Drugs Details

Drugs Info of Klaron, Mexar, Ovace, Ovace Plus, RE 10, Sebizon, Seb-Prev
Drugs Details
  • Drugs Type  : FDA
  • Date : 14th Jul 2015 04:26 am
  • Brand Name : Klaron, Mexar, Ovace, Ovace Plus, RE 10, Sebizon, Seb-Prev
  • Generic Name :  sulfacetamide sodium topical (Pronunciation: SUL fa SEET a mide SOE dee um TOP i kal)
Descriptions

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:

  • 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...

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,...

Indications

Klaron (sodium sulfacetamide lotion) Lotion is indicated in the topical treatment of acne vulgaris.

Dosage Administration

Apply a thin film to affected areas twice daily.

How Supplied

4 FL OZ (118mL) bottles (NDC 0066-7500-04).

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP].

Shake well before using. Keep tightly closed.

Side Effects

In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Klaron (sodium sulfacetamide lotion) Lotion was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Klaron (sodium sulfacetamide lotion) Lotion had adverse reactions of erythema, itching and edema. It has been reported that sodium sulfacetamide may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of medication has to be discontinued.

Interactions

No information provided.

Warnings

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).

Klaron (sodium sulfacetamide lotion) Lotioncontains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section).

Precautions

General

For external use only. Keep away from eyes. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sodium sulfacetamide can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

Keep out of the reach of children.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

Category C: Animal reproduction studies have not been conducted with Klaron® (sodium sulfacetamide lotion) Lotion. It is also not known whether Klaron (sodium sulfacetamide lotion) Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Klaron (sodium sulfacetamide lotion) Lotion should be given to a pregnant woman only if clearly needed.

Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Klaron (sodium sulfacetamide lotion) Lotion in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Nursing Mothers

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Klaron (sodium sulfacetamide lotion) Lotion. Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

Pediatric Use

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

OverDose

No information provided.

ContrainDications

Klaron (sodium sulfacetamide lotion) Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).

Clinical Pharamacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.

The pharmacokinetics of sulfacetamide and its major metabolite sulfaniliamide in Klaron (sodium sulfacetamide lotion) Lotion was evaluated in adult subjects (N=14) with acne vulgaris. The subjects applied Klaron (sodium sulfacetamide lotion) Lotion to their face, back, chest and shoulders every 12 hours for 28 days. The percentage of the applied dose of Klaron (sodium sulfacetamide lotion) Lotion excreted in the urine as sulfacetamide plus sulfanilamide, ranged from 0.08 to 0.33%.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

SODIUM SULFACETAMIDE SUSPENSION - TOPICAL (ACNE ONLY)

 

(sull-fuh-SEET-uh-mide)

 

COMMON BRAND NAME(S): Klaron

 

USES: This medication is used to treat acne. It works by stopping the growth of certain bacteria on the skin that can worsen acne. Sodium sulfacetamide belongs to a class of drugs known as sulfa antibiotics.

 

HOW TO USE: This medication is for use on the skin only.

Shake the container well before each use. With clean hands, apply a thin film of the lotion to the areas of skin with acne, usually twice daily or as directed by your doctor. Wash your hands with soap and water after each use.

Avoid getting this medication in the eyes, nose, or mouth. If you do get medication into these areas, rinse with plenty of water.

Use this medication regularly to get the most benefit from it. Do not use large amounts of this medication, use it more often, or use it for a longer time than prescribed. Your condition will not improve any faster, and your risk of side effects may be increased.

Tell your doctor if your acne does not improve after a few weeks. Stop using this medication and tell your doctor immediately if your acne worsens, or if you develop a rash or other serious side effects. See Side Effects section.

Consumer Overview Side Effect

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.

 

Read the Klaron (sodium sulfacetamide lotion) Side Effects Center for a complete guide to possible side effects

Learn More »

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.

 

 

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: skin products containing silver.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Keep all medical appointments.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C). Keep the container cap tightly closed. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Patient Detailed Side Effect

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

Generic Name: sulfacetamide sodium topical (Pronunciation: SUL fa SEET a mide SOE dee um 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 antibiotic that fights 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 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:

  • 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;
  • nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

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.

Read the Klaron (sodium sulfacetamide lotion) Side Effects Center for a complete guide to possible side effects

Learn More »

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 lupus, asthma or a sulfite allergy, or if you are also using silver sulfadiazine (Silvadene, Thermazene).

Do not use sulfacetamide sodium topical over large skin areas.

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).

Patient Detailed How Take

What should I discuss with my healthcare provider before using sulfacetamide sodium topical?

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

To make sure you can safely use sulfacetamide sodium topical, tell your doctor if you have lupus, asthma or a sulfite allergy.

FDA pregnancy category C. It is not known whether sulfacetamide sodium topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether sulfacetamide sodium topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child younger than 12 years old.

How should I use sulfacetamide sodium topical?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may need to shake the medication before each use. Follow the directions on your medicine label.

Make sure the treatment area is clean and dry before using sulfacetamide sodium topical cream, gel, lotion, or solution. Apply the medication in a thin layer and rub in gently.

To use sulfacetamide sodium soap, wet the skin and apply enough of the medication to work into a lather. Massage the lather on the skin gently and then rinse thoroughly with plain water. Pat the skin dry with a clean towel.

Apply the foam to dry hair when treating your scalp. Massage gently into the scalp until all the foam dissolves. Allow the foam to dry completely on the treated area.

Do not apply sulfacetamide sodium topical over large skin areas.

Wash your hands after applying this medication.

If you are using this medication on your scalp, wash your hair with a non-medicated shampoo at least once per week during treatment.

Sulfacetamide sodium topical is usually applied 2 times per day for 8 to 10 days. Space your doses evenly by applying the medication at the same times each day.

You may need to keep using the medication once or twice per week, or once every other week. Follow your doctor's instructions. Call your doctor if your condition comes back after you stop using sulfacetamide sodium topical.

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

Store at room temperature away from moisture and heat. Do not freeze.

Store the foam canister upright and keep away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

Patient Detailed Avoid Taking

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea and vomiting, blood in your urine, or urinating less than usual.

What should I avoid while using sulfacetamide sodium topical?

Do not use this medication for any skin infection that has not been checked by a doctor.

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use the medication on sunburned, windburned, dry, chapped, irritated, or broken skin. Avoid getting sulfacetamide sodium topical soap on your eyelids or lips while washing with it.

Avoid getting this medication on your clothing. Sulfacetamide sodium topical may leave a slight yellow color on light fabrics.

Avoid exposure to sunlight or tanning beds. Sulfacetamide sodium topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using other medications on the areas you treat with sulfacetamide sodium topical unless your doctor tells you to.

What other drugs will affect sulfacetamide sodium topical?

Tell your doctor about all other medications you use, especially silver sulfadiazine (Silvadene, Thermazene, and others).

This list is not complete and other drugs may interact with sulfacetamide sodium topical. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about sulfacetamide sodium topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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