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OvacePlus Plus

RxNorm 1006683· SULFACETAMIDE SODIUM· TOPICAL

Mission Pharmacal Company

Indications and usage

INDICATIONS: This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Dosage and administration

DOSAGE AND ADMINISTRATION: Seborrheic dermatitis including seborrhea sicca - Shake well before using. Apply to affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Repeat application as described for eight to ten days. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of this product should be reinitiated as at the beginning of treatment. Secondary cutaneous bacterial infections - Shake well before using. Apply to affected areas twice daily for eight to ten days.

Warnings

WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF THE REACH OF CHILDREN.

Contraindications

CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

Adverse events

Most frequently reported events (FDA FAERS). Report frequency does not imply causation.

  • drug hypersensitivity62
  • drug ineffective51
  • nausea36
  • dyspnoea33
  • headache33
  • rash29
  • off label use28
  • pain27
  • weight decreased24
  • fatigue23
  • dizziness20
  • vomiting20
  • anxiety19
  • erythema19
  • asthenia18
  • back pain18

Adverse reactions (label)

ADVERSE REACTIONS: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).