MORPHINE SULFATE tablet, film coated, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

ETHEX Corporation

INN (Tên quốc tế):

MORPHINE SULFATE

Thành phần:

MORPHINE SULFATE 15 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Morphine sulfate extended-release tablets are a controlled-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 mg and 200 mg tablet strengths are high dose, controlled-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 to 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 onl

Tóm tắt sản phẩm:

Morphine sulfate extended-release 15 mg tablets are oval, film-coated, green tablets, debossed “E” on one side and “15” on the other side, packaged as follows: NDC 58177-310-04 bottle of 100 tablets NDC 58177-310-11 unit dose package of 100 tablets (10 tablets per blister card) Morphine sulfate extended-release 30 mg tablets are oval, film-coated, pink tablets, debossed “E” on one side and “30” on the other side, packaged as follows: NDC 58177-320-04 bottle of 100 tablets NDC 58177-320-11 unit dose package of 100 tablets (10 tablets per blister card) Morphine sulfate extended-release 60 mg tablets are oval, film-coated, white tablets, debossed “E” on one side and “60” on the other side, packaged as follows: NDC 58177-330-04 bottle of 100 tablets NDC 58177-330-11 unit dose package of 100 tablets (10 tablets per blister card) Morphine sulfate extended-release 100 mg tablets are oval, film-coated, gray tablets, debossed “E” on one side and “100” on the other side, packaged as follows: NDC 58177-340-04 bottle of 100 tablets NDC 58177-340-09 bottle of 1000 tablets NDC 58177-340-11 unit dose package of 100 tablets (10 tablets per blister card) Morphine sulfate extended-release 200 mg tablets are oval, film-coated, brown tablets, debossed “E” on one side and “200” on the other side, packaged as follows: NDC 58177-380-04 bottle of 100 tablets NDC 58177-380-09 bottle of 1000 tablets NDC 58177-380-11 unit dose package of 100 tablets (10 tablets per blister card) Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant and child-resistant containers as defined in the USP. Healthcare professionals can telephone ETHEX Corporation’s Medical Affairs Department (1-800-321-1705) for information on this product. CAUTION DEA Order Form Required. Manufactured by KV Pharmaceutical Co. for ETHEX Corporation St. Louis,MO  63044 P5694     11/07

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

MORPHINE SULFATE - MORPHINE SULFATE TABLET, FILM COATED, EXTENDED
RELEASE
ETHEX CORPORATION
----------
CII
MORPHINE SULFATE EXTENDED-RELEASE TABLETS
15 MG, 30 MG, 60 MG, 100 MG* AND 200 MG*
*100 MG AND 200 MG ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
RX ONLY
P5694 11/07
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 ANALGESICS.
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 A CONTROLLED-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 MG 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 mg, 30 mg, 60 mg, 100
mg and 200 mg tablet strengths. The tablet strengths describe the
amount of morphine per tablet as the
pentahydrated sulfate salt (m