APIDINE PLUS _{Eye Drops
‍}

(Povidone-Iodine Sterile Ophthalmic Prep Solution)

THIS LEAFLET CONTAINS IMPORTANT PRODUCT USE AND SAFETY INFORMATION, PLEASE READ CAREFULLY AND RETAIN FOR FURTHER FUTURE REFERENCE

DESCRIPTION:

APIDINE PLUS(Povidone-Iodine Sterile Ophthalmic Prep Solution) is a broad-spectrum microbicide with the chemical formulas: 2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine.

COMPOSITION:

Each ML Contains :

• Povidone lodine IP        50 mg
 (Available lodine   0.5%  w/v)
Water for Injections IP              q.s.
‍

INDICATIONS AND USAGE

APIDINE PLUS(Povidone-Iodine Sterile Ophthalmic Prep Solution) for preparation of skin and ocular surface prior to surgery. APIDINE PLUS(Povidone-Iodine Sterile Ophthalmic Prep Solution) for single use only under medical supervision. APIDINE PLUS(Povidone-Iodine Sterile Ophthalmic Prep Solution) for cutaneous peri-ocular and conjunctival antisepsis prior to ocular surgery to support postoperative infection control.

CLINICAL PHARMACOLOGY

Pharmocodynamic:

Povidone Iodine is a complex of the polymer polyvinylpyrrolidone (povidone)with Iodine which, after application, continues to deliver iodine to the ocular surface over the short time that the solution is in contact with the eye. After application, exposure of the ocular surface to iodine arises from the presence of free iodine in solution, and iodine bound to the polymer, which serves as a reservoir. As the preparation comes in contact with the eye, more and more iodine dissociates from the polymer. Mechanisms of resistance there are no reports of bacterial cross-resistance to antibiotics arising from exposure to povidone iodine, or iodine, or of co-resistance due to any known genetic linkage of resistance determinants. There are limited reports of contamination of iodophores with Pseudomonas species, in nutrient restricted environments, such as hospital waste water, indicating that resistance to povidone-iodine can occur. However, this is of limited relevance to the use of povidone iodine in ocular antisepsis.

Pharmocokinetic:                                                                                    

The available Iodine in lodinatedPovidone is able to cross the conjunctival barrier to a limitedextent. At the concentration used, the potentialfor systemic exposureto iodine is very low. Conjunctival and peri-ocular sterilisation with lodinated Povidone (1.25% or 10% results in increased urinaryelimination of iodide.Elimination is almost exclusively by the renal route. Povidonealone is unlikely to be absorbed systemically.

CONTRAINDICATIONS

Hypersensitivity to the active substance iodinated povidone or to any of the excipients. APIDINE PLUS (Povidone-Iodine Sterile Ophthalmic Prep Solution)sterile preparative solution is contraindicated for intra-ocular or peri-ocular injection history of hypersensitivity to Ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones may also contraindicate the use of Ciprofloxacin.

WARNINGS AND PRECAUTIONS

There is no experience of ocular instillation, other than for pre-operative antisepsis. The use of APIDINEPLUS(Povidone-Iodine Sterile OphthalmicPrep Solution) is restricted to pre-operative ocularantisepsis only.After two minutes contact with the conjunctival surface, the product should be thoroughly rinsed off using sterilesaline solution.

Pregnancy  &  Lactation

Pregnancy: No effects during pregnancy are anticipated, since systemic exposure to iodine is negligible. APIDINEPLUS(Povidone-Iodine Sterile Ophthalmic Prep Solution) can be used during pregnancy.
 Breast-feeding: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to iodine is negligible.
 Fertility: No effects on fertility are anticipated, since systemic exposure to iodine is negligible.

ADVERSE REACTIONS

The most serious adverse reaction that occur with   APIDINE PLUS( Povidone- Iodine Sterile Ophthalmic  Prep  Solution)   is hypersensitivity reaction Adverse reactions are ranked under heading of frequency, using the following convention: Very common (21/10);common (>1/100 to <1/10); uncommon (21/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Immune system disorders Uncommon: Hypersensitivity Nervous system disorders Not Known
Overdose: No case of overdose has been reported. An overdose of Povidone lodine sterile preparative solution can be washed out of the eye with saline or water.

DOSAGE AND ADMINISTRATION

Mechanism of Action Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v), solution contains the fluoroquinolone ciprofloxacin. The cidal and inhibitory activity of Ciprofloxacin against bacteria results from an interference with the DNA gyrase, an enzyme needed by the bacterium for the synthesis of DNA. Thus the vital information from the bacterial chromosomes cannot be transcribed which causes a breakdown of the bacterial metabolism. Ciprofloxacin has in vitro activity against a wide range of Gram-positive and Gram- negative bacteria. Mechanism of  Resistance Fluoroquinolone resistance, particularly Ciprofloxacin, requires significant genetic changes in one or more of five major bacterial mechanisms: a) enzymes for DNA synthesis, b) protecting proteins, c) cell permeability, d) drug efflux, or e) plasmid-mediated aminoglycoside 6'-N-acetyltransferase.Fluoroquinolones, including Ciprofloxacin, differ in chemical structure and mode of action from aminoglycosides, β-lactam antibiotics, macrolides, tetracyclines, sulfonamides, trimethoprim, and chloramphenicol. Therefore, organisms resistant to these drugs may be susceptible to Ciprofloxacin. Susceptibility              to              Ciprofloxacin: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. The presentation below lists bacterial species recovered from external ocular infections of the eye.

STORAGE

Store protected from light, moisture & Direct Sunlight. Store between 15°Cto 30°C. Do not allow to freeze.

SHELF LIFE

24   Months  

HOW SUPPLIED

APIDINE PLUS/ 5mL (Povidone-Iodine Sterile Ophthalmic Prep Solution) is available in 5mL poly bottle
‍