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standards of non-Merck sources.
Medication Safety Issues
Sound-alike/look-alike issues:
Bleph®-10 may be confused with Blephamide®
Klaron® may be confused with Klor-Con®
Pronunciation
(sul fa SEE ta mide)
U.S. Brand Names
Index Terms
Generic Available
Yes: Ointment, solution, suspension
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Ophthalmic: Treatment and prophylaxis of conjunctivitis due to susceptible organisms; corneal ulcers; adjunctive treatment with systemic sulfonamides for therapy of trachoma
Dermatologic: Scaling dermatosis (seborrheic); bacterial infections of the skin; acne vulgaris
Pregnancy Risk Factor
C
Pregnancy Considerations
Animal reproduction studies have not been conducted and there are no adequate and well-controlled studies in pregnant women. Use of systemic sulfonamides during pregnancy may cause kernicterus in the newborn; the amount of systemic absorption following topical administration is not known. Use during pregnancy only if clearly needed.
Lactation
Excretion in breast milk unknown/use caution
Breast-Feeding Considerations
The amount of systemic absorption following topical administration is not known. When used orally, small amounts of sulfonamides are excreted in breast milk.
Contraindications
Hypersensitivity to sulfacetamide, sulfonamides, or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:
• Blood dyscrasias: Severe reactions including agranulocytosis, aplastic anemia and other blood dyscrasias have occurred with sulfonamides (regardless of route).
• Dermatologic reactions: Severe reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have occurred with sulfonamides (regardless of route).
• Hepatic necrosis: Fatalities associated with fulminant hepatic necrosis have occurred with sulfonamides (regardless of route).
• Sulfonamide allergy: Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated in product labeling, however, a risk of cross-reaction exists in patients with allergy to any of these compounds; avoid use when previous reaction has been severe.
Dosage form specific issues:
• Ophthalmic: Inactivated by purulent exudates containing PABA; use with caution in severe dry eye. For topical application to the eye only; not for injection. Safety and efficacy have not been established in children <2 months of age.
• Topical: Use caution if applied to denuded or abraded skin. Some products contain sodium metabisulfite which may cause allergic reactions in certain individuals. For external use only; avoid contact with eyes. Safety and efficacy have not been established in children <12 years of age.
Adverse Reactions
Frequency not defined.
Cardiovascular: Edema
Dermatologic: Burning, erythema, irritation, itching, stinging, Stevens-Johnson syndrome
Ocular (following ophthalmic application): Burning, conjunctivitis, conjunctival hyperemia, corneal ulcers, irritation, stinging
Miscellaneous: Allergic reactions, systemic lupus erythematosus
Drug Interactions
Methotrexate: Sulfonamide Derivatives may enhance the adverse/toxic effect of Methotrexate. Risk D: Consider therapy modification
Phenytoin: Sulfonamide Derivatives may decrease the metabolism of Phenytoin. Risk C: Monitor therapy
Procaine: May diminish the therapeutic effect of Sulfonamide Derivatives. Risk X: Avoid combination
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Sulfonamide Derivatives may enhance the anticoagulant effect of Vitamin K Antagonists. Risk D: Consider therapy modification
Storage
Store at controlled room temperature.
Ophthalmic solution: Solution may be used if yellow; do not use if darkened.
Carmol® Scalp treatment: Do not freeze. May be used if slightly discolored.
Compatibility
Incompatible with silver and zinc sulfate.
Incompatible with blood or purulent exudates.
Mechanism of Action
Interferes with bacterial growth by inhibiting bacterial folic acid synthesis through competitive antagonism of PABA
Pharmacodynamics/Kinetics
Half-life elimination: 7-13 hours
Excretion: When absorbed, primarily urine (as unchanged drug)
Dosage
Children >2 months and Adults: Ophthalmic: Solution: Instill 1-2 drops several times daily up to every 2-3 hours in lower conjunctival sac during waking hours and less frequently at night; increase dosing interval as condition responds. Usual duration of treatment: 7-10 days
Trachoma: Instill 2 drops into the conjunctival sac every 2 hours; must be used in conjunction with systemic therapy
Children >12 years and Adults: Topical:
Acne: Apply thin film to affected area twice daily
Seborrheic dermatitis: Apply at bedtime and allow to remain overnight; in severe cases, may apply twice daily. Duration of therapy is usually 8-10 applications; dosing interval may be increased as eruption subsides. Applications once or twice weekly, or every other week may be used to prevent eruptions.
Secondary cutaneous bacterial infections: Apply 2-4 times/day until infection clears
Administration: Topical
Scalp lotion: Shampoo hair with a nonirritating shampoo prior to application. Part hair in sections and apply small quantities of lotion to scalp; rub in gently. Brush hair for 2-3 minutes. May discolor white fabric.
Acne lotion: Shake well before using.
Monitoring Parameters
Response to therapy
Patient Education
Use as directed. Complete full course of therapy even if condition appears improved. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.
Ophthalmic: Do not use other eye preparations at this time without consulting prescriber. Store at room temperature. Shake solution before using. Apply prescribed amount as often as directed. Wash hands before using. Do not let tip of applicator touch eye; do not contaminate tip of applicator (may cause eye infection, eye damage, or vision loss). When using solution, tilt head back and look upward. Gently pull down lower lid and put drop(s) in inner corner of eye. Do not blink for 1/2 minute. Apply gentle pressure to inner corner of eye for 30 seconds. Wipe away excess from skin around eye. Do not use any other eye preparation for at least 10 minutes. Do not share medication with anyone else. May cause sensitivity to bright light (dark glasses may help); temporary stinging or blurred vision may occur. Inform prescriber if you experience eye pain, redness, burning, watering, dryness, double vision, puffiness around eye, vision changes, or other adverse eye response; worsening of condition or lack of improvement within 3-4 days.
Topical: For external use only. Apply a thin film to affected area as often as directed. Do not cover with occlusive dressing; do not apply other lotions, creams, or medications to the area while using this medication. Report increased skin redness, irritation, or development of open sores; or if condition worsens or does not improve.
Geriatric Considerations
Assess whether patient can adequately instill drops or ointment.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Assess for previous sulfonamide allergy. Assess effectiveness (resolution of infection). Teach patient appropriate use (ophthalmic/topical), interventions to reduce side effects, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Aerosal, topical, as sodium [foam]:
Ovace®: 10% (50 g [DSC], 100 g)
Cream, topical, as sodium:
Ovace®: 10% (30 g, 60 g) [DSC]
Seb-Prev™: 10% (30 g, 60 g)
Gel, topical, as sodium:
Ovace® [DSC], Seb-Prev™: 10% (30 g, 60 g)
Lotion, topical, as sodium: 10% (120 mL)
Carmol® Scalp Treatment: 10% (85 g) [contains urea 10%]
Klaron®: 10% (120 mL) [contains sodium metabisulfite]
Lotion, topical, as sodium [wash]:
Ovace®: 10% (180 mL, 360 mL)
Lotion, topical, as sodium [emulsion-based wash]:
Ovace® Plus: 10% (180 mL [DSC], 360 mL [DSC], 480 mL)
Pad, topical, as sodium:
Rosula® NS: 10% (30s) [contains urea 10%]
Soap, topical, as sodium [wash]:
Seb-Prev™: 10% (170 mL, 340 mL)
Solution, ophthalmic, as sodium [drops]: 10% (15 mL)
Bleph®-10: 10% (5 mL) [contains benzalkonium chloride]
Suspension, topical, as sodium: 10% (118 mL)
Pricing: U.S. (www.drugstore.com)
Cream (Ovace)
10% (60): $109.99
Gel (Ovace)
10% (30): $65.99
Liquid (Ovace Plus)
10% (180): $102.22
Liquid (Ovace Wash)
10% (170): $84.32
10% (360): $175.97
Lotion (Carmol Scalp Treatment)
10-10% (85): $131.07
Lotion (Klaron)
10% (118): $142.56
Lotion (Sulfacetamide Sodium (Acne))
10% (118): $97.00
Pads (Rosula NS)
10-10% (30): $176.00
Solution (Bleph-10)
10% (5): $20.99
Solution (Sulfacetamide Sodium)
10% (15): $12.99
References
Lohr JA, Austin RD, Grossman M, et al, “Comparison of Three Topical Antimicrobials for Acute Bacterial Conjunctivitis,” Pediatr Infect Dis J, 1988, 7(9):626-9.
International Brand Names
Lexi-Comp.com
Last full review/revision July 2009
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