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.

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.

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.

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.

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.