Bleph 10

• Allergan, Inc.

• Compumed Pharmaceuticals, Inc.

• Dispensing Solutions, Inc.

• Pharma Pac (A Service Of H.J. Harkins Co., Inc.)

Before taking Bleph-10, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have or recently have had any fungal, viral, or bacterial infections
• have recently taken antibiotics for any reason
• are allergic to 'sulfa' drugs
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take Bleph-10 exactly as prescribed.

This medication comes in eyedrop form and is typically taken every 2 to 3 hours for 7 to 10 days.

Bleph-10 is not effective for treating bacterial infections caused by Neisseria species, Serratia marcescens or Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs like Bleph-10.

To avoid contamination, do not touch the tip of the Bleph-10 container to the eye, eyelid or any surface.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Bleph-10 at the same time.

If you take too much Bleph-10, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Bacterial Ophthalmic Infections

Treatment of conjunctivitis, corneal ulcers, and other superficial infections of the eye caused by susceptible Staphylococcus aureus, Streptococcus pneumoniae, viridans streptococci, Haemophilus influenzae, Enterobacter, Escherichia coli, and Klebsiella.107 108 f

Used alone or in fixed combination with topical corticosteroids (e.g., fluorometholone, prednisolone) when such combination therapy is indicated.b c e g

Ineffective for treatment of infections caused by Neisseria, Serratia marcescens, or Pseudomonas aeruginosa.108 b c e f g Consider that staphylococci frequently are resistant to sulfonamides.108 b c e f g

Chlamydial Ophthalmic Infections

Has been used as an adjunct to systemic anti-infectives for treatment of trachoma; 107 108 f however, systemic anti-infectives are recommended.106 No data to support use of topical anti-infectives in conjunction with systemic therapy.106

Administration

Ophthalmic Administration

Apply topically to the eye(s) as an ophthalmic ointment, solution, or suspension.107 108 b c e f g

Not for injection;107 108 b c e f do not inject subconjunctivally or instill directly into the anterior chamber of the eye.g

Avoid contamination of the tip of the container.b c e f g

Shake suspension well prior to use.b g

Dosage

Available as sulfacetamide sodium; dosage expressed in terms of the salt.f

Available as fixed combinations containing sulfacetamide sodium and prednisolone acetate, prednisolone sodium phosphate, or fluorometholone; dosage expressed in terms of the salt.b c e g

Pediatric Patients

Children ≥2 months of age: Initially, 1 or 2 drops into the conjunctival sac of the affected eye(s) every 2–3 hours.f Reduce dosing frequency as infection improves.f Usual duration of treatment is 7–10 days.f

Children ≥2 years of age: 1 drop into the conjunctival sac of the affected eye(s) 4 times daily.g Reduce dosing frequency as infection improves.g

If improvement does not occur after 2 days, reevaluate the patient.g Do not discontinue prematurely.g

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.g

Children ≥6 years of age: Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3 or 4 times daily during the day and once or twice during the night.c Reduce dosing frequency as infection improves.c

If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c

Children ≥6 years of age: 2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.b Reduce dosing frequency as infection improves.b

If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c

Children ≥6 years of age: 2 drops into the affected eye(s) every 4 hours.e Reduce dosing frequency as infection improves.e

If improvement does not occur after 2 days, reevaluate the patient.e Do not discontinue prematurely.e

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.e

Sulfacetamide 10% in children ≥2 months of age: 2 drops into the conjunctival sac of the affected eye(s) every 2 hours in conjunction with systemic anti-infectives.f

Adults

Initially, 1 or 2 drops of solution into the conjunctival sac of the affected eye(s) every 2–3 hours.f Reduce dosing frequency as infection improves.f Usual duration of treatment is 7–10 days.f

1 drop into the conjunctival sac of the affected eye(s) 4 times daily.g Reduce dosing frequency as infection improves.g

If improvement does not occur after 2 days, reevaluate the patient.g Do not discontinue prematurely.g

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.g

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3 or 4 times daily during the day and once or twice during the night.c Reduce dosing frequency as infection improves.c

If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c

2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.b Reduce dosing frequency as infection improves.b

If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c

2 drops into the affected eye(s) every 4 hours.e Reduce dosing frequency as infection improves.e

If improvement does not occur after 2 days, reevaluate the patient.e Do not discontinue prematurely.e

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.e

Sulfacetamide 10%: 2 drops into the conjunctival sac of the affected eye(s) every 2 hours, in conjunction with systemic anti-infectives.f

Special Populations

No special population dosage recommendations at this time.a b c e f g

Absorption

Extent

Sulfonamides do not appear to be appreciably absorbed from mucous membranes.107

Distribution

Extent

Systemic sulfonamides cross the placenta and are distributed into human milk in low concentrations.h

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sulfacetamide is an antibiotic.

Sulfacetamide ophthalmic (for use in the eyes) is used to treat bacterial infections of the eyes.

This medicine will not treat a viral or fungal infection. Sulfacetamide ophthalmic is for use only in treating eye infections caused by bacteria.

Sulfacetamide ophthalmic may also be used for purposes not listed in this medication guide.

This medicine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Do not use other eye medications unless your doctor tells you to.

• Store at room temperature. Do not freeze.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

BLEPH®-10 solution is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.

For conjunctivitis and other superficial ocular infections: Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For trachoma: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

Sulfacetamide ophthalmic is an antibiotic.

Sulfacetamide ophthalmic is used to treat bacterial infections of the eyes.

Sulfacetamide ophthalmic may also be used for purposes other than those listed in this medication guide.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Use caution when driving, operating machinery, or performing other hazardous activities. Sulfacetamide ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with sulfacetamide ophthalmic. After applying the medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with sulfacetamide ophthalmic unless otherwise directed by your doctor.

Applies to sulfacetamide sodium ophthalmic: ophthalmic ointment, ophthalmic solution, ophthalmic suspension

Side effects include:

Local irritation, transient stinging or burning.

Applies to sulfacetamide sodium ophthalmic: ophthalmic ointment, ophthalmic solution

General

The side effects reported most often were local/conjunctival irritation, stinging, and burning.[Ref]

Ocular

Frequency not reported: Local/conjunctival irritation, stinging, burning, nonspecific conjunctivitis, conjunctival hyperemia, bacterial corneal ulcers, fungal corneal ulcers[Ref]

Hypersensitivity

At least 1 case of local hypersensitivity has been reported that progressed to a SLE-like fatal syndrome.[Ref]

Rare (less than 0.1%): Sensitivity reactions
Frequency not reported: Allergic reactions/hypersensitivity, local hypersensitivity progressing to fatal syndrome resembling systemic lupus erythematosus (SLE)[Ref]

Other

Frequency not reported: Secondary infections[Ref]

Dermatologic

Sulfonamides:
-Frequency not reported: Stevens-Johnson syndrome, toxic epidermal necrolysis[Ref]

Fatalities reported rarely due to severe reactions to sulfonamides (including toxic epidermal necrolysis, Stevens-Johnson syndrome, fulminant hepatic necrosis, aplastic anemia, agranulocytosis, other blood dyscrasias).

Stevens-Johnson syndrome was reported in a patient with history of blistering drug reaction to an oral sulfonamide.[Ref]

Hematologic

Sulfonamides:
-Frequency not reported: Agranulocytosis, aplastic anemia, other blood dyscrasias[Ref]

Fatalities reported rarely due to severe reactions to sulfonamides (including toxic epidermal necrolysis, Stevens-Johnson syndrome, fulminant hepatic necrosis, aplastic anemia, agranulocytosis, other blood dyscrasias).[Ref]

Hepatic

Sulfonamides:
-Frequency not reported: Fulminant hepatic necrosis[Ref]

Fatalities reported rarely due to severe reactions to sulfonamides (including toxic epidermal necrolysis, Stevens-Johnson syndrome, fulminant hepatic necrosis, aplastic anemia, agranulocytosis, other blood dyscrasias).[Ref]

Some side effects of Bleph-10 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.