sulfacetamide topical (Rx)

Brand and Other Names:Klaron, Ovace Plus, more...Ovace Plus Shampoo, Ovace Plus Wash, Ovace Wash
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lotion

  • 10% (Klaron)

cream

  • 10% (Ovace Plus)

shampoo

  • 10% (Ovace Plus Shampoo)

wash, oil in water emulsion

  • 10% (Ovace Plus Wash)

wash

  • 10% (Ovace Wash)

Acne Vulgaris

Klaron: Apply thin film topically to affected areas BID

Seborrheic Dermatitis

Indicated for scaling dermatoses (eg, seborrheic dermatitis, seborrhea sicca [dandruff]); also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides

Ovace Plus Cream: Apply to affeted areas BID x8-10 days

Ovace Wash, Ovace Plus Wash: Wash affected areas BID x 8-10 days

For cream or wash, as condition subsides, lengthen interval between applications to once or twice weekly or every other week to prevent recurrence

Ovace Plus Shampoo: Apply to wet hair and massage vigorously into scalp; rinse thoroughly; use at least twice/week

Administration

Avoid contact with eyes or mucous membranes

Dosage Forms & Strengths

lotion

  • 10% (Klaron)

cream

  • 10% (Ovace Plus)

shampoo

  • 10% (Ovace Plus Shampoo)

wash, oil in water emulsion

  • 10% (Ovace Plus Wash)

wash

  • 10% (Ovace Wash)

Acne Vulgaris

<12 years: Safety and efficacy not established

Klaron ≥12 years: Apply thin film topically to affected areas BID

Seborrheic Dermatitis

Indicated for scaling dermatoses (eg, seborrheic dermatitis, seborrhea sicca [dandruff]); also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides

<12 years: Safety and efficacy not established

≥12 years

  • Ovace Plus Cream: Apply to affeted areas BID x8-10 days
  • Ovace Wash, Ovace Plus Wash: Wash affected areas BID x 8-10 days
  • For cream or wash, as condition subsides, lengthen interval between applications to once or twice weekly or every other week to prevent recurrence
  • Ovace Plus Shampoo: Apply to wet hair and massage vigorously into scalp; rinse thoroughly; use at least twice/week

Administration

Avoid contact with eyes or mucous membranes

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Interactions

Interaction Checker

and sulfacetamide topical

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (1)

                • silver nitrate

                  silver nitrate decreases effects of sulfacetamide topical by Other (see comment). Use Caution/Monitor. Comment: Topical preparations are physically incompatible.

                Minor (0)

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                  Adverse Effects

                  1-10%

                  Erythema

                  Itching

                  Edema

                  Local irritation

                  Stinging

                  Burning

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                  Warnings

                  Contraindications

                  Hypersensitivity

                  Cautions

                  Avoid contact with eyes or mucous membranes

                  Severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias reported

                  Avoid UV exposure

                  Contains sodium metabisulfite that is known to cause allergic reactions

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                  Pregnancy & Lactation

                  Pregnancy Category: C

                  Lactation: not known whether excreted in breast milk, use caution

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Para-aminobenzoic acid (PABA) inhibitor; restricts folic acid synthesis required for bacterial growth

                  Absorption

                  4%

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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  sulfacetamide sodium (acne) topical
                  -
                  10 % suspension
                  sulfacetamide sodium (acne) topical
                  -
                  10 % suspension
                  sulfacetamide sodium (acne) topical
                  -
                  10 % suspension
                  Klaron topical
                  -
                  10 % suspension

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Patient Education
                  sulfacetamide sodium (acne) topical

                  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 right away if your acne worsens, or if you develop a rash or other serious side effects. See Side Effects section.

                  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 this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: 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, get medical help right away 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 or at www.fda.gov/medwatch.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.

                  DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: skin products containing silver.

                  OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. 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. Use your next dose at the regular time. Do not double the dose to catch up.

                  STORAGE: Store at room temperature. Keep all medications 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.

                  Information last revised September 2021. Copyright(c) 2021 First Databank, Inc.

                  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.

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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

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                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.