ANTI BACTERIAL & ANTI INFLAMMATORY

Moxifur -Dm /5mL

Moxifur-Dm

Pack : 5ml Pack

DESCRIPTION:

Moxifur-K Eye Drops is indicated for the reduction of post-operative inflammatory conditions of the eye.

COMPOSITION:

Label Claim: Each ML Contains:

Moxifloxacin Hydrochloride IP Eq to Moxifloxacin ...............5.0 mg
Dexamethasone Sodium Phosphate IP Eq to Dexamethasone Phosphate..........1.0mg
Benzalkonium Chloride Solution IP........0.2 mg
Aqueous Buffered Vehicle ..........q.s.

PACKAGING:

Primary packing - 5ml Opaque 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 Opaque poly bottles with white caps & nozzles in properly sealed.

CLINICAL PHARMACOLOGY:

Moxifur-DM Eye Drops combines moxifloxacin, an 8-methoxy fluroquinolone antibiotic and ketorolac tromethamine, a non-steroidal anti-inflammatory drug, intended for topical ophthalmic use.

INDICATIONS AND USAGE:

Moxifur-DM Eye Drops is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.

CONTRAINDICATIONS:

Moxifur-DM Eye Drops is contraindicated in epithelial herpes simplex keratitis (Dendritic keratitis), vaccinia, varicella, and in many other viral diseases of the conjunctiva and cornea, Mycobacterial infection of the eye and fungal diseases of ocular structures and in individuals hypersensitive to any of the components of the medication.

WARNINGS:

Prolonged use of steroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.

DOSAGE AND ADMINISTRATION:

One or two drops instilled into the conjunctival sac(s), every 4 to 6 hours. During the initial 24 to 48 hours, the dosage may be increased to 1 or 2 drops every two hours.Frequency must be decreased gradually or warranted by improvement in clinical signs. Care should be taken not to discontinue the therapy prematurely.

SUPPLY:

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

Moxifur-K

Pack : 5ml Pack

DESCRIPTION:

Moxifur-K Eye Drops is indicated for the reduction of post-operative inflammatory conditions of the eye.
Moxifur-K Eye Drops is a medicine that is used for the treatment of Intense Pain, Pain in Eye after eye surgery, swelling in eye after eye surgery, respiratory tract infections, abdominal infections, female genital tract infection and other conditions.
Moxifur-K Eye Drops contains Ketorolac, and Moxifloxacin as active ingredients.
‍Moxifur-K Eye Drops works by blocking the effect of chemicals causing pain; inhibiting enzymes involved in DNA processes;

COMPOSITION:

Label Claim: Each ML Contains :
Moxifloxacin Hydrochloride IP

• Eq. Moxifloxacin............. 0.5% w/v
• Ketorolac Tromethamine IP 0.5% w/v
• Benzalkonium chloride solution IP 0.01% v/v (As preservative)
• Aqueous buffered vehicle...............q.s.

PACKAGING

Primary packing - 5ml Opaque 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 Opaque poly bottles with white caps & nozzles in properly sealed.

CLINICAL PHARMACOLOGY:

Moxifur-K Eye Drops combines moxifloxacin, an 8-methoxy fluroquinolone antibiotic and ketorolac tromethamine, a non-steroidal anti-inflammatory drug, intended for topical ophthalmic use.

Mechanism Of Action:

The antibacterial action results from inhibition of the topoisomerase II (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 key role in the partitioning of the chromosomal DNA during bacterial cell division.The mechanism of action of quinolones, including moxifloxacin is different from that of macrolides, aminoglycosides or tetracyclines. Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and aforementioned classes of antibiotics. Cross resistance has been observed between systemic moxifloxacin and some other quinolones.In vitro resistance to moxifloxacin develops via multiple step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8×10-9 to <1×10-11 for gram-positive bacteria.Moxifloxacin has been shown to be active against most strains of the aerobic gram-positive microorganisms including Cornyebacterium species*,Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group; aerobic gram-negative microorganisms including Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*; and other microorganisms including Chlamydia trachomatis, both in vitro and in clinical infections.*Efficacy for this organism was studied in fewer than 10 infections.Ketorolac tromethamine is a non-steroidal anti-inflammatory drug which when administered systemically has demonstrated analgesic, anti-inflammatory, and antipyretic activities. Ketorolac tromethamine inhibits the cyclooxygenase enzyme essential for biosynthesis of prostaglandins. Ketorolac tromethamine has been shown to reduce prostaglandin levels in the aqueous humor after topical ophthalmic administration. Ketorolac tromethamine given systemically does not cause pupil constriction. Results from clinical studies indicate that ketorolac tromethamine has no significant effect on intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

Pharmacokinetics:

Moxifloxacin Hydrochloride: Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of moxifloxacin ophthalmic solution 3 times a day. The mean steady state Cmax (2.7ng/mL) and estimated daily exposure AUC (45ng.hr/ml) values were 1,600 and 1000 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.Ketorolac tromethamine: One drop of 0.5% ketorolac tromethamine ophthalmic solution was instilled into one eye and one drop of vehicle into the other eye, TID in 26 normal subjects. Only 5 of 26 subjects had a detectable amount of ketorolac in their plasma (range 10.7 to 22.5ng/mL) at day 10 during topical ocular treatment. When ketorolac tromethamine 10 mg is administered systemically every 6 hours, peak plasma levels at steady state are around 960ng/mL.

INDICATIONS AND USAGE:

Moxifur-K Eye Drops is indicated for the reduction of post-operative inflammatory conditions of the eye. Instill one drops tree a day in the affected eyes). The frequency of instillation of drops and the duration of treatment will vary depending on the severity of the underlying condition and the response to the treatment.

CONTRAINDICATIONS

In patients with previously demonstrated hypersensitivity to ketorolac, moxifloxacin, other quinolones or any other ingredient in the formulation.The potential exists for cross-sensitivity to aspirin, and other non-steroidal anti-inflammatory drugs. This drug is contraindicated in individuals who have previously exhibited sensitivities to these drugs.

WARNINGS:
FOR EXTERNAL USE ONLY. NOT FOR INJECTION.

Moxifur-K Eye Drops should not be injected subconjunctivally; nor should it be introduced directly into the anterior chamber of eye.

DOSAGE AND ADMINISTRATION:

Instill one drop three times a day in the affected eye(s). The frequency of instillation of drops and the duration of treatment will vary depending on the severity of the underlying condition and the response to the treatment.
The dropper tip should not be allowed to touch any surface since this may contaminate the solution. If irritation persists or increases, the use should be discontinued.

SUPPLY:

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

MOXIFUR-LP

Pack : 5ml Pack

DESCRIPTION:

Moxifur-LP Eye Drops contains Loteprednol Etabonate 0.5% and Moxifloxacin 0.5%. Loteprednol etabonate (LE) is a soft steroid used for the treatment of steroid responsive inflammatory conditions of the eye such as allergic conjunctivitis, uveitis, iritis, cyclitis, and selected infective conjunctivitis. Loteprednol etabonate has good ocular permeation properties. Moxifloxacin is a quinolone/fluoroquinolone antibiotic. It is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria.

COMPOSITION:

Label Claim: Each ML Contains :

Moxifloxacin HCl IP

• Eq to Moxifloxacin...............0.5%
• Loteprednol Etabonate ...............0.5%
• Benzalkonium Chloride Solution I.P................0.02%v/v (As preservative)
• Sterile aqueous vehicle..................q.s.

PACKAGING

Primary packing - 5ml Opaque 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 Opaque poly bottles with white caps & nozzles in properly sealed.

CLINICAL PHARMACOLOGY :

Mechanism Of Action:
Loteprednol etabonate is glucocorticosteroids, that act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. 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 membrane phospholipids by phospholipase A2). Moxifloxacin has bactericidal action that results from inhibition of the enzymes topoisomerase II DNA gyrase (which is essential enzyme involve in replication , transcription , repair bacterial DNA) and topoisomerase IV (is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division).

INDICATIONS AND USAGE:

Moxifur-LP Eye Drops can be used in the treatment of the following conditions: Ocular infection & inflammation (steroid-responsive inflammation)1. Seasonal allergic Conjuctivities with secondary infections.
2. Keratitis.
3. Post-operative ocular infection.
4. lritis.
5. cyclitis.

CONTRAINDICATIONS:

Moxifur-LP Eye Drops, as with other steroid anti-infective ophthalmic combination drugs, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Moxifur-LP Eye Drops is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS:

DOSAGE AND ADMINISTRATION:

One drop of Moxifur-LP Eye Drops into the conjunctival sac of the affected eye(s) every 6-8 hours or as directed by Physician.

SUPPLY:

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

TOBOTOR-DM

Pack : 5ml Pack

DESCRIPTION:

Tobotor-Dm Eye Drops is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use.

Each mL of Tobotor-Dm Eye Drops contains: Actives: tobramycin 0.3% (3 mg) and Dexamethasone 0.1% (1 mg). Preservative: Benzalkonium Chloride 0.01%.

COMPOSITION:

Label Claim: Each ML Contains :

Tobramycin Sulphate USP

• Equivalent to Tobramycin.......3 mg
• Dexamethasone Sodium Phosphate I.P.............1 mg
• Chlorbutol IP. ........................................5 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 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 30ºC.Do not allow to Freeze.

CLINICAL PHARMACOLOGY:

Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body s defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. Dexamethasone is a potent corticoid. The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases microorganisms resistant to gentamicin remain susceptible to tobramycin. No data are available on the extent of systemic absorption from Tobramycin and Dexamethasone Ophthalmic Suspension; however, it is known that some systemic absorption can occur with ocularly applied drugs. If the maximum dose of Tobramycin and Dexamethasone Ophthalmic Suspension is given for the first 48 hours (two drops in each eye every 2 hours) and complete systemic absorption occurs, which is highly unlikely, the daily dose of dexamethasone would be 2.4 mg. The usual physiologic replacement dose is 0.75 mg daily. If Tobotor-Dm Eye Drops is given after the first 48 hours as two drops in each eye every 4 hours, the administered dose of dexamethasone would be 1.2 mg daily.

INDICATIONS AND USAGE:

Tobotor-Dm Eye Drops is indicated for steroidresponsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

CONTRAINDICATIONS:

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

WARNINGS :

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied amino glycosides may occur in some patients. If a sensitivity reaction does occur, discontinue use.Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

DOSAGE AND ADMINISTRATION:

One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

SUPPLY:

Tobotor-Dm 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.

TOBOTOR-DM

AFLOX-D* _{Eye Drops
‍}

(Ofloxacin and Dexamethasone Ophthalmic Solution)

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

DESCRIPTION:

AFLOX-D Eye Drops (Ofloxacin and Dexamethasone Ophthalmic Solution) is a clear, pale yellow color solution, multiple dose antibiotic and steroid combination for ophthalmic use

COMPOSITION:

Composition: Each ML Contains :

• Ofloxacin             USP          3mg
• Dexamethasone Sodium Phosphate   USP         1 mg
• Benzalkonium Chloride SolutionUSP 0.1 mg
  (As preservative)
• Sterile Aqueous Vehicle q.s.
‍

CLINICAL PHARMACOLOGY:

Mechanism of Action:

Ofloxacin: Ofloxacin is fluoroquinolone 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 fluoquinolone, and this inhibition kills the bacterial. It is active against Citrobacter,Enterobacter, E.coli. Neisseria gonorrhoea, Proteus mirabilis, S.aureus,S.epidermis, S- pneumoniae, P.aeruginosa, h.influenzae, and most other gram-negative bacteria.Dexamethasone Sodium Phosphate: Dexamethasone Sodium Phosphate is a synthetic analog of Hydrocortisone has an anti-inflammatory action. Its action is primarily anti-inflammatory with very little sodium retaining property. It has wide spread metabolic effects and modification of immune responses can cause suppression of the pituitary-adrenal axis which may result in secondary adrenocortical insufficiency.

INDICATIONS AND USAGE :

AFLOX-D Eye Drops (Ofloxacin and Dexamethasone Ophthalmic Solution) is indicated in the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:

CONJUNCTIVITS: CORNEAL ULCER:
Gram-positive bacteria: Gram-positive bacteria:
Staphylococcus aureus Staphylococcus aureus
Staphylococcus epidermis Staphylococcus epidermis
Gram-negative bacteria: Gram-negative bacteria:
Enterobacter cloacae Pseudomonas aeruginosa
Haemophilus influenzae Serratia marcescens
Proteus mirabilis Anaerobic species:
Pseudomonas aeruginosa Propionibacterium acnes

AFLOX-D Eye Drops (Ofloxacin and Dexamethasone Ophthalmic Solution) is indicated for steroid- responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conductivity is accepted to option a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

CONTRAINDICATIONS:

AFLOX-D Eye Drops (Ofloxacin and Dexamethasone Ophthalmic Solution) is contraindicated in patients with a history of hypersensitivity to Ofloxacin, to other quinolones, or any of the components in this medication. It is also contraindicated in the patients having herpes simplex keratitis (dendritic keratitis), varicella and many other viral infections.

WARNING :

NOT FOR INJECTION. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some of the following the first dose, have been reported in patients receiving systemic quinolones, including Ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema),airway obstruction, dyspnea, urticaria, and itching. A rare occurrence of Stevens-Johson syndrome, which progresses to toxic epidermal necrolysis, has been reported. Prolonged use of AFLOX-D Eye Drops (Ofloxacin and Dexamethasone Ophthalmic Solution) may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. IOP should be routine monitored even though it may be difficult in children and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. AFLOX-D Eye Drops (Ofloxacin and Dexamethasone Ophthalmic Solution) should be discontinued at the first sign or symptom of any allergic reaction. If irritation persists or increases on using AFLOX-D Eye Drops (Ofloxacin and Dexamethasone Ophthalmic Solution), discontinue the use and consult the Physician.

PRECAUTIONS:

General:

As with other anti-infections. prolonged use may result in overgrowth of non susceptible organisms, Including fungi.If super-infection occurs discontinue use and institute alternative therapy. Whenever clinical judgement dictates, the patients should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

INFORMATION FOR PATIENTS:

Avoid contaminating the applicator tip with material from the eye, fingers or other source. Systemic quinolones, including Ofloxacin, have been associated with hypersensitivity reactions, even following a single dose. Discontinue the use immediately and contact your physician at the first sign of a rash or allergic reaction.
Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted to evaluate the carcinogenic or mutagenic potential. Pregnancy: Teratogenic Effects: Category C: Ofloxacin has been shown to have embryocidal effect in rats and in rabbits when given in doses of 810mg/kg/day and 160mg/kg/day. Corticosteroids have been found to be Teratogenic in animal studies.

NURSINGMOTHERS:

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects-It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. “Pediatric use” Safety and eﬃcacy in pediatric patients have not been established.

ADVERSE REACTIONS:

The most frequently reported adverse reaction was hypersensitivity and localized ocular toxicity including stinging , redness, itching,chemical conjuctivities / keratitis, periocular / facial edema, foreign body sensation. photophobia, blurred vision, tearing,dryness, and eye pain. The reactions due to steroids: Elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage: posterior subcapsular cataract formation: and delayed wound healing.

DOSAGE AND ADMINISTRATION:

The recommended dosage of AFLOX-D Eye Drops (Ofloxacin and Dexamethasone Ophthalmic Solution) ophthalmic solution is one to two drops for every 4 hours or as directed by the Physician.

SHELF LIFE

24 Months

STORAGE

Keep in a cool & dark place. Store below 25°C. Do not allow to Freeze.

HOW SUPPLIED

Aflox-D Eye Drops( Ofloxacin and Dexamethasone Ophthalmic Solution) sterile solutionis available in 10mL Poly bottle
‍

AFLOX-D* _{Eye Drops
‍}

MOXIFUR-P _{Eye Drops
‍}

Moxifloxacin & Prednisolone Acetate Sterile Ophthalmic Suspension

COMPOSITION:

Composition: Each ML Contains :

• Moxifloxacin Hydrochloride IP
• Eq. to Moxifloxacin 0.5% w/v
• Prednisolone Acetate IP 1%w/v
• Benzalkonium Chloride Solution IP 0.02% w/v
(As preservative)
• Sterile Aqueous Vehicle q.s.
‍

INDICATIONS AND USAGE :

For short-term treatment of steroid-responsive inflammatory conditions of the eye, after excluding the presence of viral, fungal and bacterial pathogens in adults.

WARNING :

should not use prednisolone if you have an eye infection (including herpes simplex).

DOSAGE AND ADMINISTRATION:

One to two drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours the dosing frequency may be safely increased to 2 drops every hour. Care should be taken not to discontinue therapy prematurely. No overall differences in safety or effectiveness have been observed between elderly and younger patients. Method of administration: Route of administration is by ocular instillation. To reduce possible systemic absorption, it may be recommended that the lacrimal sac be compressed at the medial canthus (punctal occlusion) for 1 minute. This should be performed immediately following the instillation of each drop.

SHELF LIFE

24 Months

STORAGE

Store in dry place at a temperature not exceeding 25°C. Do not allow to Freeze.

HOW SUPPLIED

Supplied in 5 mL sterile poly bottle.
‍

MOXIFUR-P _{Eye Drops
‍}

Q4G-DM _{Eye Drops
‍}

(Gatiﬂoxacin & Dexamethasone Eye Drops)

COMPOSITION:

Composition: Each ML Contains :

• Gatifloxacin 3 mg
• Dexamethasone Sodium Phosphate IP
• Eq. to Dexamethasone Phosphate 1 mg
• Benzalkonium Chloride Solution IP 0.01% v/v
(As preservative)
• Aqueous Buffered Vehicle q.s.

DESCRIPTION:

Gatifloxacin and Dexamethasone belongs to a group of medications called 'Antibiotics and Corticosteroids' used in the treatment of bacterial eye infections or eye discomfort, especially in patients who have undergone eye surgeries. It also decreases the risk of eye infections such as conjunctivitis(inflammation of the conjunctiva) and other inflammatory conditions of the eye (cornea, iris, and connective tissue) in postoperative patients. Gatifloxacin and Dexamethasone is a combination of two medicines: Gatifloxacin and Dexamethasone. Gatifloxacin is anantibiotic that acts by interfering with the formation of essential proteins required for bacterial growth. Dexamethasone is a steroid that reduces inflammation and symptoms associated with infection such as redness and irritation. It works by inhibiting the chemicals such as prostaglandins that cause inflammation.

INDICATION FOR USE

Gatifloxacin & Dexamethasone Eye Drops is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms:·
- Bacterial Eye Infection In Adults And Children OlderThan 1 Year Of Age·
-Skin Inflammation·
- Allergy·
-Ulcerative Colitis·
-Breathing Problems·
-Lupus Vulgaris Or Lupus Erythematosus·
-Arthritis

MECHANISM OF ACTION AND PHARMACOLOGY

Gatifloxacin and Dexamethasone is a combination of two medicines: Gatifloxacin and Dexamethasone. Gatifloxacin is a fluoroquinolone and broad-spectrum antibiotic. It can act against both gram-positive and gram-negative bacteria. It acts by interfering with the formation of essential proteins required for bacterial growth. Dexamethasone is a corticosteroid that has anti- inflammatory properties and acts by inhibiting the chemicals such as prostaglandins that cause inflammation. It also reduces symptoms associated with infection such as redness and irritation of the eye and also decreases the risk of infections.

DIRECTIONS FOR USE

Gatifloxacin and Dexamethasone is available in the form of eye drops. Eye drops: Wash your hands thoroughly with water before and after use. Take the prescribed amount of dose with the dropper and squeeze out a drop without touching the eye. Wipe any excess liquid with a tissue. Do not wipe or rinse the dropper tip after use. Place the dropper back on the bottle and tighten the cap. Note: Do not touch the tip of the dropper as it may contaminate the contents. Do not place the tip directly into the eye while instilling the drop. If the dropper touches the eye, immediately squeeze two to three drops onto the tissue and wipe the dropper's tip with saltwater. Discard any unused medicine after the completion of the course of therapy or within 4 weeks after opening the bottle

SIDE-EFFECTS

The following is a list of possible side effects that may occur from all constituting ingredients or Gatifloxacin & Dexamethasone Eye Drops.This is not a comprehensive list.These side effects are possible, but do not always occur. Some of the side effects may be rare but serious. Consult your doctor if you observe any of the following side effects, especially if they do not go away.

-Depressed
-Labile Mood
-Suicidal Thoughts
-Menstrual Irregularity
-Swelling Due To Fluid Retention
-Potassium Loss.

PRECAUTIONS & HOW TOUSE

Before using this drug, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below.·
-Avoid coffee or other beverages containing caffeine during treatment·
- Do not drive or operate machinery·
-Do not stop using dexamethasone suddenly·
-Do not use it if you have a fungal infection, stomach or duodenal ulcer, kidney or liver problems·
-Do precaution if you have high blood pressure, heart disease or you have recently had a heart attack·
-Use eye drops as recommended

CONTRAINDICATIONS

If you are suffering from any of the following diseases, you should not take Dexamethasone + Gatifloxacin unless your doctor advises you to do so - Allergy

STORAGE

Storage: Store in a dry place, at a temperature not exceeding 25°C. Do not allow to freeze.

SHELF LIFE

24 Months

HOW SUPPLIED

Q4G-DM Eye Drops (Gatifloxacin and Dexamethasone Eye Drops) is suppliedin 5 mL poly bottles.
‍

Q4G-DM_‍

TOBOTOR-LP
‍_‍

(Loteprednol Etabonate and Tobramycin Sulphate Ophthalmic Suspension)

THIS LEAFLET CONTAINSIMPORTANT PRODUCT USE AND SAFETYINFORMATION, PLEASE READ CAREFULLY AND RETAIN FOR FURTHER FUTURE REFERENCE.

COMPOSITION:

Composition: Each ML Contains :

• Loteprednol Etabonate 5mg
• Tobramycin Sulphate USP
• Eq. to Tobramycin 3 mg
• Benzalkonium Chloride Solution IP 0.02% w/v
(As preservative)
• Sterial Aqueous Buffered Vehicle q.s.

DESCRIPTION:

TOBOTOR-LP (Loteprednol Etabonate and Tobramycin SulphateOphthalmic Suspension) is a sterile,multiple dose topicalanti-inflammatory corticosteroid and antibiotic combination for ophthalmic use.

INDICATION

TOBOTOR-LP (Loteprednol Etabonate and Tobramycin Sulphate Ophthalmic Suspension) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

CLINICAL PHARMACOLOGY
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 f inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Corticosteroids are capable of producing a rise in intraocular pressure. Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent.

DOSAGE AND ADMINISTRATION

SHAKE VIGOROUSLY BEFORE USING. Apply one or two drops of TOBOTOR-LP (Loteprednol Etabonate and Tobramycin Sulphate Ophthalmic Suspension) into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in precautions above.

CONTRAINDICATIONS

TOBOTOR-LP (Loteprednol Etabonate and Tobramycin Sulphate Ophthalmic Suspension) as with other steroid anti-infective ophthalmic combination drugs, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis),vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

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WARNINGS

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma. Sensitivity to topically applied amino glycosides may occur in some patients. If sensitivity reaction does occur, discontinue use. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye(including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

PRECAUTIONS

For ophthalmic use only. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. If this product is used for10 days or longer, intraocular pressure should be monitored even though it may be diﬃcult in children and uncooperative patients(See warnings).Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate. As with other antibiotic preparations, prolonged use may result in overgrowth of non susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

PREGNANCY AND LACTATION

Teratogenic effects: Pregnancy Category C. Loteprednol Etabonate was shown to be teratogenic when administered orally to rats and rabbits during organogenesis at 5 and 3 mg/kg/day, respectively (50 and 30 times the maximum daily clinical dose in rats and rabbits, respectively). An oral dose of loteprednol etabonate in rats at 50 mg/kg/day(500 times the maximum daily clinical dose) during late pregnancy through the weaning period showed a decrease in the growth and survival of pups without dystocia. However, no adverse effect in the pups was observed at 5 mg/kg/day (50 times the maximum daily clinical dose).Parenteral doses of tobramycin did not show any harm to fetuses up to 100 mg/kg/day (1700times the maximum daily clinical dose)in rats and rabbits. There are no adequate and well controlled studies in pregnant women. TOBOTOR-LP (Loteprednol Etabonate and Tobramycin Sulphate OphthalmicSuspension) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

SIDE EFFECT

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .Burning, dry or itching eyes; change in vision; eye discharge; pain in eye; redness of eye; swelling of eye, eyelid, or inner lining of eyelid; tearing.

STORAGE

Keep in a cool & dark place. Store below 25°C. Do not allow to freeze. Keep out of reach of children.

SHELF LIFE

24 Months

HOW SUPPLIED

TOBOTOR-LP (Loteprednol Etabonate and Tobramycin Sulphate Ophthalmic Suspension) Sterile suspension is available in 5mL clear Poly bottle.
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ANTI BACTERIAL & ANTI INFLAMMATORY

Moxifur -Dm /5mL

Moxifur-Dm

Pack : 5ml Pack

DESCRIPTION:

COMPOSITION:

Label Claim: Each ML Contains:

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Moxifur-K

Moxifur-K

Pack : 5ml Pack

DESCRIPTION:

COMPOSITION:

Label Claim: Each ML Contains :Moxifloxacin Hydrochloride IP

PACKAGING

SHELF LIFE:

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Pharmacokinetics:

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WARNINGS:FOR EXTERNAL USE ONLY. NOT FOR INJECTION.

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MOXIFUR-LP

MOXIFUR-LP

Pack : 5ml Pack

DESCRIPTION:

COMPOSITION:

Label Claim: Each ML Contains :

Moxifloxacin HCl IP

PACKAGING

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TOBOTOR-DM

Pack : 5ml Pack

DESCRIPTION:

COMPOSITION:

Label Claim: Each ML Contains :

Tobramycin Sulphate USP

PACKAGING

AVAILABILITY

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TOBOTOR-DM

AFLOX-D* Eye Drops‍

(Ofloxacin and Dexamethasone Ophthalmic Solution)

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

DESCRIPTION:

COMPOSITION:

Composition: Each ML Contains :

CLINICAL PHARMACOLOGY:

Mechanism of Action:

INDICATIONS AND USAGE :

CONTRAINDICATIONS:

WARNING :

Label Claim: Each ML Contains :
Moxifloxacin Hydrochloride IP

WARNINGS:
FOR EXTERNAL USE ONLY. NOT FOR INJECTION.

AFLOX-D* _{Eye Drops
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AFLOX-D* _{Eye Drops
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MOXIFUR-P _{Eye Drops
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MOXIFUR-P _{Eye Drops
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Q4G-DM _{Eye Drops
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Q4G-DM_‍

TOBOTOR-LP
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CLINICAL PHARMACOLOGY
Mechanism of action