Approved Drug Label (PDF)
5
Warnings and Precautions
Newly added
subsections:
5.8 Vision Blurred
Vision may be
temporarily blurred following dosing with TOBRADEX ST. Care should be exercised
in operating machinery or driving a motor vehicle.
5.9 Risk of
Contamination
Do not touch the
dropper tip of the bottle to any surface, as this may contaminate the contents.
5.10 Contact Lens
Use
TOBRADEX ST
contains benzalkonium chloride, an antimicrobial preservative, that may be
absorbed by soft contact lenses. Contact lenses should not be worn during the
use of TOBRADEX ST.
6
Adverse Reactions
6.1 Clinical
Trials Experience
Newly added
information:
Because clinical trials
are conducted under widely varying conditions, adverse reaction rates observed
in the clinical trials of a drug cannot be directly compared to rates in the
clinical trials of another drug and may not reflect the rates observed in
practice.
Newly added to end
of subsection:
The following
additional adverse reactions have been reported with the individual components
below:
Aminoglycosides:
Neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients
receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle
weakness in patients with known or suspected neuromuscular disorders, such as
myasthenia gravis or Parkinson’s disease, because of their potential effect on
neuromuscular function.
Dexamethasone:
Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone
in excess of the listed dosing instructions in predisposed patients, including
children and patients treated with CYP3A4 inhibitors.
Newly added
subsection:
6.2 Postmarketing
Experience
The following
adverse reactions have been identified during postapproval use of TOBRADEX ST.
Because these reactions are reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate their frequency or
establish a causal relationship to drug exposure.
Additional adverse
reactions identified from postapproval use include, anaphylactic reaction, and
erythema multiforme.
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or
revisions underlined:
There
are no adequate and well-controlled studies in pregnant women. However,
prolonged or repeated corticoid use during pregnancy has been associated with
an increased risk of intra-uterine growth retardation. Infants born of mothers who
have received substantial doses of corticosteroids during pregnancy should be
observed carefully for signs of hypoadrenalism. TOBRADEX ST Ophthalmic
Suspension should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus [see Nonclinical Toxicology (13.1)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
Storage and
Handling
Instruct the
patient to store the bottle upright and away from light. Shake well before
using [see Dosage and Administration (2.1) and How Supplied/Storage
and Handling (16)].
Avoid
Contamination
Instruct the
patient not to touch dropper tip to any surface, as this may contaminate the
contents [see Warnings and Precautions (5.9)].
Contact Lens Wear
Advise the patient
that contact lenses should not be worn during the use of this product [see
Warnings and Precautions (5.10)].
Newly added information:
Ability to Drive
and Use Machines
Advise the patient
that vision may be temporarily blurred following dosing with TOBRADEX ST. Care
should be exercised in operating machinery or driving a motor vehicle [see
Warnings and Precautions (5.8)].
Approved Drug Label (PDF)
5
Warnings and Precautions
Newly added
subsections:
5.8 Vision Blurred
Vision may be
temporarily blurred following dosing with TOBRADEX ST. Care should be exercised
in operating machinery or driving a motor vehicle.
5.9 Risk of
Contamination
Do not touch the
dropper tip of the bottle to any surface, as this may contaminate the contents.
5.10 Contact Lens
Use
TOBRADEX ST
contains benzalkonium chloride, an antimicrobial preservative, that may be
absorbed by soft contact lenses. Contact lenses should not be worn during the
use of TOBRADEX ST.
6
Adverse Reactions
6.1 Clinical
Trials Experience
Newly added
information:
Because clinical trials
are conducted under widely varying conditions, adverse reaction rates observed
in the clinical trials of a drug cannot be directly compared to rates in the
clinical trials of another drug and may not reflect the rates observed in
practice.
Newly added to end
of subsection:
The following
additional adverse reactions have been reported with the individual components
below:
Aminoglycosides:
Neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients
receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle
weakness in patients with known or suspected neuromuscular disorders, such as
myasthenia gravis or Parkinson’s disease, because of their potential effect on
neuromuscular function.
Dexamethasone:
Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone
in excess of the listed dosing instructions in predisposed patients, including
children and patients treated with CYP3A4 inhibitors.
Newly added
subsection:
6.2 Postmarketing
Experience
The following
adverse reactions have been identified during postapproval use of TOBRADEX ST.
Because these reactions are reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate their frequency or
establish a causal relationship to drug exposure.
Additional adverse
reactions identified from postapproval use include, anaphylactic reaction, and
erythema multiforme.
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or
revisions underlined:
There
are no adequate and well-controlled studies in pregnant women. However,
prolonged or repeated corticoid use during pregnancy has been associated with
an increased risk of intra-uterine growth retardation. Infants born of mothers who
have received substantial doses of corticosteroids during pregnancy should be
observed carefully for signs of hypoadrenalism. TOBRADEX ST Ophthalmic
Suspension should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus [see Nonclinical Toxicology (13.1)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
Storage and
Handling
Instruct the
patient to store the bottle upright and away from light. Shake well before
using [see Dosage and Administration (2.1) and How Supplied/Storage
and Handling (16)].
Avoid
Contamination
Instruct the
patient not to touch dropper tip to any surface, as this may contaminate the
contents [see Warnings and Precautions (5.9)].
Contact Lens Wear
Advise the patient
that contact lenses should not be worn during the use of this product [see
Warnings and Precautions (5.10)].
Newly added information:
Ability to Drive
and Use Machines
Advise the patient
that vision may be temporarily blurred following dosing with TOBRADEX ST. Care
should be exercised in operating machinery or driving a motor vehicle [see
Warnings and Precautions (5.8)].
Approved Drug Label (PDF)
5
Warnings and Precautions
Newly added
subsections:
5.8 Vision Blurred
Vision may be
temporarily blurred following dosing with TOBRADEX ST. Care should be exercised
in operating machinery or driving a motor vehicle.
5.9 Risk of
Contamination
Do not touch the
dropper tip of the bottle to any surface, as this may contaminate the contents.
5.10 Contact Lens
Use
TOBRADEX ST
contains benzalkonium chloride, an antimicrobial preservative, that may be
absorbed by soft contact lenses. Contact lenses should not be worn during the
use of TOBRADEX ST.
6
Adverse Reactions
6.1 Clinical
Trials Experience
Newly added
information:
Because clinical trials
are conducted under widely varying conditions, adverse reaction rates observed
in the clinical trials of a drug cannot be directly compared to rates in the
clinical trials of another drug and may not reflect the rates observed in
practice.
Newly added to end
of subsection:
The following
additional adverse reactions have been reported with the individual components
below:
Aminoglycosides:
Neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients
receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle
weakness in patients with known or suspected neuromuscular disorders, such as
myasthenia gravis or Parkinson’s disease, because of their potential effect on
neuromuscular function.
Dexamethasone:
Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone
in excess of the listed dosing instructions in predisposed patients, including
children and patients treated with CYP3A4 inhibitors.
Newly added
subsection:
6.2 Postmarketing
Experience
The following
adverse reactions have been identified during postapproval use of TOBRADEX ST.
Because these reactions are reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate their frequency or
establish a causal relationship to drug exposure.
Additional adverse
reactions identified from postapproval use include, anaphylactic reaction, and
erythema multiforme.
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or
revisions underlined:
There
are no adequate and well-controlled studies in pregnant women. However,
prolonged or repeated corticoid use during pregnancy has been associated with
an increased risk of intra-uterine growth retardation. Infants born of mothers who
have received substantial doses of corticosteroids during pregnancy should be
observed carefully for signs of hypoadrenalism. TOBRADEX ST Ophthalmic
Suspension should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus [see Nonclinical Toxicology (13.1)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
Storage and
Handling
Instruct the
patient to store the bottle upright and away from light. Shake well before
using [see Dosage and Administration (2.1) and How Supplied/Storage
and Handling (16)].
Avoid
Contamination
Instruct the
patient not to touch dropper tip to any surface, as this may contaminate the
contents [see Warnings and Precautions (5.9)].
Contact Lens Wear
Advise the patient
that contact lenses should not be worn during the use of this product [see
Warnings and Precautions (5.10)].
Newly added information:
Ability to Drive
and Use Machines
Advise the patient
that vision may be temporarily blurred following dosing with TOBRADEX ST. Care
should be exercised in operating machinery or driving a motor vehicle [see
Warnings and Precautions (5.8)].
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