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Ofloxacin

Generic Name: Ofloxacin
Trade Name: Dizoflox
Manufacturer: Ashford Pharmaceutical Laboratories, Inc.
Source of Supply: Vendiz Pharmaceuticals, Inc.
Pharmacologic Classification: Fluoroquinolone Ear Anti-infectives
Mechanism of Action: Ofloxacin has in vitro activity against a wide range of gram- negative and gram-positive microorganisms. Ofloxacin exerts its antibacterial activity by inhibiting DNA gyrase, a bacterial topoisomerase. DNA gyrase is an essential enzyme which controls DNA topology and assists in DNA replication, repair, deactivation, and transcription.
Therapeutic Indication : Indicated for the treatment of external otic infections caused by Staphylococcus Spp., Streptococcus spp., Enterococcus spp., Corynebacterium spp., and Gram negative bacteria like P. aeruginosa, H. influenza, E. coli, Citrobacter spp., Klebsiella spp., Enterobacter spp., Providencia spp., S. marescens, Proteus spp., and anaerobes.
Dosage Forms & Strength: 3mg/mL (0.3%)
Pharmacokinetics: Studies have shown that a single administration of 10 drops of Oflocaxin 0.3% otic solution in adult patients with otic infections yielded serum ofloxacin concentrations of –<0.017 ug/mL and -<0.007 ug/mL after 30minutes and 1 hour respectively. Ten drops of 0.3% ofloxacin otic solution applied twice daily for 7 days showed a serum concentration of -<0.012 ug/mL 30minutes after every administration. Dosage and Administration: Tilt head sidewards to allow infected otic to face up and instill 1-2 drops of Ofloxacin otic solution twice daily for 7 days for a maximum of 14 days, morning and evening into the affected otic. Prevent the tip of the container from touching the otic. Keep head tilted up to 5 minutes and remove excess solution with a clean cotton. Or as prescribed by the physician. Adverse Reactions: Hypersensitivity reaction, otalgia, tinnitus & itchiness Contraindications: Hypersensitivity to Ofloxacin Storage Condition: Store at temperature not exceeding 300 C.

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Polymyxin B sulfate, Neomycin sulfate, Hydrocortisone

Generic name: Polymyxin B sulfate,
Formulation: Neomycin sulfate, Hydrocortisone ( as acetate )
Each ml contains: Polymyxin B sulfate 10,000 Units Neomycin sulfate 3,400 Units, Hydrocortisone 10 mg
Classification: Ear Antiseptic with Corticosteriods
Indications: Anti-inflammatory and Anti-infective in the treatment of dermatoses of the ear due to allergic, neurogenic and seborrhoeic factors. Otitis media and in the management of cavities after mastoidectomy and fenestration operation.
Dosage: Instill into the affected ear(s) with the head tilted to one side 3 drops 3 – 4 times daily. The position should be maintained for a few minutes.
Contraindications: Hypersensitivity to any of the components of the Ear Drops.
Warnings: In case of chronic otitis media and where the ear drum is perforated, the drops should be used with care and for short periods only because of the risk of the ototoxicity. As with other antibiotics, prolonged use may result in overgrowth of non susceptible organisms.
Storage: Store below 250 C.
Availability: 5 mL white dropper bottle

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Neomycin Sulfate / Dexamethasone sodium phosphate/ Polymyxin B Sulfate

Generic Name: Neomycin Sulfate / Dexamethasone sodium phosphate/ Polymyxin B Sulfate
Trade Name: OTIXIN
Manufacturer: Ashford Pharmaceutical Laboratories, Inc.
Source of Supply: Vendiz Pharmaceuticals, Inc.
Pharmacologic Classification: Ear Antiseptics with Corticosteroids
Therapeutic Indication: For the treatment of ear infections due to susceptible gram-positive and gram-negative organisms, especially Staphylococci and Pseudomonas aeruginosa; and for the management of the inflammation caused by these infections.
Dosage Forms & Strength: 5mg/ 1mg /10,000units Otic Solution (Drops)
Dosage and Administration: Initially three to four drops 2-3 times a day, then may be reduced gradually or as prescribed by the physician
Adverse Reactions: Long term use may cause ototoxicity
Contraindications: Infectious tuberculosis lesions of the ear, chickenpox. Vaccina & herpes simplex. Hypersensitivity
Storage Condition: Store at temperature not exceeding 30°C

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Neomycin / Triamcinolone acetonide/ Gramicidin / Nystatin

Generic Name: Neomycin / Triamcinolone acetonide/ Gramicidin / Nystatin
Trade Name: Vendicom Manufacturer : Ashford Pharmaceutical Laboratories, Inc.
Source of Supply: Vendiz Pharmaceuticals, Inc.
Pharmacologic Classification: Ear Antiseptics with Cortecosteroids
Mechanism of Action: Nystatin acts by binding to steroids in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated sub culturing with increasing levels of Nystatin, Candida albicans does not develop resistance to Nystatin. Generally, resistance to Nystatin does not develop during therapy. Nystatin Exhibits no activity against bacteria, protozoa or viruses. Neomycin exerts its antibacterial activity against a number of Gram negative organisms by inhibiting protein synthesis. It is not active against Pseudomonas aeruginosa, and resistant strains of Gram negative bacteria may develop. Gramicidin exerts its antibacterial activity against many Gram positive organism by altering cell membrane permeability.
Therapeutic Indication: For the treatment of otitis externa ( acute and chronic) when a topical corticosteroid is required and active infections with susceptible organisms are either present or likely to supervene. It is recommended for short term use.
Dosage Forms & Strength: 2.5mg/1mg/250mcg/100,000 units per mL

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