statrol- neomycin sulfate and polymyxin B sulfate solution

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

INN (International Name):

neomycin sulfate and polymyxin B sulfate

Pharmaceutical form:

SOLUTION

Composition:

3.5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

STRATOL Ophthalmic Solution 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 Solution, USP) in 5 mL plastic DROP-TAINER® dispenser: NDC 0998-0623-05. STORAGE: Store at 46° - 80°F (8° - 27°C). Federal (USA) law prohibits dispensing without prescription. Alcon® OPHTHALMIC ALCON (Puerto Rico) INC. Humacao, Puerto Rico 00791 USA Revised: June 1995  Printed in USA 238382

Summary of Product characteristics

STATROL- NEOMYCIN SULFATE AND POLYMYXIN B SULFATE SOLUTION
ALCON
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STATROL®
NEOMYCIN AND POLYMYXIN B
SULFATES OPHTHALMIC SOLUTION, USP
DESCRIPTION
STATROL® (Neomycin and Polymyxin B Sulfates Ophthalmic Solution, USP)
is a sterile ophthalmic
drug combining two antibacterials in solution form.
Each mL of solution contains: ACTIVE: Neomycin Sulfate equivalent to
3.5 mg Neomycin base,
Polymyxin B Sulfate equal to 16,250 polymyxin B units.
PRESERVATIVE: Benzalkonium Chloride .004%. VEHICLE: 0.5% Hydroxypropyl
Methylcellulose 2910.
INACTIVE: Boric Acid, Sodium Chloride, Hydrochloric Acid and/or Sodium
Hydroxide (to adjust pH),
Purified Water. DM-02
CLINICAL PHARMACOLOGY
The anti-infective components in STATROL Ophthalmic Solution 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 Solution 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.
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
o