Drug information for TOBREX

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
OINTMENT; OPHTHALMIC 0.3% Prescription  (Reference Drug) TOBRAMYCIN Tobramycin ALCON 50555
2004-07-21 Label

2004-07-21 Label

2004-07-21 Letter

2004-07-21 Letter

2003-03-26 Label

2003-03-26 Label

2003-03-26 Letter

2003-03-26 Label

2003-03-26 Letter

2003-03-26 Letter
SOLUTION/DROPS; OPHTHALMIC 0.3% Prescription AT (Reference Drug) TOBRAMYCIN Tobramycin FALCON PHARMS 50541
2003-07-28 Label

2003-07-28 Letter
SOLUTION/DROPS; OPHTHALMIC 0.3% Prescription AT  TOBRAMYCIN Tobramycin ALCON 62535

Drug Adverse Effects information for TOBREX

Role code Indications Reaction # Reports
PS PURULENT DISCHARGE CONDITION AGGRAVATED 1
PS PURULENT DISCHARGE OCULAR HYPERAEMIA 1
PS PURULENT DISCHARGE OPHTHALMIA NEONATORUM 1
C ACUTE SINUSITIS ANAEMIA 4
C ACUTE SINUSITIS ASCITES 4
C ACUTE SINUSITIS BAND NEUTROPHIL COUNT INCREASED 1
C ACUTE SINUSITIS CAESAREAN SECTION 1
C ACUTE SINUSITIS CARDIAC ARREST 4
C ACUTE SINUSITIS CARDIO-RESPIRATORY ARREST 1
C ACUTE SINUSITIS EXOMPHALOS 4
C ACUTE SINUSITIS FOETAL EXPOSURE DURING PREGNANCY 4
C ACUTE SINUSITIS FOETAL HEART RATE DECELERATION 1
C ACUTE SINUSITIS GROWTH RETARDATION 4
C ACUTE SINUSITIS HEART DISEASE CONGENITAL 4
C ACUTE SINUSITIS HEART RATE DECREASED 4
C ACUTE SINUSITIS HEPATIC VEIN THROMBOSIS 4
C ACUTE SINUSITIS HYPERGLYCAEMIA 4
C ACUTE SINUSITIS INTESTINAL DILATATION 4
C ACUTE SINUSITIS JAUNDICE 4
C ACUTE SINUSITIS METABOLIC ACIDOSIS 1
C ACUTE SINUSITIS NEONATAL RESPIRATORY DISTRESS SYNDROME 1
C ACUTE SINUSITIS OLIGURIA 1
C ACUTE SINUSITIS PATENT DUCTUS ARTERIOSUS 3
C ACUTE SINUSITIS PNEUMONIA 1
C ACUTE SINUSITIS RESPIRATORY FAILURE 1
C ACUTE SINUSITIS SEPSIS 3
C ACUTE SINUSITIS VENTRICULAR TACHYCARDIA 4
C ANXIETY ANAEMIA 2
C ANXIETY ASCITES 2
C ANXIETY CARDIAC ARREST 2
C ANXIETY EXOMPHALOS 2
C ANXIETY FOETAL EXPOSURE DURING PREGNANCY 2
C ANXIETY GROWTH RETARDATION 2
C ANXIETY HEART DISEASE CONGENITAL 2
C ANXIETY HEART RATE DECREASED 2
C ANXIETY HEPATIC VEIN THROMBOSIS 2
C ANXIETY HYPERGLYCAEMIA 2
C ANXIETY INTESTINAL DILATATION 2
C ANXIETY JAUNDICE 2
C ANXIETY PATENT DUCTUS ARTERIOSUS 2
C ANXIETY SEPSIS 2
C ANXIETY VENTRICULAR TACHYCARDIA 2
C CONJUNCTIVITIS ANAEMIA 4
C CONJUNCTIVITIS ASCITES 4
C CONJUNCTIVITIS BAND NEUTROPHIL COUNT INCREASED 1
C CONJUNCTIVITIS CAESAREAN SECTION 1
C CONJUNCTIVITIS CARDIAC ARREST 4
C CONJUNCTIVITIS CARDIO-RESPIRATORY ARREST 1
C CONJUNCTIVITIS EXOMPHALOS 4
C CONJUNCTIVITIS FOETAL EXPOSURE DURING PREGNANCY 4
C CONJUNCTIVITIS FOETAL HEART RATE DECELERATION 1
C CONJUNCTIVITIS GROWTH RETARDATION 4
C CONJUNCTIVITIS HEART DISEASE CONGENITAL 4
C CONJUNCTIVITIS HEART RATE DECREASED 4
C CONJUNCTIVITIS HEPATIC VEIN THROMBOSIS 4
C CONJUNCTIVITIS HYPERGLYCAEMIA 4
C CONJUNCTIVITIS INTESTINAL DILATATION 4
C CONJUNCTIVITIS JAUNDICE 4
C CONJUNCTIVITIS METABOLIC ACIDOSIS 1
C CONJUNCTIVITIS NEONATAL RESPIRATORY DISTRESS SYNDROME 1
C CONJUNCTIVITIS OLIGURIA 1
C CONJUNCTIVITIS PATENT DUCTUS ARTERIOSUS 3
C CONJUNCTIVITIS PNEUMONIA 1
C CONJUNCTIVITIS RESPIRATORY FAILURE 1
C CONJUNCTIVITIS SEPSIS 3
C CONJUNCTIVITIS VENTRICULAR TACHYCARDIA 4
C DEPRESSION ANAEMIA 2
C DEPRESSION ASCITES 2
C DEPRESSION CARDIAC ARREST 2
C DEPRESSION EXOMPHALOS 2
C DEPRESSION FOETAL EXPOSURE DURING PREGNANCY 2
C DEPRESSION GROWTH RETARDATION 2
C DEPRESSION HEART DISEASE CONGENITAL 2
C DEPRESSION HEART RATE DECREASED 2
C DEPRESSION HEPATIC VEIN THROMBOSIS 2
C DEPRESSION HYPERGLYCAEMIA 2
C DEPRESSION INTESTINAL DILATATION 2
C DEPRESSION JAUNDICE 2
C DEPRESSION PATENT DUCTUS ARTERIOSUS 2
C DEPRESSION SEPSIS 2
C DEPRESSION VENTRICULAR TACHYCARDIA 2
C KERATITIS HERPETIC ALTERNARIA INFECTION 4
C KERATITIS HERPETIC CHOLESTASIS 4
C KERATITIS HERPETIC GRANULOMA 4
C KERATITIS HERPETIC HEPATIC FUNCTION ABNORMAL 4
C KERATITIS HERPETIC HEPATOTOXICITY 4
C KERATITIS HERPETIC LUNG DISORDER 4
C KERATITIS HERPETIC MYCOBACTERIUM KANSASII INFECTION 4
C KERATITIS HERPETIC SKIN LESION 4
C KERATITIS HERPETIC TRANSAMINASES INCREASED 4
C MYCOBACTERIUM KANSASII INFECTION ALTERNARIA INFECTION 3
C MYCOBACTERIUM KANSASII INFECTION CHOLESTASIS 3
C MYCOBACTERIUM KANSASII INFECTION GRANULOMA 3
C MYCOBACTERIUM KANSASII INFECTION HEPATIC FUNCTION ABNORMAL 3
C MYCOBACTERIUM KANSASII INFECTION HEPATOTOXICITY 3
C MYCOBACTERIUM KANSASII INFECTION LUNG DISORDER 3
C MYCOBACTERIUM KANSASII INFECTION MYCOBACTERIUM KANSASII INFECTION 3
C MYCOBACTERIUM KANSASII INFECTION SKIN LESION 3
C MYCOBACTERIUM KANSASII INFECTION TRANSAMINASES INCREASED 3
C PRODUCT USED FOR UNKNOWN INDICATION ALTERNARIA INFECTION 6
C PRODUCT USED FOR UNKNOWN INDICATION CHOLESTASIS 6
C PRODUCT USED FOR UNKNOWN INDICATION GRANULOMA 6
C PRODUCT USED FOR UNKNOWN INDICATION HEPATIC FUNCTION ABNORMAL 6
C PRODUCT USED FOR UNKNOWN INDICATION HEPATOTOXICITY 6
C PRODUCT USED FOR UNKNOWN INDICATION LUNG DISORDER 6
C PRODUCT USED FOR UNKNOWN INDICATION MYCOBACTERIUM KANSASII INFECTION 6
C PRODUCT USED FOR UNKNOWN INDICATION SKIN LESION 6
C PRODUCT USED FOR UNKNOWN INDICATION TRANSAMINASES INCREASED 6
C PYREXIA ASTHMA 2
C PYREXIA BLEPHARITIS 2
C PYREXIA BLINDNESS 2
C PYREXIA BLOOD PRESSURE INCREASED 2
C PYREXIA BRONCHITIS 2
C PYREXIA CONJUNCTIVAL SCAR 2
C PYREXIA CONJUNCTIVITIS BACTERIAL 2
C PYREXIA CONSTIPATION 2
C PYREXIA CORNEAL DISORDER 2
C PYREXIA CORNEAL OPACITY 2
C PYREXIA DERMATITIS BULLOUS 2
C PYREXIA DISCOMFORT 2
C PYREXIA DISEASE COMPLICATION 2
C PYREXIA EAR HAEMORRHAGE 2
C PYREXIA EYE IRRITATION 2
C PYREXIA HEART RATE INCREASED 2
C PYREXIA HYPERSENSITIVITY 2
C PYREXIA KERATITIS 2
C PYREXIA LUNG TRANSPLANT 2
C PYREXIA OBLITERATIVE BRONCHIOLITIS 2
C PYREXIA OCULAR HYPERAEMIA 2
C PYREXIA PAIN 2
C PYREXIA RESPIRATORY DISTRESS 2
C PYREXIA RESPIRATORY FAILURE 2
C PYREXIA RHINITIS ALLERGIC 2
C PYREXIA STEVENS-JOHNSON SYNDROME 2
C PYREXIA TOXICITY TO VARIOUS AGENTS 2
C PYREXIA TRICHIASIS 2
C PYREXIA UPPER RESPIRATORY TRACT INFECTION 2
C PYREXIA WHITE BLOOD CELL DISORDER 2
C TYPE 2 DIABETES MELLITUS ANAEMIA 4
C TYPE 2 DIABETES MELLITUS ASCITES 4
C TYPE 2 DIABETES MELLITUS BAND NEUTROPHIL COUNT INCREASED 1
C TYPE 2 DIABETES MELLITUS CAESAREAN SECTION 1
C TYPE 2 DIABETES MELLITUS CARDIAC ARREST 4
C TYPE 2 DIABETES MELLITUS CARDIO-RESPIRATORY ARREST 1
C TYPE 2 DIABETES MELLITUS EXOMPHALOS 4
C TYPE 2 DIABETES MELLITUS FOETAL EXPOSURE DURING PREGNANCY 4
C TYPE 2 DIABETES MELLITUS FOETAL HEART RATE DECELERATION 1
C TYPE 2 DIABETES MELLITUS GROWTH RETARDATION 4
C TYPE 2 DIABETES MELLITUS HEART DISEASE CONGENITAL 4
C TYPE 2 DIABETES MELLITUS HEART RATE DECREASED 4
C TYPE 2 DIABETES MELLITUS HEPATIC VEIN THROMBOSIS 4
C TYPE 2 DIABETES MELLITUS HYPERGLYCAEMIA 4
C TYPE 2 DIABETES MELLITUS INTESTINAL DILATATION 4
C TYPE 2 DIABETES MELLITUS JAUNDICE 4
C TYPE 2 DIABETES MELLITUS METABOLIC ACIDOSIS 1
C TYPE 2 DIABETES MELLITUS NEONATAL RESPIRATORY DISTRESS SYNDROME 1
C TYPE 2 DIABETES MELLITUS OLIGURIA 1
C TYPE 2 DIABETES MELLITUS PATENT DUCTUS ARTERIOSUS 3
C TYPE 2 DIABETES MELLITUS PNEUMONIA 1
C TYPE 2 DIABETES MELLITUS RESPIRATORY FAILURE 1
C TYPE 2 DIABETES MELLITUS SEPSIS 3
C TYPE 2 DIABETES MELLITUS VENTRICULAR TACHYCARDIA 4
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