BANZEL Film-coated tablet / Oral suspension (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Eisai Inc.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.

2. Dosage and Administration

2.1 Dosage Information Pediatric patients (1 year to less than 17 years) The recommended starting daily dose of BANZEL in pediatric patients with Lennox-Gastaut Syndrome is approximately 10 mg/kg administered ...

3. Dosage Forms and Strengths

Film-coated Tablets: 200 mg (pink) and 400 mg (pink). Tablets are scored on both sides. Oral Suspension: 40 mg/mL.

4. Contraindications

BANZEL is contraindicated in patients with Familial Short QT syndrome [see Warnings and Precautions (5.3)].

5. Warnings and Precautions

5.1 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including BANZEL, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with ...

6. Adverse Reactions

The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [see Warnings and Precautions (5.1)] Central Nervous System Reactions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of BANZEL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Effects of BANZEL on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, and valproate showed ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as BANZEL, during pregnancy. Encourage women who are taking BANZEL during ...

8.2. Lactation

Risk Summary There are no data on the presence of rufinamide in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of ...

8.3. Females and Males of Reproductive Potential

Contraception Use of BANZEL may reduce the effectiveness of hormonal contraceptives containing ethinyl estradiol or norethindrone. Advise women of reproductive potential taking BANZEL who are using a contraceptive ...

8.4. Pediatric Use

Safety and effectiveness have been established in pediatric patients 1 to 17 years of age. The effectiveness of BANZEL in pediatric patients 4 years of age and older was based upon an adequate and well-controlled ...

8.5. Geriatric Use

Clinical studies of BANZEL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly ...

8.6. Renal Impairment

Rufinamide pharmacokinetics in patients with severe renal impairment (creatinine clearance <30 mL/min) was similar to that of healthy subjects. Dose adjustment in patients undergoing dialysis should be ...

8.7. Hepatic Impairment

Use of BANZEL in patients with severe hepatic impairment (Child-Pugh score 10 to 15) is not recommended. Caution should be exercised in treating patients with mild (Child-Pugh score 5 to 6) to moderate ...

10. Overdosage

Because strategies for the management of overdose are continually evolving, it is advisable to contact a Certified Poison Control Center to determine the latest recommendations for the management of an ...

11. Description

BANZEL (rufinamide) is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 ...

12.1. Mechanism of Action

The precise mechanism(s) by which rufinamide exerts its antiepileptic effect is unknown. The results of in vitro studies suggest that the principal mechanism of action of rufinamide is modulation ...

12.3. Pharmacokinetics

Overview BANZEL oral suspension is bioequivalent on a mg per mg basis to BANZEL tablets. BANZEL is well absorbed after oral administration. However, the rate of absorption is relatively slow and the extent ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Rufinamide was given in the diet to mice at 40, 120, and 400 mg/kg per day and to rats at 20, 60, and 200 mg/kg per day for 2 years. The doses in mice were associated with plasma AUCs 0.1 ...

14. Clinical Studies

Adult and Pediatric Patients ages 4 years and older The effectiveness of BANZEL as adjunctive treatment for the seizures associated with Lennox-Gastaut Syndrome (LGS) in adult and pediatric patients ages ...

16.1. How Supplied

BANZEL 200 mg tablets (containing 200 mg rufinamide) are pink in color, film-coated, oblong-shape tablets, with a score on both sides, imprinted with " 262" on one side. They are available in bottles ...

16.2. Storage and Handling

Store the tablets at 25ºC (77ºF); excursions permitted to 15º-30ºC (59ºF-86ºF). Protect from moisture. Replace cap securely after opening. Store the oral suspension at 25ºC (77ºF); excursions permitted ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Administration Information Advise patients to take BANZEL with food [see Dosage and Administration ...