Adult Dosing

Inflammatory ocular conditions with superficial bacterial infections

• Instill 2 gtt topically into the conjunctival sac q4 hrs while awake; max: 20 mL (initial prescription)
• Alt: Apply 0.5 inch ribbon of ointment in the conjunctival sac tid-qid and once or twice at night; max: 8 g (initial prescription)

• In chronic conditions, taper the dose gradually to discontinue the therapy
• If signs and symptoms fail to improve after two days, consider re-evaluating the patient

Pediatric Dosing

• Safety and effectiveness in pediatric patients <6 yrs of age have not been established

Inflammatory ocular conditions with superficial bacterial infections

Children >6 yrs

• Instill 2 gtt topically into the conjunctival sac q4 hrs while awake; max: 20 mL (initial prescription)
• Alt: Apply 0.5 inch ribbon of ointment in the conjunctival sac tid-qid and once or twice at night; max: 8 g (initial prescription)

• In chronic conditions, taper the dose gradually to discontinue the therapy
• If signs and symptoms fail to improve after two days, consider re-evaluating the patient

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of steroid-responsive inflammatory ocular conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe and where superficial bacterial ocular infection or a risk of bacterial infection exists
• Indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies

• Hypersensitivity to any of the ingredients of the product
• Viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
• Ocular mycobacterial infections
• Ocular fungal infections
• Hypersensitivity to other sulfonamides and to other corticosteroids
• Silver ophthalmic preparations
• Contact lens use

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Not for injection into the eye
• Ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation may occur with long-term use of corticosteroids. Prolonged use of this product may also suppress the host immune response and increase the hazard of secondary ocular infections
• Therapy may cause acute anterior uveitis in susceptible individuals, primarily blacks
• Various ocular diseases and long-term use of topical corticosteroids induce corneal and scleral thinning. Use of topical corticosteroids in the presence of diseases causing thinning of the cornea or sclera leads to perforation
• Acute purulent infections of the eye may be masked or activity may be enhanced by the presence of corticosteroid medication
• Routinely monitor intraocular pressure even though it may be difficult in children and uncooperative patients if this drug is used for 10 days
• Most of staphylococcal isolates are fully resistant to sulfonamides
• Increased incidence of filtering blebs and delayed healing may occur with the use of steroids after cataract surgery
• Use of ocular steroids may prolong the course and exacerbate the severity of viral infections of the eye; hence, use with extreme caution in patients with a history of herpes simplex and perform frequent slit lamp microscopy
• Do not use topical steroids for the treatment of mustard gas keratitis and Sjogren's keratoconjunctivitis as they are not effective
• Incidence of fatal reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias have been reported rarely; sensitization may recur on re-administration of the drug, irrespective of the route of administration
• Discontinue use on appearance of first sign of hypersensitivity, skin rash or other reaction
• Physician should renew medication order beyond 20 mL or 8 g only after examining the patient’s intraocular pressure and examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and fluorescein staining
• Long-term corticosteroid use may cause fungal infections of the cornea
• The p-aminobenzoic acid present in purulent exudates competes with sulfonamides, which can reduce their effectiveness
• Ophthalmic ointments may retard corneal healing

Cautions: Use cautiously in

• Cataract surgery
• Severe dry eye

Supplemental Patient Information

• Advise patients not to touch the applicator tip to any surface, including the eye, in order to prevent contamination of the solution; inform them not to use if the solution has darkened
• Instruct patients to discontinue use of the medication and consult a physician, if inflammation or pain persists longer than 48 hours or becomes aggravated
• Inform them not to wear contact lenses during the use of this product

Pregnancy Category:C

Breastfeeding: Limited literature indicates that maternal doses of prednisolone up to 50 mg/day produce low levels in milk and is not expected to cause any adverse effects in breastfed infants. With high maternal doses, avoiding breastfeeding for 4 hrs after a dose should significantly reduce the dose received by the infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 15 June 2011). Because there exists a potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug analyzing the importance of the drug to the mother.

• EENT: Elevation of intraocular pressure (IOP), glaucoma, optic nerve damage, posterior subcapsular cataract formation, delayed ocular wound healing, eye irritation, secondary ocular infection, acute anterior uveitis, corneal thinning, globe perforation, ocular burning/stinging, blurred vision, vision changes
• GI: Fulminant hepatic necrosis
• HEMA: Agranulocytosis, aplastic anemia, other blood dyscrasias
• DERM: Stevens-Johnson Syndrome, toxic epidermal necrolysis

Prednisolone

• Corticosteroid; precise mechanism of anti-inflammatory action unknown; induces phospholipase A2 inhibitory proteins; inhibits multiple inflammatory cytokines and produces multiple glucocorticoid and mineralocorticoid effects
• Minimal systemic absorption
• Primarily metabolized by liver
• Renally excreted
• Half-life: 2-3 hrs

Sulfacetamide

• Bacteriostatic agent; inhibits bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase
• Metabolism: Liver [Data based on topical route]
• Excreted in urine [Data based on topical route]
• Half-life: 7-13 hrs [Data based on topical route]

US Trade Name(s)

• Blephamide
• Vasocidin

US Availability

prednisolone/sulfacetamide (generic)

• OPTH SOLN: 0.23%/10%

Blephamide (prednisolone/sulfacetamide)

• OPTH SUSP: 0.2%/10%

Blephamide S.O.P. (prednisolone/sulfacetamide) (generic)

• OPTH OINT: 0.2%/10%

Vasocidin (prednisolone/sulfacetamide)

• OPTH SOLN: 0.23%/10%

Canadian Trade Name(s)

• Ak Cide
• Blephamide
• Dioptimyd

Canadian Availability

Ak Cide (prednisolone/sulfacetamide)

• OPTH SOLN: [5 mg/100 mg]/mL

Blephamide (prednisolone/sulfacetamide)

• OPTH SUSP: 0.2%/10%
• OPTH OINT: 0.2%/10%

Dioptimyd (prednisolone/sulfacetamide)

• OPTH OINT: [5 mg/100 mg]/g
• OPTH SUSP: 0.5%/10%

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Ophthalmic Steroids With Anti-infectives

Infectious Disease

Ophthalmic Steroids With Anti-infectives

Ophthalmic

Ophthalmic Steroids With Anti-infectives

Pricing data from www.DrugStore.com in U.S.A.

• Blephamide 10-0.2 % SUSP [Bottle] (ALLERGAN)
  10 % = $105.99
  30 % = $295.96
• Blephamide 10-0.2 % SUSP [Bottle] (ALLERGAN)
  5 % = $70.99
  15 % = $199.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.