Trimethoprim Sulfate And Polymyxin B Sulfate

Prescription

Nomes comerciais: Trimethoprim sulfate and Polymyxin B sulfate

Forma Farmacêutica

Drops

Via de Administração

OPHTHALMIC

Fabricante

Proficient Rx LP

About This Medication

DESCRIPTION Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is a sterile antimicrobial solution for topical ophthalmic use. Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine sulfate (2:1), occurs as a white, odorless, crystalline powder with a molecular weight of 678.72. The structural formula is as follows: Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 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 as follows: Each mL contains: Actives: Trimethoprim Sulfate equivalent to Trimethoprim 1 mg (0.1%) and Polymyxin B Sulfate 10,000 units. Preservative: Benzalkonium Chloride 0.04 mg (0.004%). Inactives: Sodium Chloride, Sulfuric Acid and Sodium Hydroxide may be added to adjust pH (3.0 to 5.5), and Purified Water USP. Structural Formula Structural Formula

Princípios Ativos

Ingrediente	Concentração
Polymyxin B Sulfate	-
Trimethoprim Sulfate	-

Indicações e Uso

INDICATIONS AND USAGE Trimethoprim Sulfate and Polymyxin B Sulfate 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 influenza and Pseudomonas aeruginosa. * *Efficacy for this organism in this organ system was studied in fewer than 10 infections.

Posologia e Administração

DOSAGE AND ADMINISTRATION Adults: 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. Pediatric Use: Clinical studies have shown Trimethoprim and Polymyxin B Sulfate Ophthalmic Solution to be safe and effective for use in pediatric patients over two months of age. The dosage regimen is the same as for adults.

Side Effects Overview

ADVERSE REACTIONS The most frequent adverse reaction to Trimethoprim Sulfate and Polymxin B Sulfate 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.

Advertências e Precauções

WARNINGS NOT FOR INJECTION INTO THE EYE. If a sensitivity reaction to Trimethoprim and Polymyxin B Sulfate Ophthalmic Solution occurs, discontinue use. Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is not indicated for the prophylaxis or treatment of ophthalmic neonatorum.

Contraindicações

CONTRAINDICATIONS Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.

Frequently Asked Questions

INDICATIONS AND USAGE Trimethoprim Sulfate and Polymyxin B Sulfate 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 influenza and Pseudomonas aeruginosa. * *Efficacy for this organism in this organ system was studied in fewer than 10 infections.

DOSAGE AND ADMINISTRATION Adults: 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. Pediatric Use: Clinical studies have shown Trimethoprim and Polymyxin B Sulfate Ophthalmic Solution to be safe and effective for use in pediatric patients over two months of age. The dosage regimen is the same as for adults.

WARNINGS NOT FOR INJECTION INTO THE EYE. If a sensitivity reaction to Trimethoprim and Polymyxin B Sulfate Ophthalmic Solution occurs, discontinue use. Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is not indicated for the prophylaxis or treatment of ophthalmic neonatorum.

CONTRAINDICATIONS Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.

Trimethoprim Sulfate And Polymyxin B Sulfate is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Trimethoprim Sulfate And Polymyxin B Sulfate drug label (National Library of Medicine)
• openFDA — Trimethoprim Sulfate And Polymyxin B Sulfate label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 244967 (NLM Normalized Drug Names)
• NDC Directory — Trimethoprim Sulfate And Polymyxin B Sulfate (FDA National Drug Code)

Aviso Médico

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Fontes de dados: DailyMed (NLM), openFDA, MFDS