ABSTRAL- fentanyl tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

FENTANYL CITRATE (UNII: MUN5LYG46H) (FENTANYL - UNII:UF599785JZ)

Mevcut itibaren:

ProStrakan, Inc.

INN (International Adı):

FENTANYL CITRATE

Kompozisyon:

FENTANYL 100 ug

Uygulama yolu:

SUBLINGUAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

ABSTRAL (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid medication daily for a week or longer. Patients must remain on around-the-clock opioids when taking ABSTRAL. ABSTRAL is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could result at any dose in patients not on a chronic regimen of opioids. For this reason, ABSTRAL is contraindicated in the management of acute or postoperative pain,

Ürün özeti:

ABSTRAL is supplied in individually sealed child-resistant blister packages contained in a cardboard outer carton, in pack sizes of 12 (100 mcg, 200 mcg, 300 mcg and 400 mcg strengths) or 32 (all strengths) tablets. The packaging is color-coded for each ABSTRAL tablet strength. The amount of fentanyl contained in ABSTRAL can be fatal to a child, individual for whom it is not prescribed or non-opioid tolerant adult. Patients and their caregivers must be instructed to keep ABSTRAL out of the reach of children [see Boxed Warning - Warnings: Potential For Abuse and Importance Of Proper Patient Selection and Warnings And Precautions (5), and Patient Counseling Information (17.1)]. Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Patients and their household members must be advised to dispose of any tablets remaining from a prescription as soon as they are no longer needed. Instructions are included in Patient Counseling Information (17.2) and in the Medication Guide . To dispose of any unused ABSTRAL tablets, remove them from the blister cards and flush down the toilet. Do not dispose of the ABSTRAL blister cards or cartons down the toilet. If additional assistance is required, call ProStrakan, Inc. at 1-888-227-8725. ABSTRAL is supplied in six dosage strengths. Tablets are supplied in child-resistant, protective blister cards with peelable foil. Each blister card contains 4 tablets, in pack sizes of 12 (100 mcg, 200 mcg, 300 mcg and 400 mcg strengths) or 32 (all strengths) tablets. Each tablet is white in color, with the strength distinguishable by the shape of the dosage unit and by de-bossing on the tablet surface: Note: Colors and shapes are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.

Yetkilendirme durumu:

New Drug Application

Bilgilendirme broşürü

ABSTRAL- FENTANYL TABLET
ProStrakan, Inc.
----------
Medication Guide
ABSTRAL® (AB-stral) CII
(fentanyl)
Sublingual tablets
100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, 800 mcg
IMPORTANT:
Do not use ABSTRAL unless you are regularly using another opioid pain
medicine around-the-clock for
your cancer pain and your body is used to these medicines (this means
that you are opioid tolerant).
Keep ABSTRAL in a safe place away from children.
Get emergency medical help right away if:
•
a child takes ABSTRAL. ABSTRAL can cause an overdose and death in any
child who takes it.
•
an adult who has not been prescribed ABSTRAL takes it
•
an adult who is not already taking opioids around-the-clock, takes
ABSTRAL
These are medical emergencies that can cause death. If possible, try
to remove ABSTRAL from the
mouth.
Read this Medication Guide completely before you start taking ABSTRAL,
and each time you get a new
prescription. There may be new information. This Medication Guide does
not take the place of talking to
your healthcare provider about your medical condition or your
treatment. Be sure to share this important
information with members of your household and other caregivers.
What is the most important information I should know about ABSTRAL?
ABSTRAL can cause life-threatening breathing problems which can lead
to death.
1.
Do not take ABSTRAL if you are not opioid tolerant.
2.
If you stop taking your around-the-clock opioid pain medicine for your
cancer pain, you must stop
taking ABSTRAL. You may no longer be opioid tolerant. Talk to your
healthcare provider about
how to treat your pain.
3.
Take ABSTRAL exactly as prescribed by your healthcare provider.
•
You must not take more than 2 doses of ABSTRAL for each episode of
breakthrough
cancer pain.
•
You must wait two hours before treating a new episode of breakthrough
pain with
ABSTRAL. See the Medication Guide section "How should I take ABSTRAL?"
and the
Patient Instructions for Use at the end of this Medication Guide for
detailed information
about how to take ABSTR

Ürün özellikleri

ABSTRAL- FENTANYL TABLET
PROSTRAKAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABSTRAL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ABSTRAL.
ABSTRAL (FENTANYL) SUBLINGUAL TABLETS CII
INITIAL U.S. APPROVAL: 1968
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE
POTENTIAL
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DUE TO THE RISK OF FATAL RESPIRATORY DEPRESSION, ABSTRAL IS
CONTRAINDICATED IN OPIOID NON-TOLERANT
PATIENTS (1) AND IN MANAGEMENT OF ACUTE OR POSTOPERATIVE PAIN,
INCLUDING HEADACHE/MIGRAINES. (4)
KEEP OUT OF REACH OF CHILDREN. (5.3)
USE WITH CYP3A4 INHIBITORS MAY CAUSE FATAL RESPIRATORY DEPRESSION. (7)
WHEN PRESCRIBING, DO NOT CONVERT PATIENTS ON A MCG PER MCG BASIS FROM
ANY OTHER ORAL TRANSMUCOSAL
FENTANYL PRODUCT TO ABSTRAL. (2.1, 5.2)
WHEN DISPENSING, DO NOT SUBSTITUTE WITH ANY OTHER FENTANYL PRODUCTS.
(5.2)
CONTAINS FENTANYL, A SCHEDULE II CONTROLLED SUBSTANCE WITH ABUSE
LIABILITY SIMILAR TO OTHER OPIOID
ANALGESICS. (9.1)
ABSTRAL IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE TIRF
REMS ACCESS PROGRAM.
OUTPATIENTS, HEALTHCARE PROFESSIONALS WHO PRESCRIBE TO OUTPATIENTS,
PHARMACIES, AND DISTRIBUTORS ARE
REQUIRED TO ENROLL IN THE PROGRAM. (5.10)
RECENT MAJOR CHANGES
Indications and Usage (1) 12/2011
Warnings and Precautions - TIRF REMS Access Program (5.10) 12/2011
INDICATIONS AND USAGE
ABSTRAL is an opioid agonist indicated for the management of
breakthrough pain in cancer patients 18 years of age and
older who are already receiving and who are tolerant to opioid therapy
for their underlying persistent cancer pain. (1)
Limitations of Use:
ABSTRAL may be dispensed only to patients enrolled in the TIRF REMS
Access program.
DOSAGE AND ADMINISTRATION
Patients must require and use around-the-clock opioids when taking
ABSTRAL (1)
Initial dose of ABSTRAL: 100 mcg. (2.1)
Individually titrate to a tolerable dose that provides adequate
analgesia. (2.1)
No more than two doses