Klaron

DRUG DESCRIPTION

Each mL of Klaron® (sodium sulfacetamide lotion) Lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of purified water; propylene glycol; lauramide DEA (and) diethanolamine; polyethylene glycol 400, monolaurate; hydroxyethyl cellulose; sodium chloride; sodium metabisulfite; methylparaben; xanthan gum; EDTA and simethicone.

Sodium sulfacetamide is a sulfonamide with antibacterial activity. Chemically, sodium sulfacetamide is N' -[(4-aminophenyl) sulfonyl] - acetamide, monosodium salt, monohydrate. The structural formula is:

KLARON® (sodium sulfacetamide) Structural Formula Illustration

What are the possible side effects of sulfacetamide sodium topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • patchy skin color, red spots, a butterfly-shaped skin rash over your cheeks and nose;
  • the first sign of any skin rash, no matter how mild;
  • ...

Read All Potential Side Effects and See Pictures of Klaron »

What are the precautions when taking sodium sulfacetamide lotion (Klaron)?

Before using sulfacetamide lotion, tell your doctor or pharmacist if you are allergic to it; or to sulfa antibiotics (such as sulfamethoxazole); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), 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.

Tell your doctor if there are areas of skin near where this product will be applied that are cut, scraped, burned, or infected. Injured skin may absorb more of this product, and the chance of serious side effects may increase.

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

Read All Potential Precautions of Klaron »


Klaron Consumer (continued)

SIDE EFFECTS: Skin redness, irritation, stinging, and burning at the application site may occur and lessen over time as your body adjusts to the medication. If any of these effects persist or worsen, stop using this medication and 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.

Rarely, sodium sulfacetamide products applied to the skin 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 lotion, tell your doctor or pharmacist if you are allergic to it; or to sulfa antibiotics (such as sulfamethoxazole); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), 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.

Tell your doctor if there are areas of skin near where this product will be applied that are cut, scraped, burned, or infected. Injured skin may absorb more of this product, and the chance of serious side effects may increase.

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.


Klaron Patient Information Including Side Effects

Brand Names: Klaron, Mexar, Ovace, Ovace Plus, RE 10, Sebizon, Seb-Prev

Generic Name: sulfacetamide sodium topical (Pronunciation: SO dee um SUL fa SEET a myde TOP i kal)

  • What is sulfacetamide sodium topical (Klaron)?
  • What are the possible side effects of sulfacetamide sodium topical?
  • What is the most important information I should know about sulfacetamide sodium topical?
  • What should I discuss with my healthcare provider before using sulfacetamide sodium topical?
  • How should I use sulfacetamide sodium topical?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using sulfacetamide sodium topical?
  • What other drugs will affect sulfacetamide sodium topical?
  • Where can I get more information?

What is sulfacetamide sodium topical (Klaron)?

Sulfacetamide sodium is an antibacterial medication that interferes with the growth of bacteria on the skin.

Sulfacetamide sodium topical (for the skin) is used to treat acne, dandruff, seborrheic dermatitis (red, flaking skin rash), and certain skin infections.

Sulfacetamide sodium topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sulfacetamide sodium topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • patchy skin color, red spots, a butterfly-shaped skin rash over your cheeks and nose;
  • the first sign of any skin rash, no matter how mild;
  • joint pain, swelling, or stiffness;
  • signs of infection such as fever, sore throat, mouth sores, unusual weakness;
  • pale skin, easy bruising or bleeding;
  • new or worsening skin infection; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild swelling, itching, or redness of treated skin;
  • dry skin; or
  • yellow discoloration of treated skin (may be a sign that you have applied too much of the medication).

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 sodium topical?

You should not use this medication if you are allergic to sulfacetamide sodium or sulfa drugs.

Before using this medication, tell your doctor if you have asthma or are sensitive to sulfites, or if you are also using silver sulfadiazine (Silvadene, Thermazene).

Do not spread sulfacetamide sodium topical over a large skin area. Your body may absorb more of this medication if you use too much, or if you apply it to skin that is severely burned, scraped, or irritated.

Stop using this medication and call your doctor if your symptoms do not improve or if they get worse during treatment.

Avoid getting this medication in your nose, mouth, or eyes.

Stop using sulfacetamide sodium topical and call your doctor at once if you have any type of skin rash (mild or severe), joint pain or swelling, fever or sore throat, mouth sores, pale skin, easy bruising or bleeding, unusual weakness, a new or worsening infection, or stomach pain with loss of appetite, dark urine, clay-colored stools, and jaundice (yellowing of the skin or eyes).

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