ANTI BACTERIAL & ANTI INFLAMMATORY

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:

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 aminoglycosides 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.

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.