EMBEDA- morphine sufate capsule, extended release

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C), NALTREXONE HYDROCHLORIDE (UNII: Z6375YW9SF) (NALTREXONE - UNII:5S6W795CQM)

Доступна з:

STAT RX USA LLC

ІПН (Міжнародна Ім'я):

MORPHINE SULFATE

Склад:

MORPHINE SULFATE 20 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

EMBEDA is an extended-release oral formulation of morphine sulfate and naltrexone hydrochloride 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. EMBEDA is NOT intended for use as a prn analgesic. EMBEDA is not indicated for acute/postoperative pain or if the pain is mild or not expected to persist for an extended period of time. EMBEDA is only indicated for postoperative use if the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate EMBEDA is contraindicated in patients with a known hypersensitivity to morphine, morphine salts, naltrexone, or in any situation where opioids are contraindicated. EMBEDA is contraindicated in patients with significant respiratory depression in u

Огляд продуктів:

HOW SUPPLIED/STORAGE AND HANDLING 0.8 mg Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F). Dispense in a sealed, tamper-evident, childproof, light-resistant container.

Статус Авторизація:

New Drug Application

інформаційний буклет

EMBEDA - MORPHINE SUFATE CAPSULE, EXTENDED RELEASE
STAT RX USA LLC
----------
MEDICATION GUIDE
EMBEDA™ (im-bed-a)
(morphine sulfate and naltrexone hydrochloride)
Extended Release Capsules CII
IMPORTANT: Keep EMBEDA in a safe place away from children. Accidental
use by a child is a
medical emergency and can result in death. If a child accidentally
takes EMBEDA, get emergency help
right away.
Read the Medication Guide that comes with EMBEDA before you start
taking it and each time you get a
new prescription. There may be new information. This information does
not take the place of talking with
your healthcare provider about your medical condition or your
treatment. Share this important
information with members of your household.
What Is the Most Important Information I Should Know About EMBEDA?
•
Do not crush, dissolve, or chew EMBEDA capsules or the capsule
contents before swallowing. If
EMBEDA is taken in this way, both the morphine and naltrexone in
EMBEDA will be released
too fast. This is dangerous. It may cause you to have trouble
breathing, and lead to death.
•
If your body is not used to taking opioids and your body absorbs too
much morphine, you
could overdose and die.
•
If you have been taking opioids (narcotics) for a period of time, and
your body absorbs the
naltrexone in EMBEDA, this could cause you to have uncomfortable
withdrawal
symptoms.
•
Take EMBEDA exactly as prescribed by your healthcare provider.
•
EMBEDA is not for use to treat pain that you only have once in a while
(“as needed”).
•
If you cannot swallow capsules, tell your healthcare provider. There
may be another way to take
EMBEDA that may be right for you. See “How should I take EMBEDA?”
•
Do not take the highest dose of EMBEDA (morphine sulfate 100 mg and
naltrexone hydrochloride
4 mg) unless you are “opioid tolerant.” Opioid tolerant means that
you regularly use another
opioid medicine for your constant (around the clock) pain and your
body is used to it.
•
Do not drink alcohol, or use prescription or non-

Характеристики продукта

EMBEDA - MORPHINE SUFATE CAPSULE, EXTENDED RELEASE
STAT RX USA LLC
----------
11 DESCRIPTION
EMBEDA Capsules contain pellets of morphine sulfate and naltrexone
hydrochloride at a ratio of
100:4. Morphine sulfate is an agonist and naltrexone hydrochloride is
an antagonist at the mu-opioid
receptor.
The chemical name of morphine sulfate is 7,8-didehydro-4,5
α-epoxy-17-methyl-morphinan-3,6 α-diol
sulfate (2:1) (salt) pentahydrate. The empirical formula is (C
H NO ) ●H SO ●5H O and its
molecular weight is 758.85.
Morphine sulfate is an odorless, white, crystalline powder with a
bitter taste. It has a solubility of 1 in
21 parts of water and 1 in 1000 parts of alcohol, but is practically
insoluble in chloroform or ether. The
octanol: water partition coefficient of morphine is 1.42 at
physiologic pH and the pK is 7.9 for the
tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula
is:
STRUCTURE IMAGE 1
The chemical name of naltrexone hydrochloride is
(5α)-17-(Cyclopropylmethyl)-4,5-epoxy-3,14-
dihydroxymorphinan-6-one hydrochloride. The empirical formula is C
H NO •HCl and its
molecular weight is 377.46.
Naltrexone hydrochloride is a white to slightly off-white powder that
is soluble in water. Its structural
formula is
STRUCTURE IMAGE 2
Each capsule contains the following inactive ingredients common to all
strengths: talc, ammonio
methacrylate copolymer, sugar spheres, ethylcellulose, sodium
chloride, polyethylene glycol,
hydroxypropyl cellulose, dibutyl sebacate, methacrylic acid copolymer,
diethyl phthalate, magnesium
stearate, sodium lauryl sulfate, and ascorbic acid. The capsule shells
contain gelatin, titanium dioxide,
and grey ink, D and C yellow #10 (EMBEDA 20 mg/0.8 mg), FD and C red
#3, FD and C blue #1
(EMBEDA 30 mg/1.2 mg), D and C red #28, FD and C red #40, FD and C
blue #1 (EMBEDA 50 mg/2
mg), D and C red #28, FD and C red #40, FD and C blue #1 (EMBEDA 60
mg/2.4 mg), FD and C blue
#1, FD and C red #40, FD and C yellow #6 (EMBEDA 80 mg/3.2 mg), D and
C yellow #10, FD and C
blue #1 (EMBE