FLECTOR Patch Ref.[27463] Active ingredients: Diclofenac

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

FLECTOR PATCH is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

2. Dosage and Administration

2.1 General Dosing Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].

The recommended dose of FLECTOR PATCH is one (1) patch to the most painful area twice a day.

2.2 Special Precautions

  • Inform patients that, if FLECTOR PATCH begins to peel-off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad Hold Tite, Surgilast Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable).
  • Do not apply FLECTOR PATCH to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds.
  • Do not wear a FLECTOR PATCH when bathing or showering.
  • Wash your hands after applying, handling or removing the patch.
  • Avoid eye contact
  • Do not use combination therapy with FLECTOR PATCH and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

10. Overdosage

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions (5.1, 5.2, 5.4, 5.6)].

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

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