Drug information for PREVPAC

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET; ORAL	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	Prescription	(Reference Drug)	AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE	Amoxicillin	TAKEDA PHARMS USA	50757 2009-04-03 Letter 2007-11-08 Letter 2007-11-07 Label 2007-06-04 Letter 2006-08-14 Letter 2006-08-14 Letter 2005-04-28 Label 2005-04-28 Letter 2004-07-30 Letter 2004-07-30 Letter 2004-06-14 Letter 2004-06-14 Label 2002-11-22 Label 2002-11-22 Letter 1999-10-22 Review 1999-10-22 Label 1999-10-22 Letter 1999-08-20 Review 1999-08-20 Letter 1999-08-20 Label 1999-01-22 Review 1999-01-22 Letter 1999-01-22 Label 1997-12-02 Review

Drug Adverse Effects information for PREVPAC

Role code	Indications	Reaction	# Reports
PS	HELICOBACTER INFECTION	DIARRHOEA	1
PS	HELICOBACTER INFECTION	DISORIENTATION	1
PS	HELICOBACTER INFECTION	DIZZINESS	1
PS	HELICOBACTER INFECTION	FALL	1
C	CHOLECYSTECTOMY	ABDOMINAL PAIN UPPER	1
C	CHOLECYSTECTOMY	CHOLECYSTITIS CHRONIC	1
C	CHOLECYSTECTOMY	DECREASED APPETITE	1
C	CHOLECYSTECTOMY	GALLBLADDER DISORDER	1
C	CHOLECYSTECTOMY	HEADACHE	1
C	COLITIS ULCERATIVE	COLITIS ULCERATIVE	1
C	COLITIS ULCERATIVE	DRUG INEFFECTIVE	1
C	COMPUTERISED TOMOGRAM ABDOMEN	URTICARIA	1
C	CONTRACEPTION	DEEP VEIN THROMBOSIS	2
C	CONTRACEPTION	PULMONARY EMBOLISM	2
C	CORONARY ARTERY BYPASS	ANHEDONIA	1
C	CORONARY ARTERY BYPASS	ANXIETY	1
C	CORONARY ARTERY BYPASS	DEATH	1
C	CORONARY ARTERY BYPASS	EMOTIONAL DISTRESS	1
C	CORONARY ARTERY BYPASS	FEAR	1
C	CORONARY ARTERY BYPASS	INJURY	1
C	CORONARY ARTERY BYPASS	MULTI-ORGAN FAILURE	1
C	CORONARY ARTERY BYPASS	PAIN	1
C	CORONARY ARTERY BYPASS	RENAL FAILURE	1
C	CORONARY ARTERY BYPASS	RENAL IMPAIRMENT	1
C	CORONARY ARTERY BYPASS	RENAL INJURY	1
C	CORONARY ARTERY BYPASS	STRESS	1
C	CORONARY ARTERY BYPASS	UNEVALUABLE EVENT	1
C	ORAL CONTRACEPTION	ABDOMINAL PAIN	1
C	ORAL CONTRACEPTION	ANXIETY	1
C	ORAL CONTRACEPTION	BILIARY DYSKINESIA	1
C	ORAL CONTRACEPTION	CHOLECYSTITIS CHRONIC	1
C	ORAL CONTRACEPTION	GALLBLADDER NON-FUNCTIONING	1
C	ORAL CONTRACEPTION	NAUSEA	1
C	ORAL CONTRACEPTION	VOMITING	1
C	PRODUCT USED FOR UNKNOWN INDICATION	ABDOMINAL PAIN UPPER	1
C	PRODUCT USED FOR UNKNOWN INDICATION	ANHEDONIA	6
C	PRODUCT USED FOR UNKNOWN INDICATION	ANXIETY	6
C	PRODUCT USED FOR UNKNOWN INDICATION	CHOLECYSTITIS CHRONIC	1
C	PRODUCT USED FOR UNKNOWN INDICATION	DEATH	6
C	PRODUCT USED FOR UNKNOWN INDICATION	DECREASED APPETITE	1
C	PRODUCT USED FOR UNKNOWN INDICATION	EMOTIONAL DISTRESS	6
C	PRODUCT USED FOR UNKNOWN INDICATION	FEAR	6
C	PRODUCT USED FOR UNKNOWN INDICATION	GALLBLADDER DISORDER	1
C	PRODUCT USED FOR UNKNOWN INDICATION	HEADACHE	1
C	PRODUCT USED FOR UNKNOWN INDICATION	INJURY	6
C	PRODUCT USED FOR UNKNOWN INDICATION	MULTI-ORGAN FAILURE	6
C	PRODUCT USED FOR UNKNOWN INDICATION	PAIN	6
C	PRODUCT USED FOR UNKNOWN INDICATION	RENAL FAILURE	6
C	PRODUCT USED FOR UNKNOWN INDICATION	RENAL IMPAIRMENT	6
C	PRODUCT USED FOR UNKNOWN INDICATION	RENAL INJURY	6
C	PRODUCT USED FOR UNKNOWN INDICATION	STRESS	6
C	PRODUCT USED FOR UNKNOWN INDICATION	UNEVALUABLE EVENT	6
C	THROMBOSIS PROPHYLAXIS	DEEP VEIN THROMBOSIS	1
C	THROMBOSIS PROPHYLAXIS	PULMONARY EMBOLISM	1
C	THYROID DISORDER	DEEP VEIN THROMBOSIS	1
C	THYROID DISORDER	PULMONARY EMBOLISM	1

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