Sunday, September 7, 2008

Various anti-inflammatory drugs developed so far have directed against various mediators (histamines, leukotrienes etc) of inflammation. Anti-inflammatory drugs can be broadly classified as-

1) Corticosteroids
2) NSAIDS (Non- steroidal anti-inflammatory drugs)
3) Immunosuppressive agents

Many ocular disorders are treated by the judicious use of corticosteroids commonly know as steroids (Corticosteroids or glucocorticoids, often just called “steroids”). They are involved in a wide range of physiologic system such as stress response, immune response, regulation of inflammation, carbohydrate metabolism, protein catabolism, blood electrolyte levels and behavior. Some effects of steroid & mechanisms in human body are given bellow-

Effect of Steroid
Mechanism
Anti-inflammatory
; Reduce T cells & B cells responsible for Inflammatory response
; Inhabit mast cell & Neutrophil migration
; Inhabit prostaglandin by inhibition of Phospholipase A2
; Inhibits synthesis of histamine within mast cells
Allergic Reaction
; Reduce symptom (unknown mechanism)
Hyperglycemia
; Increase Liver glycogen storage
; Inhibits glucose oxidation
; Increase insulin resistance by cell
Alteration of lipid distribution
; Increase fat deposits on face/ neck
; Decrease fat from extremities
; Increase lipid production from protein
Blood cell constituents
; Increase RBC & polymorphonuclear leukocyte number
; Decrease Eosinophil, Basophil & Monocyte
Central Nervous System
; Various mood change (unknown mechanism)


Most commonly used steroid for the treatment of ocular disorders are-
Dexamethasone
Betamethasone
Prednisolone
Hydrocortisone
Rimexolone &
Fluorometholone

Fluorometholone is corticosteroids, most often used after laser-based refractive surgery all over the world. Fluorometholone ophthalmic suspension is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eye.
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NGS
Eye Drops


Composition: Each ml Suspension contains Fluorometholone USP 1 mg.

Description: Fluorometholone is a powerful antiinflammatory agent of steroid group. It prevents the release of substances in the body that cause inflammation.
Fluorometholone ophthalmic suspension is used to treat eye swelling caused by infections, injury, surgery or other conditions.

Indications: For steroid responsive Inflammation of the conjunctiva, cornea and anterior segment of the globe, like-
q Scleritis and Episcleritis
q Traumatic inflammation of the eye
q Panuveitis
q Disciform and Interstitial Keratitis
q Post Surgical Inflammation

Dosage & administration: Instill 1-2 drops into conjunctival sac every hour during day, every 2 hours at night until favorable response is obtained, then use 1 drop every 4 hours; for mild to moderate inflammation, instill 1-2 drops into conjunctival sac 2-4 times/day.

Contraindications: Hypersensitivity to Fluorometholone or any component of the formulation; viral diseases of the cornea and conjunctiva, mycobacterial or fungal infections of the eye, untreated eye infections which may be enhanced by a steroid.

Pediatric Use: Not recommended in children <2 years of age
Use in pregnancy: The extent of systemic absorption is not known. Use with caution in pregnant women.

Use in lactation: Excretion of Fluorometholone in breast milk is unknown, Use with caution in lactating women.

Side effects: Anterior uveitis, burning or stinging upon application, cataract formation, conjunctival hyperemia, conjunctivitis, corneal ulcers, glaucoma with optic nerve damage, perforation of the globe, secondary ocular infection (bacterial, fungal, viral), intraocular pressure elevation, visual acuity and delayed wound healing.

Precaution: Prolonged use may result in glaucoma, elevated intraocular pressure or other ocular damage; may exacerbate severity of viral infections, Use cautiously in patients with history of herpes simplex.

Drug interaction: No data reported.

Package quantities: NGS Eye Drops are available in 5 ml Polyethylene bottle.

Storage: Keep in a dry & cool place, Protect from light. Keep out of the reach of children.


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Unique Feature

® Microfine suspension, ensures uniform particle distribution, longer residence time & rapid absorption
® Well-established efficacy on ocular surface
® Safer than currently available low dose hydrocortisone preparation
® Liquifilm advantages soothes, cools, enhances patients comfort
® Least risk to raise IOP



Ref: Product Management Department, Opso Saline Ltd., Bangladesh

Saturday, September 6, 2008

FLOMOX

Eye Drops




Executive Summary



One of the New, 4th Generation Fluoroquinolones

Excellent invitro-activity against Gram-negative organisms that fluoroquinolones are known to treat.

Expanded activity against Gram- positive organisms including resistant Gram- positive organisms.

Moxifloxacin has tremendous activity as monotherapy against numerous organisms which are difficult to treat.

Able to treat keratitis caused by the organisms resistant to the earlier generation of Fluoroquinolones



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Flomox
Eye Drops

Composition : Each ml solution contains Moxifloxacin 5 mg as Moxifloxacin Hydrochloride INN. Preservative: Benzalkonium Chloride 0.01%
Description: Moxifloxacin is a fourth-generation 8- methoxy fluoroquinolone antibacterial agent having an enhanced broad-spectrum activity against Gram-positive bacteria and Gram-negative bacteria. It is also active against atypical microorganisms, Mycobacterium and anaerobes. It works by stopping the life cycle of bacteria.

Mechanism of Action: Moxifloxacin inhibits bacterial enzyme topoisomerase II (DNA gyrase) and topoisomerase IV. Topoisomerases are essential enzymes which play a crucial role in the replication and repair of bacterial DNA. This mechanism is lethal to susceptible bacteria.

Indications: Flomox eye drops are indicated in the treatment of a variety of ocular infections caused by susceptible bacteria. Such as-
î Conjunctivitis î Blepharitis î Blepharo-conjunctivitis î Corneal ulcer î Dacryocystitis î Traumatic ocular injuries î Meibomianitis î Keratitis î Eliminate conjunctival microorganisms prior to ocular surgery & î In the treatment of postoperative infections

Dosage & administration: Instill one drop in the affected eye(s) 3 times a day for 7 days.

Contraindications: Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to Moxifloxacin, to other quinolones or to any of the components of the preparation.

Pediatric Use: The safety and effectiveness of Moxifloxacin ophthalmic solution in infants below 1 year of age has not been established. There is no evidence that the ophthalmic administration of Moxifloxacin solution has any effect on weight bearing joints.

Use in pregnancy: Moxifloxacin should be used during pregnancy only if the potential benefit justifies against the potential risk to the fetus.

Use in lactation : Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin Solution is administered to nursing mothers.

Side effects: The most frequently reported ocular side effects were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage and tearing. These events occurred in approximately 1-6% of patients.


Precaution: In patients receiving systemically administered quinolones, including Moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to Moxifloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment.

Drug interaction: Drug-drug interaction studies have not been conducted with Moxifloxacin solution. In vitro studies indicate that Moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that Moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes

Package quantities: Flomox Eye Drops are supplied in 5 ml Polyethylene bottle

Storage: Keep in a dry & cool place, Protect from light. Keep out of the reach of children.
Ref: Product Management Department, Opso Saline Ltd., Bangladesh.
A change to make a difference


GATIDEX
Eye Drops


Gatifloxacin is a broad-spectrum 8- methoxy fluoroquinolone effective against a wide range of bacterial pathogens and has an increased potency against gram-positive and gram-negative bacteria. Dexamethasone is a long acting synthetic powerful steroid. It has the most potent anti-inflammatory and the most potent anti-allergic action. Thus, the combination will effectively resolve infection and associated inflammation in severe eye conditions.

Gatifloxacin inhibit bacterial DNA gyrase, the enzyme responsible for replication, transcription and repair of bacterial DNA and Topoisomerase IV responsible for partitioning of the chromosomal DNA during bacterial cell division, thus cause death of bacteria. Dexamethasone suppresses the inflammation by decreasing the production of inflammatory mediators through the inhibition of the enzyme Phospholipase A2.


Feature:
Gatidex Eye Drops – there are Benzalkonium Chloride (BAK) as Preservative

Advantage:
* Prevent contamination of solution in the Bottle & Keep the drug stable
* Help to augment antimicrobial activity of Gatifloxacin
* Help penetration of drugs in to the Target Organisms

Benefit:
Increase the speed of killing of Susceptible Pathogens


Feature:
Gatidex Eye Drops – there are Dexamethasone as Active Ingredient

Advantage:
Dexamethasoneis a Powerful steroid, reduces the irritation, redness, burning and swelling caused by chemicals, heat, radiation, infection, allergy or foreign bodies.

Benefit:
Promptly reduces ocular Inflammation


Feature:
There are Gatifloxacin, A new 4th generation Fluoroquinolone

Advantage:
# 8-methoxy group expands the spectrum of activity of the agents to include gram-positive pathogens and
even anaerobes
# Cyclopropyl group maintain gram-negative Activity
# Bactericidal Mechanism of Action, Biocompatibiliy & Bioavailibility with favourable pharmacodynamics
#Start action within 15 minutes of exposure

Benefit:
Cures a wide range of Infections & Ensures patients’ compliance


Composition : Each ml solution contains Gatifloxacin 3 mg as Gatifloxacin Sesquihydrate INN & Dexamethasone Phosphate 1 mg as Dexamethasone Sodium Phosphate BP. Preservative: Benzalkonium Chloride 0.01%

Indications : Steroid responsive inflammatory conditions with involvement of bacteria;
Such as-
¨ Blepharitis, Scleritis, Episcleritis, Iritis, Cyclitis, Iridocyclitis, Choroiditis, Optic neuritis and chronic anterior uveitis.
¨ Disciform and interstitial keratitis
¨ Allergic corneal marginal ulcers
¨ Corneal injury from chemical radiation or thermal burns

Dosage & administration : Instill 1-2 drops into the conjunctival sac 3 to 4 times a day.

Contraindications : Gatidex Eye Drops are contraindicated in fungal disease of ocular structures, viral conjunctivitis and Hypersensitivity to any of the components of the formulation.

Pediatric Use : The safety in Paediatric patients has not been established.

Pregnancy : Gatidex eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Lactation : Gatifloxacin or Dexamethasone has not been measured in human milk, although it can be presumed to be excreted in human milk following topical administration. Caution should be exercised when the combination is administered to a nursing woman.

Side Effects : Frequently reported reactions related to Gatifloxacin are transient ocular burning or discomfort. Other reported reactions include chemosis, redness, dry eye, pain, itching, swelling of the eyelid & reduced visual acuity. The reactions due to steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma, infrequent Optic nerve damage, delayed wound healing and posterior subcapsular cataract formation. Secondary infection may develop after use of combination containing steroid & antibacterial. Fungal or viral infections of the cornea are particularly prone to develop coincidently with long-term use of steroids.

Warning & Precaution : If the product is used for 10 days or more, intra ocular pressure should be monitored routinely. Prolonged use of steroid may result in glaucoma, elevated intraocular pressure or other ocular damage. It may exacerbate severity of viral infections. Use cautiously in patients with history of herpes simplex.

Package quantities : Gatidex Eye Drops are supplied in 5 ml Polyethylene bottle

Storage : Keep in a dry & cool place, Protect from light. Keep out of the reach of children.



Ref: Product Management Department, Opso Saline Ltd., Bangladesh