducted in pregnant mice, rats, and rabbits, eslicarbazepine acetate demons

Resumo do produto:

Eslicarbazepine acetate tablets, 200 mg are white to off-white, oblong tablets, with functional scoring on both the side and engraved with ‘E31’ on one side and ‘H’ on the other side. They are supplied as follows: Bottle of 30 tablets                                                                            NDC 31722-428-30 Cartons of 100 (10x10) unit-dose tablets                                          NDC 31722-428-32 Eslicarbazepine acetate tablets, 400 mg are white to off-white, circular bi-convex tablets, engraved with ‘E32’ on one side and ‘H’ on the other side. They are supplied as follows: Bottle of 30 tablets                                                                            NDC 31722-429-30 Cartons of 80 (10x8) unit-dose tablets                                              NDC 31722-429-32 Eslicarbazepine acetate tablets, 600 mg are white to off-white, oblong tablets, with functional scoring on both the side and engraved with ‘E33’ on one side and ‘H’ on the other side. They are supplied as follows: Bottle of 60 tablets                                                                            NDC 31722-430-60 Bottle of 90 tablets                                                                            NDC 31722-430-90 Cartons of 100 (10x10) unit-dose tablets                                          NDC 31722-430-32 Eslicarbazepine acetate tablets, 800 mg are white to off-white, oblong tablets, with functional scoring on both the side and engraved with ‘E34’ on one side and ‘H’ on the other side. They are supplied as follows: Bottle of 30 tablets                                                                            NDC 31722-431-30 Bottle of 90 tablets                                                                            NDC 31722-431-90 Cartons of 100 (10x10) unit-dose tablets                                          NDC 31722-431-32  Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Keep tightly closed.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ESLICARBAZEPINE ACETATE - ESLICARBAZEPINE ACETATE TABLET
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESLICARBAZEPINE
ACETATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ESLICARBAZEPINE ACETATE TABLETS.
ESLICARBAZEPINE ACETATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
Eslicarbazepine acetate tablets are indicated for the treatment of
partial-onset seizures in patients 4
years of age and older. (1) (1)
DOSAGE AND ADMINISTRATION
• Adult Patients: The recommended initial dosage of eslicarbazepine
acetate tablets is 400 mg once daily.
For some patients, treatment may be initiated at 800 mg once daily if
the need for seizure reduction
outweighs an increased risk of adverse reactions. Increase the dose in
weekly increments of 400 mg to
600 mg once daily, based on clinical response and tolerability, to a
recommended maintenance dosage of
800 mg to 1,600 mg once daily. ( 2.2)
• Pediatric Patients: The recommended dosage of eslicarbazepine
acetate tablets is based on body weight
and is administered orally once daily. Increase the dose in weekly
intervals based on clinical response and
tolerability, to the recommended maintenance dosage. ( 2.2)
• Patients with Moderate or Severe Renal Impairment: Reduce dosage
by 50%. ( 2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg, 400 mg, 600 mg, 800 mg (3) (3)
CONTRAINDICATIONS
Hypersensitivity to eslicarbazepine acetate or oxcarbazepine. (4) (4)
WARNINGS AND PRECAUTIONS
• Suicidal Behavior and Ideation: Monitor for suicidal thoughts or
behavior. ( 5.1)
• Serious Dermatologic Reactions, Drug Reaction with Eosinophilia
and Systemic Symptoms (DRESS),
Anaphylactic Reactions and Angioedema: Monitor and discontinue if
another cause cannot be established.
( 5.2, 5.3, 5.4)
• Hyponatremia: Monitor sodium levels in patients at risk or
patients experiencing hyponatremia
symptoms. ( 5.5)
• Neurological Adverse Reactions: Monitor f