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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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Ofloxacin

Generic Name: Ofloxacin
Trade Name: Dizoflox
Manufacturer: Ashford Pharmaceutical Laboratories, Inc.
Source of Supply: Vendiz Pharmaceuticals Inc.
Pharmacologic Classification: Fluoroquinolone Eye 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 bacterial enzyme which is a critical catalyst in the duplication, transcription, and repair of bacterial DNA.
Therapeutic Indication: It is indicated for the treatment of external eye infections such as blepharitis, hordeolum, dacryocystitis, conjunctivitis, meibomitis, keratitis, trachoma, and for the prevention of infection following corneal ulceration.
Dosage Forms & Strength: 3mg/mL (0.3%) Ophthalmic Solution
Dosage and Administration: Instill 1 to 2 drops twice daily for 7 days to a maximum of 2 weeks or as prescribed by the physician.
Adverse Reactions: Irritation and stinging effect
Contraindications: It is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.
Storage Condition: Store at temperature not exceeding 300

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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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Polymyxin B sulfate

Generic Name: Polymyxin B sulfate
Formulation: Neomycin sulfate Dexamethasone
Each ml contains: Polymyxin B sulfate – 6000 Units, Neomycin sulfate – 5 mg, Dexamethasone ( as Sodium Phosphate ) – 1 mg
Indication: Management of ocular infections and inflammations produced by organisms which are sensitive to Neomycin and Polymyxin B sulfate. Acute or chronic non-purulent conjunctivitis, kerato-conjunctivitis, nonspecific superficial keratitis, Herpes zoster ophthalmicus, mild acute iritis, iridocyclitis, corneal ulcer, non-purulent blepharitis, scleritis, post-operatively to prevent ocular infection.
Dosage: Instill 1 – 2 drops in the conjunctival sacs 4 – 6 times daily. Dosage may be reduced after 3 to 4 days when a satisfactory response has been obtained.
Contraindications: This eye drop is contraindicated in tuberculous, fungal and most viral lesions of the eyes. Also in those patients who have shown hypersensitivity to any of its components.
Warning: Contains Sodium Metabisulfite, a sulfite that may cause allergic-type reactions
including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible individuals.
Storage: Store below 250 C.
Maxoptic Eye Drops is a sterile, buffered, and isotonic solution.

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Polymyxin B sulfate

Generic Name: Polymyxin B sulfate,
Formulation: Neomycin sulfate Gramicidin
Each ml contains: Polymyxin B sulfate 5,000 Units Neomycin sulfate 1,700 Units Gramicidin 25 Units
Classification: Eye Anti-infectives and Antiseptics
Indications: For the prophylaxis and treatment of externalbacterial infections of the eye including conjunctivitis, blepharitis, keratitis, corneal ulcers, styes, abrations and lacerations.
Dosage: Instill 1 – 2 drops 2 – 4 times daily. In acute infections, therapy may be repeated every 15 to 30 minutes until infection is controlled.
Contraindications: Hypersensitivity to any of the components of the Ophthalmic Solutions.
Storage: Store below 250 C. Protect from light.
Availability: Box of 12’s

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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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Prednisolone Acetate

Generic Name: Prednisolone Acetate
Trade Name: Venpred
Manufacturer: Ashford Pharmaceutical Laboratories, Inc.
Source of Supply: Vendiz Pharmaceuticals, Inc.
Pharmacologic Classification: Eye Corticosteroids
Mechanism of Action: Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.
There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from the membrane phospholipids by phospholipase A2.
Therapeutic Indication: For steroid responsive inflammation and allergic ocular conditions, inflammatory keratitis and otherinflammatory disorders of the anterior segments of the globe.
Dosage Forms & Strength: 10mg/mL Ophthalmic Suspension
Dosage and Administration: One to two drops twice a day to four times a day or as prescribed by a physician.
Adverse Reactions: Increased intraocular pressure with optic nerve damage, visual field defects. Systemic side effects may occur with extensive use of steroids.
Contraindications: Acute superficial herpes simplex keratitis; systemic fungal infections; varicella; Hypersensitivity to prednisolone
Storage Condition: Store at temperatures not exceeding 300 C.

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