Bleph 10

DRUG DESCRIPTION

BLEPH®-10 (sulfacetamide sodium ophthalmic solution, USP) 10% is a sterile, topical antibacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula:

BLEPH®-10  (sulfacetamide sodium)   Structural Formula Illustration

C8H9N2NaO3S•H2O ...... MW = 254.24

Chemical Name

N-Sulfanilylacetamide monosodium salt monohydrate.

Contains: Active: sulfacetamide sodium 10% (100 mg/mL). Preservative: benzalkonium chloride 0.005%. lnactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium phosphate dibasic; sodium phosphate monobasic; sodium thiosulfate; hydrochloric acid and/or sodium hydroxide to adjust the pH (6.8 to 7.5).

What are the possible side effects of sulfacetamide ophthalmic?

Serious side effects are not expected with this medication.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Bleph 10 »

What are the precautions when taking sulfacetamide sodium ophthalmic solution 10% (Bleph 10)?

Before using sulfacetamide, tell your doctor or pharmacist if you are allergic to it; or to other sulfa antibiotics (such as sulfamethoxazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription...

Read All Potential Precautions of Bleph 10 »


Bleph 10 Consumer (continued)

SIDE EFFECTS: Eye stinging/burning/redness and temporary blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged or repeated periods may result in other types of eye infections, including fungal infections. Stop using this medication and contact your doctor if you notice new or worsening eye symptoms (such as pain, swelling, thick discharge or pus).

Rarely, sulfacetamide products used in the eye may be absorbed and may cause serious side effects. Stop using this product and tell your doctor immediately if any of these rare but serious side effects occur: aching/swollen joints, rash on nose and cheeks, signs of infection (such as fever, persistent sore throat), signs of anemia (such as unusual tiredness/weakness, rapid breathing, fast heartbeat), unusual bleeding/bruising, signs of liver problems (such as dark urine, yellowing eyes/skin, stomach/abdominal pain, persistent nausea, vomiting), mouth sores.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using sulfacetamide, tell your doctor or pharmacist if you are allergic to it; or to other sulfa antibiotics (such as sulfamethoxazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Bleph 10 Patient Information Including Side Effects

Brand Names: Bleph-10, Ocu-Sul 10, Ocu-Sul 15, Ocu-Sul 30, Sodium Sulamyd, Sulf-10, Sulfac 10%

Generic Name: sulfacetamide ophthalmic (Pronunciation: SUL fa SEET a mide off THAL mik)

  • What is sulfacetamide ophthalmic (Bleph 10)?
  • What are the possible side effects of sulfacetamide ophthalmic?
  • What is the most important information I should know about sulfacetamide ophthalmic?
  • Who should not use sulfacetamide ophthalmic?
  • How should I use sulfacetamide ophthalmic?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using sulfacetamide ophthalmic?
  • What other drugs will affect sulfacetamide ophthalmic?
  • Where can I get more information?

What is sulfacetamide ophthalmic (Bleph 10)?

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.

What are the possible side effects of sulfacetamide ophthalmic?

Serious side effects are not expected with this medication.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sulfacetamide ophthalmic?

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.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

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