statrol- neomycin sulfate and polymyxin B sulfate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297), polymyxin B sulfate (UNII: 19371312D4) (polymyxin B - UNII:J2VZ07J96K)

Available from:

ALCON LABORATORIES, INC.

INN (International Name):

neomycin sulfate and polymyxin B sulfate

Pharmaceutical form:

OINTMENT

Composition:

3.5 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

STRATOL Ophthalmic Ointment is indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis, and keratoconjunctivitis, blepharitis and blepharoconjunctivitis, acute meibomianitis and dacryocystitis. Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

Product summary:

STATROL (Neomycin and Polymyxin B Sulfates Ophthalmic Ointment, USP) in 3.5 g ophthalmic tube: NDC 0065-0624-36. STORAGE: Store at 46° - 80°F (8° - 27°C). Federal (USA) law prohibits dispensing without prescription. Alcon® OPHTHALMIC ALCON LABORATORIES, INC. Fort Worth, Texas; 76134; USA Revised: June 1995 Printed in USA 298392

Summary of Product characteristics

STATROL- NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT
ALCON LABORATORIES, INC.
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STATROL®
NEOMYCIN AND POLYMYXIN B
SULFATES OPHTHALMIC OINTMENT, USP
DESCRIPTION
STATROL® (Neomycin and Polymyxin B Sulfates Ophthalmic Ointment, USP)
is a sterile ophthalmic
drug combining two antibacterials in ointment form.
Each gram of ointment contains: ACTIVE: Neomycin Sulfate equivalent to
3.5 mg Neomycin base,
Polymyxin B Sulfate equal to 10,000 polymyxin B units.
PRESERVATIVES: Methylparaben 0.05%, Propylparaben 0.01%. INACTIVE:
White Petrolatum, Anhydrous
Liquid Lanolin. DM-01
CLINICAL PHARMACOLOGY
The anti-infective components in STATROL Ophthalmic Ointment provide
action against specific
organisms susceptible to them. Polymyxin B Sulfate and Neomycin
Sulfate are active _in vitro _against
_Staphylococcus aureus, Escherichia coli, Klebsiella/Enterobacter_
species, _Neisseria _species, _Pseudomonas_
_aeruginosa_. This product does not provide adequate coverage against:
_Serratia marcescens,_
Streptococci, including _Streptococcus pneumoniae._
INDICATIONS AND USAGE
STRATOL Ophthalmic Ointment is indicated in the topical treatment of
infections of the external eye
and its adnexa caused by susceptible bacteria. Such infections
encompass conjunctivitis, keratitis, and
keratoconjunctivitis, blepharitis and blepharoconjunctivitis, acute
meibomianitis and dacryocystitis.
CONTRAINDICATIONS
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia,
varicella, and many other viral diseases
of the cornea and conjunctiva. Mycobacterial infection of the eye.
Fungal diseases of ocular structures.
Hypersensitivity to a component of the medication.
WARNINGS
NOT FOR INJECTION INTO THE EYE. Should a sensitivity reaction occur,
discontinue use.
Ophthalmic ointments may retard corneal wound healing. Neomycin
Sulfate may cause cutaneous
sensitization. Remove contact lenses before using.
PRECAUTIONS
GENERAL
As with other antibiotic preparations, prolonged use may result in
overgrowth of nonsusceptible
organisms including