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Ciprofloxacin And Dexamethasone (Ciprodex)

Trade Name : CIPRODEX

Alcon Laboratories, Inc.

SUSPENSION/ DROPS

Strength 31 mg/mLmg/mL

CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ciprofloxacin And Dexamethasone (Ciprodex) which is also known as CIPRODEX and Manufactured by Alcon Laboratories, Inc.. It is available in strength of 3; 1 mg/mL; mg/mL per ml. Read more

Ciprofloxacin And Dexamethasone (Ciprodex) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • CIPRODEX is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
  • Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to , , , , and .
  • Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to and .
  • CIPRODEX is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
  • Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to , , , , and . ()
  • Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to and . (n
  • CIPRODEX is for otic use (ears) only, not for ophthalmic use, or for injection.
  • 2.1
  • Shake well immediately before use. ()
  • Instill four drops into the affected ear twice daily, for seven days. ()
  • Otic Suspension: Each mL of CIPRODEX contains ciprofloxacin hydrochloride 0.3% (equivalent to 3 mg ciprofloxacin base) and dexamethasone 0.1% equivalent to 1 mg dexamethasone.
  • Otic Suspension: Each mL of CIPRODEX contains ciprofloxacin hydrochloride 0.3% (equivalent to 3 mg ciprofloxacin base) and dexamethasone 0.1% (equivalent to 1 mg dexamethasone). ()
  • No data
  • CIPRODEX is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. (n
  • Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections. ()
  • No data
  • Hypersensitivity and anaphylaxis have been reported with systemic use of quinolones. Discontinue use if this occurs with use of CIPRODEX. ()
  • Prolonged use may result in overgrowth of non-susceptible bacteria and fungi. ()
  • The following serious adverse reactions are described elsewhere in the labeling:
  • Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%). ()
  • No data
  • Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of this product.
  • CIPRODEX (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension contains the quinolone antimicrobial, ciprofloxacin hydrochloride, combined with the corticosteroid, dexamethasone, in a sterile, preserved suspension for otic use. Each mL of CIPRODEX contains ciprofloxacin hydrochloride (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are acetic acid, boric acid, edetate disodium, hydroxyethyl cellulose , purified water, sodium acetate, sodium chloride, and tyloxapol. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH.
  • Ciprofloxacin, a quinolone antimicrobial is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline carboxylic acid. The empirical formula is CHFNOu00b7HClu00b7HO.u00a0The molecular weight is 385.82 g/mol and the structural formula is:
  • Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The empirical formula is CHFO.u00a0The molecular weight is 392.46 g/mol and the structural formula is:
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  • In a randomized, multicenter, controlled clinical trial, CIPRODEX dosed 2 times per day for 7 days demonstrated clinical cures in the per protocol analysis in 86% of AOMT patients compared to 79% for ofloxacin solution, 0.3%, dosed 2 times per day for 10 days. Among culture positive patients, clinical cures were 90% for CIPRODEX compared to 79% for ofloxacin solution, 0.3%. Microbiological eradication rates for these patients in the same clinical trial were 91% for CIPRODEX compared to 82% for ofloxacin solution, 0.3%.
  • In 2 randomized multicenter, controlled clinical trials, CIPRODEX dosed 2 times per day for 7 days demonstrated clinical cures in 87% and 94% of per protocol evaluable AOE patients, respectively, compared to 84% and 89%, respectively, for otic suspension containing neomycin 0.35%, polymyxin B 10,000 units/mL, and hydrocortisone 1.0% (neo/poly/HC). Among culture positive patients clinical cures were 86% and 92% for CIPRODEX compared to 84% and 89%, respectively, for neo/poly/HC. Microbiological eradication rates for these patients in the same clinical trials were 86% and 92% for CIPRODEX compared to 85% and 85%, respectively, for neo/poly/HC.
  • How Supplied:
  • CIPRODEX (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension is a white-to off-white suspension supplied as follows: 7.5 mL fill in a DROP-TAINER system. The DROP-TAINER system consists of a natural polyethylene bottle and natural plug, with a white polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.
  • 7.5 mL fillu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0065-8533-02
  • Storage:
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • For Otic Use Only
  • Advise patients that CIPRODEX is for n
  • Administration Instructions
  • Instruct patients to warm the bottle in their hand for one to two minutes prior to use and shake well immediately before using .
  • Allergic Reactions
  • Advise patients to discontinue use immediately and contact their physician, if rash or allergic reaction occurs .
  • Avoid Contamination of the Product
  • Advise patients to avoid contaminating the tip with material from the ear, fingers, or other sources .
  • Duration of Use
  • Advise patients that it is very important to use the eardrops for as long as their doctor has instructed, even if the symptoms improve .
  • Protect From Light
  • Advise patients to protect the product from light .
  • Unused Product
  • Advise patients to discard unused portion after therapy is completed .
  • DROP-TAINER is a trademark of Alcon.
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936ntttttt
  • T2019-37
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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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