Blephamide (Sulfacetamide and prednisolone) is a combination of a steroid and anti-infective medicine that is used to treat inflammatory ocular conditions.

Blephamide (Sulfacetamide and Prednisolone) Uses:

• Inflammatory ocular conditions:

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

Blephamide dose in Adults

Blephamide dose in the treatment of Inflammatory ocular conditions:

• Ointment:

  • Apply about 1/2 an inch ribbon to lower conjunctival sac 3 to 4 times daily and 1 to 2 times at night

• Solution:

  • Instill 2 drops every 4 hours

• Suspension:

  • Instill 2 drops in eyes every 4 hours during the day and at bedtime

Blephamide dose in Childrens

Blephamide dose in the treatment of Inflammatory ocular conditions:

• Children ≥6 years and Adolescents:

  • Ophthalmic: Refer to adult dosing.

Pregnancy Risk Category: C

• Animal reproduction studies have not been conducted yet with this combination.
• The use of systemic sulfonamides during pregnancy may cause kernicterus in the newborn.
• See individual agents.

Sulfacetamide and prednisolone use during breastfeeding:

• It is unknown if topical use results in sufficient absorption to produce detectable quantities in breast milk.
• Use of systemic sulfonamides while breast-feeding may cause kernicterus in the newborn; the amount of systemic absorption following ophthalmic administration is not known.
• Due to the high potential for serious adverse reactions in the breast-feeding infant, the drug manufacturer recommends a decision to be made whether to discontinue breast-feeding or to discontinue the drug, taking into account the need for treatment to the mother.
• See individual agents (sulfacetamide and prednisolone)

Blephamide dose in Kidney Disease:

• There are no dosage adjustments provided in the drug manufacturer's labeling.

Blephamide dose in Liver disease:

• There are no dosage adjustments provided in the drug manufacturer's labeling.

Side effects of Blephamide:

• Also see individual agents.

• Dermatologic:

  • Stevens-Johnson Syndrome
  • Toxic Epidermal Necrolysis

• Hematologic & Oncologic:

  • Agranulocytosis
  • Aplastic Anemia

• Hepatic:

  • Fulminant Hepatic Necrosis

• Hypersensitivity:

  • Hypersensitivity Reaction

• Infection:

  • Secondary Infection (Bacterial
  • Fungal)

• Local:

  • Local Irritation

• Ophthalmic:

  • Accommodation Disturbance
  • Anterior Uveitis (Acute)
  • Blepharoptosis
  • Eye Perforation
  • Glaucoma
  • Increased Intraocular Pressure
  • Mydriasis
  • Optic Nerve Damage (Infrequent)
  • Subcapsular Posterior Cataract

• Miscellaneous:

  • Wound Healing Impairment

Contraindications to Blephamide (Sulfacetamide and prednisolone):

• Hypersensitivity/hyperresponsiveness to sulfacetamide, prednisolone, other sulfonamides or corticosteroids, or any component of the formulation/packaging;
• viral diseases (including epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella) of the cornea or conjunctiva;
• fungal diseases of ocular structures;
• mycobacterial ocular infections

Note:

• Although the FDA-approved product labeling claims that this is contraindicated with other sulfonamide-containing drug groups, the scientific basis of this statement has been challenged now. See "Warnings/Precautions" for more detail.

• Canadian labeling: Additional contraindications (not in US labeling):

  • Purulent untreated ocular infections.

Warnings and Precautions

• Blood dyscrasias:

  • Severe reactions including agranulocytosis,
  • aplastic anemia, and
  • other blood dyscrasias have occurred with sulfonamides as well (regardless of route);
  • fatalities have occurred (rare).
  • Discontinue at the first sign of serious reaction.

• Dermatologic reactions:

  • Severe reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with sulfonamides (regardless of route);
  • fatalities have occurred (rare).
  • Discontinue at the first sign of a rash.

• Hepatic necrosis:

  • Severe reactions, including fulminant hepatic necrosis, have been reported with sulfonamides (regardless of route);
  • fatalities have occurred (rare).
  • Discontinue at the first sign of serious reaction.

• Hypersensitivity reactions:

  • Hypersensitivity reactions, skin rash, or other serious reactions may occur;
  • discontinue at the first sign of hypersensitivity reaction.
  • Cross sensitivity among corticosteroids has occurred.

• Infection:

  • Prolonged use of corticosteroids may raise the incidence of superseded secondary infection, also can mask acute infection (including fungal infections), or prolong or exacerbate viral infections.
  • Corticosteroids should not be used for the treatment of ocular herpes simplex; use extreme caution in patients with a past history of ocular herpes simplex.
  • Fungal infection should be suspected in any patient having persistent corneal ulceration and has received corticosteroids.

• Ocular effects:

  • Prolonged use of steroids may end in posterior sub-capsular cataract formation and may result in increase intraocular pressure, resulting in ocular hypertension/glaucoma with damage to the optic nerve, causing defects in visual acuity, and fields of vision.
  • Acute anterior uveitis may occur in susceptible patients, primarily black patients.
  • Use with caution in patients with glaucoma (steroids increase intraocular pressure).
  • Perforation may occur with topical steroids in diseases with thin cornea or sclera.
  • Intraocular pressure should be monitored if this product is used >10 days.

• Sulfonamide ("sulfa") allergy:

  • Traditionally, concerns for cross-reactivity have extended to all compounds containing the sulfonamide structure (SO-NH ).
  • An expanded understanding of allergic mechanisms shows that cross-reactivity between antibiotic sulfonamides and non-antibiotic sulfonamides may not develop, or at the very least this potential is very rare (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004).
  • In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are least likely to occur with nonantibiotic sulfonamides and antibiotics sulfonamides.
  • A nonantibiotic sulfonamide compound that has an arylamine structure may cross-react with antibiotic sulfonamides is sulfasalazine.
  • T-cell–mediated i.e type IV reactions (eg, maculopapular rash) are less understood and it is impossible to completely exclude this potential based on current insights.
  • In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians prefer to avoid exposure to these classes.

• Dry eye:

  • Caution is advised in patients with severe dry eye.

Sulfacetamide and prednisolone: Drug Interaction

Monitoring parameters:

• Signs and symptoms of improvement after 2 days of therapy;
• signs and symptoms of secondary infection;
• intraocular pressure in patients with glaucoma or with prolonged use (≥10 days);
• periodic exam of lens with prolonged use

How to administer Blephamide (Sulfacetamide and prednisolone)?

• For topical ophthalmic use only;
• to avoid contamination, do not touch the container tip to the eyelids or other surfaces while placing drops or ointment in the eyes.
• Do not apply with silver preparations.
• Discontinue if symptoms do not improve after 2 days.
• Not more than 20 mL or 8 gm should be prescribed without proper re-evaluation of the patient.

• Ointment:

  • Apply into the pocket between the eyeball and lower lid;
  • The patient should be advised to look down before closing the eye.

Solution/Suspension:

• Tilt head back,
• instill into the conjunctival sac and close eye(s).
• Apply light finger pressure on the lacrimal sac for about 1 minute following instillation.
• Shake the suspension well before using.

Mechanism of action of Blephamide (Sulfacetamide and prednisolone):

• Sulfacetamide interferes with bacterial growth by inhibiting the bacterial folic acid synthesis of PABA through competitive antagonism ;
• Prednisolone decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reduction of increased capillary permeability;
• It also suppresses the immune system by decreasing the activity and volume of the lymphatic system

International Brands of Sulfacetamide and prednisolone:

• Blephamide
• Blefamide
• AK Cide Oph
• Dioptimyd
• Blefamide SF
• Blefamide SOP
• Deltamid Ofteno
• Metimyd
• Phenamide-P
• Premid
• Sterilid-V

Sulfacetamide and prednisolone Brand Names in Pakistan:

No Brands Available in Pakistan.