ANTI-BACTERIAL

Aflox

Pack : 5ml Pack

DESCRIPTION:

Aflox Eye Drops is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Ofloxacin Ophthalmic Solution is unbuffered and formulated with a pH range - 6.0 to 6.8.

COMPOSITION:

Each Ml Contains:

• Ofloxacin I.P .................3 mg
• Benzalkonium Chloride Solution I.P. ........0.05 mg (As preservative)
• Aqueous buffered vehicle   ......................q. s.

PACKAGING

Primary packing - 5ml Clear Poly bottles White caps & Nozzles.
Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.

AVAILABILITY

5ml in clear poly bottles with white caps & nozzles in properly sealed.

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:

5ml of solution in Opaque poly bottles with white caps & nozzles in properly sealed.

USES

Aflox Eye Drops is used in the treatment of bacterial infections.

HOW IT WORKS

Aflox Eye Drops are an antibiotic. It kills bacteria by inhibiting the DNA replication.

INDICATIONS AND USAGE:

AFLOX ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:

CONJUNCTIVITIS:

Gram-Positive Bacteria:
• Staphylococcus aureus
• Staphylococcus epidermidis
• Streptococcus pneumoniae

Gram-Negative Bacteria:

• Enterobacter cloacae
• Haemophilus influenzae
• Proteus mirabilis• Pseudomonas aeruginosa

CORNEAL ULCERS:

Gram-Positive Bacteria:

• Staphylococcus aureus
• Staphylococcus epidermidis
• Streptococcus pneumoniae

Gram-Negative Bacteria:

• Pseudomonas aeruginosa
• erratia marcescens*
• Anaerobic species: Propionibacterium acnes
*Efficacy for this organism was studied in fewer than 10 infections

CONTRAINDICATIONS: Aflox Eye Drops is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.

DOSAGE AND ADMINISTRATION: The recommended dosage regimen for the treatment of bacterial conjunctivitis is:

Days 1 and 2

Instill one to two drops every two to four hours in the affected eye(s).

Days 3 through 7

Instill one to two drops four times daily.

The recommended dosage regimen for the treatment of bacterial corneal ulcer is:

Days 1 and 2

Instill one to two drops into the affected eye every 30 minutes, while awake. Awaken at approximately four and six hours after retiring and instill one to two Drops.

Days 3 through 7 to 9

Instill one to two drops hourly while awake.

Days 7 to 9 through Treatment completion

Instill one to two drops, four times daily.

SUPPLY:

Aflox Eye Drops is supplied in 5ml Clear Poly bottles packed with printed labeled in a unit carton and, Such 25 Carton Packed in a Shrink Sleeves.Such 12 shrinks packed in a shipper.

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Aflox

Moxifur 1mL

MOXIFUR 1ml

Moxifloxacin Ophthalmic Solution USP

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

DESCRIPTION:

Moxifur (Moxifloxacin Ophthalmic Solution USP) is a sterile 1 ml clear, pale yellow coloured, isotonic, preservative free ophthalmic solution.

COMPOSITION:

Each ML Contains:

Moxifloxacin Hydrochloride USP
• Eq. to Moxifloxacin 0.5% w/v
• Aqueous Buffered Vehicle q.s.

INDICATIONS:

Topical treatment of purulent bacterial conjunctivitis, caused by moxifloxacin susceptible strains. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

PHARMACOLOGICAL CLASSIFICATION:

Pharmacotherapeutic group: Ophthalmologicals; anti-infectives, other anti-infectives,

PHARMACODYNAMICS/ PHARMACOKINETICS:

Pharmacodynamics:

Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and topoisomerase IV required for bacterial DNA replication, repair, and recombination.

Pharmacokinetics:

Following topical ocular administration of Moxifur (Moxifloxacin Ophthalmic Solution USP), moxifloxacin was absorbed into the systemic circulation. Plasma concentrations of moxifloxacin were measured in 21 male and female subjects who received bilateral topical ocular doses of the medicinal product 3 times a day for 4 days. The mean steady-state Cmax and AUC were 2.7 ng/ml and 41.9 ng· hr/ml, respectively. These exposure values are approximately 1,600 and 1,200 times lower than the mean Cmax and AUC reported after therapeutic 400 mg oral doses of moxifloxacin. The plasma half-life of Moxifloxacin was estimated to be 13 hours.

RECOMMENDED DOSE:

For ocular use only. Not for injection. Moxifur (Moxifloxacin Ophthalmic Solution USP), solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. Use in adults including the elderly ( 65 years) The dose is one drop in the affected eye(s) 3 times a day. The infection normally improves within 5 days and treatment should then be continued for a further 2- 3 days. If no improvement is observed within 5 days of initiating therapy, the diagnosis and/or treatment should be reconsidered. The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection. Paediatric patients. No dosage adjustment is necessary. Use in hepatic and renal impairment No dosage adjustment is necessary. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. In order to prevent the drops from being absorbed via the nasal mucosa, particularly in new-born infants or children, the nasolacrimal ducts should be held closed for 2 to 3 minutes with the fingers after administering the drops. After cap is removed, if tamper evident snap collar is loose, remove before using the product. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart. Eye ointments should be administered last.

CONTRA-INDICATIONS:

Hypersensitivity to the active substance, to other quinolones,

WARNING AND PRECAUTION:

In patients receiving systemically administered quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching.
If an allergic reaction to Moxifur (Moxifloxacin Ophthalmic Solution USP) occurs, discontinue use of the medicinal product. Serious acute hypersensitivity reactions to moxifloxacin or any other product ingredient may require immediate emergency treatment. Oxygen and airway management should be administered where clinically indicated.
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including moxifloxacin, particularly in older patients and those treated concurrently with corticosteroids. Following ophthalmic administration of Moxifur (Moxifloxacin Ophthalmic Solution USP) plasma concentrations of moxifloxacin are much lower than after therapeutic oral doses of moxifloxacin, however , caution should be exercised and treatment with Moxifur (Moxifloxacin Ophthalmic Solution USP) should be discontinued at the first sign of tendon inflammation.
Data are very limited to establish efficacy and safety of Moxifur (Moxifloxacin Ophthalmic Solution USP) in the treatment of conjunctivitis in neonates. Therefore use of this medicinal product to treat conjunctivitis in neonates is not recommended.
Moxifur (Moxifloxacin Ophthalmic Solution USP) should not be used for the prophylaxis or empiric treatment of gonococcal conjunctivitis, including gonococcal ophthalmia neonatorum, because of the prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae. Patients with eye infections caused by Neisseria gonorrhoeae should receive appropriate systemic treatment.
The medicinal product is not recommended for the treatment of Chlamydia trachomatis in patients less than 2 years of age as it has not been evaluated in such patients. Patients older than 2 years of age with eye infections caused by Chlamydia trachomitis should receive appropriate systemic treatment.
Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition, e.g. systemic treatment in cases caused by Chlamydia trachomitis or Neisseria gonorrhoeae. Patients should be advised not to wear contact lenses if they have signs and symptoms of a bacterial ocular infection.

INTERACTIONS WITH OTHER MEDICAMENTS:

No specific interaction studies have been performed with Moxifur (Moxifloxacin Ophthalmic Solution USP). Given the low systemic concentration of moxifloxacin following topical ocular administration of the medicinal product, drug interactions are unlikely to occur.

OVERDOSE AND TREATMENT:

The limited holding capacity of the conjunctival sac for ophthalmic products practically precludes any overdosing of the medicinal product. The total amount of moxifloxacin in a single container is too small to induce adverse effects after accidental ingestion.

STORAGE CONDITION:

Preserve in tight containers. Store between 2°C to 25°C.

SHELF LIFE:

24 Months.

HOW SUPPLIED:

Moxifur (Moxifloxacin Ophthalmic Solution USP) 1mL is available in sterile 2ml Glass vial with pouch pack.

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MOXIFUR 5mL

MOXIFUR

Pack : 5 Ml Pack

DESCRIPTION:

Moxifur- Eye Drops is a sterile topical ophthalmic solution. Moxifloxacin is a fourthgeneration fluoroquinolone antibacterial agent active against a broad spectrum of Grampositive and Gram-negative ocular pathogens, atypical microorganisms and anaerobes. Moxifur- Eye Drops is a clear, greenish-yellow solution formulated as a sterile, multipledose product, for topical ophthalmic use.

COMPOSITION:

Label Claim: Each ML Contains :
Moxifloxacin Hydrochloride IP

  • Eq. to Moxifloxacin.     ......0.5%w/v.
  • Sterile aqueous base.    .......q.

PACKAGING

Primary packing - 5ml White Poly bottles White caps & Nozzles.
Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:  

Keep in a cool & dark place. Below 25ºC.Do not allow to Freeze.

AVAILABILITY:

5ml of solution in White poly bottles with white caps & nozzles in properly sealed.

CLINICAL PHARMACOLOGY:

Mechanism Of Action:

Moxifloxacin is fluroquinolone derivative interfere with DNA synthesis during bacterial replication by inhibiting DNA gyrase activity. Bacterial gyrase, unlike the comparable human enzyme, is susceptible to inhibition by the fluroquinolone, and this inhibition kills the bacterial. It is active against citrobactar, Enterobacter, E-coli, Neeisseria gonorrhea, Proteus mirables,S.aureus,s.epidermis,S-pneumoniae,P.aeruginosa,H.influenzae and most other gram-negative bacteria.

INDICATIONS AND USAGE:

Moxifur - Eye Drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible microorganisms.

CONTRAINDICATIONS:

Moxifur - Eye Drops are contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, to any of the excipients in this medication.

WARNINGS:

Moxifur - Eye Drops are contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, to any of the excipients in this medication.

DOSAGE AND ADMINISTRATION:

Instil one drop in the affected eye(s) 3 times a day for 4 days. To prevent contamination of the dropper tip and solution, care should be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle.

SUPPLY:

Moxifur - Eye Drops is supplied in one White polethylene Bottle packed with printed labelled & cartons And Such 25 Carton Packed in a Shrink Sleeves & corrugated box.

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TOBOTOR 5mL

TOBOTOR

Pack : 5 Ml Pack

DESCRIPTION:

Tobotor-Eye Drops is an antibiotic eye drop. Tobotor-Eye Drops is an aminoglycoside antibiotic that kills susceptible bacteria by blocking bacterial protein synthesis. Death of susceptible bacteria occurs because of the lack of functional proteins.Tobotor-Eye Drops treats only bacterial eye infections and does not work for other types of eye infections.

COMPOSITION:

Label Claim: Each ML Contains:

Tobramycin Sulphate USP

  • TEquivalent to Tobramycin...........3 mg
  • Benzalkonium Chloride Solution IP.............0.05 mg (As preservative)
  • Sterile Aqueous buffered vehicle..............q.s.

PACKAGING:

Primary packing - 5ml Clear Poly bottles White caps & Nozzles.
Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.

AVAILABILITY:

5ml of solution in Clear poly bottles with white caps & nozzles in properly sealed.

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:

Keep in a cool & dark place. Below 25ºC.Do not allow to Freeze.

CLINICAL PHARMACOLOGY:

Studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including and (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some . , most strains and and some species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin. In Vitro Data: In vitroS. aureusS. epidermidisStreptococcus pneumoniaePseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganiiProteus vulgaris, Haemophilus influenzaeH. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus Neisseria.

INDICATIONS AND USAGE:

Tobotor-Eye Drops is used to treat eye infections. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria.
Tobotor-Eye Drops treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

CONTRAINDICATIONS:

The uses of Tobotor-Eye Drops is contraindicated in patients with known hypersensitivity to any of the ingredients of the formulation.The use of Tobotor-Eye Drops is also contraindicated in epithelial herpes simplex keyratitis (dendritic keratitis), vaccinia,varicellanad may other viral diseases of the cornea and conjunctiva, mycobacterial infection of the eye and fungal diseases of ocular structures.

WARNINGS:

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to Tobotor-Eye Drops occurs, discontinue use.

DOSAGE AND ADMINISTRATION:

In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation. Bottle

SUPPLY:

Tobotor-Eye Drops is supplied in 5 ml clear poly bottles packed with printed labeled in a unit carton and, Such 25 Carton packed in a shrink sleeves.such,12 shrinks packed in a shipper.

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Q4G

Q4G

Pack : 5 Ml Pack

DESCRIPTION:

Q4G-Eye Drops (Gatifloxacin Ophthalmic Solution) is used to treat infections of the eye, such as bacterial conjunctivitis. Gatifloxacin belongs to a group of medicines called fluoroquinolone antibiotics. It works by killing bacteria that cause conjunctivitis.

COMPOSITION:

Label Claim: Each ML Contains :

• Gatifloxacin ..............3 mg
• Benzalkonium Chloride Solution IP. ..........0.02 mg (As preservative)
• Aqueous buffered vehicle.............q.s.

PACKAGING

Primary packing - 5ml Clear Poly bottles White caps & Nozzles.
Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:

Keep in a cool & dark place. Below 25ºC.Do not allow to Freeze.

AVAILABILITY:

5ml of solution in Clear poly bottles with white caps & nozzles in properly sealed.

CLINICAL PHARMACOLOGY:

Mechanism Of Action:

Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl substituent at C7. The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
The mechanism of action of fluoroquinolones including gatifloxacin is different from that of aminoglycoside, macrolide, and tetracycline antibiotics. Therefore, gatifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to gatifloxacin. There is no cross-resistance between gatifloxacin and the aforementioned classes of antibiotics. Cross-resistance has been observed between systemic gatifloxacin and some other fluoroquinolones.
Resistance to gatifloxacin in vitro develops via multiple-step mutations. Resistance to gatifloxacin in vitrooccurs at a general frequency of between 1 x 10-7 to 10-10.
Gatifloxacin has been shown to be active against most strains of the organisms both in vitro and clinically, in conjunctival infections.

Pharmacokinetics:

Gatifloxacin ophthalmic solution 0.3% or 0.5% was administered to one eye of 6 healthy male subjects each in an escalated dosing regimen starting with a single 2-drop dose, then 2 drops 4 times daily for 7 days and finally 2 drops 8 times daily for 3 days. At all time points, serum gatifloxacin levels were below the lower limit of quantification (5 ng/mL) in all subjects.

INDICATIONS AND USAGE:

Q4G-Eye Drops is a topical quinolone antimicrobial for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Haemophilus influenzae, Corynebacterium propinquum*, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group*, Streptococcus pneumoniae

CONTRAINDICATIONS:

Q4G-Eye Drops is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication.

WARNINGS:

Hypersensitivity,growth of resistant organisms with prolonged use avoidance of contact lenses corneal endothelial cell injury

DOSAGE AND ADMINISTRATION:

The recommended dosage regimen for the treatment of bacterial conjunctivitis is:Days 1 and 2: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times daily.
Days 3 through 7: Instill one drop up to four times daily while awake.

SUPPLY:

Q4G-Eye Drops is supplied in one Clear Polethylene Bottle packed with printed labelled & cartons And Such 25 carton packed in a shrink Sleeves & corrugated box.

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A-Genta Eye Drops

(Gentamicin Sulfate Ophthalmic Solution USP)

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

DESCRIPTION:

A-Genta Eye Drops (Gentamicin Sulfate Ophthalmic Solution USP) is a sterile, topical anti- infective agent for ophthalmic use. The active ingredient, Gentamicin Sulfate, is a water- soluble antibiotic of the aminoglycoside group. Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of Gentamicin C1,C 2, and C 1A. All three components appear to have similar antimicrobial activities. Gentamicin Sulfate occurs as a white to buff powder and is soluble in water but insoluble in alcohol.

COMPOSITION:

Each ML Contains :

• Gentamicin                 Sulfate                  USP
• Eq.    to   Gentamicin     0.3%w/v
• Benzalkonium Chloride Solution USP 0.02%w/v
  (As preservative)
• Sterile Buffered Vehicle                                 q.s.

CLINICAL PHARMACOLOGY

Microbiology Gentamicin Sulfate is active in vitro against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

INDICATIONS AND USAGE

A-Genta Eye Drops(Gentamicin Sulfate Ophthalmic Solution USP) is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharo conjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. Treatment of infections of the external structures of the eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis and blepharo conjunctivitis, acute meibomianitis, episcleritis and dacryocystitis. It may be used for the prevention of ocular infection after: removal of a foreign body, burns or lacerations of the conjunctiva; damage from chemical or physical agents and after ocular surgery.

DOSAGE & ADMINISTATION

A-Genta Eye Drops (GentamicinSulfate Ophthalmic Solution USP): Instill one or two drops into the affected eye every 4 hours. In severe infections, dosage may be increased to as much as two drops once every hour.

CONTRAINDICATIONS

Should not be administered to patients with a known allergy to Gentamicin and other amino glycosides. Evidence exists that Gentamicin may cause neuromuscular blockade and is therefore contraindicated in myasthenia gravis and related conditions.

PRECAUTIONS

General

Prolonged use of topical antibiotics may give rise to over growth of nonsusceptible organisms including fungi. Bacterial resistance to Gentamicin may also develop. If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician. If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation, and appropriate therapy should be instituted. Information for patients: Do not touch dropper tip to any surface, as this may contaminate the solution. If irritation persist or increases discontinue the use and consult the physician Carcinogenesis, Mutagenesis, Impairment of Fertility .There are no published carcinogenicity or impairment of fertility studies on Gentamicin. Aminoglycoside antibiotics have been found to be nonmutagenic.

Pregnancy

Pregnancy Category C: Gentamicin has been shown to depress body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pediatric Use Safety and effectiveness in neonates have not been established.

ADVERSE EFFECTS

Bacterial and fungal corneal ulcers have developed during treatment with Gentamicin ophthalmic preparations. The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, nonspecific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia. Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura, and hallucinations.

STORAGE

Keep in a cool & dark place. Storebelow 30°C. Do not allowto freeze.

SHELF LIFE

24 Months

HOW SUPPLIED

A-Genta Eye Drops (Gentamicin SulfateOphthalmic Solution USP) is availablein 5mL poly bottle.

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A-Genta Eye Drops

Appachloro Eye Drops

Chloramphenicol Ophthalmic Solution USP

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

DESCRIPTION:

Appachloro (Chloramphenicol Ophthalmic Solution USP) is a sterile ophthalmic solution. Appachloro (Chloramphenicol Ophthalmic Solution USP) contains an antibiotic called chloramphenicol. It is used to treat bacterial infections that affect the front surfaces of the eye.
The most common type of infection in this area is called acute bacterial conjunctivitis. When you have acute bacterial conjunctivitis the white part of one or both of your eyes will be red and /or your eyelids will be red or swollen.

COMPOSITION:

Each ML Contains :

• Chloramphenicol USP           0.5%w/v
•Phenyl Mercuric
• Nitrate USP    0.001%w/v
  (As preservative)
• Sterile Buffered Vehicle              q.s.

INDICATIONS AND USAGE

Appachloro (Chloramphenicol Ophthalmic Solution USP) is indicated for the treatment of superficial ocular infections involving the conjunctiva and/ or cornea caused by chloramphenicol-susceptible organisms. 
Bacteriological studies should be performed to determine the causativeorganisms and their sensitivity to chloramphenicol. 
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Appachloro (Chloramphenicol Ophthalmic Solution USP) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

CLINICAL PHARMACOLOGY

Chloramphenicol is a broad spectrum antibiotic originally isolated from Streptomyces venezuelae. It is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes. Development of resistance to chloramphenicol can be regarded as minimal for staphylococci and many other species of bacteria.

CONTRAINDICATIONS

Sensitivity to chloramphenicol with signs of local irritation, symptoms of burning, angioneurotic edema, itching, urticaria, vesicular and maculopapular dermatitis. If these signs appear, withdraw the medication and consult your physician. Hypersensitivity to any components of the medication. Appachloro (Chloramphenicol Ophthalmic Solution USP)is especially contraindicated in epithelial herpes simplex, keratitis, vaccina, varicella, viral diseases of the cornea and conjunctiva, tuberculosis of the eye; fungal diseases of the eye, acute purulent untreated infections of the eye, which, like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid.

WARNING

Bone marrow hypoplasia including aplastic anemia and death has been reported following topical application of chloramphenicol. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.

PRECAUTION

It should be borne in mind that a patient may become sensitized to chloramphenicol when it is applied topically. Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea or sclera, perforation has been known to occur. It is recommended that intraocular pressure be checked frequently.
Safety of the use of corticosteroids during pregnancy has not been substantiated. In all serious infections, the topical use of chloramphenicol should be supplemented by appropriate systemic medication.

ADVERSE REACTIONS

Blood dyscrasias may be associated with the systemicuse of chloramphenicol. One case of bone-marrow hypoplasia followingthe prolonged (23 month) topical use of chloramphenicol ophthalmic solution has been reported. 

OVER DOSAGE

For management of a suspected drug overdose, contact your regional Poison Control Centre.

DOSAGE AND ADMINISTRATION

Two drops applied to the affected eye(s) every three hours, or more frequently, if deemed advisable by the prescribing physician. Administration should be continued day and night for the first 48 hours, after which the interval between applications may be increased. Treatment should be continued for at least 48 hours after the eye(s) appears normal.

SHELF LIFE

24 Months

STORAGE

Preserve in tight containers, and store in a refrigerator until dispensed. Store below 30°C. Keep out of reach of children.

HOW SUPPLIED

A-Genta Eye Drops (Gentamicin SulfateOphthalmic Solution USP) is availablein 5mL poly bottle.

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Appachloro Eye Drops

APPACIPRO Eye Drops

(Ciprofloxacin Ophthalmic Solution USP)

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

DESCRIPTION:

Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v) is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4- oxo-7-(1-piperazinyl)-3- quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical   formula   is  C17H18FN3O3HClH2O. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position.

COMPOSITION:

Each ML Contains :

• Ciprofloxacin   Hydrochloride   USP
• Eq. to Ciprofloxacin     0.3 % w/v
• Benzalkonium Chloride Solution USP 0.02% w/v
  (As preservative)
• Sterile Aqueous Vehicle                                 q.s.

INDICATIONS AND USAGE

Appacipro Eye Drops(Ciprofloxacin Ophthalmic SolutionUSP 0.3% w/v) is indicated for the treatment of infections causedby susceptible strainsof the designated microorganisms in the conditions listed below:
CornealUlcers:  Pseudomon aeruginosa
 Serratia marcescens*
 Staphylococcus aureus  Staphylococcus epidermidis
 Streptococcus pneumoniae  Streptococcus (Viridans Group)
*Efficacy for this organism was studied in fewer than 10 infections.

CLINICAL PHARMACOLOGY

a)Therapeutic indications

Adults, newborn infants(0-27 days), infantsand toddlers (28 days to 23 months),children (2-11 years) and adolescents (12-16 years).Appacipro Eye Drops(Ciprofloxacin Ophthalmic SolutionUSP 0.3% w/v) is indicated for the treatment of corneal ulcers and superficial infections of the eye and adnexa caused by susceptible strains of bacteria.Consideration should be given to official guidance on the appropriate use of antibacterial agents.

a)  Dosage and Administration

Adults, newborn infants(0-27 days), infantsand toddlers (28 days to 23 months),children (2-11 years) and adolescents (12-16 years).Corneal Ulcers:Appacipro Eye Drops (Ciprofloxacin Ophthalmic SolutionUSP 0.3% w/v) must be administered in the following     intervals,     even     during     night     time: On the firstday, instil 2 drops into the affectedeye every 15 minutes for the firstsix hours and then 2 drops into the affectedeye every 30 minutes for the remainder of the day.On the second day, instil 2 drops in the affected eye hourly.On the third through the fourteenth day, place two dropsin the affected eye every 4 hours. If the patient needs to be treated longerthan 14 days,the dosing regimenis at the discretion of the attending physician.Superficial               Ocular   Infection: The usual dose is one or two drops in the affectedeye(s) four times a day. In severeinfections, the dosagefor the first two days may be one or two drops every two hours during waking hours.For either indication a maximum durationof therapy of 21 days is recommended. The dosage in children above the age of 1 year is the same as for adults.Use                 in                 children Safety and effectiveness of Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v) were determined in 230 childrenbetween the ages of 0 and 12 years of age. No serious adversedrug reaction was reported in this groupof patients.Use   in  renal  and  hepatic      impairment Nostudies have been performed using Appacipro Eye Drops (Ciprofloxacin OphthalmicSolution USP 0.3% w/v) in patients with kidney or liver problems.

c) Contraindications                                

a) A history of hypersensitivity to Ciprofloxacin or any other component of the medication is a contraindication to its use. A historyof hypersensitivity to other quinolones may also contraindicate the use of Ciprofloxacin.

d) Warning

a) The clinical experience in children less than one year old, particularly in neonates is very limited.The use of AppaciproEye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v) in neonates withophthalmia neonatorum of gonococcal or chalamydial originis not recommended as it has not been evaluated in such patients.Neonates with ophthalmia neonatorum should receiveappropriate treatment for their condition. When using Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v) one shouldtake into account the risk of rhinopharyngealpassage which can contribute to the occurrence and the diffusion of bacterial                              resistance. Serious and occasionally fatalhypersensitivity (anaphylactic) reactions, some following the first dose,were observed in patients receiving treatment based on systematicallyadministered quinolones. Some reactionswere accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial oedema,dyspnoea, urticaria and itching. Only a few patients had a historyof hypersensitivity reactions . Serious acutehypersensitivity reactions to ciprofloxacin may require immediate emergencytreatment. Oxygen and airway management should be administered where clinically indicated. Appacipro Eye Drops(Ciprofloxacin Ophthalmic SolutionUSP 0.3% w/v) should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.As with all antibacterialpreparations prolonged use may lead to overgrowth of non-susceptible bacterial strainsor fungi. If superinfection occurs,appropriate therapy shouldbe initiated.Tendoninflammation and rupture may occur with systemic fluoroquinolone therapyincluding ciprofloxacin, particularly in elderly patients and those treated concurrently withcorticosteroids. Therefore, treatment with Appacipro Eye Drops (CiprofloxacinOphthalmic Solution USP 0.3% w/v) should be discontinued at the first sign of tendon inflammation .In patients with corneal ulcer andfrequent administration of Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v), white topical ocularprecipitates (medication residue)have been observedwhich resolved after continued application of Appacipro Eye Drops(Ciprofloxacin Ophthalmic Solution USP 0.3% w/v). The precipitatedoes not preclude the continued application ofAppacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v) nor does itadversely affect the clinical course of the recovery process. The onset of the precipitate was within 24 hours to 7 days after starting therapy. Resolution of the precipitate variedfrom immediately to 13 days after therapycommencing.Contact lens wear is not recommended during treatment of an ocular infection. Therefore, patients should be advised not to wear contact lensesduring treatment with Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v).Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v) contains Benzalkonium chloride which may cause irritation and is known to discoloursoft contact lenses.Avoid contact with soft contact lenses.In case patientsare allowed to wear contactlenses they shouldbe instructed to remove them prior to application of Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v) and wait at least15 minutes beforereinsertion.b) Interaction with othermedicinal products andother forms of interactionSpecific drug interaction studieshave not been conducted with ophthalmic Ciprofloxacin. Given the low systemic concentration of Ciprofloxacinfollowing topical ocular administration of the product, drug interactions are unlikely to occur.If more than one topicalophthalmic medicinal productis being used, the medicinesmust be administered at least 5 minutesapart. Eye ointmentsshould be administered last.

f) Fertility, pregnancy and lactation

 Fertility

Studies have not been performedin humans to evaluate the effect of topical administration of Ciprofloxacin on fertility. Oral administration in animals does not indicatedirect harmful effectswith respect to fertility.Pregnancy                                   There are no adequate data from the use of Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v) in pregnantwoman. Animal studiesdo not indicate direct harmfuleffects with respectto reproductive toxicity.Systemic exposure to Ciprofloxacin after topical use is expectedto be low.As a precautionary measure, it ispreferable to avoid the use of Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v) duringpregnancy, unless the therapeutic benefit is expected to outweigh the potential risk to the fetus.BreastfeedingOrally administered Ciprofloxacinis excreted in the human milk. It is unknown whether Ciprofloxacin is excreted in human breast milk followingtopical ocular or otic administration. Arisk to the suckling child cannot beexcluded. Therefore, caution should be exercised when Appacipro Eye Drops(Ciprofloxacin Ophthalmic SolutionUSP 0.3% w/v) is administered to nursing women.

g) Undesirable

a) In clinical trials,the most frequently reported adverse drug reactions were ocular discomfort, dysgeusia and cornealdeposits occurring approximately in 6%, 3% and 3% of patientsrespectively.Tabulated summary of adverse reactionsThe adversereactions listed beloware classified according to the following convention: very common(≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100),rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannotbe estimated from the availabledata). Within each frequency-grouping, adverse reactions are presented in orderof decreasing seriousness. The adverse reactions have been observedduring clinical trialsand post-marketing experience.

The following undesirable effects were reported in association with the ophthalmic use of Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v):

System Organ Classification

Preferred Term

Immune system disorders

Rare: hypersensitivity

Nervous system disorders

Uncommon: headache, Rare:  dizziness

Eye disorders

Common: corneal  deposits, ocular discomfort, ocular hyperaemiaUncommon:keratopathy,  punctate keratitis, corneal infiltrates, photophobia, visual  acuity reduced, eyelid  oedema, blurred vision,  eye pain, dry  eye, eye swelling, eye pruritus, lacrimation increased, eye discharge, eyelid margin crusting, eyelid exfoliation, conjunctival oedema, erythema of eyelid Rare:  ocular toxicity, keratitis,  conjunctivitis, corneal epithelium defect, diplopia, hypoaesthesia eye,  asthenopia, eye irritation, eye inflammation, hordeolum

Ear and labyrinth disorders

Rare: ear pain

Respiratory, thoracic and mediastinal disorders

Rare: paranasal sinus  hypersecretion, rhinitis

Gastrointestinal disorders

Common: dysgeusia
Uncommon: nausea
‍Rare: diarrhoea, abdominal pain

Skin and subcutaneous tissuedisorders

Rare: dermatitis

Musculoskeletal and connectivetissue disorders

Not known: tendon  disorder



Description of selected adverse eventsWith locally appliedfluoroquinolones (generalized) rash, toxic epidermolysis, dermatitisexfoliative, Stevens-Johnson syndromeand urticaria occurvery rarely.Serious andoccasionally fatal hypersensitivity (anaphylactic) reactions, some followingthe first dose, have been reported in patientsreceiving systemic quinolone therapy. Some reactions were accompanied by cardiovascularcollapse, loss of consciousness, tingling, pharyngeal or facial oedema,dyspnoea, urticaria, and itching.Ruptures of the shoulder, hand,Achilles, or other tendons that required surgical repair or resulted in prolongeddisability have been reported in patients receivingsystemic fluoroquinolones. Studiesand post marketing experience with systemicfluoroquinolones indicate that the risk of these ruptures may be increased in patients receivingcorticosteroids, especially geriatric patients and in tendons under high stress, including the Achilles tendon. To date, clinical and post marketing data have not demonstrateda clear association between Appacipro Eye Drops (CiprofloxacinOphthalmic Solution USP 0.3% w/v) and musculoskeletal and connective tissue adverse reactions.In isolated casesblurred vision, decreased visual acuity and medication residuehave been observedwith ophthalmic Ciprofloxacin .Moderate to severephototoxicity has been observed in patients treatedwith systemic quinolones. Nevertheless, phototoxic reactions to ciprofloxacin are uncommon.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Mechanism of ActionAppacipro Eye Drops (CiprofloxacinOphthalmic Solution USP 0.3% w/v), solution contains the fluoroquinolone ciprofloxacin. The cidal and inhibitory activityof Ciprofloxacin againstbacteria results from an interference with the DNA gyrase, an enzyme neededby the bacterium for the synthesis of DNA. Thus the vital information from the bacterialchromosomes cannot be transcribed which causes a breakdown of the bacterial metabolism. Ciprofloxacin has in vitro activity againsta wide range of Gram-positive and Gram- negativebacteria.Mechanism             of             Resistance Fluoroquinolone resistance, particularly Ciprofloxacin, requires significant geneticchanges in one or more of five major bacterialmechanisms: a) enzymesfor DNA synthesis, b) protecting proteins, c) cell permeability, d) drug efflux,or e) plasmid-mediated aminoglycoside 6'-N-acetyltransferase.Fluoroquinolones, includingCiprofloxacin, differ in chemical structure and mode of action from aminoglycosides, β-lactam antibiotics,macrolides, tetracyclines, sulfonamides, trimethoprim, and chloramphenicol. Therefore, organisms resistantto these drugs may be susceptible to Ciprofloxacin.Susceptibility              to              Ciprofloxacin: The prevalence of acquired resistance may vary geographically and with time for selectedspecies and local informationon resistance is desirable,particularly when treating severe infections.As necessary, expertadvice should be sought when the local prevalence of resistance is such that the utilityof the agent in at least some types of infections is questionable.The presentation below lists bacterial species recovered from externalocular infections of the eye.

Commonly susceptible species

Aerobic Gram-positive microorganisms
Corynebacterium accolens
Corynebacterium auris
Corynebacterium propinquum
Corynebacterium psudodiphtheriticum
Corynebacterium striatum
‍Staphylococcus aureus (methicillin susceptible - MSSA) Staphylococcus capitis
‍Staphylococcus epidermidis (methicillin susceptible - MSSE) Staphylococcus hominis
‍Staphylococcus
saprophyticus
Staphylococcus warneri
Streptococcus pneumoniae
Streptococcus viridans Group
Aerobic Gram-negative microorganisms
Acinetobacter species
Haemophilus influenzae
Moraxella catarrhalis
Pseudomonas aeruginosa
Serratiamarcescens

Species for which  acquired resistance may be a  problem

Aerobic Gram-positive micro-organisms:
Staphylococcus aureus (methicillin resistant - MRSA)
Staphylococcus epidermidis (methicillin resistant - MRSE)
Staphylococcus lugdunensis
Aerobic Gram-negative micro-organisms:
None
Other micro-organisms:
None

Inherently resistant organisms

Aerobic Gram-positivemicro-organisms:
Corynebacterium jeikium
Aerobic Gram-negative micro-organisms:
None
Other micro-organisms:
None

PHARMACOKINETIC PROPERTIES

Appacipro Eye Drops (Ciprofloxacin Ophthalmic Solution USP 0.3% w/v) solution is rapidly absorbed into the eye following topical ocular administration. Systemic levels are low following topical administration. Plasma levels of Ciprofloxacin in human subjects following 2 drops of 0.3% Ciprofloxacin solution every 2 hours for two days and then every four hours for 5 days ranged from non-quantifiable (<1.0ng/mL) to 4.7 ng/mL. The mean peak Ciprofloxacin plasma level obtained in this study is approximately 450-fold less than that seen following a single oral dose of 250 mg Ciprofloxacin. The systemic pharmacokinetic properties of Ciprofloxacin have been well studied. Ciprofloxacin widely distributes to tissues of the body. The apparent volume of distribution at steady state is 1.7 to 5.0 l/kg. Serum protein binding is 20-40%. The half-life of Ciprofloxacin in serum is 3-5 hours. Both Ciprofloxacin and its four primary metabolites are excreted in urine and faeces. Renal clearance accounts for approximately two-thirds of the total serum clearance with biliary and faecal routes accounting for the remaining percentages. In patients with impaired renal function, the elimination half-life of Ciprofloxacin is only moderately increased due to extrarenal routes of elimination. Similarly, in patients with severely reduced liver function the elimination half-life is only slightly longer. There are no pharmacokinetic data available in respect of use in children.

PACKAGING AND STORAGE

Preserve in tight containers, protected from light, at room temperature.

SHELF LIFE

24   Months   (Unopened   Container)
To be used within one month after opening the container.

HOW SUPPLIED

Appacipro Eye Drops (Ciprofloxacin Ophthalmic SolutionUSP 0.3% w/v) sterile solution is available in10mL/5mL poly bottle.

Aod address

APPACIPRO Eye Drops