AVINZA morphine sulfate capsule coated extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Lake Erie Medical DBA Quality Care Products LLC

INN (Tarptautinis Pavadinimas):

MORPHINE SULFATE

Sudėtis:

MORPHINE SULFATE 60 mg

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

New Drug Application

Prekės savybės

AVINZA - MORPHINE SULFATE CAPSULE, COATED, EXTENDED RELEASE
AVINZA - MORPHINE SULFATE CAPSULE, EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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AVINZA C II
(MORPHINE SULFATE EXTENDED-RELEASE CAPSULES)
30 MG, 45 MG, 60 MG, 75 MG, 90 MG, 120 MG
R ONLY
WARNING:
AVINZA CAPSULES ARE A MODIFIED-RELEASE FORMULATION OF MORPHINE SULFATE
INDICATED FOR
ONCE DAILY ADMINISTRATION FOR THE RELIEF OF MODERATE TO SEVERE PAIN
REQUIRING CONTINUOUS,
AROUND-THE-CLOCK OPIOID THERAPY FOR AN EXTENDED PERIOD OF TIME. AVINZA
CAPSULES ARE
TO BE SWALLOWED WHOLE OR THE CONTENTS OF THE CAPSULES
SPRINKLED ON APPLESAUCE. THE CAPSULE BEADS ARE NOT TO BE CHEWED,
CRUSHED, OR DISSOLVED DUE TO THE RISK OF RAPID RELEASE AND
ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE. PATIENTS
MUST NOT CONSUME ALCOHOLIC BEVERAGES WHILE ON AVINZA THERAPY.
ADDITIONALLY, PATIENTS MUST NOT USE PRESCRIPTION OR NON-
PRESCRIPTION MEDICATIONS CONTAINING ALCOHOL WHILE ON AVINZA
THERAPY. CONSUMPTION OF ALCOHOL WHILE TAKING AVINZA MAY RESULT
IN THE RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE
OF MORPHINE.
DESCRIPTION
AVINZA (morphine sulfate extended-release capsules) 30, 45, 60, 75,
90, and 120 mg contain both
immediate release and extended release beads of morphine sulfate for
once daily oral administration.
Chemically, morphine sulfate is 7,8-didehydro-4,5
alpha-epoxy-17-methylmorphinan-3,6 alpha-diol
sulfate (2:1) (salt) pentahydrate with a molecular weight of 758.
Morphine sulfate occurs as white,
feathery, silky crystals; cubical masses of crystal; or white
crystalline powder. It is soluble in water and
slightly soluble in 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
(the majority is ionized at pH 7.4).
Each AVINZA Capsule contains either 30, 45, 60, 75, 90, or 120 mg of
morphine sulfate, USP and the
following inactive ingredients: ammoniomethacrylate copolymers, NF,
fumaric acid, NF, povid