KADIAN morphine sulfate capsule extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Beli Sekarang

Unduh Karakteristik produk (SPC)
10-01-2018

Bahan aktif:

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

Tersedia dari:

Lake Erie Medical DBA Quality Care Products LLC

INN (Nama Internasional):

MORPHINE SULFATE

Komposisi:

MORPHINE SULFATE 20 mg

Jenis Resep:

PRESCRIPTION DRUG

Status otorisasi:

New Drug Application

Karakteristik produk

                                KADIAN- MORPHINE SULFATE CAPSULE, EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
KADIAN (MORPHINE SULFATE) EXTENDED-RELEASE CAPSULES, FOR ORAL USE, CII
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KADIAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR KADIAN.
KADIAN® (MORPHINE SULFATE) EXTENDED-RELEASE CAPSULES, FOR ORAL USE,
CII
INITIAL U.S. APPROVAL: 1941
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND
INTERACTION
WITH ALCOHOL
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
KADIAN EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH
CAN LEAD TO OVERDOSE AND DEATH.
ASSESS EACH PATIENT’S RISK BEFORE PRESCRIBING, AND MONITOR REGULARLY
FOR DEVELOPMENT OF THESE
BEHAVIORS OR CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS TO SWALLOW
KADIAN CAPSULES WHOLE TO AVOID
EXPOSURE TO A POTENTIALLY FATAL DOSE OF MORPHINE. (5.2)
ACCIDENTAL INGESTION OF KADIAN, ESPECIALLY IN CHILDREN, CAN RESULT IN
FATAL OVERDOSE OF MORPHINE. (5.3)
PROLONGED USE OF KADIAN DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID
WITHDRAWAL SYNDROME, WHICH
MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. IF OPIOID USE
IS REQUIRED FOR A PROLONGED PERIOD
IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID
WITHDRAWAL SYNDROME AND
ENSURE THAT APPROPRIATE TREATMENT WILL BE AVAILABLE. (5.3)
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCTS CONTAINING
ALCOHOL WHILE TAKING KADIAN
BECAUSE CO-INGESTION CAN RESULT IN FATAL PLASMA MORPHINE LEVELS. (5.4)
RECENT MAJOR CHANGES
Boxed Warning
04/2014
Indications and Usage (1)
04/2014
Dosage and Administration (2) 04/2014
Warnings and Precautions (5)
04/2014

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

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

                        

                                
                                
                                            

                            

                                
                                    
 Produsen atau pemegang autorisasi                                    
                                        Lake Erie Medical DBA Quality Care Products LLC
                                    
                                    

                                    Lake Erie Medical DBA Quality Care Products LLC                                
                            

                        

                                
                                            

                            

                                
                                    
 INN (Nama Internasional)                                    
                                        MORPHINE SULFATE
                                    
                                    

                                    MORPHINE SULFATE                                
                            

                        

                                        
                    

                        

            

                
        
        
        
        
        
            	
        
                
        
        
                    

                

                
                    
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                                    KADIAN morphine sulfate capsule extended release