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Flector
Overview
What is Flector?
Flector® Patch (10 cm x 14 cm) is comprised of an adhesive
material containing 1.3% diclofenac epolamine which is applied to a non-woven
polyester felt backing and covered with a polypropylene film release liner. The
release liner is removed prior to topical application to the skin.
Diclofenac epolamine is a non-opioid analgesic chemically designated as
2-[(2,6-dichlorophenyl) amino]benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol
salt, with a molecular formula of CHCNO (molecular weight 411.3), an n-octanol/water partition
coefficient of 8 at pH 8.5, and the following structure:
Each adhesive patch contains 180 mg of diclofenac epolamine (13 mg per gram
adhesive) in an aqueous base. It also contains the following inactive
ingredients: 1,3-butylene glycol, dihydroxyaluminum aminoacetate, disodium
edetate, D-sorbitol, fragrance (Dalin PH), gelatin, kaolin, methylparaben,
polysorbate 80, povidone, propylene glycol, propylparaben, sodium
carboxymethylcellulose, sodium polyacrylate, tartaric acid, titanium dioxide,
and purified water.
What does Flector look like?
What are the available doses of Flector?
Sorry No records found.
What should I talk to my health care provider before I take Flector?
Sorry No records found
How should I use Flector?
Carefully consider the potential benefits and risks of Flector®
Patch and other treatment options before deciding to use Flector® Patch. Use the
lowest effective dose for the shortest duration consistent with individual
patient treatment goals (see).
Flector® Patch is indicated for the topical treatment of acute pain due to
minor strains, sprains, and contusions.
Carefully consider the potential benefits and risks of Flector®
Patch and other treatment options before deciding to use Flector® Patch. Use
the lowest effective dose for the shortest duration consistent with individual
patient treatment goals (see).
The recommended dose of Flector® Patch is one (1) patch to the most painful
area twice a day.
Flector® patch should not be applied to damaged or non-intact skin.
Flector® patch should not be worn when bathing or showering.
What interacts with Flector?
Flector® Patch is contraindicated in patients with known hypersensitivity to diclofenac.
Flector® Patch should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see, and).
Flector® Patch is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see).
Flector® Patch should not be applied to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds.
What are the warnings of Flector?
Sulfonamide derivatives, including thiazides, have been reported to
exacerbate or activate systemic lupus erythematosus.
Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to
three years duration have shown an increased risk of serious cardiovascular (CV)
thrombotic events, myocardial infarction, and stroke, which can be fatal. All
NSAIDs, both COX-2 selective and nonselective, may have a similar risk.
Patients with known CV disease or risk factors for CV disease may be at greater
risk. To minimize the potential risk for an adverse CV event in patients
treated with an NSAID, the lowest effective dose should be used for the shortest
duration possible. Physicians and patients should remain alert for the
development of such events, even in the absence of previous CV symptoms.
Patients should be informed about the signs and/or symptoms of serious CV events
and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the
increased risk of serious CV thrombotic events associated with NSAID use. The
concurrent use of aspirin and an NSAID does increase the risk of serious GI
events (see).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the
treatment of pain in the first 10-14 days following CABG surgery found an
increased incidence of myocardial infarction and stroke (see).
NSAIDs, including Flector® Patch, can lead to onset of new
hypertension or worsening of pre-existing hypertension, either of which may
contribute to the increased incidence of CV events. Patients taking thiazides
or loop diuretics may have impaired response to these therapies when taking
NSAIDs. NSAIDs, including Flector® Patch, should be used with caution in
patients with hypertension. Blood pressure (BP) should be monitored closely
during the initiation of NSAID treatment and throughout the course of
therapy.
Fluid retention and edema have been observed in some patients
taking NSAIDs. Flector® Patch should be used with caution in patients with fluid
retention or heart failure.
NSAIDs, including Flector® Patch, can cause serious
gastrointestinal (GI) adverse events including inflammation, bleeding,
ulceration, and perforation of the stomach, small intestine, or large intestine,
which can be fatal. These serious adverse events can occur at any time, with or
without warning symptoms, in patients treated with NSAIDs. Only one in five
patients, who develop a serious upper GI adverse event on NSAID therapy, is
symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs
occur in approximately 1% of patients treated for 3-6 months, and in about 2-4%
of patients treated for one year. These trends continue with longer duration of
use, increasing the likelihood of developing a serious GI event at some time
during the course of therapy. However, even short-term therapy is not without
risk.
NSAIDs should be prescribed with extreme caution in those with a prior
history of ulcer disease or gastrointestinal bleeding. Patients with a who use NSAIDs have a greater than 10-fold increased risk for
developing a GI bleed compared to patients with neither of these risk factors.
Other factors that increase the risk for GI bleeding in patients treated with
NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer
duration of NSAID therapy, smoking, use of alcohol, older age, and poor general
health status. Most spontaneous reports of fatal GI events are in elderly or
debilitated patients and therefore, special care should be taken in treating
this population.
To minimize the potential risk for an adverse GI event in patients treated
with an NSAID, the lowest effective dose should be used for the shortest
possible duration. Patients and physicians should remain alert for signs and
symptoms of GI ulceration and bleeding during NSAID therapy and promptly
initiate additional evaluation and treatment if a serious GI adverse event is
suspected. This should include discontinuation of the NSAID until a serious GI
adverse event is ruled out. For high risk patients, alternate therapies that do
not involve NSAIDs should be considered.
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 a
nonsteroidal anti-inflammatory drug 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.
As with other NSAIDs, anaphylactoid reactions may occur in
patients without known prior exposure to Flector® Patch. Flector® Patch should
not be given 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 (see
and). Emergency help should be sought in cases where an
anaphylactoid reaction occurs.
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. Patients should be informed about the signs and symptoms of
serious skin manifestations and use of the drug should be discontinued at the
first appearance of skin rash or any other sign of hypersensitivity.
In late pregnancy, as with other NSAIDs, Flector® Patch should be
avoided because it may cause premature closure of the ductus arteriosus.
What are the precautions of Flector?
Flector® Patch cannot be expected to substitute for
corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation
of corticosteroids may lead to disease exacerbation. Patients on prolonged
corticosteroid therapy should have their therapy tapered slowly if a decision is
made to discontinue corticosteroids.
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.
Borderline elevations of one or more liver tests may occur in up
to 15% of patients taking NSAIDs including Flector® Patch. These laboratory
abnormalities may progress, may remain unchanged, or may be transient with
continuing therapy. Notable elevations of ALT or AST (approximately three or
more times the upper limit of normal) have been reported in approximately 1% of
patients in clinical trials with NSAIDs. In addition, rare cases of severe
hepatic reactions, including jaundice and fatal fulminant hepatitis, liver
necrosis and hepatic failure, some of them with fatal outcomes have been
reported.
A patient with symptoms and/or signs suggesting liver dysfunction, or in whom
an abnormal liver test has occurred, should be evaluated for evidence of the
development of a more severe hepatic reaction while on therapy with Flector®
Patch. If clinical signs and symptoms consistent with liver disease develop, or
if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Flector®
Patch should be discontinued.
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. Patients receiving
Flector® Patch who may be adversely affected by alterations in platelet
function, such as those with coagulation disorders or patients receiving
anticoagulants, should be carefully monitored.
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, Flector® Patch should not be
administered to patients with this form of aspirin sensitivity and should be
used with caution in patients with preexisting asthma.
Contact of Flector® Patch with eyes and mucosa, although not
studied, should be avoided. If eye contact occurs, immediately wash out the eye
with water or saline. Consult a physician if irritation persists for more than
an hour.
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.
Patients should be informed of the following
information before initiating therapy with an NSAID and periodically during the
course of ongoing therapy. Patients should also be encouraged to read the NSAID
Medication Guide that accompanies each prescription dispensed.
Because serious GI tract ulcerations and bleeding can occur
without warning symptoms, physicians should monitor for signs or symptoms of GI
bleeding. Patients on long-term treatment with NSAIDs, should have their CBC
and a chemistry profile checked periodically. If clinical signs and symptoms
consistent with liver or renal disease develop, systemic manifestations occur
(e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen,
Flector® Patch should be discontinued.
ACE-inhibitors
Reports suggest that NSAIDs may diminish the antihypertensive effect of
ACE-inhibitors. This interaction should be given consideration in patients
taking NSAIDs concomitantly with ACE-inhibitors.
Aspirin
When Flector® Patch is administered with aspirin, the binding of diclofenac
to protein is reduced, although the clearance of free diclofenac is not altered.
The clinical significance of this interaction is not known; however, as with
other NSAIDs, concomitant administration of diclofenac and aspirin is not
generally recommended because of the potential of increased adverse effects.
Diuretics
Clinical studies, as well as post marketing observations, have shown that
Flector® Patch may reduce the natriuretic effect-of furosemide and thiazides in
some patients. This response has been attributed to inhibition of renal
prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient
should be observed closely for signs of renal failure (see), as well as to assure diuretic efficacy.
Lithium
NSAIDs have produced an elevation of plasma lithium levels and a reduction in
renal lithium clearance. The mean minimum lithium concentration increased 15%
and the renal clearance was decreased by approximately 20%. These effects have
been attributed to inhibition of renal prostaglandin synthesis by the NSAID.
Thus, when NSAIDs and lithium are administered concurrently, subjects should be
observed carefully for signs of lithium toxicity.
Methotrexate
NSAIDs have been reported to competitively inhibit methotrexate accumulation
in rabbit kidney slices. This may indicate that they could enhance the toxicity
of methotrexate. Caution should be used when NSAIDs are administered
concomitantly with methotrexate.
Warfarin
The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that
users of both drugs together have a risk of serious GI bleeding higher than
users of either drug alone.
Carcinogenesis
Long-term studies in animals have not been performed to evaluate the
carcinogenic potential of either diclofenac epolamine or Flector Patch.
Mutagenesis
Diclofenac epolamine is not mutagenic in strains, nor does it induce an increase in metabolic
aberrations in cultured human lymphocytes, or the frequency of micronucleated
cells in the bone marrow micronucleus test performed in rats.
Impairment of Fertility
Male and female Sprague Dawley rats were administered 1, 3, or 6 mg/kg/day
diclofenac epolamine via oral gavage (males treated for 60 days prior to
conception and during mating period, females treated for 14 days prior to mating
through day 19 of gestation). Diclofenac epolamine treatment with 6 mg/kg/day
resulted in increased early resorptions and postimplantation losses; however, no
effects on the mating and fertility indices were found. The 6 mg/kg/day dose
corresponds to 3-times the maximum recommended daily exposure in humans based on
a body surface area comparison.
Pregnant Sprague Dawley rats were administered 1, 3, or 6 mg/kg
diclofenac epolamine via oral gavage daily from gestation days 6-15. Maternal
toxicity, embryotoxicity, and increased incidence of skeletal anomalies were
noted with 6 mg/kg/day diclofenac epolamine, which corresponds to 3-times the
maximum recommended daily exposure in humans based on a body surface area
comparison. Pregnant New Zealand White rabbits were administered 1, 3, or 6
mg/kg diclofenac epolamine vial oral gavage daily from gestation days 6-18. No
maternal toxicity was noted; however, embryotoxicity was evident at 6 mg/kg/day
group which corresponds to 6.5-times the maximum recommended daily exposure in
humans based on a body surface area comparison.
There are no adequate and well-controlled studies in pregnant women. Flector
Patch should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
Because of the known effects of nonsteroidal anti-inflammatory
drugs on the fetal cardiovascular system (closure of ductus arteriosus), use
during pregnancy (particularly late pregnancy) should be avoided.
Male rats were orally administered diclofenac epolamine (1, 3, 6 mg/kg) for
60 days prior to mating and throughout the mating period, and females were given
the same doses 14 days prior to mating and through mating, gestation, and
lactation. Embryotoxicity was observed at 6 mg/kg diclofenac epolamine (3-times
the maximum recommended daily exposure in humans based on a body surface area
comparison), and was manifested as an increase in early resorptions,
post-implantation losses, and a decrease in live fetuses. The number of live
born and total born were also reduced as was F1 postnatal survival, but the
physical and behavioral development of surviving F1 pups in all groups was the
same as the deionized water control, nor was reproductive performance adversely
affected despite a slight treatment-related reduction in body weight.
In rat studies with NSAIDs, as with other drugs known to inhibit
prostaglandin synthesis, an increased incidence of dystocia, delayed
parturition, and decreased pup survival occurred. The effects of Flector® Patch
on labor and delivery in pregnant women are unknown.
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human-milk and because of the potential for
serious adverse reactions in nursing infants from Flector® Patch, a decision
should be made whether to discontinue nursing or to discontinue the drug, taking
into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been
established.
Clinical studies of Flector® Patch did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond
differently from younger subjects. Other reported clinical experience has not
identified differences in responses between the elderly and younger
patients.
Diclofenac, as with any NSAID, is known to be substantially excreted by the
kidney, and the risk of toxic reactions to Flector® Patch may be greater in
patients with impaired renal function. Because elderly patients are more likely
to have decreased renal function, care should be taken when using Flector® Patch
in the elderly, and it may be useful to monitor renal function.
Flector® Patch, like other NSAIDs, may cause serious CV side
effects, such as MI or stroke, which may result in hospitalization and even
death. Although serious CV events can occur without warning symptoms, patients
should be alert for the signs and symptoms of chest pain, shortness of breath,
weakness, slurring of speech, and should ask for medical advice when observing
any indicative sign or symptoms. Patients should be apprised of the importance
of this follow-up (see).
Flector® Patch, like other NSAIDs, may cause GI discomfort and,
rarely, serious GI side effects, such as ulcers and bleeding, which may result
in hospitalization and even death. Although serious GI tract ulcerations and
bleeding can occur without warning symptoms, patients should be alert for the
signs and symptoms of ulcerations and bleeding, and should ask for medical
advice when observing any indicative sign or symptoms including epigastric pain,
dyspepsia, melena, and hematemesis. Patients should be apprised of the
importance of this follow-up (see).
Flector® Patch, like other NSAIDs, may cause serious skin side
effects such as exfoliative dermatitis, SJS, and TEN, which may result in
hospitalizations and even death. Although serious skin reactions may occur
without warning, patients should be alert for the signs and symptoms of skin
rash and blisters, fever, or other signs of hypersensitivity such as itching,
and should ask for medical advice when observing any indicative signs or
symptoms. Patients should be advised to stop the drug immediately if they
develop any type of rash and contact their physicians as soon as
possible.
Patients should be instructed to promptly report signs or
symptoms of unexplained weight gain or edema to their physicians (see).
Patients should be informed of the warning signs and symptoms of
hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper
quadrant tenderness, and "flu-like" symptoms). If these occur, patients should
be instructed to stop therapy and seek immediate medical therapy.
Patients should be informed of the signs of an anaphylactoid
reaction (e.g. difficulty breathing, swelling of the face or throat). If these
occur, patients should be instructed to seek immediate emergency help (see).
In late pregnancy, as with other NSAIDs, Flector® Patch should be
avoided because it may cause premature closure of the ductus
arteriosus.
Patients should be advised not to use Flector® Patch if they have
a aspirin-sensitive asthma. Flector® Patch, like other NSAIDs, could cause
severe and even fatal bronchospasm in these patients (see). Patients should discontinue use of Flector® Patch and
should immediately seek emergency help if they experience wheezing or shortness
of breath.
Patients should be informed that Flector® Patch should be used
only on intact skin.
Patients should be advised to avoid contact of Flector® Patch
with eyes and mucosa. Patients should be instructed that if eye contact occurs,
they should immediately wash out the eye with water or saline, and consult a
physician if irritation persists for more than an hour.
Patients and caregivers should be instructed to wash their hands
after applying, handling or removing the patch.
Patients should be informed that, if Flector® Patch begins to
peel off, the edges of the patch may be taped down.
Patients should be instructed not to wear Flector® Patch during
bathing or showering. Bathing should take place in between scheduled patch
removal and application (see).
Patients should be advised to store Flector® Patch and to discard
used patches out of the reach of children and pets. If a child or pet
accidentally ingests Flector® Patch, medical help should be sought immediately
(see).
What are the side effects of Flector?
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.
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.
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.”
| Diclofenac N=572 | Placebo N=564 | ||||||
| N | Percent | N | Percent | ||||
| Application Site Conditions | 64 | 11 | 70 | 12 | |||
| Pruritus | 31 | 5 | 44 | 8 | |||
| Dermatitis | 9 | 2 | 3 | less than 1 | |||
| Burning | 2 | less than 1 | 8 | 1 | |||
| Other | 22 | 4 | 15 | 3 | |||
| Gastrointestinal Disorders | 49 | 9 | 33 | 6 | |||
| Nausea | 17 | 3 | 11 | 2 | |||
| Dysgeusia | 10 | 2 | 3 | less than 1 | |||
| Dyspepsia | 7 | 1 | 8 | 1 | |||
| Other | 15 | 3 | 11 | 2 | |||
| Nerous 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 | less than 1 |
What should I look out for while using Flector?
Flector® Patch is contraindicated in patients with known
hypersensitivity to diclofenac.
Flector® Patch should not be given to patients who have experienced asthma,
urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported
in such patients (see, and).
Flector® Patch is contraindicated for the treatment of peri-operative pain in
the setting of coronary artery bypass graft (CABG) surgery (see).
Flector® Patch should not be applied to non-intact or damaged skin resulting
from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or
wounds.
Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to
three years duration have shown an increased risk of serious cardiovascular (CV)
thrombotic events, myocardial infarction, and stroke, which can be fatal. All
NSAIDs, both COX-2 selective and nonselective, may have a similar risk.
Patients with known CV disease or risk factors for CV disease may be at greater
risk. To minimize the potential risk for an adverse CV event in patients
treated with an NSAID, the lowest effective dose should be used for the shortest
duration possible. Physicians and patients should remain alert for the
development of such events, even in the absence of previous CV symptoms.
Patients should be informed about the signs and/or symptoms of serious CV events
and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the
increased risk of serious CV thrombotic events associated with NSAID use. The
concurrent use of aspirin and an NSAID does increase the risk of serious GI
events (see).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the
treatment of pain in the first 10-14 days following CABG surgery found an
increased incidence of myocardial infarction and stroke (see).
NSAIDs, including Flector® Patch, can lead to onset of new
hypertension or worsening of pre-existing hypertension, either of which may
contribute to the increased incidence of CV events. Patients taking thiazides
or loop diuretics may have impaired response to these therapies when taking
NSAIDs. NSAIDs, including Flector® Patch, should be used with caution in
patients with hypertension. Blood pressure (BP) should be monitored closely
during the initiation of NSAID treatment and throughout the course of
therapy.
Fluid retention and edema have been observed in some patients
taking NSAIDs. Flector® Patch should be used with caution in patients with fluid
retention or heart failure.
NSAIDs, including Flector® Patch, can cause serious
gastrointestinal (GI) adverse events including inflammation, bleeding,
ulceration, and perforation of the stomach, small intestine, or large intestine,
which can be fatal. These serious adverse events can occur at any time, with or
without warning symptoms, in patients treated with NSAIDs. Only one in five
patients, who develop a serious upper GI adverse event on NSAID therapy, is
symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs
occur in approximately 1% of patients treated for 3-6 months, and in about 2-4%
of patients treated for one year. These trends continue with longer duration of
use, increasing the likelihood of developing a serious GI event at some time
during the course of therapy. However, even short-term therapy is not without
risk.
NSAIDs should be prescribed with extreme caution in those with a prior
history of ulcer disease or gastrointestinal bleeding. Patients with a who use NSAIDs have a greater than 10-fold increased risk for
developing a GI bleed compared to patients with neither of these risk factors.
Other factors that increase the risk for GI bleeding in patients treated with
NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer
duration of NSAID therapy, smoking, use of alcohol, older age, and poor general
health status. Most spontaneous reports of fatal GI events are in elderly or
debilitated patients and therefore, special care should be taken in treating
this population.
To minimize the potential risk for an adverse GI event in patients treated
with an NSAID, the lowest effective dose should be used for the shortest
possible duration. Patients and physicians should remain alert for signs and
symptoms of GI ulceration and bleeding during NSAID therapy and promptly
initiate additional evaluation and treatment if a serious GI adverse event is
suspected. This should include discontinuation of the NSAID until a serious GI
adverse event is ruled out. For high risk patients, alternate therapies that do
not involve NSAIDs should be considered.
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 a
nonsteroidal anti-inflammatory drug 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.
As with other NSAIDs, anaphylactoid reactions may occur in
patients without known prior exposure to Flector® Patch. Flector® Patch should
not be given 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 (see
and). Emergency help should be sought in cases where an
anaphylactoid reaction occurs.
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. Patients should be informed about the signs and symptoms of
serious skin manifestations and use of the drug should be discontinued at the
first appearance of skin rash or any other sign of hypersensitivity.
In late pregnancy, as with other NSAIDs, Flector® Patch should be
avoided because it may cause premature closure of the ductus arteriosus.
What might happen if I take too much Flector?
There is limited experience with overdose of Flector® Patch. In
clinical studies, the maximum single dose administered was one Flector® Patch
containing 180 mg of diclofenac epolamine. There were no serious adverse
events.
Should systemic side effects occur due to incorrect use or accidental
overdose of this product, the general measures recommended for intoxication with
non-steroidal anti-inflammatory drugs should be taken.
How should I store and handle Flector?
Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.The Flector® Patch is supplied in resealable envelopes, each containing 5 patches (10 cm x 14 cm), with 6 envelopes per box (). Each individual patch is embossed with “Diclofenac Epolamine Patch 1.3%”.ManufacturerDistributorVersion June 20088283Ed II/06.08 Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 The Flector® Patch is supplied in resealable envelopes, each containing 5 patches (10 cm x 14 cm), with 6 envelopes per box (). Each individual patch is embossed with “Diclofenac Epolamine Patch 1.3%”.ManufacturerDistributorVersion June 20088283Ed II/06.08 Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 The Flector® Patch is supplied in resealable envelopes, each containing 5 patches (10 cm x 14 cm), with 6 envelopes per box (). Each individual patch is embossed with “Diclofenac Epolamine Patch 1.3%”.ManufacturerDistributorVersion June 20088283Ed II/06.08 Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 The Flector® Patch is supplied in resealable envelopes, each containing 5 patches (10 cm x 14 cm), with 6 envelopes per box (). Each individual patch is embossed with “Diclofenac Epolamine Patch 1.3%”.ManufacturerDistributorVersion June 20088283Ed II/06.08 Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 The Flector® Patch is supplied in resealable envelopes, each containing 5 patches (10 cm x 14 cm), with 6 envelopes per box (). Each individual patch is embossed with “Diclofenac Epolamine Patch 1.3%”.ManufacturerDistributorVersion June 20088283Ed II/06.08 Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Flector® Patch applied to intact skin provides local analgesia by
releasing diclofenac epolamine from the patch into the skin. Diclofenac is a
nonsteroidal anti-inflammatory drug (NSAID). In pharmacologic studies,
diclofenac has shown anti-inflammatory, analgesic, and antipyretic activity. As
with other NSAIDs, its mode of action is not known; its ability to inhibit
prostaglandin synthesis, however, may be involved in its anti-inflammatory
activity, as well as contribute to its efficacy in relieving pain associated
with inflammation.
Absorption
Following a single application of the Flector Patch on the upper inner arm,
peak plasma concentrations of diclofenac (range 0.7 – 6 ng/mL) were noted
between 10 – 20 hours of application. Plasma concentrations of diclofenac in
the range of 1.3 – 8.8 ng/mL were noted after five days with twice-a-day Flector
Patch application.
Systemic exposure (AUC) and maximum plasma concentrations of diclofenac,
after repeated dosing for four days with Flector® Patch, were lower (less than 1%)
than after a single oral 50 mg diclofenac sodium tablet.
The pharmacokinetics of Flector® Patch has been tested in healthy volunteers
at rest or undergoing moderate exercise (cycling 20 min/h for 12 h at a mean HR
of 100.3 bpm). No clinically relevant differences in systemic absorption were
observed, with peak plasma concentrations in the range of 2.2 – 8.1 ng/m while
resting, and 2.7 – 7.2 ng/mL during exercise.
Distribution
Diclofenac has a very high affinity (greater than 99%) for human serum albumin.
Metabolism and Excretion
The plasma elimination half-life of diclofenac after application of Flector
Patch is approximately 12 hours. Diclofenac is eliminated through metabolism
and subsequent urinary and biliary excretion of the glucuronide and the sulfate
conjugates of the metabolites.
Non-Clinical Toxicology
Flector® Patch is contraindicated in patients with known hypersensitivity to diclofenac.Flector® Patch should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see, and).
Flector® Patch is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see).
Flector® Patch should not be applied to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds.
Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see).
NSAIDs, including Flector® Patch, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Flector® Patch, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Fluid retention and edema have been observed in some patients taking NSAIDs. Flector® Patch should be used with caution in patients with fluid retention or heart failure.
NSAIDs, including Flector® Patch, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
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 a nonsteroidal anti-inflammatory drug 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.
As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Flector® Patch. Flector® Patch should not be given 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 (see and). Emergency help should be sought in cases where an anaphylactoid reaction occurs.
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. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
In late pregnancy, as with other NSAIDs, Flector® Patch should be avoided because it may cause premature closure of the ductus arteriosus.
(Seeand Clinically or potentially significant drug interactions between fluconazole and the following agents/classes have been observed. These are described in greater detail below:
Oral hypoglycemicsCoumarin-type anticoagulantsPhenytoinCyclosporineRifampinTheophyllineTerfenadineCisaprideAstemizoleRifabutinTacrolimusShort-term benzodiazepines
Astemizole:
Fluconazole tablets coadministered with ethinyl estradiol- and levonorgestrel-containing oral contraceptives produced an overall mean increase in ethinyl estradiol and levonorgestrel levels; however, in some patients there were decreases up to 47% and 33% of ethinyl estradiol and levonorgestrel levels. (See .) The data presently available indicate that the decreases in some individual ethinyl estradiol and levonorgestrel AUC values with fluconazole treatment are likely the result of random variation. While there is evidence that fluconazole can inhibit the metabolism of ethinyl estradiol and levonorgestrel, there is no evidence that fluconazole is a net inducer of ethinyl estradiol or levonorgestrel metabolism. The clinical significance of these effects is presently unknown.
Physicians should be aware that interaction studies with medications other than those listed in the section have not been conducted, but such interactions may occur.
Flector® Patch cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
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.
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Flector® Patch. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.
A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with Flector® Patch. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Flector® Patch should be discontinued.
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. Patients receiving Flector® Patch who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
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, Flector® Patch should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.
Contact of Flector® Patch with eyes and mucosa, although not studied, should be avoided. If eye contact occurs, immediately wash out the eye with water or saline. Consult a physician if irritation persists for more than an hour.
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.
Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.
Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs, should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, Flector® Patch should be discontinued.
ACE-inhibitors
Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
Aspirin
When Flector® Patch is administered with aspirin, the binding of diclofenac to protein is reduced, although the clearance of free diclofenac is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.
Diuretics
Clinical studies, as well as post marketing observations, have shown that Flector® Patch may reduce the natriuretic effect-of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see), as well as to assure diuretic efficacy.
Lithium
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Methotrexate
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Warfarin
The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
Carcinogenesis
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of either diclofenac epolamine or Flector Patch.
Mutagenesis
Diclofenac epolamine is not mutagenic in strains, nor does it induce an increase in metabolic aberrations in cultured human lymphocytes, or the frequency of micronucleated cells in the bone marrow micronucleus test performed in rats.
Impairment of Fertility
Male and female Sprague Dawley rats were administered 1, 3, or 6 mg/kg/day diclofenac epolamine via oral gavage (males treated for 60 days prior to conception and during mating period, females treated for 14 days prior to mating through day 19 of gestation). Diclofenac epolamine treatment with 6 mg/kg/day resulted in increased early resorptions and postimplantation losses; however, no effects on the mating and fertility indices were found. The 6 mg/kg/day dose corresponds to 3-times the maximum recommended daily exposure in humans based on a body surface area comparison.
Pregnant Sprague Dawley rats were administered 1, 3, or 6 mg/kg diclofenac epolamine via oral gavage daily from gestation days 6-15. Maternal toxicity, embryotoxicity, and increased incidence of skeletal anomalies were noted with 6 mg/kg/day diclofenac epolamine, which corresponds to 3-times the maximum recommended daily exposure in humans based on a body surface area comparison. Pregnant New Zealand White rabbits were administered 1, 3, or 6 mg/kg diclofenac epolamine vial oral gavage daily from gestation days 6-18. No maternal toxicity was noted; however, embryotoxicity was evident at 6 mg/kg/day group which corresponds to 6.5-times the maximum recommended daily exposure in humans based on a body surface area comparison.
There are no adequate and well-controlled studies in pregnant women. Flector Patch should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.
Male rats were orally administered diclofenac epolamine (1, 3, 6 mg/kg) for 60 days prior to mating and throughout the mating period, and females were given the same doses 14 days prior to mating and through mating, gestation, and lactation. Embryotoxicity was observed at 6 mg/kg diclofenac epolamine (3-times the maximum recommended daily exposure in humans based on a body surface area comparison), and was manifested as an increase in early resorptions, post-implantation losses, and a decrease in live fetuses. The number of live born and total born were also reduced as was F1 postnatal survival, but the physical and behavioral development of surviving F1 pups in all groups was the same as the deionized water control, nor was reproductive performance adversely affected despite a slight treatment-related reduction in body weight.
In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Flector® Patch on labor and delivery in pregnant women are unknown.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human-milk and because of the potential for serious adverse reactions in nursing infants from Flector® Patch, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Flector® Patch did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Diclofenac, as with any NSAID, is known to be substantially excreted by the kidney, and the risk of toxic reactions to Flector® Patch may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when using Flector® Patch in the elderly, and it may be useful to monitor renal function.
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.
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.
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.”
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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