FENTANYL patch, extended release

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ)

متاح من:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (الاسم الدولي):

FENTANYL

تركيب:

FENTANYL 7.5 mg in 72 h

طريقة التعاطي:

TRANSDERMAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Fentanyl transdermal system is indicated for management of persistent , moderate to severe chronic pain that: - requires continuous, around-the-clock opioid administration for an extended period of time, and requires continuous, around-the-clock opioid administration for an extended period of time, and - cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. Fentanyl transdermal system should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/h (see DOSAGE AND ADMINISTRATION ). Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg

ملخص المنتج:

Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Fentanyl transdermal system is supplied in sealed transdermal systems which pose little risk of exposure to health care workers. If the gel from the drug reservoir accidentally contacts the skin, the area should be washed with copious amounts of water. Do not use soap, alcohol, or other solvents to remove the gel because they may enhance the drug’s ability to penetrate the skin. Do not use a fentanyl transdermal system patch if the seal is broken or the patch is cut, damaged, or changed in any way. Using a patch that is cut, damaged, or changed in any way can expose the patient or caregiver to the contents of the patch, which can result in an overdose of fentanyl that may be fatal. KEEP FENTANYL TRANSDERMAL SYSTEM OUT OF THE REACH OF CHILDREN AND PETS. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.] Apply immediately after removal from individually sealed package. Do not use if the seal is broken. For transdermal use only. A SCHEDULE CII NARCOTIC. DEA ORDER FORM REQUIRED. Manufactured by: Watson Laboratories, Inc Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Revised: August 2008

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

FENTANYL - FENTANYL PATCH, EXTENDED RELEASE
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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FENTANYL TRANSDERMAL SYSTEM C-II
REVISED: AUGUST 2008
RX ONLY
FULL PRESCRIBING INFORMATION
FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
FENTANYL TRANSDERMAL SYSTEM CONTAINS A HIGH CONCENTRATION OF A POTENT
SCHEDULE II OPIOID
AGONIST, FENTANYL. SCHEDULE II OPIOID SUBSTANCES WHICH INCLUDE
FENTANYL, HYDROMORPHONE,
METHADONE, MORPHINE, OXYCODONE, AND OXYMORPHONE HAVE THE HIGHEST
POTENTIAL FOR ABUSE
AND ASSOCIATED RISK OF FATAL OVERDOSE DUE TO RESPIRATORY DEPRESSION.
FENTANYL CAN BE ABUSED
AND IS SUBJECT TO CRIMINAL DIVERSION. THE HIGH CONTENT OF FENTANYL IN
THE PATCHES (FENTANYL
TRANSDERMAL SYSTEM) MAY BE A PARTICULAR TARGET FOR ABUSE AND
DIVERSION.
FENTANYL TRANSDERMAL SYSTEM IS INDICATED FOR MANAGEMENT OF PERSISTENT,
MODERATE TO SEVERE
CHRONIC PAIN THAT:
REQUIRES CONTINUOUS, AROUND-THE-CLOCK OPIOID ADMINISTRATION FOR AN
EXTENDED PERIOD OF
TIME, AND
CANNOT BE MANAGED BY OTHER MEANS SUCH AS NON-STEROIDAL ANALGESICS,
OPIOID
COMBINATION PRODUCTS, OR IMMEDIATE-RELEASE OPIOIDS
FENTANYL TRANSDERMAL SYSTEM SHOULD ONLY BE USED IN PATIENTS WHO ARE
ALREADY RECEIVING
OPIOID THERAPY, WHO HAVE DEMONSTRATED OPIOID TOLERANCE, AND WHO
REQUIRE A TOTAL DAILY DOSE
AT LEAST EQUIVALENT TO FENTANYL TRANSDERMAL SYSTEM 25 MCG/H. PATIENTS
WHO ARE CONSIDERED
OPIOID-TOLERANT ARE THOSE WHO HAVE BEEN TAKING, FOR A WEEK OR LONGER,
AT LEAST 60 MG OF
MORPHINE DAILY, OR AT LEAST 30 MG OF ORAL OXYCODONE DAILY, OR AT LEAST
8 MG OF ORAL
HYDROMORPHONE DAILY OR AN EQUIANALGESIC DOSE OF ANOTHER OPIOID.
BECAUSE SERIOUS OR LIFE-THREATENING HYPOVENTILATION COULD OCCUR,
FENTANYL TRANSDERMAL
SYSTEM IS CONTRAINDICATED:
IN PATIENTS WHO ARE NOT OPIOID-TOLERANT
IN THE MANAGEMENT OF ACUTE PAIN OR IN PATIENTS WHO REQUIRE OPIOID
ANALGESIA FOR A SHORT
PERIOD OF TIME
IN THE MANAGEMENT OF POST-OPERATIVE PAIN, INCLUDING USE AFTER
OUT-PATIENT OR DAY
SURGERIES (E.G., TONSILLECTOMIES)
IN THE MANAGEMENT OF MILD PAIN
IN THE MANAGEMENT OF INTERMITTENT PAIN [E.G