Polymyxin B 10000 UNT/ML / Trimethoprim 1 MG/ML Ophthalmic Solution
WARNINGS
NOT FOR INJECTION INTO THE EYE.
If a sensitivity reaction to polymyxin B sulfate and trimethoprim ophthalmic solution occurs, discontinue use.
Polymyxin B sulfate and trimethoprim ophthalmic solution is not indicated for the prophylaxis or treatment of ophthalmia neonatorum.
DESCRIPTION
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP* is a sterile antimicrobial solution for topical ophthalmic use.
It has a pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg.
Chemical Names: Trimethoprim sulfate, 2,4-diamino-5-(3,4 5-trimethoxybenzyl)pyrimidine sulfate (2:1), is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula: C 28 H 38 N 8 O 10 S Mol.
Wt.
678.72 Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam.
Bacillaceae).
It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis.
The structural formula is: Each mL contains: ACTIVES: Polymyxin B Sulfate equal to 10,000 polymyxin B units, Trimethoprim Sulfate (equivalent to trimethoprim 1 mg); INACTIVES: Purified Water, Sodium Chloride.
Sulfuric acid and, if necessary, sodium hydroxide may be added to adjust pH (4.0 – 6.2).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.004%.
Trimethoprim sulfate (Structural formula) Polymyxin B Sulfate, the sulfate salt of polymyxin B1 and B2 (Structural formula)
HOW SUPPLIED
Product: 50090-2398 NDC: 50090-2398-0 10 mL in a BOTTLE, DROPPER
GERIATRIC USE
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
INDICATIONS AND USAGE
Polymyxin B sulfate and trimethoprim ophthalmic solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.
** **Efficacy for this organism in this organ system was studied in fewer than 10 infections.
PEDIATRIC USE
Pediatric Use: Safety and effectiveness in children below the age of 2 months have not been established (see WARNINGS ).
PREGNANCY
Pregnancy: Teratogenic Effects: Pregnancy Category C.
Animal reproduction studies have not been conducted with polymyxin B sulfate.
It is not known whether polymyxin B sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Trimethoprim has been shown to be teratogenic in the rat when given in oral doses 40 times the human dose.
In some rabbit studies, the overall increase in fetal loss (dead and resorbed and malformed conceptuses) was associated with oral doses 6 times the human therapeutic dose.
While there are no large well-controlled studies on the use of trimethoprim in pregnant women, Brumfitt and Pursell, in a retrospective study, reported the outcome of 186 pregnancies during which the mother received either placebo or oral trimethoprim in combination with sulfamethoxazole.
The incidence of congenital abnormalities was 4.5% (3 of 66) in those who received placebo and 3.3% (4 of 120) in those receiving trimethoprim and sulfamethoxazole.
There were no abnormalities in the 10 children whose mothers received the drug during the first trimester.
In a separate survey, Brumfitt and Pursell also found no congenital abnormalities in 35 children whose mothers had received oral trimethoprim and sulfamethoxazole at the time of conception or shortly thereafter.
Because trimethoprim may interfere with folic acid metabolism, trimethoprim should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects: The oral administration of trimethoprim to rats at a dose of 70 mg/kg/day commencing with the last third of gestation and continuing through parturition and lactation caused no deleterious effects on gestation or pup growth and survival.
NUSRING MOTHERS
Nursing Mothers: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when polymyxin B sulfate and trimethoprim ophthalmic solution is administered to a nursing woman.
INFORMATION FOR PATIENTS
Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers, or other source.
This precaution is necessary if the sterility of the drops is to be maintained.
If redness, irritation, swelling or pain persists or increases, discontinue use immediately and contact your physician.
Patients should be advised not to wear contact lenses if they have signs and symptoms of ocular bacterial infections.
DOSAGE AND ADMINISTRATION
In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.