REDNILEF

® (prednisolone acetate ophthalmic suspension, USP) 1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the following structure: Each mL of PRED FORTE ® contains: Active: prednisolone acetate (microfine suspension) 1% Inactives: benzalkonium chloride as preservative; boric acid; edetate disodium; hypromellose; polysorbate 80; purified water; sodium bisulfite; sodium chloride; and sodium citrate.

The pH during its shelf life ranges from 5.0.

The following structure for PRED

FORTE® (prednisolone acetate ophthalmic suspension, USP) 1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate.

® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Thromboembolic accident Lactation History of psychiatric illness Recent history of intestinal anastomosis Cancer Septic shock Cirhrosis Ulcerous colitis Diabetes Diverticulitis Child between 30 months and 15 years Epilepsy Stress Glaucoma Glaucoma, family history (de) Pregnancy Herpes eye Hypertension Hypothyroidism Bacterial infection Intramuscular injection Congestive heart failure Hepatic impairment Renal impairment Surreal impairment Exanthemous disease Psychiatric illness Severe myasthenia Cortisonic myopathy Infants under 30 months of age Newborn exposed in utero to the medicine Osteoporosis Brain malaria Dialysis patient High dose treated patient Phoechromocytoma Poliomyelitis Premature Presence of varicella or measles in patient's environment Psychosis Systemic scleroderma Multiple sclerosis Sports Elderly Subject at risk of heart Subject at risk of thromboembolic accident Subject at risk of seizure Subject at risk of psychiatric illness Subject at risk for tumour lysis syndrome Subject at risk of tuberculosis Subject with a positive reaction to tuberculin Subject from an anguillasis endemic area Cushing's syndrome Allergic field Extended treatment Renal transplantation Cranial trauma Neuromuscular disorder Tuberculosis, history Evolutionary tuberculosis Gastroduodenal ulcer, history (d) Evolving gastroduodenal ulcer Non-live or inactivated vaccines.

Prednisolone acetate is a glucocorticoid that, on the basis of weight, has to 5 times the anti-inflammatory potency of hydrocortisone.

Glucocorticoids inhibit 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.

Mechanism of action

Physiological glucocorticoids ( cortisone and hydrocortisone) are essential metabolic hormones.

Synthetic corticosteroids, including dexamethasone, are used primarily for their anti-inflammatory effect.

At high doses, they decrease the immune response.

Their metabolic and sodium retention effect is less than that of hydrocortisone.

• Alkaline phosphates (increase)
• Leucocytosis Hyperuricaemia ASAT (increase)
• Lipidaemia (amendment)
• Hypokalaemia Hypercalcuria ALT (increase)
• Skin atrophy (Common)
• Acne (Common)
• Rash
• Skin Erythema Vergeture Skin striation Skin depigmentation Urticaria Hyperhidrosis
• Pruritus Pétechie Recovery delay (Common)
• Fatigue Peripheral edema Hypopituitarism
• Cushingoid syndrome Hirsutism Inhibition of hypothalamo-pituito-adrenal axis Menstrual irregularity
• Echymosis Hematoma Hepatitis Abnormal skin test Oedema of Quincke Hypersensitivity
• Anaphylactoid reaction Anaphylactic reaction Esophagus candidiasis Infection (Common)
• Opportunistic infection Peritonitis Injection site reaction Waterproof detention (Common)
• Negative nitrogen balance Insulin resistance Hypokalemic alkalosis Glucose tolerance
• Weight (increase)
• Metabolic acidosis Appetite increased Epidural lipomatosis Subcapsular cataract (Common)
• Papillary edema Glaucoma Chorioretinopathy Cataract Intraocular hypertension Blurty vision
• Eye infection (aggravation)
• Exophthalmia Cornea thinning Feeling dizzy Dysgueusia
• Insomnia (Common)
• Confusion-oniric state (Rare)
• Manic access (Rare)
• Cognitive disorder
• Mood disorder Irritability Drug addiction Suicidal ideation Behavioural disorder
• Schizophrenia (aggravation)
• Hallucination Depression Euphoria Mental confusion Emotional disorder
• Mania Psychosis Delicious Personality disorder Anxiety Hypertension (Common)
• Hypertrophic cardiomyopathy
• Arrhythmia Congestive puff Hypotension Myocardial closure Lung embolism Telangiectasia
• Malaise Thromboembolic accident Congestive heart failure Gastroduodenal ulcer (Common)
• Digestive perforation Abdominal distension Acute Pancreatitis Dyspepsia Vomiting
• Cystic pneumatosis of the intestine Hoquet Nausea Digestive haemorrhage Abdominal pain
• Diarrhoea Esophagus Ulcer Esophagitis Muscle weakness (Common)
• Growth retardation (Common)
• Cortisonic myopathy Osteonecrosis Osteoporosis Myopathy Pathological fracture Muscle atrophy
• Muscle pain Strand cut Aseptic osteonecrosis of femoral heads Joint pain Convulsions (Rare)
• Headache Amnesia Intracranial hypertension Weaning syndrome Renal scleroderma crisis.

Overdosage will not ordinarily cause acute problems.

If accidentally ingested, drink fluids to dilute.

Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.

Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

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.

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.

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.

FORTE ® suspension contains sodium bisulfite, 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.

® suspension is contraindicated in acute untreated purulent ocular infections, 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.

FORTE ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Shake well before using.

Instill one to two drops into the conjunctival sac two to four times daily.

During the initial to 48 hours, the dosing frequency may be increased if necessary.

Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

® (prednisolone acetate ophthalmic suspension, USP) 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with pink high impact polystyrene (HIPS) caps as follows: 1 mL in 5 mL bottle.

• NDC 11980-180-01 5 mL in 10 mL bottle.

• NDC 11980-180-05 10 mL in 15 mL bottle.

• NDC 11980-180-10 15 mL in 15 mL bottle.

• NDC 11980-180-15 Storage: Store at up to 25°C (77°F).

Protect from freezing.

Store in an upright position.

Revised: 02 / 2024 Distributed by: AbbVie, Inc.

Chicago, IL 60064 © 2024 AbbVie.

All rights reserved.

Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. v2.0USPI180 Shape Description automatically generated.

Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human dose.

Dexamethasone, hydrocortisone, and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through of gestation.

A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice.

There are no adequate well-controlled studies in pregnant women.

Prednisolone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

Because of the potential for serious adverse reactions in nursing infants from prednisolone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

The safety and effectiveness in pediatric patients have been established.

Use in pediatric patients is supported by evidence from adequate and well-controlled studies of prednisolone acetate ophthalmic suspension in adults with additional data in pediatric patients.

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

Because of the potential for serious adverse reactions in nursing infants from prednisolone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

The safety and effectiveness in pediatric patients have been established.

Use in pediatric patients is supported by evidence from adequate and well-controlled studies of prednisolone acetate ophthalmic suspension in adults with additional data in pediatric patients.

No overall differences in safety or effectiveness have been observed between elderly and younger patients.