Drug information for HYCAMTIN

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL EQ 0.25MG BASE Prescription   TOPOTECAN HYDROCHLORIDE Topotecan SMITHKLINE BEECHAM 20981
2011-10-12 Letter
2011-10-12 Label
2010-07-06 Label
2010-07-02 Letter
2009-01-15 Review
2009-01-15 Summary Review
2007-10-22 Letter
2007-10-12 Label
CAPSULE; ORAL EQ 1MG BASE Prescription  (Reference Drug) TOPOTECAN HYDROCHLORIDE Topotecan SMITHKLINE BEECHAM   "
INJECTABLE; INJECTION EQ 4MG BASE/VIAL Prescription AP (Reference Drug) TOPOTECAN HYDROCHLORIDE Topotecan GLAXOSMITHKLINE 20671
2010-04-05 Letter
2010-04-05 Letter
2010-04-05 Label
2010-04-05 Label
2006-06-20 Letter
2006-06-15 Label
2003-06-08 Letter
2003-05-29 Label
2003-03-28 Letter
2003-03-26 Other
2002-03-06 Letter
1998-11-30 Letter
1998-11-30 Review
1998-11-30 Label

Drug Adverse Effects information for HYCAMTIN

Role code Indications Reaction # Reports
PS BRAIN NEOPLASM MALIGNANT DEATH 1
PS BRONCHIAL CARCINOMA BLOOD BILIRUBIN INCREASED 1
PS BRONCHIAL CARCINOMA CHOLESTASIS 1
PS CERVIX CANCER METASTATIC CONDITION AGGRAVATED 2
PS CERVIX CANCER METASTATIC THROMBOCYTOSIS 2
PS CHRONIC OBSTRUCTIVE PULMONARY DISEASE SMALL CELL LUNG CANCER STAGE UNSPECIFIED 3
PS CONSTIPATION PLATELET COUNT INCREASED 1
PS CONSTIPATION THROMBOCYTOSIS 1
PS CONSTIPATION WHITE BLOOD CELL COUNT DECREASED 1
PS COUGH SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1
PS DEEP VEIN THROMBOSIS PLATELET COUNT INCREASED 1
PS DEEP VEIN THROMBOSIS THROMBOCYTOSIS 1
PS DEEP VEIN THROMBOSIS WHITE BLOOD CELL COUNT DECREASED 1
PS DEPRESSION SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1
PS HEPATITIS B TUBERCULOSIS 2
PS HORMONE REPLACEMENT THERAPY SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1
PS ILL-DEFINED DISORDER SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1
PS LUNG NEOPLASM MALIGNANT ADVERSE DRUG REACTION 1
PS LUNG NEOPLASM MALIGNANT ANAEMIA 1
PS LUNG NEOPLASM MALIGNANT DIARRHOEA 1
PS LUNG NEOPLASM MALIGNANT DRUG INEFFECTIVE 1
PS LUNG NEOPLASM MALIGNANT EPISTAXIS 2
PS LUNG NEOPLASM MALIGNANT HAEMATOTOXICITY 1
PS LUNG NEOPLASM MALIGNANT NEUTROPENIA 1
PS LUNG NEOPLASM MALIGNANT PYREXIA 1
PS LUNG NEOPLASM MALIGNANT THROMBOCYTOPENIA 2
PS LUNG NEOPLASM MALIGNANT TUBERCULOSIS 2
PS LUNG NEOPLASM MALIGNANT WHITE BLOOD CELL COUNT DECREASED 1
PS MUSCLE SPASMS SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1
PS NAUSEA SMALL CELL LUNG CANCER STAGE UNSPECIFIED 2
PS NEUTROPHIL COUNT DECREASED PLATELET COUNT INCREASED 2
PS NEUTROPHIL COUNT DECREASED THROMBOCYTOSIS 2
PS NEUTROPHIL COUNT DECREASED WHITE BLOOD CELL COUNT DECREASED 2
PS OVARIAN CANCER ALANINE AMINOTRANSFERASE INCREASED 1
PS OVARIAN CANCER ASPARTATE AMINOTRANSFERASE INCREASED 1
PS OVARIAN CANCER FEBRILE NEUTROPENIA 1
PS OVARIAN CANCER PLATELET COUNT INCREASED 1
PS OVARIAN CANCER THROMBOCYTOSIS 2
PS OVARIAN CANCER VISUAL ACUITY REDUCED 2
PS OVARIAN CANCER VITREOUS FLOATERS 1
PS OVARIAN CANCER WHITE BLOOD CELL COUNT DECREASED 2
PS OVARIAN CANCER RECURRENT BLOOD CREATININE INCREASED 2
PS OVARIAN CANCER RECURRENT BLOOD PRESSURE DECREASED 2
PS OVARIAN CANCER RECURRENT BONE MARROW FAILURE 1
PS OVARIAN CANCER RECURRENT CONDITION AGGRAVATED 1
PS OVARIAN CANCER RECURRENT DEATH 2
PS OVARIAN CANCER RECURRENT HEPATIC ENZYME INCREASED 2
PS OVARIAN CANCER RECURRENT HYPOPHAGIA 2
PS OVARIAN CANCER RECURRENT INTERSTITIAL LUNG DISEASE 1
PS OVARIAN CANCER RECURRENT LOSS OF CONSCIOUSNESS 2
PS OVARIAN CANCER RECURRENT NEOPLASM PROGRESSION 1
PS OVARIAN CANCER RECURRENT NEUTROPENIA 2
PS OVARIAN CANCER RECURRENT NEUTROPHIL COUNT DECREASED 1
PS OVARIAN CANCER RECURRENT OVARIAN CANCER RECURRENT 1
PS OVARIAN CANCER RECURRENT PANCYTOPENIA 2
PS OVARIAN CANCER RECURRENT PLEURAL EFFUSION 1
PS OVARIAN CANCER RECURRENT RESPIRATORY FAILURE 1
PS OVARIAN CANCER RECURRENT VOMITING 2
PS OVARIAN EPITHELIAL CANCER ALANINE AMINOTRANSFERASE INCREASED 1
PS OVARIAN EPITHELIAL CANCER ASPARTATE AMINOTRANSFERASE INCREASED 1
PS OVARIAN EPITHELIAL CANCER BLOOD ALKALINE PHOSPHATASE INCREASED 1
PS OVARIAN EPITHELIAL CANCER GAMMA-GLUTAMYLTRANSFERASE INCREASED 1
PS OVARIAN EPITHELIAL CANCER NEUTROPHIL COUNT DECREASED 1
PS OVARIAN EPITHELIAL CANCER WHITE BLOOD CELL COUNT DECREASED 1
PS PAIN SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1
PS PICA SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1
PS PREMEDICATION CONDITION AGGRAVATED 3
PS PREMEDICATION THROMBOCYTOSIS 3
PS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISCOMFORT 1
PS PRODUCT USED FOR UNKNOWN INDICATION ADVERSE DRUG REACTION 2
PS PRODUCT USED FOR UNKNOWN INDICATION CONDITION AGGRAVATED 3
PS PRODUCT USED FOR UNKNOWN INDICATION CONSTIPATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION EATING DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 2
PS PRODUCT USED FOR UNKNOWN INDICATION FEBRILE NEUTROPENIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 2
PS PRODUCT USED FOR UNKNOWN INDICATION THROMBOCYTOSIS 3
PS PROPHYLAXIS TUBERCULOSIS 2
PS PROPHYLAXIS OF NAUSEA AND VOMITING VISUAL ACUITY REDUCED 3
PS PROPHYLAXIS OF NAUSEA AND VOMITING VITREOUS FLOATERS 3
PS PROSTATE CANCER DEATH 1
PS PROSTATE CANCER OFF LABEL USE 1
PS PYREXIA PLATELET COUNT INCREASED 1
PS PYREXIA THROMBOCYTOSIS 1
PS PYREXIA WHITE BLOOD CELL COUNT DECREASED 1
PS SMALL CELL LUNG CANCER STAGE UNSPECIFIED OVERDOSE 1
PS SMALL CELL LUNG CANCER STAGE UNSPECIFIED RENAL INFARCT 3
PS SMALL CELL LUNG CANCER STAGE UNSPECIFIED SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1
SS ANTITUSSIVE THERAPY INJECTION SITE ERYTHEMA 1
SS ANTITUSSIVE THERAPY INJECTION SITE INDURATION 1
SS ANTITUSSIVE THERAPY INJECTION SITE PAIN 1
SS ANTITUSSIVE THERAPY INJECTION SITE SWELLING 1
SS ANTITUSSIVE THERAPY INJECTION SITE VASCULITIS 1
SS CERVIX CARCINOMA THROMBOCYTOSIS 2
SS CONSTIPATION INJECTION SITE ERYTHEMA 1
SS CONSTIPATION INJECTION SITE INDURATION 1
SS CONSTIPATION INJECTION SITE PAIN 1
SS CONSTIPATION INJECTION SITE SWELLING 1
SS CONSTIPATION INJECTION SITE VASCULITIS 1
SS HERPES ZOSTER INJECTION SITE ERYTHEMA 1
SS HERPES ZOSTER INJECTION SITE INDURATION 1
SS HERPES ZOSTER INJECTION SITE PAIN 1
SS HERPES ZOSTER INJECTION SITE SWELLING 1
SS HERPES ZOSTER INJECTION SITE VASCULITIS 1
SS LUNG NEOPLASM MALIGNANT ANAEMIA 1
SS LUNG NEOPLASM MALIGNANT EPISTAXIS 1
SS LUNG NEOPLASM MALIGNANT HAEMATOTOXICITY 1
SS LUNG NEOPLASM MALIGNANT INJECTION SITE ERYTHEMA 1
SS LUNG NEOPLASM MALIGNANT INJECTION SITE INDURATION 1
SS LUNG NEOPLASM MALIGNANT INJECTION SITE PAIN 1
SS LUNG NEOPLASM MALIGNANT INJECTION SITE SWELLING 1
SS LUNG NEOPLASM MALIGNANT INJECTION SITE VASCULITIS 1
SS LUNG NEOPLASM MALIGNANT NEUTROPENIA 1
SS LUNG NEOPLASM MALIGNANT THROMBOCYTOPENIA 1
SS PREMEDICATION THROMBOCYTOSIS 3
SS PRODUCTIVE COUGH INJECTION SITE ERYTHEMA 1
SS PRODUCTIVE COUGH INJECTION SITE INDURATION 1
SS PRODUCTIVE COUGH INJECTION SITE PAIN 1
SS PRODUCTIVE COUGH INJECTION SITE SWELLING 1
SS PRODUCTIVE COUGH INJECTION SITE VASCULITIS 1
SS PROPHYLAXIS OF NAUSEA AND VOMITING INJECTION SITE ERYTHEMA 1
SS PROPHYLAXIS OF NAUSEA AND VOMITING INJECTION SITE INDURATION 1
SS PROPHYLAXIS OF NAUSEA AND VOMITING INJECTION SITE PAIN 1
SS PROPHYLAXIS OF NAUSEA AND VOMITING INJECTION SITE SWELLING 1
SS PROPHYLAXIS OF NAUSEA AND VOMITING INJECTION SITE VASCULITIS 1
SS SEDATION INJECTION SITE ERYTHEMA 1
SS SEDATION INJECTION SITE INDURATION 1
SS SEDATION INJECTION SITE PAIN 1
SS SEDATION INJECTION SITE SWELLING 1
SS SEDATION INJECTION SITE VASCULITIS 1
C ANTITUSSIVE THERAPY INJECTION SITE ERYTHEMA 1
C ANTITUSSIVE THERAPY INJECTION SITE INDURATION 1
C ANTITUSSIVE THERAPY INJECTION SITE PAIN 1
C ANTITUSSIVE THERAPY INJECTION SITE SWELLING 1
C ANTITUSSIVE THERAPY INJECTION SITE VASCULITIS 1
C CHEMOTHERAPY INJECTION SITE ERYTHEMA 1
C CHEMOTHERAPY INJECTION SITE INDURATION 1
C CHEMOTHERAPY INJECTION SITE PAIN 1
C CHEMOTHERAPY INJECTION SITE SWELLING 1
C CHEMOTHERAPY INJECTION SITE VASCULITIS 1
C CONSTIPATION INJECTION SITE ERYTHEMA 1
C CONSTIPATION INJECTION SITE INDURATION 1
C CONSTIPATION INJECTION SITE PAIN 1
C CONSTIPATION INJECTION SITE SWELLING 1
C CONSTIPATION INJECTION SITE VASCULITIS 1
C HERPES ZOSTER INJECTION SITE ERYTHEMA 1
C HERPES ZOSTER INJECTION SITE INDURATION 1
C HERPES ZOSTER INJECTION SITE PAIN 1
C HERPES ZOSTER INJECTION SITE SWELLING 1
C HERPES ZOSTER INJECTION SITE VASCULITIS 1
C PRODUCTIVE COUGH INJECTION SITE ERYTHEMA 1
C PRODUCTIVE COUGH INJECTION SITE INDURATION 1
C PRODUCTIVE COUGH INJECTION SITE PAIN 1
C PRODUCTIVE COUGH INJECTION SITE SWELLING 1
C PRODUCTIVE COUGH INJECTION SITE VASCULITIS 1
C PROPHYLAXIS OF NAUSEA AND VOMITING INJECTION SITE ERYTHEMA 1
C PROPHYLAXIS OF NAUSEA AND VOMITING INJECTION SITE INDURATION 1
C PROPHYLAXIS OF NAUSEA AND VOMITING INJECTION SITE PAIN 1
C PROPHYLAXIS OF NAUSEA AND VOMITING INJECTION SITE SWELLING 1
C PROPHYLAXIS OF NAUSEA AND VOMITING INJECTION SITE VASCULITIS 1
C SEDATION INJECTION SITE ERYTHEMA 1
C SEDATION INJECTION SITE INDURATION 1
C SEDATION INJECTION SITE PAIN 1
C SEDATION INJECTION SITE SWELLING 1
C SEDATION INJECTION SITE VASCULITIS 1
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