Blephamide S.O.P.

Ophthalmological Corticosteroid and Anti-infective Combinations

Ophthalmic Solution or Suspension:
Sulfacetamide; prednisolone solution and suspension are indicated for topical administration to the eye; do NOT administer parenterally.
Instruct patient on proper instillation of eye solution and suspension (see Patient Information).
Do not touch the tip of the dropper to the eye, fingertips, or other surface to prevent contamination.
Shake the suspension well prior to use.
Wash hands before and after use.
Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. Close eyes to spread drops. To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 1 to 2 minutes following application to the eye.
To avoid contamination or the spread of infection, do not use dropper for more than one person.
Protect from light; product will darken upon prolonged exposure to heat and light. Do not use if product has darkened. Yellowing of solution or suspension does not affect activity and is acceptable.
 
Ophthalmic Ointment:
Instruct patient on proper instillation of eye ointment (see Patient Information).
Do not touch the tip of the tube to the eye, fingertips, or other surface to prevent contamination.
Wash hands before and after use.
Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Place a small amount (about one-half of an inch) of the ointment into the pouch. Look downward before closing eyes.
To avoid contamination or the spread of infection, do not use tube for more than one person.

ocular hypertension / Delayed / 0-1.0
toxic epidermal necrolysis / Delayed / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
aplastic anemia / Delayed / Incidence not known
hepatic necrosis / Delayed / Incidence not known
agranulocytosis / Delayed / Incidence not known
uveitis / Delayed / Incidence not known

erythema / Early / Incidence not known
blurred vision / Early / Incidence not known
hyperemia / Delayed / Incidence not known
impaired wound healing / Delayed / Incidence not known
cataracts / Delayed / Incidence not known
ocular infection / Delayed / Incidence not known
superinfection / Delayed / Incidence not known

pruritus / Rapid / Incidence not known
ocular pain / Early / Incidence not known
ocular discharge / Delayed / Incidence not known
rash / Early / Incidence not known
ocular pruritus / Rapid / Incidence not known
ocular irritation / Rapid / Incidence not known
urticaria / Rapid / Incidence not known
dizziness / Early / Incidence not known
mydriasis / Early / Incidence not known
ptosis / Delayed / Incidence not known

Blephamide, Sulster, Vasocidin

Rx

Sulfonamide and corticosteroid ophthalmic combination
Used for inflammatory conditions of the eyes where there is also a bacterial infection or risk of bacterial infection
Prolonged use can lead to systemic absorption and increase the risk of secondary ocular infections

Instill 2 drops topically to affected eye(s) every 4 hours. Re-evaluate patient if signs and symptoms do not improve after 48 hours of treatment. Withdrawal therapy gradually by decreasing administration frequency; do not discontinue abruptly or prematurely. Prescribe no more than 20 mL initially; examination by physician is recommended prior to renewal of medication.

Instill 2 drops topically into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime. Re-evaluate patient if signs and symptoms do not improve after 48 hours of treatment. Withdrawal therapy gradually by decreasing administration frequency; do not discontinue abruptly or prematurely. Prescribe no more than 20 mL initially; examination by physician is recommended prior to renewal of medication.

Apply a half-inch ribbon of ointment topically in the conjunctival sac of the affected eye(s) 3 to 4 times daily and once or twice at bedtime. Re-evaluate patient if signs and symptoms do not improve after 48 hours of treatment. Withdrawal therapy gradually by decreasing administration frequency; do not discontinue abruptly or prematurely. Prescribe no more than 8 g initially; examination by physician is recommended prior to renewal of medication.

No dosage adjustments are needed.

No dosage adjustments are needed.

There are no drug interactions associated with Sulfacetamide; Prednisolone products.

Blephamide Ophthalmic Susp: 10-0.2%
Blephamide S.O.P. Ophthalmic Ointment: 10-0.2%
Sulfacetamide Sodium, Prednisolone Sodium Phosphate/Sulfacetamide, Prednisolone/Sulster/Vasocidin Ophthalmic Drops: 10-0.25%
Sulfacetamide Sodium, Prednisolone Sodium Phosphate/Sulfacetamide, Prednisolone/Sulster/Vasocidin Ophthalmic Sol: 10-0.25%

12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).

12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).

12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).

6 years or older: 12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).
Younger than 6 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Sulfacetamide; prednisolone is indicated for the treatment of inflammatory ocular conditions where a risk of superficial bacterial infection exists. Clinicians may wish to consult the individual monographs for more information about each component.
Sulfacetamide: Sulfacetamide interferes with bacterial synthesis of folic acid by competitively blocking the incorporation of p-aminobenzoic acid (PABA) into tetrahydropteroic acid. Folic acid is a coenzyme required by bacterial cells for the synthesis of nucleotides and ultimately bacterial cell growth. Sulfacetamide does not affect bacterial cells that use preformed (dietary) folic acid or mammalian cells. Sulfacetamide displays in vitro bacteriostatic activity against Enterobacter species, Escherichia coli, Haemophilus influenzae, Klebsiella species, Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus viridans group.
Prednisolone: Prednisolone is a corticosteroid with anti-inflammatory action. Corticosteroids are naturally occurring hormones that bind to specific protein receptors on targeted tissues. This binding induces a response by modifying transcription and, ultimately, protein synthesis to achieve the steroid's intended action. The anti-inflammatory action of prednisolone results from the inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, and suppression of humoral immune responses. The end result of treatment with prednisolone includes reduction in edema or scar tissue as well as a general suppression of the immune response.

Sulfacetamide; prednisolone is administered topically to the eyes. No pharmacokinetic information is available from the manufacturers of these combination ophthalmic products.

There are no adequate studies of sulfacetamide; prednisolone use in pregnant women. In mice, prednisolone doses of 1 to 10 times the human ocular dose resulted in an increased incidence of cleft palate; rabbits receiving corticosteroids experienced fetal resorption and abnormalities involving the head, ears, limbs, and palate. Consider monitoring for signs of hypoadrenalism in infants born to mothers who received substantial doses of corticosteroids during pregnancy. The fetal effects of sulfacetamide are unknown; however, sulfonamides are known to cause kernicterus in infants when administered during the third trimester. Administer sulfacetamide; prednisolone during pregnancy only when the benefits clearly outweigh the potential risk to the fetus.

According to the manufacturer, it is not known if ophthalmic administered prednisolone is detectable in human milk; however, systemically administered corticosteroids do appear in human milk and may suppress infant growth and endogenous corticosteroid production. Due to lowered systemic absorption, ophthalmic use of prednisolone poses little concern to the nursing infant, and previous American Academy of Pediatrics recommendations considered ophthalmic prednisolone compatible with breast-feeding. Sulfonamides, when administered topically, can produce kernicterus in breast-fed infants. Short term use of usual moderate ocular doses of these products for milder eye conditions probably poses little risk to the nursing infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.