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neomycin sulfate, polymyxin b sulfate and gramicidin
Overview
What is NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN?
Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP is a sterile antimicrobial solution for ophthalmic use.
Each mL contains:
PRESERVATIVE ADDED: Thimerosal 0.001%.
Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis.
The structural formulae are:
Polymyxin B Sulfate is the sulfate salt of polymyxin B and B which are produced by the growth of (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are:
Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Dubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are:
What does NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN look like?
What are the available doses of NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN?
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What should I talk to my health care provider before I take NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN?
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How should I use NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN?
Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour.
What interacts with NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN?
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What are the warnings of NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN?
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What are the precautions of NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN?
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What are the side effects of NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN?
Adverse reactions have occurred with the anti-infective components of this product. The exact incidence is not known. Reactions occurring most often are allergic reactions including itching, swelling, and conjunctival erythema (see ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.
Local irritation on instillation has also been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN?
This product is contraindicated in those persons who have shown hypersensitivity to any of its components.
NOT FOR INJECTION INTO THE EYE. This product should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally.
Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known.
The manifestations of sensitization to topical antibiotics are usually itching, reddening and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter. (See , ).
What might happen if I take too much NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN?
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How should I store and handle NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN?
RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.Product: 50090-0247NDC: 50090-0247-0 10 mL in a BOTTLE, DROPPER Product: 50090-0247NDC: 50090-0247-0 10 mL in a BOTTLE, DROPPER
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin.
Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.
Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.
Gramicidin is bactericidal for a variety of gram-positive organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bilayer of the membrane.
Non-Clinical Toxicology
This product is contraindicated in those persons who have shown hypersensitivity to any of its components.NOT FOR INJECTION INTO THE EYE. This product should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally.
Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known.
The manifestations of sensitization to topical antibiotics are usually itching, reddening and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter. (See , ).
The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe prolonged hypertension.
Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.
Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential.
Concurrent administration of vasopressor drugs (for the treatment of hypotension related to obstetric blocks) and ergot-type oxytoxic drugs may cause severe persistent hypertension or cerebrovascular accidents.
As with other antibiotic preparations, prolonged use of this product may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.
Bacterial resistance to this product may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see : ).
Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.
Adverse reactions have occurred with the anti-infective components of this product. The exact incidence is not known. Reactions occurring most often are allergic reactions including itching, swelling, and conjunctival erythema (see ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.
Local irritation on instillation has also been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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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