MORPHINE SULFATE tablet, film coated, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)

Διαθέσιμο από:

H.J. Harkins Company, Inc.

INN (Διεθνής Όνομα):

MORPHINE SULFATE

Σύνθεση:

MORPHINE SULFATE 15 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Morphine Sulfate Extended-Release Tablets are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine Sulfate Extended-Release Tablets are NOT intended for use as a prn analgesic. The Morphine Sulfate Extended-Release Tablets 100 and 200 mg tablet strengths are high dose, extended-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine Sulfate Extended-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine Sulfate Extended-Release Tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine Sulfate Extended-Release Tablets are

Περίληψη προϊόντος:

Morphine Sulfate Extended-Release Tablets 15 mg are round, blue-colored, film-coated tablets bearing the symbol ABG on one side and 15 on the other. They are supplied as follows: NDC 42858-801-01: opaque plastic bottles containing 100 tablets Morphine Sulfate Extended-Release Tablets 30 mg are round, lavender-colored, film-coated tablets bearing the symbol ABG on one side and 30 on the other. They are supplied as follows: NDC 42858-805-01: opaque plastic bottles containing 100 tablets Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container. Healthcare professionals can telephone Rhodes Pharmaceuticals at 1-888-827-0616 for information on this product. CAUTION DEA Order Form Required. Distributed By: Rhodes Pharmaceuticals L.P. Coventry, RI 02816 Manufactured By: Purdue Pharmaceuticals L.P. Wilson, NC 27893 Component No: 302567-0A Repacked By: H.J. Harkins Company, Inc. Nipomo, CA 93444

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

MORPHINE SULFATE - MORPHINE SULFATE TABLET, FILM COATED, EXTENDED
RELEASE
H.J. HARKINS COMPANY, INC.
----------
MORPHINE SULFATE EXTENDED-RELEASE TABLETS
CII 15 MG 30 MG 60 MG 100 MG* 200 MG* *100 MG AND 200 MG ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
WARNING:
MORPHINE SULFATE EXTENDED-RELEASE TABLETS CONTAIN MORPHINE SULFATE, AN
OPIOID AGONIST
AND A SCHEDULE II CONTROLLED SUBSTANCE, WITH AN ABUSE LIABILITY
SIMILAR TO OTHER OPIOID
ANALGES ICS .
MORPHINE CAN BE ABUSED IN A MANNER SIMILAR TO OTHER OPIOID AGONISTS,
LEGAL OR ILLICIT. THIS
SHOULD BE CONSIDERED WHEN PRESCRIBING OR DISPENSING MORPHINE SULFATE
EXTENDED-RELEASE
TABLETS IN SITUATIONS WHERE THE PHYSICIAN OR PHARMACIST IS CONCERNED
ABOUT AN INCREASED
RISK OF MISUSE, ABUSE, OR DIVERSION.
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE AN EXTENDED-RELEASE ORAL
FORMULATION OF
MORPHINE SULFATE INDICATED FOR THE MANAGEMENT OF MODERATE TO SEVERE
PAIN WHEN A
CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC IS NEEDED FOR AN
EXTENDED PERIOD OF TIME.
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE NOT INTENDED FOR USE AS
A PRN ANALGESIC.
MORPHINE SULFATE EXTENDED-RELEASE 100 AND 200 MG TABLETS ARE FOR USE
IN OPIOID-
TOLERANT PATIENTS ONLY. THESE TABLET STRENGTHS MAY CAUSE FATAL
RESPIRATORY
DEPRESSION WHEN ADMINISTERED TO PATIENTS NOT PREVIOUSLY EXPOSED TO
OPIOIDS.
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED
WHOLE AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED.
TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MORPHINE SULFATE
EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION
OF A POTENTIALLY FATAL DOSE OF MORPHINE.
DESCRIPTION
Chemically, morphine sulfate is
7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1)
(salt) pentahydrate and has the following structural formula:
Morphine Sulfate Extended-Release Tablets are opiate analgesics
supplied in 15, 30, 60, 100 and 200
mg tablet strengths. The tablet strengths describe the amount of
morphine per tablet as the pentahydrated
sulfate salt (morphine sulfate, USP). Morphine