Flector (Page 2 of 5)

5.4 Hypertension

NSAIDs, including Flector Patch, can lead to new onset or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Use Flector Patch, with caution in patients with hypertension. Monitor blood pressure (BP) closely during the initiation of treatment and throughout the course of therapy.

Patients taking ACE inhibitors, thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs.

5.5 Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs, including Flector Patch. Use Flector Patch with caution in patients with fluid retention or heart failure.

5.6 Renal Effects

Use caution when initiating treatment with Flector Patch in patients with considerable dehydration.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

No information is available from controlled clinical studies regarding the use of Flector Patch in patients with advanced renal disease. Therefore, treatment with Flector Patch is not recommended in these patients with advanced renal disease. If Flector Patch therapy is initiated, close monitoring of the patient’s renal function is advisable.

5.7 Anaphylactic Reactions

As with other NSAIDs, anaphylactic reactions may occur both in patients with the aspirin triad and in patients without known sensitivity to NSAIDs or prior exposure to Flector Patch. Do not prescribe Flector Patch to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Anaphylaxis type reactions have been reported with NSAID products, including diclofenac products, such as Flector Patch [see Contraindications (4) and Warnings and Precautions (5.13)]. Seek emergency help in cases where an anaphylactic reaction occurs.

5.8 Skin Reactions

NSAIDs, including Flector Patch, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin manifestations, and discontinue use of the drug at the first appearance of skin rash or any other signs of hypersensitivity.

5.9 Pregnancy

Starting at 30 weeks gestation, Flector Patch, and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur [see Use in Specific Populations (8.1)].

5.10 Corticosteroid Monitoring

Flector Patch cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Slowly taper patients on prolonged corticosteroid therapy if a decision is made to discontinue corticosteroids.

5.11 Inflammation

The pharmacological activity of Flector Patch in reducing inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

5.12 Hematological Effects

Anemia is sometimes seen in patients receiving NSAIDs. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Flector Patch, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Carefully monitor patients receiving Flector Patch who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants.

5.13 Preexisting Asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, do not administer Flector Patch to patients with this form of aspirin sensitivity and use with caution in patients with preexisting asthma.

5.14 Accidental Exposure in Children

Even a used Flector Patch contains a large amount of diclofenac epolamine (as much as 170 mg). The potential therefore exists for a small child or pet to suffer serious adverse effects from chewing or ingesting a new or used Flector Patch. It is important for patients to store and dispose of Flector Patch out of the reach of children and pets.

5.15 Eye Exposure

Avoid contact of Flector Patch with eyes and mucosa. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour.

5.16 Oral Nonsteroidal Anti-inflammatory Drugs

Concomitant use of oral and topical NSAIDs may result in a higher rate of hemorrhage, more frequent abnormal creatinine, urea and hemoglobin. Do not use combination therapy with Flector Patch and an oral NSAID unless the benefit outweighs the risk.

5.17 Monitoring

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, monitor for signs or symptoms of GI bleeding. Check CBC and a chemistry profile periodically in patients on long-term treatment with NSAIDs. Discontinue Flector Patch if abnormal liver tests or renal tests persist or worsen.

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled trials during the premarketing development of Flector Patch, approximately 600 patients with minor sprains, strains, and contusions have been treated with Flector Patch for up to two weeks.

Adverse Events Leading to Discontinuation of Treatment

In the controlled trials, 3% of patients in both the Flector Patch and placebo patch groups discontinued treatment due to an adverse event. The most common adverse events leading to discontinuation were application site reactions, occurring in 2% of both the Flector Patch and placebo patch groups. Application site reactions leading to dropout included pruritus, dermatitis, and burning.

Common Adverse Events

Localized Reactions

Overall, the most common adverse events associated with Flector Patch treatment were skin reactions at the site of treatment.

Table 1 lists all adverse events, regardless of causality, occurring in ≥ 1% of patients in controlled trials of Flector Patch. A majority of patients treated with Flector Patch had adverse events with a maximum intensity of “mild” or “moderate.”

Table 1. Common Adverse Events (by body system and preferred term) in ≥1% of Patients treated with Flector Patch or Placebo Patch *
Diclofenac N=572 Placebo N=564
N Percent N Percent
*
The table lists adverse events occurring in placebo-treated patients because the placebo-patch was comprised of the same ingredients as Flector Patch except for diclofenac. Adverse events in the placebo group may therefore reflect effects of the non-active ingredients.
Includes: application site dryness, irritation, erythema, atrophy, discoloration, hyperhidriosis, and vesicles.
Includes: gastritis, vomiting, diarrhea, constipation, upper abdominal pain, and dry mouth.
§
Includes: hypoaesthesia, dizziness, and hyperkinesias.
Application Site Conditions 64 11 70 12
Pruritus 31 5 44 8
Dermatitis 9 2 3 <1
Burning 2 <1 8 1
Other 22 4 15 3
Gastrointestinal Disorders 49 9 33 6
Nausea 17 3 11 2
Dysgeusia 10 2 3 <1
Dyspepsia 7 1 8 1
Other 15 3 11 2
Nervous System Disorders 13 2 18 3
Headache 7 1 10 2
Paresthesia 6 1 8 1
Somnolence 4 1 6 1
Other § 4 1 3 <1

Foreign labeling describes that dermal allergic reactions may occur with Flector Patch treatment. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.