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Neomycin, Polymyxin B Sulfates and Hydrocortisone
Overview
What is Neomycin, Polymyxin B Sulfates and Hydrocortisone?
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic
Suspension is a sterile antimicrobial and anti-inflammatory suspension for
ophthalmic use.
Each mL contains: Actives:
Preservative:
Inactives:
Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced
by the growth of Waksman (Fam.
Streptomycetacae). It has a potency equivalent to not less than 600 μg of
neomycin standard per mg, calculated on an anhydrous basis. Its structural
formula are:
Polymyxin B sulfate is the sulfate salt of Polymyxin, B1 and B2, which are
produced by the growth of (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than
6,000 polymyxin B units per mg calculated on an anhydrous basis. Its structural
formula are:
Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20 dione, is an
anti-inflammatory hormone. Its structural formula is:
What does Neomycin, Polymyxin B Sulfates and Hydrocortisone look like?
What are the available doses of Neomycin, Polymyxin B Sulfates and Hydrocortisone?
Sorry No records found.
What should I talk to my health care provider before I take Neomycin, Polymyxin B Sulfates and Hydrocortisone?
Sorry No records found
How should I use Neomycin, Polymyxin B Sulfates and Hydrocortisone?
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic
Suspension is indicated for steroid-responsive inflammatory ocular conditions
for which a corticosteroid is indicated and where bacterial infection or a risk
of bacterial ocular infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the
palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where
the inherent risk of corticosteroid use in certain infective conjunctivitides is
accepted to obtain a diminution in edema and inflammation. They are also
indicated in chronic anterior uveitis and corneal injury from chemical,
radiation, or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated
where the risk of infection is high or where there is an expectation that
potentially dangerous numbers of bacteria will be present in the eye (See ).
The particular anti-infective drugs in this product are active against the
following common bacterial eye pathogens: , , , species, species, and .
The product does not provide adequate coverage against and streptococci, including .
One or two drops in the affected eye every 3 or 4 hours,
depending on the severity of the condition. The suspension may be used more
frequently if necessary.
Not more than 20 mL should be prescribed initially and the prescription
should not be refilled without further evaluation as outlined in PRECAUTIONS
above.
What interacts with Neomycin, Polymyxin B Sulfates and Hydrocortisone?
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.
What are the warnings of Neomycin, Polymyxin B Sulfates and Hydrocortisone?
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
NOT FOR INJECTION INTO THE EYE. Neomycin and Polymyxin B Sulfates
and Hydrocortisone Ophthalmic Suspension should never be directly introduced
into the anterior chamber of the eye.
Prolonged use of corticosteroids may result in ocular hypertension and/or
glaucoma, with damage to the optic nerve, defects in visual acuity and fields of
vision, and posterior subcapsular cataract formation.
Prolonged use may suppress the host response and thus increase the hazard of
secondary ocular infections. In those diseases causing thinning of the cornea or
sclera, perforations have been known to occur with the use of topical
corticosteroids. In acute purulent conditions of the eye, corticosteroids may
mask infection or enhance existing infection.
If these products are used for 10 days or longer, intraocular pressure should
be routinely monitored even though it may be difficult in uncooperative
patients. Corticosteroids should be used with caution in the presence of
glaucoma.
The use of corticosteroids after cataract surgery may delay healing and
increase the incidence of filtering blebs.
Use of ocular corticosteroids may prolong the course and may exacerbate the
severity of many viral infections of the eye (including herpes simplex).
Employment of corticosteroid medication in the treatment of herpes simplex
requires great caution.
Topical antibiotics, particularly, neomycin sulfate, may cause cutaneous
sensitization. A precise incidence of hypersensitivity reactions (primarily skin
rash) due to topical antibiotics is not known. The manifestations of
sensitization to topical antibiotics are usually itching, reddening, and edema
of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a
failure to heal. During long-term use of topical antibiotic products, periodic
examination for such signs is advisable, and the patient should be told to
discontinue the product if they are observed. Symptoms usually subside quickly
on withdrawing the medication. Application of products containing these
ingredients should be avoided for the patient thereafter (see ).
What are the precautions of Neomycin, Polymyxin B Sulfates and Hydrocortisone?
The initial prescription and renewal of the medication order
beyond 20 mL should be made by a physician only after examination of the patient
with the aid of magnification, such as slit lamp biomicroscopy and, where
appropriate, fluorescein staining. If signs and symptoms fail to improve after 2
days, the patient should be re-evaluated.
The possibility of fungal infections of the cornea should be considered after
prolonged corticosteroid dosing. Fungal cultures should be taken when
appropriate.
If this product is used for 10 days or longer, intraocular pressure should be
monitored (see ).
There have been reports of bacterial keratitis associated with the use of
topical ophthalmic products in multiple-dose containers which have been
inadvertently contaminated by patients, most of whom had a concurrent corneal
disease or a disruption of the ocular epithelial surface (see ).
Allergic cross-reactions may occur which could prevent the use of any or all
of the following antibiotics for the treatment of future infections: kanamycin,
paromomycin, streptomycin, and possibly gentamicin.
Patients should be instructed to avoid allowing the tip of the
dispensing container to contact the eye, eyelid, fingers, or any other surface.
The use of this product by more than one person may spread infection.
Patients should also be instructed that ocular products, if handled
improperly, can become contaminated by common bacteria known to cause ocular
infections. Serious damage to the eye and subsequent loss of vision may result
from using contaminated products (see ).
If the condition persists or gets worse, or if a rash or allergic reaction
develops, the patient should be advised to stop use and consult a physician. Do
not use this product if you are allergic to any of the listed ingredients.
Keep tightly closed when not in use. Keep out of reach of children.
Long-term studies in animals to evaluate carcinogenic or
mutagenic potential have not been conducted with polymyxin B sulfate. Treatment
of cultured human lymphocytes with neomycin
increased the frequency of chromosome aberrations at the highest concentrations
(80 ug/mL) tested; however, the effects of neomycin on carcinogenesis and
mutagenesis in humans are unknown.
Long-term studies in animals (rats, rabbits, mice) showed no evidence of
carcinogenicity or mutagenicity attributable to oral administration of
corticosteroids. Long-term animal studies have not been performed to evaluate
the carcinogenic potential of topical corticosteroids. Studies to determine
mutagenicity with hydrocortisone have revealed negative results. Use of
corticosteroid medication in the treatment of herpes simplex requires great
caution. Polymyxin B has been reported to impair the motility of equine sperm,
but its effects on male or female fertility are unknown. Long-term animal
studies have not been performed to evaluate the effect on fertility of topical
corticosteroids.
Teratogenic Effects:
It is not known whether topical administration of corticosteroids
could result in sufficient systemic absorption to produce detectable quantities
in human milk. Systemically administered corticosteroids appear in human milk
and could suppress growth, interfere with endogenous corticosteroid production,
or cause other untoward effects. Because of the potential for serious adverse
reactions in nursing infants from Neomycin and Polymyxin B Sulfates and
Hydrocortisone Ophthalmic Suspension, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been
established.
No overall differences in safety or effectiveness have been
observed between elderly and younger patients.
What are the side effects of Neomycin, Polymyxin B Sulfates and Hydrocortisone?
Adverse reactions have occurred with
corticosteroid/anti-infective combination drugs which can be attributed to the
corticosteroid component, the anti-infective component, or the combination. The
exact incidence is not known.
Reactions occurring most often from the presence of the anti-infective
ingredient are allergic sensitization reactions including itching, swelling, and
conjunctival erythema (see ). More serious hypersensitivity
reactions, including anaphylaxis, have been reported rarely.
The reactions due to the corticosteroid component in decreasing order of
frequency are: elevation of intraocular pressure (IOP) with possible development
of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract
formation; and delayed wound healing.
Secondary Infection:
Local irritation on instillation has been reported.
What should I look out for while using Neomycin, Polymyxin B Sulfates and Hydrocortisone?
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic
Suspension is contraindicated in most viral diseases of the cornea and
conjunctiva including: epithelial herpes simplex keratitis (dendritic
keratitis), vaccinia, and varicella, and also in mycobacterial infection of the
eye and fungal diseases of ocular structures.
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is
also contraindicated in individuals who have shown hypersensitivity to any of
its components. Hypersensitivity to the antibiotic component occurs at a higher
rate than for other components.
NOT FOR INJECTION INTO THE EYE. Neomycin and Polymyxin B Sulfates
and Hydrocortisone Ophthalmic Suspension should never be directly introduced
into the anterior chamber of the eye.
Prolonged use of corticosteroids may result in ocular hypertension and/or
glaucoma, with damage to the optic nerve, defects in visual acuity and fields of
vision, and posterior subcapsular cataract formation.
Prolonged use may suppress the host response and thus increase the hazard of
secondary ocular infections. In those diseases causing thinning of the cornea or
sclera, perforations have been known to occur with the use of topical
corticosteroids. In acute purulent conditions of the eye, corticosteroids may
mask infection or enhance existing infection.
If these products are used for 10 days or longer, intraocular pressure should
be routinely monitored even though it may be difficult in uncooperative
patients. Corticosteroids should be used with caution in the presence of
glaucoma.
The use of corticosteroids after cataract surgery may delay healing and
increase the incidence of filtering blebs.
Use of ocular corticosteroids may prolong the course and may exacerbate the
severity of many viral infections of the eye (including herpes simplex).
Employment of corticosteroid medication in the treatment of herpes simplex
requires great caution.
Topical antibiotics, particularly, neomycin sulfate, may cause cutaneous
sensitization. A precise incidence of hypersensitivity reactions (primarily skin
rash) due to topical antibiotics is not known. The manifestations of
sensitization to topical antibiotics are usually itching, reddening, and edema
of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a
failure to heal. During long-term use of topical antibiotic products, periodic
examination for such signs is advisable, and the patient should be told to
discontinue the product if they are observed. Symptoms usually subside quickly
on withdrawing the medication. Application of products containing these
ingredients should be avoided for the patient thereafter (see ).
What might happen if I take too much Neomycin, Polymyxin B Sulfates and Hydrocortisone?
Sorry No Records found
How should I store and handle Neomycin, Polymyxin B Sulfates and Hydrocortisone?
Store at controlled room temperature between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).Keep out of reach of children.Store at controlled room temperature between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).Keep out of reach of children.Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USA
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Corticosteroids suppress the inflammatory response to a variety
of agents, and they probably delay or slow healing. Since corticosteroids may
inhibit the body's defense mechanism against infection, concomitant
antimicrobial drugs may be used when this inhibition is considered to be
clinically significant in a particular case.
When a decision to administer both a corticosteroid and antimicrobials is
made, the administration of such drugs in combination has the advantage of
greater patient compliance and convenience, with the added assurance that the
intended dosage of all drugs is administered. When each type of drug is in the
same formulation, compatibility of ingredients is assured and the correct volume
of drug is delivered and retained.
The relative potency of corticosteroids depends on the molecular structure,
concentration, and release from the vehicle.
Microbiology:
in vitro
Staphylococcus aureus
Escherichia
coli
Haemophilus influenzae
Klebsiella/Enterbacter
Neisseria
Pseudomonas
aeruginosa
Serratia marcescens
Streptococcus pneumoniae
Non-Clinical Toxicology
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.
NOT FOR INJECTION INTO THE EYE. Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension should never be directly introduced into the anterior chamber of the eye.
Prolonged use of corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.
If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma.
The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs.
Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.
Topical antibiotics, particularly, neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Application of products containing these ingredients should be avoided for the patient thereafter (see ).
The initial prescription and renewal of the medication order beyond 20 mL should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.
If this product is used for 10 days or longer, intraocular pressure should be monitored (see ).
There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see ).
Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.
Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see ).
If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.
Keep tightly closed when not in use. Keep out of reach of children.
Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate. Treatment of cultured human lymphocytes with neomycin increased the frequency of chromosome aberrations at the highest concentrations (80 ug/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.
Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity attributable to oral administration of corticosteroids. Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids. Studies to determine mutagenicity with hydrocortisone have revealed negative results. Use of corticosteroid medication in the treatment of herpes simplex requires great caution. Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. Long-term animal studies have not been performed to evaluate the effect on fertility of topical corticosteroids.
Teratogenic Effects:
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. The exact incidence is not known.
Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.
The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
Secondary Infection:
Local irritation on instillation has been reported.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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