ANTI-INFLAMMATORY

I-NAC

Pack : 5ml Pack

DESCRIPTION:

I-NAC Eye Drops is a sterile, topical, nonsteroidal anti-inflammatory (NSAID) prodrug for ophthalmic use. Each mL of I-NAC Eye Drops contains 1 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-benzoylbenzeneacetamide with an empirical formula of C15H14N2O2.

COMPOSITION:

Label Claim: Each ML Contains :

Nepafenac...................0.1 % w/v
Benzalkonium Chloride Solution IP.................0.01 %v/v (As preservative)
Sterile Aqueous vehicle..................q.s.

PACKAGING:

Primary packing - 5ml White Poly bottles White caps & Nozzles.

Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.

SHELF LIFE:

18 months from the date of manufacturing.

STORAGE:

Store at 2ºC - 25 ºC in a dark place. Do not allow to Freeze.

AVAILABILITY:

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

CLINICAL PHARMACOLOGY:

I-NAC Eye Drops contains Nepafenac (0.1%), a nonsteroidal anti-inflammatory and analgesic prodrug. After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.

INDICATIONS AND USAGE:

I-NAC Eye Drops is indicated for the treatment of pain and inflammation associated with cataract surgery.

CONTRAINDICATIONS:

I-NAC Eye Drops is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation or to other NSAIDs.

WARNINGS AND PRECAUTIONS:

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

DOSAGE AND ADMINISTRATION:

Shake well before use. One drop of I-NAC Eye Drops ophthalmic suspension should be applied to the affected eye(s) three-times-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period.

SUPPLY:

I-NAC Eye Drops is supplied in one 5 mL Opeque Polethylene Bottle packed with printed labeled in a unit carton and, Such 25 Carton Packed in a Shrink Sleeves.Such 12 shrinks packed in a shipper.

Ketorocin-0.5

Pack : 5ml Pack

DESCRIPTION:

Ketorocin 0.5 Eye Drops is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs ( NSAIDS ) for ophthalmic use .

COMPOSITION:

Label Claim: Each ML Contains :

• Ketorolac Tromethamine IP...............5 mg
• Benzalkonium Chloride Solution I.P..........0.1 mg (As preservative)
• Water for injection IP............q.s.

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:

Ketorocin 0.5 Eye Drops
a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis. Ketorocin 0.5 Eye Drops given systemically does not cause pupil constriction.

INDICATIONS AND USAGE:

Ketorocin 0.5 Eye Drops is indicated for the relief of ocular itching due to seasonal allergic conjunctivitis . It is also indicated for the prophylaxis and relief of post operative ocular inflammation.

CONTRAINDICATIONS

Ketorocin 0.5 Eye Drops is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

WARNINGS:

There is the potential for cross-sensitivity to acetylsalicylic acid derivatives and other non-steroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitiveness to these drugs. With some non-steroidal anti-inflammatory drugs there exists the potential for increased bleeding time due to interference with thrombocyte aggregation . There have been reports that ocularly applied non steroida antiinflammatory drugs may cause increased bleeding of ocular tissue (including hyphemas) in conjunction with ocular surgery.

DOSAGE AND ADMINISTRATION:

The recommended dose of Ketorocin 0.5 Eye Drops is one drop four times a day in the operated eye a needed for pain and burning/ stinging for up to 4 days following corneal refractive surgery.Ketorolac tromethamine has been safely administered in conjunction with other ophthalmic medications as anti biotics, beta blockers, carbonic anhydrase inhibitors, cyclopegics and mydriatics.

SUPPLY:

Ketorocin 0.5 Eye Drops is supplied in one 5 mL Opeque Polethylene Bottle packed with printed labeled in a unit carton and, Such 25 Carton Packed in a Shrink Sleeves.Such 12 shrinks packed in a shipper.

Ketorocin

Ketorocin-Ls

Pack : 5ml Pack

DESCRIPTION:

Ketorocin-LS Eye Drops is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs ( NSAIDS ) for ophthalmic use.

COMPOSITION:

Label Claim: Each ML Contains :

• Ketorolac Tromethamine IP...............4 mg
• Stabilized Oxychloro complex..........0.05 mg (As preservative)
• Water for injections IP............ .q.s.

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:

Ketorocin-LS Eye Drops is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis. Ketorolac tromethamine given systemically does not cause pupil constriction.

Pharmacokinetics:

One drop (0.05 mL) of 0.5% Ketorocin-LS Eye Drops 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 5 ng/mL) at day 10 during topical ocular treatment.

Clinical Studies:

In two double-masked, multi-centered, parallel-group studies, 313 patients who had undergone photorefractive keratectomy received Ketorocin-LS Eye Drops or its vehicle QID for up to 4 days. Significant differences favored Ketorocin-LS Eye Drops for the reduction of ocular pain and burning/stinging following photorefractive keratectomy surgery.
‍
Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure.
‍
‍Ketorocin-LS Eye Drops is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis. Ketorolac tromethamine given systemically does not cause pupil constriction.

INDICATIONS AND USAGE:

Ketorocin-LS Eye Drops is indicated for the relief of ocular itching due to seasonal allergic conjunctivitis. It is also indicated for the prophylaxis and relief of post operative ocular inflammation.

CONTRAINDICATIONS

Ketorocin-LS Eye Drops is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulations..

WARNINGS:

There is the potential for cross-sensitivity to acetylsalicylic acid derivatives and other non-steroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitiveness to these drugs. With some non-steroidal anti-inflammatory drugs there exists the potential for increased bleeding time due to interference with thrombocyte aggregation . There have been reports that ocularly applied non steroidal antiinflammatory drugs may cause increased bleeding of ocular tissue (including hyphemas) in conjunction with ocular surgery.

DOSAGE AND ADMINISTRATION:

The recommended dose of Ketorocin-LS Eye Drops is one drop four times a day . Ketorocin-LS Eye Drops has been safely administered in conjunction with other ophthalmic medications as anti biotics, beta blockers, carbonic anhydrase inhibitors, cyclopegics and mydriatics.

SUPPLY:

Ketorocin-LS Eye Drops is supplied in one Opeque Polethylene Bottle packed with printed labeled in a unit carton and, Such 25 Carton Packed in a Shrink Sleeves.Such 12 shrinks packed in a shipper.

Ketorocin-Ls

PREDS

Pack : 5ml & 10ml Pack

DESCRIPTION:

PREDS-Ophthalmic Suspension (Prednisolone acetate Ophthalmic Suspension USP) is synthetic analog of glucocorticoide hydrocortisone (cortisol), has an anti-inflammatory action for ophthalmic use.

COMPOSITION:

Label Claim: Each ML Contains :

• Prednisolone Acetate IP ........................10 mg.
• Benzalkonium Chloride Solution IP ......0.2 mg (As preservative)
• Sterile aqueous vehicle ........................q.s.

PACKAGING

Primary packing - 5mL & 10mL 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 & 10mL of solution in Clear poly bottles with white caps & nozzles in properly sealed.

CLINICAL PHARMACOLOGY:

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 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.Corticosteroids are capable of producing a rise in intraocular pressure.

INDICATIONS AND USAGE:

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

CONTRAINDICATIONS:

PREDS-Ophthalmic Suspension 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.
Prednisolone Acetate Ophthalmic Suspension USP, 1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS:

FOR TOPICAL OPHTHALMIC USE ONLY. 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. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. 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; frequent slit lamp microscopy is recommended. Corticosteroids are not effective in mustard gas keratitis and Sjogren's keratoconjunctivitis.

DOSAGE AND ADMINISTRATION:

SHAKE WELL BEFORE USING. Two drops topically in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be
re-evaluated The dosing of PREDS-Ophthalmic Suspension 1% may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

SUPPLY:

PREDS-Ophthalmic Suspension is supplied in one Clear Polethylene Bottle packed with printed labelled & cartons And Such 25 Carton Packed in a Shrink Sleeves & corrugated box.

PREDS

Flurocot

Pack : 5ml Pack

DESCRIPTION:

Flurocot Eye Drops is an anti inflammatory agent inhibits the edema,fibrin deposition,capillary dilation and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, deposition of collagen and scar formation.

COMPOSITION:

Label Claim: Each ML Contains :

• Fluorometholone Acetate USP.........1 mg
• Benzalkonium Chloride Solution IP .......0.1 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.

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.

INDICATIONS AND USAGE:

Flurocot Eye Drops 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.
Flurocot Eye Drops is used to treat certain eye conditions due to inflammation or injury. Fluorometholone works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.

CONTRAINDICATIONS:

Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; tuberculosis; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation.

WARNINGS AND PRECAUTIONS:

Use in the treatment of herpes simplex infection requires great caution. Prolonged use may result in glaucoma, damage to the optic nerve, defect in visual acuity and visual field, cataract formation and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host response. Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids. It is advisable that the intraocular pressure be checked frequently.

DOSAGE AND ADMINISTRATION:

Shake Well Before Using. One to two drops instilled into the conjunctival sac(s) four times daily. During the initial 24 to 48 hours the dosage may be safely increased to two drops every two hours. If no improvement after two weeks, consult physician. Care should be taken not to discontinue therapy prematurely.

SUPPLY:

Flurocot 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.

Flurocot

Aflur

Pack : 5ml Pack

DESCRIPTION:

Aflur- Eye Drops (Flurbiprofen eye drops) are used to keep the pupils of the eye from getting smaller (miosis) during an eye surgery. This medicine is a topical nonsteroidal anti-inflammatory drug (NSAID).

COMPOSITION:

Label Claim: Each ML Contains :

• Flurbiprofen Sodium IP........ 0.3 mg
• Thimerosal IP............0.05 mg
• Aqueous Buffered Vehicle........q.s.

PACKAGING:

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

AVAILABILITY:

5ml of solution in White 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:

Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins.Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure.Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, Aflur- Eye Drops has been shown to inhibit the miosis induced during the course of cataract surgery.Results from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure.

INDICATIONS AND USAGE:

Aflur- Eye Drops is is indicated for the inhibition of intraoperative miosis.

CONTRAINDICATIONS:

Aflur-Eye Drops is contraindicated in individuals who are hypersensitive to any components of the medication.

WARNINGS:

With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that Aflur- Eye Drops may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.There is the potential for cross-sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

DOSAGE AND ADMINISTRATION:

A total of four (4) drops of Aflur- Eye Drops should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery.

SUPPLY:

Aflur- 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.

Aflur

A-NAC _{Eye Drops
‍}

(Bromfenac Sodium Ophthalmic Solution)

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

DESCRIPTION:

A-NAC Eye Drops (Bromfenac Sodium Ophthalmic Solution) is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID)for ophthalmic use. romfenac Sodium is designated chemically as sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, with an empirical formula of C15H11BrNNaO3. The structural structure for Bromfenac Sodium .

Bromfenac Sodium is a yellow to orange crystalline powder. The molecular weight of Bromfenac Sodium is 356.15.Bromfenac Ophthalmic Solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of Bromfenac Ophthalmic Solution is approximately 300 mOsmol/kg.

COMPOSITION:

Each ML Contains :

Bromfenac Sodium
Eq. to Bromfenac 0.9 mg
Benzalkonium Chloride
SolutionIP 0.1mg
(As Preservative)
Aqueous Buffered Vehicle q.s

INDICATION AND USAGE

A-NAC Eye Drops (Bromfenac Sodium Ophthalmic Solution)is indicated for the treatmentof postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

CLINICAL PHARMACOLOGY

Mechanism of Action
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

Pharmacokinetics
The plasma concentration of bromfenac following ocular administration of A-NAC Eye Drops (Bromfenac Sodium Ophthalmic Solution) in humans is unknown. Based on the maximum proposed dose of one drop to the eye (0.045 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady- state in humans.

CONTRAINDICATIONS

None

WARNINGS AND PRECAUTIONS

Sulﬁte Allergic Reactions
Contains sodium sulfite, a sulﬁte that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

‍Slow or Delayed Healing
All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

Potential for Cross-Sensitivity
‍There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
‍
Increased Bleeding Time
‍With some NSAIDs, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

It is recommended that bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

ADVERSE REACTIONS

Clinical Trail Experience
‍The most commonly reported adverse experiences reported following use of Bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis. These events were reported in 2-7% of patients.
‍
Post-Marketing Experience
‍The following events have been identified during post-marketing use of A-NAC Eye Drops (Bromfenac Sodium Ophthalmic Solution)in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical A-NAC Eye Drops (Bromfenac Sodium Ophthalmic Solution) or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown.

‍Treatment:
‍Treatment should be symptomatic and supportive. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Studies have shown that Timolol does not dialyse readily.
Use In Speciﬁc Populations
‍Pregnancy
‍Teratogenic Effects: PregnancyCategory C. Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300times the recommended human ophthalmic dose[RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects:
Because of the known effects of prostaglandin biosynthesis- inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of Bromfenac Ophthalmic Solution during late pregnancy should be avoided.

‍Nursing Mothers
‍Caution should be exercised when Bromfenac is administered to a nursing woman.

‍
Pediatric Use
Safety and efficacy in pediatric patients below the age of 18 have not been established.
‍
Geriatric Use
There is no evidence that the efficacy or safety profiles for bromfenac differ in patients 65 years of age and older compared to younger adult patients.

DOSAGE AND ADMINISTRATION

Recommended Dosing
‍For the treatment of postoperative inammation in patients who have undergone cataract extraction, one drop of bromfenac ophthalmic solution should be applied to the affected eye(s) once daily beginning1 day prior to cataract surgery, continued on the day of surgery, and through the 14 days of the postoperative period.
‍
‍Use withOther TopicalOphthalmicMedications
‍Bromfenac ophthalmic solution maybe administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

STORAGE:

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

SHELF LIFE

24 Months

HOW SUPPLIED:

A-NAC Eye Drops (Bromfenac Sodium Ophthalmic Solution)sterile solution is supplied in 5 mL Poly bottle.
‍

A-NAC

APPASONE _{Eye Drops
‍}

(Dexamethasone Sodium Phosphate Ophthalmic Solution USP 0.1% w/v)

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

DESCRIPTION:

APPASONE Eye Drops (Dexamethasone Sodium Phosphate Ophthalmic Solution USP 0.1% w/v) is a clear, colorless to pale yellow topical steroid solution for ophthalmic administration. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic. Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone. It is approximately three thousand times more soluble in water at 25°C than hydrocortisone.
‍Chemical Name:
9-fluoro-11β,17-dihydroxy-16α-methyl- 21-[phosphonooxy] pregna-1,4-diene-3, 20-dione disodium salt.
‍Molecular Formula:C22H28FNa2O8P
‍Mol. Wt.: 516.41

COMPOSITION:

Dexamethasone Sodium Phosphate USP
Eq. to Dexamethasone Phosphate 0.1% w/v
Aqueous Buffered Vehicle q.s
. (Solution Preservedwith Ionic Buffered System)

INDICATION AND USAGE

Steroid responsive inﬂammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies

CLINICAL PHARMACOLOGY

Dexamethasone Sodium Phosphate suppresses the inflammatory response to a variety of agents and it probably delays or slows healing. No generally accepted explanation of these steroid properties has been advanced.

Mechanism of action
‍Dexamethasone is a highly potent and long-acting glucocorticoid. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. The actions of corticosteroids are mediated by the binding of the corticosteroid molecules to receptor molecules located within sensitive cells. Corticosteroid receptors are present in human trabecular meshwork cells and in rabbit iris ciliary body tissue.

CONTRAINDICATIONS

Epithelial herpes simplex keratitis (dendritic keratitis). Acute infectious stages of vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva.
•    Mycobacterial infection of the eye.
•    Fungal diseases of ocular or auricular structures
.•     Hypersensitivity to any component of this product, including sulﬁtes
•    Perforation of a drum membrane.

WARNINGS AND PRECAUTIONS

Prolonged use may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. 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 corticosteroids. In acute purulent conditions of the eye or ear, corticosteroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.

Employment of corticosteroid medication in the treatment of herpes simplex other than epithelial herpes simplex keratitis, in which it is contraindicated, requires great caution; periodic slit-lamp microscopy is essential.

General : The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.

Pregnancy : Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.

There are no adequate or well-controlled studies in pregnant women. Dexamethasone sodium phosphate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

Nursing Mothers : Topically applied steroids are absorbed systemically. Therefore, because of the potential for serious adverse reactions in nursing infants from dexamethasone sodium phosphate, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No overall differences in safety and effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

Glaucoma with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, perforatio of the globe. Rarely, filtering blebs have been reported when topical steroids have been used following cataract surgery.
Rarely, stinging or burning may occur.

DOSAGE AND ADMINISTRATION

The duration of treatment will vary with the type of lesion and may extend from a few days to several weeks, according to therapeutic response. Relapses, more common in chronic active lesions than in self-limited conditions, usually respond to treatment.

Instill one or two drops of solution into the conjunctival sac every hour during the day and every two hours during the night as initial therapy. When a favorable response is observed, reduce dosage to one drop every four hours. Later, further reduction in dosage to one drop three or four times daily may suffice to control symptoms. If preferred, the aural canal maybe packed with a gauze wick saturated with solution. Keep the wick moist with the preparation and remove from the ear after 12 to 24 hours. Treatment may be repeated as often as necessary at the discretion of the physician.

STORAGE:

Preserve in tight, light-resistant containers. Store between 15° and 25°. Do not allow to Freeze.

SHELF LIFE

24 Months

HOW SUPPLIED:

APPASONE Eye Drops (Dexamethasone Sodium Phosphate Ophthalmic Solution USP 0.1% w/v) sterile solution is supplied in 5 mL Poly bottle.
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APPASONE

_‍LP PREDS 0.5 _{Eye Drops
‍}

(Loteprednol Etabonate Sterile Ophthalmic Suspension)

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

DESCRIPTION:

LP PREDS 0.5 (Loteprednol Etabonate Sterile Ophthalmic Suspension) is contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Ophthalmic corticosteroid with minimal systemic absorption due to ocular metabolism. Used for seasonal allergic conjunctivitis and steroid responsive ocular diseases(e.g., cyclitis, GPC, iritis, keratitis). Also used for postoperative ocular pain and inflammation and for the signs and symptoms of dry eye disease.

COMPOSITION:

Each mL contains:
Loteprednol Etabonate 0.5%w/v
Benzalkonium Chloride Solution USP 0.01% v/v
(As Preservative)
Sterile Aqueous Vehicle q.s

INDICATION AND USAGE

LP PREDS 0.5 (Loteprednol Etabonate Sterile Ophthalmic Suspension) is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inﬂammation.

CLINICAL PHARMACOLOGY

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 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.Corticosteroids are capable of producing a rise in intraocular pressure(IOP).Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent .It is highly lipid soluble which enhances its penetration into cells. Loteprednol etabonate is synthesized through structural modifications of prednisolone-related compounds so that it will undergo a predictable transformation to an inactive metabolite. Based upon in vivo and in vitro preclinical metabolism studies, Loteprednol Etabonate undergoes extensive metabolism to inactive carboxylic acid metabolites. Results from a bioavailability study in normal volunteers established that plasma levels of loteprednol etabonate and Δ1 cortienic acid etabonate(PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained following the ocular administration of one drop in each eye of0.5% Loteprednol Etabonate 8 times daily for 2 days or 4 times daily for 42 days. This study suggests that limited(<1 ng/mL) systemic absorption occurs with Loteprednol Etabonate.

CONTRAINDICATIONS

LP PREDS 0.5 (Loteprednol Etabonate Sterile Ophthalmic Suspension) , as with other ophthalmic corticosteroids, 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. LP PREDS 0.5 (Loteprednol Etabonate Sterile Ophthalmic Suspension) is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS AND PRECAUTIONS

Warning: 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. 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:
‍General:
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.

‍Pregnancy: Teratogenic effects: Pregnancy Category C. Loteprednol Etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb ﬂexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was0.5 mg/kg/day (6 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥ 5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥ 50 mg/kg/day) and embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal bodyweight and skeletal ossification with ≥ 50 mg/kg/day).Treatment of rats with 0.5 mg/kg/day (6 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol Etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥ 5 mg/kg/day.
‍Nursing Mothers: It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when LP PREDS 0.5 (Loteprednol Etabonate Sterile Ophthalmic Suspension) is administered to a nursingwoman.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

Stinging/burning of the eyes and temporary blurred vision may occur when you apply this medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Use of this medication for a longer time may cause serious eye problems (such as high pressure inside the eyes, cataracts). It may also mask signs of an eye infection and increase the risk of developing an eye infection. Tell your doctor right away if you have any serious side effects, including: vision problems, eye pain, eye discharge/swelling/redness. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

DOSAGE AND ADMINISTRATION

SHAKE WELL BEFORE USE. Steroid-Responsive Disease Treatment: Apply one to two drops of LP PREDS0.5 (Loteprednol Etabonate Sterile Ophthalmic Suspension) into the conjunctival sac of the affected eye four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated. Post-Operative Inflammation: Apply one to two drops of LP PREDS0.5 (Loteprednol Etabonate Sterile Ophthalmic Suspension) into the conjunctival sac of the operated eye four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

STORAGE:

Store in dry place, at a temperature not exceeding 30°C.Do not allow to Freeze.

SHELF LIFE

24 Months

HOW SUPPLIED:

LP PREDS 0.5 / 5 mL (Loteprednol Etabonate Sterile Ophthalmic Suspension) is supplied in 5 mL Poly bottle.
‍

LP PREDS

_PREDS
‍

(Prednisolone Acetate Ophthalmic Suspension USP)

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

DESCRIPTION:

PREDS(Prednisolone Acetate Ophthalmic Suspension USP) is a synthetic analog of glucocorticoid hydrocortisone (cortisol), has an anti-inflammatory action for ophthalmic use. The chemical name of the active ingredient is Pregna-1, 4-diene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-preds is a white colored suspension.

COMPOSITION:

Each mL contains:
Prednisolone Acetate USP      10 mg
Benzalkonium Chloride Solution USP    0.2 mg
(As preservative)
Sterile Aqueous Vehicle                        q.s

INDICATIONS

PREDS (Prednisolone Acetate Ophthalmic Suspension USP) is indicated in the treatment of infection of the Cornea of the Eye due to Herpes Zoster, Inflammation of the Iris, Uvea, Ciliary body of the Eye, Ulcer of the Cornea of the Eye, Dotted Lesions or damage on Cornea of Eye, Allergic Conjunctivitis, Inflammation of the Eye, Following Surgery, Severe Inflammation of the Cornea with Rosacea Involvement, Scratch Would on Cornea, Severe Inflammation of the Eye. Prednisolone works by relieving swelling and itching.

CLINICAL PHARMACOLOGY

Mechanism of Action
‍Prednisolone acetate is a synthetic analog of hydrocortisone, has an anti-Inflammatory action. It controls the rate of protein synthesis at both a cellular and molecular level. After passively entering a target cell, the glucocorticoid molecule rapidly binds to a specific cytoplasmic steroid-receptor complex protein. The cytoplasmic steroid-receptor complex then becomes activated, undergoing a conformational change that allows it to cross the nuclear membrane and bind to DNA directly at sites known as glucocorticoid response elements (GRE).GRE binding controls the transcription of specific genes, which in turn either promote or inhibit the production of specific mRNAs. As a consequence, the rate of translation and production of specific protein product encoded by their mRNAs is changed, thereby mediating the response of a particular cell to corticosteroids.

DOSAGE AND ADMINISTRATION

Two drops topically in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated .The dosing of PREDS (Prednisolone Acetate Ophthalmic Suspension USP) may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

CONTRAINDICATIONS

PREDS (Prednisolone Acetate Ophthalmic Suspension USP)is contraindicated in acute untreated purulent ocular infections, acute superfacial herpes simplex (dendritic keratitis), vaccinia varicella and most other viral diseases of the cornea and conjunctiva, ocular tuberculosis, and fungal diseases of the eye. It is also contraindicated for individuals sensitive to any components of the formulation

WARNING

In those diseases causing thinning of the cornea, perforation has been reported with the use of topical steroids. PREDS (Prednisolone Acetate Ophthalmic Suspension USP) should be discontinued at the first sign or symptom of any allergic reaction. If irritation persists or increases on using PREDS (Prednisolone Acetate Ophthalmic Suspension USP), discontinue the use and consult the Physician. Acute purulent infections of the eye maybe masked or enhanced by the use or topical steroids. As fungal infections of the cornea have been reported coincidentally with long- term local steroid applications, fungal invasion may be suspected in any persistent corneal ulceration where a steroid has been used, or in use. Use of topical corticosteroids may cause increased intraocular pressure in certain individuals. This may result in damage to the optic nerve, with defects in the visual fields. It is advisable to check the intraocular pressure frequently.

PRECAUTIONS

General
‍Do not touch the dropper tip or let it touch your eye or any other surface. If you are wearing contact lenses, remove them before using eye drops. Wait at least 15 minutes before replacing your contact lenses. Do not rinse the dropper. Replace the dropper cap after each use.
‍
INFORMATION FOR PATIENTS
Avoid contaminating the applicator tip with material from the eye. fingers or other source. Discontinue the use immediately and contact your physician at the first sign of a rash or allergic reaction. Do not share this medication with others. Infectionmay spared if this bottle is used by more than one person. After applying PREDS (Prednisolone Acetate Ophthalmic Suspension USP), vision may become temporarily blurred. Use caution while driving, using machinery, or doing any other activity that requires clear vision. Limit alcoholic beverages.
‍
PREGNANCY: TERATOGENIC EFFECTS
‍Category C
‍Prednisolone has been shown to be Teratogenic in mice when given in doses 1-10 times the human dose. There are no adequate well-controlled studies in pregnant women. Nursing mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk, Systematically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing women. Pediatric use Safety and efficacy in pediatric patients have not been established.

ADVERSE REACTIONS
Eye stinging/burning/redness and temporary blurred vision may occur. Use of this medication for prolonged or repeated periods may result in a new eye infection(possibly fungal e.g., itch, yellow/green discharge). Serious side effects may occur: vision changes, headache, dizziness, sore throat, irritated/runny nose, new eye pain, dry eyes, and change in taste. A very serious allergic reaction to this drug is rare. However, following symptoms of a serious allergic reaction may occur, rash, itching, swelling, severe dizziness, trouble breathing.

STORAGE:

Keep in a cool & dark place. Store below 30°C. Do not allow to freeze.

SHELF LIFE

24 Months

HOW SUPPLIED:

PREDS (Prednisolone Acetate Ophthalmic Suspension USP) Sterile Suspension is available in 5mL/10 mL Poly bottle.
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