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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