Polymyxin B Sulfate and Trimethoprim

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Overview

What is Polymyxin B Sulfate and Trimethoprim?

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:

CHNOS Mol. Wt. 678.72

Polymyxin B sulfate is the sulfate salt of polymyxin B and Bwhich 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. The structural formula is:

Each mL contains:

What does Polymyxin B Sulfate and Trimethoprim look like?

What are the available doses of Polymyxin B Sulfate and Trimethoprim?

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What should I talk to my health care provider before I take Polymyxin B Sulfate and Trimethoprim?

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How should I use Polymyxin B Sulfate and Trimethoprim?

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: and **

**Efficacy for this organism in this organ system was studied in fewer than 10 infections.

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.

What interacts with Polymyxin B Sulfate and Trimethoprim?

Polymyxin B sulfate and trimethoprim ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.

What are the warnings of Polymyxin B Sulfate and Trimethoprim?

Withdrawal symptoms (of the barbiturate type) have occurred after the abrupt discontinuation of benzodiazepines ( ).

What are the precautions of Polymyxin B Sulfate and Trimethoprim?

General:

As with other antimicrobial preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

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No adverse effects on fertility or general reproductive performance were observed in rats given trimethoprim in oral dosages as high as 70 mg/kg/day for males and 14 mg/kg/day for females.

Pregnancy:

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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.

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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.

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.

Pediatric Use:

Safety and effectiveness in children below the age of 2 months have not been established (see ).

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

What are the side effects of Polymyxin B Sulfate and Trimethoprim?

The most frequent adverse reaction to polymyxin B sulfate and trimethoprim ophthalmic solution is local irritation consisting of increased redness, burning, stinging, and/or itching. This may occur on instillation, within 48 hours, or at any time with extended use. There are also multiple reports of hypersensitivity reactions consisting of lid edema, itching, increased redness, tearing, and/or circumocular rash. Photosensitivity has been reported in patients taking oral trimethoprim.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or .

What should I look out for while using Polymyxin B Sulfate and Trimethoprim?

Polymyxin B sulfate and trimethoprim ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.

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.

What might happen if I take too much Polymyxin B Sulfate and Trimethoprim?

Sorry No Records found

How should I store and handle Polymyxin B Sulfate and Trimethoprim?

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size:10 mL - NDC 68788-8945-1DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.Storage:*Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE.Bausch + Lomb, a division ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Bausch & Lomb IncorporatedRevised: June 20169117802 9117902 Relabeled By: Preferred Pharmaceuticals Inc.Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size:10 mL - NDC 68788-8945-1DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.Storage:*Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE.Bausch + Lomb, a division ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Bausch & Lomb IncorporatedRevised: June 20169117802 9117902 Relabeled By: Preferred Pharmaceuticals Inc.Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size:10 mL - NDC 68788-8945-1DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.Storage:*Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE.Bausch + Lomb, a division ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Bausch & Lomb IncorporatedRevised: June 20169117802 9117902 Relabeled By: Preferred Pharmaceuticals Inc.Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size:10 mL - NDC 68788-8945-1DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.Storage:*Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE.Bausch + Lomb, a division ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Bausch & Lomb IncorporatedRevised: June 20169117802 9117902 Relabeled By: Preferred Pharmaceuticals Inc.Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size:10 mL - NDC 68788-8945-1DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.Storage:*Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE.Bausch + Lomb, a division ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Bausch & Lomb IncorporatedRevised: June 20169117802 9117902 Relabeled By: Preferred Pharmaceuticals Inc.Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size:10 mL - NDC 68788-8945-1DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.Storage:*Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE.Bausch + Lomb, a division ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Bausch & Lomb IncorporatedRevised: June 20169117802 9117902 Relabeled By: Preferred Pharmaceuticals Inc.Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size:10 mL - NDC 68788-8945-1DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.Storage:*Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE.Bausch + Lomb, a division ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Bausch & Lomb IncorporatedRevised: June 20169117802 9117902 Relabeled By: Preferred Pharmaceuticals Inc.Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size:10 mL - NDC 68788-8945-1DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.Storage:*Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE.Bausch + Lomb, a division ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Bausch & Lomb IncorporatedRevised: June 20169117802 9117902 Relabeled By: Preferred Pharmaceuticals Inc.Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size:10 mL - NDC 68788-8945-1DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.Storage:*Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE.Bausch + Lomb, a division ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Bausch & Lomb IncorporatedRevised: June 20169117802 9117902 Relabeled By: Preferred Pharmaceuticals Inc.Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size:10 mL - NDC 68788-8945-1DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.Storage:*Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE.Bausch + Lomb, a division ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Bausch & Lomb IncorporatedRevised: June 20169117802 9117902 Relabeled By: Preferred Pharmaceuticals Inc.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Trimethoprim is a synthetic antibacterial drug active against a wide variety of aerobic gram-positive and gram-negative ophthalmic pathogens. Trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the enzyme dihydrofolate reductase. This binding is stronger for the bacterial enzyme than for the corresponding mammalian enzyme and therefore selectively interferes with bacterial biosynthesis of nucleic acids and proteins.

Polymyxin B, a cyclic lipopeptide antibiotic, is bactericidal for a variety of gram-negative organisms, especially It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.

Blood samples were obtained from 11 human volunteers at 20 minutes, 1 hour and 3 hours following instillation in the eye of 2 drops of ophthalmic solution containing 1 mg trimethoprim and 10,000 units polymyxin B per mL. Peak serum concentrations were approximately 0.03 μg/mL trimethoprim and 1 unit/mL polymyxin B.

Microbiology:

In vitro

Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus faecalis, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus aegyptius, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis

, Proteus vulgaris

, Enterobacter aerogenes

Serratia marcescens.

Haemophilus influenzae.

Non-Clinical Toxicology

Polymyxin B sulfate and trimethoprim ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.

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.

The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.

The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.

As with other antimicrobial preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

The most frequent adverse reaction to polymyxin B sulfate and trimethoprim ophthalmic solution is local irritation consisting of increased redness, burning, stinging, and/or itching. This may occur on instillation, within 48 hours, or at any time with extended use. There are also multiple reports of hypersensitivity reactions consisting of lid edema, itching, increased redness, tearing, and/or circumocular rash. Photosensitivity has been reported in patients taking oral trimethoprim.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or .

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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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Review

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Professional

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. 315.72

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Interactions

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