text:
Label: FLECTOR patch
- NDC Code(s): 61919-566-30
- Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 60793-411
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 20, 2016
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Cardiovascular Risk
Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [See Warnings and Precautions and (5.1)].
Flector Patch is contraindicated in the peri-operative setting of coronary artery bypass graft (CABG) surgery [See Contraindications (4)].
Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [See Warnings and Precautions (5.2)].
2.1 General Instructions
The recommended dose of Flector Patch is one (1) patch to the most painful area twice a day.
2.2 Special Precautions
- Patients should be informed 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.
- Flector Patch is contraindicated in patients with a known hypersensitivity to diclofenac.
- Flector Patch is contraindicated in 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 Warnings and Precautions (5.7, 5.13)].
- Flector Patch is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)].
- Flector Patch is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds.
5.1 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, use the lowest effective dose 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. Inform patients about the signs and/or symptoms of serious CV events and the steps to take if they occur.
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 Contraindications (4)].
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 NSAIDs, such as diclofenac, does increase the risk of serious GI events [see Warnings and Precautions (5.2)].
5.2 Gastrointestinal Effects – Risk of GI Ulceration, Bleeding, and Perforation
NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse events including 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.
Prescribe NSAIDs, including Flector Patch, with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding 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, use the lowest effective dose for the shortest possible duration. Physicians and patients should remain alert for signs and symptoms of GI ulceration and bleeding during diclofenac therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. For high risk patients, consider alternate therapies that do not involve NSAIDs.
5.3 Hepatic Effects
Borderline elevations (less than 3 times the upper limit of the normal [ULN] range) or greater elevations of transaminases occurred in about 15% of oral diclofenac-treated patients in clinical trials of indications other than acute pain. Of the markers of hepatic function, ALT (SGPT) is recommended for the monitoring of liver injury.
In clinical trials of an oral diclofenac – misoprostol combination product, meaningful elevations (i.e., more than 3 times the ULN) of AST (SGOT) occurred in about 2% of approximately 5,700 patients at some time during diclofenac treatment (ALT was not measured in all studies).
In an open-label, controlled trial of 3,700 patients treated for 2-6 months, patients with oral diclofenac were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% of the 3,700 patients and included marked elevations (>8 times the ULN) in about 1% of the 3,700 patients. In this open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3-8 times the ULN), and marked (>8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis. Almost all meaningful elevations in transaminases were detected before patients became symptomatic.
Abnormal tests occurred during the first 2 months of therapy with oral diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations. In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.
Measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known. Based on clinical trial data and postmarketing experiences, monitor transaminases within 4 to 8 weeks after initiating treatment with diclofenac. However, severe hepatic reactions can occur at any time during treatment with diclofenac.
If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), discontinue Flector Patch immediately. To minimize the possibility that hepatic injury will become severe between transaminase measurements, inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms), and the appropriate action patients should take if these signs and symptoms appear.
To minimize the potential risk for an adverse liver related event in patients treated with Flector Patch, the lowest effective dose should be used for the shortest duration possible. Exercise caution when prescribing Flector Patch with concomitant drugs that are known to be potentially hepatotoxic (e.g., acetaminophen, certain antibiotics, anti-epileptics). Caution patients to avoid taking unprescribed acetaminophen while using Flector Patch.
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.
6.1 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.
7.1 Aspirin
When diclofenac 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.
7.2 Anticoagulants
The effects of anticoagulants such as 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.
7.3 ACE-inhibitors
NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors. Consider this interaction in patients taking NSAIDs concomitantly with ACE-inhibitors.
7.4 Diuretics
Clinical studies, as well as post marketing observations, have shown that NSAIDs can 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, observe the patient closely for signs of renal failure [see Warnings and Precautions (5.6)], as well as to assure diuretic efficacy.
7.5 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, observe patients carefully for signs of lithium toxicity.
7.6 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. Use caution when NSAIDs, including diclofenac, are administered concomitantly with methotrexate.
7.7 Cyclosporine
Diclofenac, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with diclofenac may increase cyclosporine's nephrotoxicity. Use caution when diclofenac is administered concomitantly with cyclosporine.
7.8 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 and conduct periodic laboratory evaluations.
8.1 Pregnancy
Teratogenic Effects
Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation.
Starting at 30 weeks gestation, avoid use of Flector Patch, and other NSAIDS, in pregnant women as premature closure of the ductus arteriosus in the fetus may occur, Flector Patch can cause fetal harm when administered to a pregnant woman starting at 30 weeks gestation. If this drug is used during this time period in pregnancy, inform the patient of the potential hazard to a fetus. There are no adequate and well-controlled studies in pregnant women. Prior to 30 weeks gestation, Flector Patch should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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 via 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.
Nonteratogenic Effects
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.
8.2 Labor and Delivery
The effects of Flector Patch on labor and delivery in pregnant women are unknown. In rat studies, maternal exposure to NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, increased the incidence of dystocia, delayed parturition, and decreased pup survival.
8.3 Nursing Mothers
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.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
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.
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.
For additional information about overdose treatment, call a poison control center (1-800-222-1222).
FLECTOR PATCH (diclofenac epolamine patch) is a nonsteroidal anti-inflammatory drug, available for topical application. FLECTOR PATCH is a 10 cm × 14 cm patch 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.
The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino]benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C20H24Cl2N2O3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical 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
12.1 Mechanism of Action
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.
12.2 Pharmacodynamics
Flector Patch applied to intact skin provides local analgesia by releasing diclofenac epolamine from the patch into the skin.
12.3 Pharmacokinetics
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 (<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/mL while resting, and 2.7 – 7.2 ng/mL during exercise.
Diclofenac has a very high affinity (>99%) for human serum albumin.
Diclofenac diffuses into and out of the synovial fluid. Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels. It is not known whether diffusion into the joint plays a role in the effectiveness of diclofenac.
Five diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4'-hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy diclofenac. The major diclofenac metabolite, 4'hydroxy-diclofenac, has very weak pharmacologic activity. The formation of 4'-hydroxy diclofenac is primarily mediated by CPY2C9. Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acylglucuronidation mediated by UGT2B7 and oxidation mediated by CPY2C8 may also play a role in diclofenac metabolism. CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy and 3'-hydroxy- diclofenac.
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. Little or no free unchanged diclofenac is excreted in the urine. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of either diclofenac epolamine or Flector Patch.
Diclofenac epolamine is not mutagenic in Salmonella typhimurium 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.
- 14.1 Ankle sprains
Efficacy of Flector Patch was demonstrated in two of four studies of patients with minor sprains, strains, and contusions. Patients were randomly assigned to treatment with the Flector Patch, or a placebo patch identical to the Flector Patch minus the active ingredient. In the first of these two studies, patients with ankle sprains were treated once daily for a week. In the second study, patients with sprains, strains and contusions were treated twice daily for up to two weeks. Pain was assessed over the period of treatment. Patients treated with the Flector Patch experienced a greater reduction in pain as compared to patients randomized to placebo patch as evidenced by the responder curves presented below.
Figure 1: Patients Achieving Various Levels of Pain Relief at Day 3; 14-Day Study
Figure 2: Patients Achieving Various Levels of Pain Relief at End of Study; 14-Day Study
Figure 3: Patients Achieving Various Levels of Pain Relief at Day 3; 7-Day Study
Figure 4: Patients Achieving Various Levels of Pain Relief at End of Study; 7-Day StudyClose
The Flector Patch is supplied in resealable envelopes, each containing 5 patches (10 cm × 14 cm), with 6 envelopes per box (NDC 60793-411-30). Each individual patch is embossed with "FLECTOR PATCH <DICLOFENAC EPOLAMINE TOPICAL PATCH> 1.3%".
- Each patch contains 180 mg of diclofenac epolamine in an aqueous base (13 mg of active per gram of adhesive or 1.3%).
- The product is intended for topical use only.
- Keep out of reach of children and pets.
- Curad® Hold Tite™ is a trademark of Medline Industries, Inc., and Surgilast® Tubular Elastic Dressing is a trademark of Derma Sciences, Inc.
Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF) [see USP Controlled Room Temperature].
Distributed by: King Pharmaceuticals Inc.
501 Fifth Street
Bristol TN 37620 USA
Telephone: 1-888-840-8884 www.FlectorPatch.com
Manufactured for: IBSA Institut Biochimique SA, CH-6903 Lugano, Switzerland
Manufactured by: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695 Japan
Ed. VII/08.11
Version August, 2011
- 14.1 Ankle sprains
See Medication Guide
17.1 Information on Medication Guide
Inform patients of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Encourage patients to read the NSAID Medication Guide that accompanies each prescription dispensed prior to using Flector Patch.
17.2 Cardiovascular Effects
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, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and to ask for medical advice when observing any indicative sign or symptoms. Inform patients of the importance of this follow-up [see Warnings and Precautions (5.1)].
17.3 Gastrointestinal Effects
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, inform patients to be alert for the signs and symptoms of ulceration and bleeding, and to ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Instruct patients of the importance of this follow-up [see Warnings and Precautions (5.2)].
17.4 Adverse Skin Reactions
Flector Patch, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious systemic skin reactions may occur without warning, instruct patients to be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and to ask for medical advice when observing any indicative signs or symptoms [see Warnings and Precautions (5.8)]. Advise patients to stop Flector Patch immediately if they develop any type of generalized rash and contact their physicians as soon as possible.
Flector Patch can cause a localized skin reaction at the application site. Advise patients to contact their physicians as soon as possible if they develop any type of localized application site rash.
Instruct patients not to apply Flector Patch to open skin wounds or infections.
17.5 Hepatotoxicity
Inform patients 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, instruct patients to stop therapy with Flector Patch and seek immediate medical therapy [see Warnings and Precautions (5.3)].
17.6 Weight gain and edema
Patients should promptly report to their physician signs or symptoms of unexplained weight gain or edema following treatment with Flector Patch [see Warnings and Precautions (5.5)].
17.7 Anaphylactic Reactions
Inform patients of the signs of an anaphylactic reaction (e.g. difficulty breathing, swelling of the face or throat). If these occur, instruct patients to seek immediate emergency help. Anaphylaxis type reactions have been reported with diclofenac products, including Flector Patch [see Warnings and Precautions (5.7)].
17.8 Preexisting Asthma
Inform patients not to use Flector Patch if they have an aspirin-sensitive asthma. Flector Patch, like other NSAIDs, could cause severe and even fatal bronchospasm in these patients [see Warnings and Precautions (5.13)]. Instruct patients to discontinue use of Flector Patch and to immediately seek emergency help if they experience wheezing or shortness of breath.
17.9 Eye Exposure
Instruct patients to avoid contact of Flector Patch with the 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 [see Warnings and Precautions (5.15)].
17.10 Effects during pregnancy
Starting at 30 weeks gestation, instruct patients to avoid the use of Flector Patch and other NSAIDS, as premature closure of the ductus arteriosus in the fetus may occur [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)].
17.11 General Information on Use
Instruct patients and caregivers to wash their hands after applying, handling or removing the patch.
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).
Instruct patients not to wear Flector Patch during bathing or showering. Bathing should take place in between scheduled patch removal and application [see Dosage and Administration (2)].
Instruct patients 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, instruct patients to seek medical help immediately [see Warnings and Precautions (5.14)].
Inform patients that Flector Patch should be used only on intact skin.
Distributed by: King Pharmaceuticals Inc
501 Fifth Street
Bristol, TN 37620 USA
Telephone: 1-888-840-8884 www.FlectorPatch.com
Manufactured for: IBSA Institut Biochimique SA, CH-6903 Lugano, Switzerland
Manufactured by: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695 Japan
Ed. VII/08.11
Version August, 2011
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Guide for a list of prescription NSAID medicines.)
What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:
- with longer use of NSAID medicines
- in people who have heart disease
NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft" (CABG).
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:
- can happen without warning symptoms
- may cause death
The chance of a person getting an ulcer or bleeding increases with:
- taking medicines called "corticosteroids" and "anticoagulants"
- longer use
- smoking
- drinking alcohol
- older age
- having poor health
NSAID medicines should only be used:
- exactly as prescribed
- at the lowest dose possible for your treatment
- for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:
- different types of arthritis
- menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
- if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
- for pain right before or after heart bypass surgery
Tell your healthcare provider:
- about all of your medical conditions.
- about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
- if you are pregnant, NSAID medicines should not be used past 30 weeks of pregnancy..
- if you are breastfeeding, talk to your doctor.
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
Serious side effects include: Other side effects include:
- heart attack
- stroke
- high blood pressure
- heart failure from body swelling (fluid retention)
- kidney problems including kidney failure
- bleeding and ulcers in the stomach and intestine
- low red blood cells (anemia)
- life-threatening skin reactions
- life-threatening allergic reactions
- liver problems including liver failure
- asthma attacks in people who have asthma
- stomach pain
- constipation
- diarrhea
- gas
- heartburn
- nausea
- vomiting
- dizziness
Get emergency help right away if you have any of the following symptoms:
- shortness of breath or trouble breathing
- chest pain
- weakness in one part or side of your body
- slurred speech
- swelling of the face or throat
Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:
- nausea
- more tired or weaker than usual
- itching
- your skin or eyes look yellow
- stomach pain
- flu-like symptoms
- vomit blood
- there is blood in your bowel movement or it is black and sticky like tar
- unusual weight gain
- skin rash or blisters with fever
- swelling of the arms and legs, hands and feet
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
- Some of these NSAID medicines are sold in lower doses without a prescription (over–the–counter). Talk to your healthcare provider before using over–the–counter NSAIDs for more than 10 days.
NSAID medicines that need a prescription Generic Name Tradename Celecoxib Celebrex Diclofenac Flector, Cataflam, Voltaren, Arthrotec (combined with misoprostol) Diflunisal Dolobid Etodolac Lodine, Lodine XL Fenoprofen Nalfon, Nalfon 200 Flurbirofen Ansaid Ibuprofen Motrin, Tab-Profen, Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone) Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan Ketoprofen Oruvail Ketorolac Toradol Mefenamic Acid Ponstel Meloxicam Mobic Nabumetone Relafen Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole) Oxaprozin Daypro Piroxicam Feldene Sulindac Clinoril Tolmetin Tolectin, Tolectin DS, Tolectin 600
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by: King Pharmaceuticals Inc.
501 Fifth Street
Bristol, TN 37620 USA
Telephone: 1-888-840-8884 www.FlectorPatch.com
Manufactured for: IBSA Institut Biochimique SA, CH-6903 Lugano, Switzerland
Manufactured by: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695 Japan
Ed. VII/08.11
Version August, 2011
flector patch
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-566(NDC:60793-411) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOFENAC EPOLAMINE (UNII: X5F8EKL9ZG) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC EPOLAMINE 180 mg Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONES (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITOL (UNII: 506T60A25R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GELATIN (UNII: 2G86QN327L) KAOLIN (UNII: 24H4NWX5CO) Product Characteristics Color white Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-566-30 30 in 1 CARTON; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021234 01/01/2014 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 relabel(61919-566)


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Sunset on horizon for Fairmont's Tonga Room bar
Looks like twilight time for the tiki torches in the Fairmont Hotel's famed Tonga Room.
The Nob Hill hotel's owners are looking into a big-time condo conversion in the Fairmont tower, and the Tonga Room - with its tropical decor and Hurricane Bar - isn't included in the plans.
The Tonga Room is one of the nation's oldest tiki palaces, dating back to 1945 when MGM's top set director, Mel Melvin, was brought in to transform the Fairmont's indoor swimming pool into a nautical bar.
The result was a South Seas paradise - with a lagoon and a floating stage for the orchestra, a dance floor built from the remains of an old lumber schooner and even periodic tropical storms, complete with thunder and lightning.
The bar underwent a $1 million restoration last year, as the Fairmont's owners sought to ride the wave of the current tiki bar revival.
San Francisco Zoning Administrator Larry Badiner said city planners only recently got word of the Tonga Room's possible demise.
Officially, the hotel's owners, Maritz, Wolff and Co. (the real estate outfit headed by A's boss Lew Wolff), say the Tonga Room's fate has yet to be decided. But hotel reps tell us that as part of the Fairmont's makeover, they hope to move the downstairs Grand Ballroom to a more accessible spot off the main entrance.
And it's that move that would displace the Tonga Room - which means move it or lose it.
"The final outcome is being studied," said Susan Sagy, a spokeswoman for the project.
Round the hall: New 49ers president Jed York and his crew are working the corridors of City Hall in what may signal a renewed push to keep the team in San Francisco.
And maybe even bring the Raiders to the party as well.
Among the ideas on the table:
-- An $8 million to $10 million upgrade of aged Candlestick Park, to be done within two years - complete with a glassed-in club seating area off the south end zone.
-- A much more extensive, $500 million makeover of the 'Stick, with new luxury box seating and a new concourse with restaurants and other amenities.
-- Or even a brand new, $900 million-plus stadium at the old Hunters Point Naval Shipyard, as the city's Candlestick development plan envisions.
York and company met briefly last week with the mayor's chief development director, Michael Cohen, and hinted that after two years of focusing on building a new stadium in Santa Clara, the Niners were ready to start talking more seriously about their options in San Francisco.
York reportedly has told city officials that the team will have more to say on all three fronts when he meets with Mayor Gavin Newsom next week. That tete-a-tete might thaw the deep freeze that developed between the mayor's office and the team when Jed's dad, John York, was in charge.
In the meantime, the 49ers say the National Football League has asked San Francisco to expand the scope of the proposed Hunters Point stadium to accommodate both the 49ers and the Oakland Raiders, who also are searching for a new home. The NFL has asked Santa Clara to do the same.
The league has made it clear that sharing a site may be the only way to privately finance a new stadium in the Bay Area.
In addition to sitting down with Cohen, Jed York had breakfast with Supervisor Sean Elsbernd and met with both new board President David Chiu and Supervisor Carmen Chu.
This week, we're told, he has meetings scheduled with two other new supervisors, John Avalosand Eric Mar.
And while the team is still hoping to make a deal in Santa Clara, "our main goal is to stay in the San Francisco Bay Area," said Niners spokeswoman Lisa Lang. "The more options to make that happen, the better it is for the team, the fans and the community."
New faces: The stars and their entourages were out in force at last weekend's state Republican Party convention in Sacramento - with former top execs Carly Fiorinaand Meg Whitman making their glad-handing debuts as potential candidates.
Of the two, former Hewlett-Packard chief and possible U.S. Senate candidate Fiorina spent the most one-on-one time with party delegates. She made a point of hitting every meeting and sub-meeting of the GOP faithful - but, for now, is turning down all media interviews.
Word is that if Fiorina does run against incumbent Democrat Barbara Boxer, she'll have a lot of East Coast money behind her.
Former eBay CEO Whitman, surrounded by a cadre of suits from Arnold Schwarzenegger's campaigns, took more of a "shock and awe" approach to the convention, saving herself for the "the big speech."
In that luncheon address, Whitman outlined what she would do as governor (be more business-friendly) and tried to explain why she hadn't voted in many past elections. (No real answer, but an apology.)
Ban to breakers: When all is said and done, runners in the Bay to Breakers will probably:
-- Be allowed to run naked.
-- Be able to have floats.
What won't be allowed:
-- Open drinking.
-- And really open drinking, from kegs on "floats."
And finally: "Who knows? It might give a whole new meaning to the smoking tent the governor has." - State Assemblyman Tom Ammiano, D-San Francisco, on his proposal to legalize and tax marijuana.
EXTRA! Catch our new blog at www.sfgate.com/matierandross.

subset: commoncrawl


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Hojjatieh is a group of ultra-orthodox Muslims, who believe that humans can stir up chaos to encourage the return of the Twelfth Imam, a 6 year-old boy who "was hidden by God " around 874 AD. In the West, the members of Hojjatieh (and their related groups in other countries, who subscribe to the same apocalyptic sentiments) are referred to as "Twelvers" or "12th'ers." They believe that they must cause apocalyptic death and destruction to hasten his return. The Ayatollah Khomeini banned the group because they rejected one of the fundamental precepts of the Iranian Revolution: Vilayat-i Faqih (Guardianship of the Jurist). In other words, the 12th'ers, in the view of Khomeini, were opposed to the very idea of an Islamic republic "because it would hinder the Twelfth Imam's return on account of it being too just and peaceful."
Who are some of the members in Hojjatieh? Ahmadinejad spoke about his belief in Twelferism in a speech on 16 November 2005. He is believed to be a member. His spiritual advisor, Mohammad-Taqi Mesbah-Yazdi, who is an ULTRA-conservative hardliner, whom Iranians refer to as the "crocodile" and the "crazed one," is considered the leader. According to reports, at least 4 of Ahmadinejad's 21 cabinet members are members of Hojjatieh. Ayatollah Messbah Yazdi has sought to place his proteges in the Assembly of Experts - the only body in Iran that can constitutionally replace the supreme leader.
Hojjatieh is an underground, Messianic cult. Before some of you jump in and start screaming that, "It is just like Christianity, especially fundamentalist Christianity!" No, it is not. While Christianity does have a Messiah and the Book of Revelations certainly predicts an apocalypse, there is no place in the Bible where the followers of Christ are ordered or even encouraged to engage in activities designed to rain down death and destruction on a mass scale in order to hasten the return of the Messiah. In fact, quite the opposite is the case. Simply put, the Bible says that only god or Christ knows the hour of his return and there is nothing that humans can do to change the timetable. (As an atheist, I encourage any Christians to correct me in the comments section if I am incorrect, but please cite the scripture so that we can all read it). It is nearly the equivalent of Heaven's Gate. You might be fine with nutters like the Hojjatieh, but I would prefer that their fingers be far, far, faraway from a nuke button. Does this mean that I want to invade and occupy Iran? No.


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This digital thank you card is available as a regular or chalkboard style and in 2 sizes 4x6 or 5x7. These thank you cards can be used for Birthdays, Baby Showers, Anniversaries, Weddings, Bridal Showers, Engagements, Holidays and any other sort of special occasion. Thank you cards will be personalized with your message that you include with your order. Ordered thank you card will not have the watermark lines on it.
**IMPORTANT** To receive all my emails in your inbox please add my email address: firstname.lastname@example.com
This thank you card is available in 2 different styles Regular or Chalkboard and 2 different sizes 4x6 or 5x7. Please choose the style and size you would like from the drop down list above.
You will receive 1 thank you card in high resolution 300 dpi as a JPG digital file, emailed to you. After you place your order I will process your order and send you a copy to proof. Pay ONE price for the digital file and you can print as many as you'd like. Ordered digital thank you card will not have the watermark lines on it.
Personalization is included, NO extra charge. A copy of your personalized thank you card will be emailed to you to proof within 24-48 hours. Please make sure you add my email address so you receive the proof in your inbox. Orders will be delayed till I receive an okay to send you the final digital file.
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Stop and check out the other thank you cards I have available. Don't see anything you like, just contact me and let me know what you're looking for so I can custom design something for you.
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Diamondbacks Thank You Card #1Click image to view larger Diamondbacks Thank You Card #1Click image to view larger Regular Thank You CardClick image to view larger Chalkboard Thank You CardClick image to view larger
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Elements Of Style
I Want to Go to There (REAL BAD): Greenwich Hotel
No, it's not in some far flung foreign locale or on a sunny beach of a tropical island- but rather in gritty but grand New York City- The Greenwich Hotel, my new "must stay at" destination for 2013! The rooms are the definition of understated luxury and each looks rather unique with tons of textural details. Did I mention Robert DeNiro owns it? Bonus cool factor.
That big pillow is killing me. So good. The team behind the interiors, Grayling Design, really took their time to craft spaces that feel like home instead of a hotel.
Oh hi amazing bathroom. Look at those sinks, will you? Insanity.
Charm. Charm. Charm.
Interesting. So not your typical hotel lobby at all.
Hold the phone- vintage rugs AND THEY TAKE DOGS?? Pack your bones, Bax and Ollie!
There's that gorgeous green I've been obsessed with! So love it mixed with the natural wood!
That is some tile, y'all.
Clean. Serene. Simple. European. J'Adore!
If those are macaron bedtime treats then you can just kill me now.
I don't think we can even talk about the penthouse. Can we? It feels like we all might freak out and get very depressed if we do.
Yeeeeaaaaahhh. I will never get to stay here.
I hear the spa is amazing. As is the pool.
The restaurant is Locanda Verde– which I also hear is the cat's pajamas (will never understand that saying, BTW)
This makes me think people are right. A good bolognese is my weakness.
Has anyone been? Do tell if you have!


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Late last week, we reported that six-figure checks from former New York City Mayor Michael Bloomberg and two other contributors helped boost the campaign for a proposed Denver college-affordability sales tax ahead of Tuesday's election, enabling the late launch of its first TV ad.
Those donations were revealed by pre-election fundraising reports for three active Denver ballot measure campaigns that covered Oct. 1 through Oct. 28. Here's an updated look at the most recent contributions to the three campaigns, totaling $970,255 for the period.
Total giving now exceeds $2.5 million, including some large-contribution reports filed since last Wednesday's report close.
The information below is an update to this earlier blog post, about the September finance reports. You can read there about individuals and interests who gave heavily during earlier reporting periods.


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Honor the Heroes of the Game, Preserve Its History, Promote its Values & Celebrate Excellence Everywhere
Share your pictures, videos, and stories from your visit to the Pro Football Hall of Fame on our social media. We might even feature you in one of our promotions!
Spirit + Sports Tats by Lulu DK are jewelry-inspired temporary metallic tattoos. Combining Lulu DK's artistic hand-drawn designs with NFL team logos and colors, these stylish fashion accessories allow you to let your pride be known from the game to your everyday ensemble and wear your spirit with style.


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Nudist & Naturist Contacts Worldwide!
Γρήγορη εγγραφή!
Partners Revealed is a trusted global nudist dating site where you can meeet someone special to share your passion for naturism. Nudism is a fun, healthy,liberating and wholesome way for men and women to socialize and live without clothes. Naturism is a long -valued philosophy that places great value on simplicity and living in harmony with nature.


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42 Dishes You Need to Grill Before Summer Is Over
For a delicious party dip to feed a crowd, try making grilled guacamole instead of your usual dip for tortilla chips. Guacamole of all kinds is incredible, but grilling the avocado gives it a smoky flavor you won't forget.
Click here for the Grilled Guacamole recipe.istockphoto.com
Citrus Grilled Shrimp Salad
Bright citrus flavors combine perfectly with basil in this refreshingly light summer salad. With grilled shrimp, pine nuts and a mix of summer produce, you can serve this either as a complete meal or as a side dish for outdoor parties.
Click here for the Citrus Grilled Shrimp Salad recipe.
Grilled Cauliflower Pasta With Lemon-Tahini Dressing
This isn't your average pasta salad. While pasta salads of any kind are one of the best side dishes at any barbecue, this one keeps things interesting with grilled florets of cauliflower and light lemon dressing.
Click here for the Grilled Cauliflower Pasta With Lemon-Tahini Dressing recipe.Pasta Fits
Grilled Peach and Arugula Salad With Mustard Herb Vinaigrette
Side salads are rarely the star of any barbecue, but this one might just steal the spotlight. It's filled with delicious ingredients such as avocado and feta cheese, with almonds to add a delightful crunch and some extra healthy fats. Guests will be coming back for seconds!
Click here for the Grilled Peach and Arugula Salad With Mustard Herb Vinaigrette recipe.California Almonds
Grilled Shrimp Cocktail
If you grew up in the '70s, you probably remember being served shrimp cocktail at dinner parties and gatherings. It's still popular in restaurants, but this appetizer is great enough to make a comeback at the dinner table. Serve up this combo of grilled shrimp and cocktail sauce while entertaining or just relaxing outside.
Click here for the Grilled Shrimp Cocktail recipe.Ditch the Gluten
Grilled Beer and Buttermilk Chicken With Sriracha Glaze
Grilled chicken should never taste boring, and this recipe is far from it. Not only are these chicken wings marinated in a rich sauce, they're also coated with a sweet and spicy Sriracha glaze for an extra kick.
Click here for the Grilled Beer and Buttermilk Chicken With Sriracha Glaze recipe.Istockphoto.com
Grilled Chicken Fajita Recipe
Chicken fajitas are a simple, healthy dinner that comes together in under 30 minutes. They're packed with protein and vegetables, and since they're loaded with a blend of Mexican-inspired spices, they're the opposite of boring. Top yours with salsa, sour cream and guacamole for even more fun.
Click here for the Grilled Chicken Fajita Recipe recipe.istockphoto.com
Grilled Fish Tacos and Taco Sauce
Take a break from grilled burgers and dogs with these light and fresh fish tacos. Tacos are sure to be a hit with any crowd. All that's missing are sides of guac and salsa!
Click here for the Grilled Fish Tacos and Taco Sauce recipe.Istockphoto.com
Grilled Peaches With Sweet Mint Mascarpone
If you're looking for a sweet summer dessert, grilled peaches are easy to make and a healthy choice. Grilling the fruit makes it taste even sweeter, and topping your peaches with mint mascarpone makes these taste like you put in more effort than you actually did.
Click here for the Grilled Peaches with Sweet Mint Mascarpone recipe.Istockphoto.com
Grilled Eggplant and Goat Cheese Salad
With all the meat-heavy dishes at an outdoor cookout, it's nice to have some savory and satisfying side dishes and salads. This one won't disappoint. Covered in cheese and charred, this eggplant dish hardly feels like a vegetable while you eat it.
Click here for the Grilled Eggplant and Goat Cheese Salad recipe.Shutterstock
Grilled Salmon With Meyer Lemons and Creamy Cucumber Salad
If you don't look forward to eating grilled salmon, you're cooking it wrong. This recipe is so simple, anyone can follow it. Once you're done, you'll have a delicious and healthy dinner. Salmon has many health benefits - it's good for your brain and your heart, and it's filled with the healthy fats your body needs.
Click here for the Grilled Salmon With Meyer Lemons and Creamy Cucumber Salad recipe.Amy Neunsinger
Grilled Shrimp With Miso Butter
Add an Asian-inspired dish to your summer cookout menu with these simple but tasty shrimp skewers. Coated in miso butter and spices, they're flavorful and sure to be a hit.
Click here for the Grilled Shrimp With Miso Butter recipe.Shutterstock
Grilled Skirt Steak With Chimichurri
This skirt steak is prepared with cumin, garlic and lime before being grilled, upping the flavor of an already-flavorful cut of meat. Chimichurri is an herb-filled and versatile sauce that adds just a little something extra to this grilled steak dinner.
Click here for the Grilled Skirt Steak With Chimichurri recipe.Signe Birck
Grilled Sweet Potatoes With Soy Sauce, Maple and Bacon
Sweet potatoes get a deep caramelized crust on the grill, especially with the added sugar of a maple-kicked marinade. The combination of sweet and savory is a winner.
Click here for the Grilled Sweet Potatoes with Soy Sauce, Maple and Bacon recipe.William Hereford
Grilled Veggie Kebabs With Green Goddess Dressing
Looking for a tastier way to prepare vegetables? Summer is the perfect time to take out the grill and make kebabs. These vegetables are served with the perfect marinade and dressing to kick up the flavor of your favorite summer produce.
Click here for the Grilled Veggie Kebabs With Green Goddess Dressing recipe.istockphoto.com
Reuben Dog
No cookout is complete without a hot dog cooked on the grill. Even better than a plain frankfurter is a hot dog with over-the-top ingredients. This hot dog is loaded with toppings inspired by a Reuben sandwich - sauerkraut, Swiss cheese, mayonnaise and relish.
Click here for the Reuben Dog recipe.istockphoto.com
Morandi's Grilled Pizza-Style Focaccia
Pizza is one of those foods you probably didn't know you could grill, but should really start. The flame chars the crust of this pizza-inspired focaccia dish, and it cooks up quickly. Serve this as an appetizer and play around with different toppings.
Click here for the Morandi's Grilled Pizza-Style Focaccia recipe.Jacqui Wedewer/The Daily Meal
Spring Herb Lamb Burgers With Whipped Feta and Grilled Tomato
Stray from your usual burger recipes with these juicy lamb burgers. Whipped feta and grilled tomatoes bring out the Mediterranean flavors in this recipe, and, along with freshly cut herbs, they help to balance out the unctuous burger patty.
Click here for the Spring Herb Lamb Burgers With Whipped Feta and Grilled Tomato recipe.Shutterstock
Tender Grilled Pork Chops
Pork and sauerkraut is a dish traditionally made on New Year's, but why not enjoy it year-round? It's warm enough to grill the pork chops in summer instead of cooking them in the oven or over the stove, and using a marinade made with sauerkraut juice adds a tangy, unique flavor that's hard to beat.
Click here for the Tender Grilled Pork Chops recipe.Shutterstock
Grilled Eggplant, Halloumi and Pesto Burgers
Plant-based burgers have gotten fancier, but what ever happened to just eating vegetables? The grilled eggplant is thick and satisfying enough that you won't even miss the meat, and halloumi with pesto adds substance to this healthy meal.
Click here for the Grilled Eggplant, Halloumi and Pesto Burgers recipe.Thinkstock
Slaw Burgers
Combine two summer cookout classics with this recipe for slaw burgers - hearty burger patties topped with slaw before they're placed on your choice of hamburger bun. Go ahead and add cheese, onion or whatever other toppings sound good.
Click here for the Slaw Burgers recipe.Miracle Whip
Grilled Corn With Butter and Lime Salt
Sweet corn is one of the end of summer's most beloved seasonal vegetables, and you want to take advantage of it while you can. Corn is simple to prepare on the grill, and with just a little spice, butter, lime and salt, you have a savory, classic dish that goes with almost any grilled entree.
Click here for the Grilled Corn With Butter and Lime Salt recipe.istockphoto.com
Grilled Peach Cobbler
Peach cobbler is one of the greatest classic American desserts, and with good reason. Summer peaches are sweet and perfect for baking. But did you know you could make this fruit-filled dessert on the grill? Grilling the peaches before cooking them into your final product makes this treat even sweeter.
Click here for the Grilled Peach Cobbler recipe.LongHorn Steakhouse
Grilled Cornbread Panzanella With Avocado
If you like regular croutons, you'll love these croutons made of cornbread. Stale chunks of cornbread are grilled until toasty and golden before they're thrown into a light, healthy panzanella. Fresh herbs elevate this salad even further - just make sure you wash them first before adding them in.
Click here for the Grilled Cornbread Panzanella With Avocado recipe.This is How I Cook
Grilled Steak
If you're grilling steak, you can't go wrong by keeping it simple. Just be sure you have the right cut of meat, some tips from the pros and a little help from a flame, you'll have a five-star dinner ready in no time.
Click here for the Best Grilled Steak recipe.Istockphoto.com
Grilled Jamaican Jerk Chicken
Turn up the heat on your grill game by making some jerk chicken - an authentic Jamaican dish covered with a spicy, savory marinade. You could make it in your oven, but it's great on the grill. You can adjust the spiciness of the marinade to your liking, but if you like spicy food, you'll probably prefer your jerk chicken with a kick.
Click here for the Grilled Jamaican Jerk Chicken recipe.istockphoto.com
Grilled Salmon and Avocado Salad
Salmon and avocado pair well together and they both provide healthy fats that are great for your brain - and they're both great for your heart, too. This recipe is so easy you won't mind making it for yourself at home, and the blend of spices turns this healthy seafood into a real treat to eat.
Click here for the Grilled Salmon and Avocado Salad recipe.shutterstock
Grilled Steak With Blue Cheese Potatoes
There are tons of great ways to cook potatoes, but adding blue cheese is always a good call. Steak and potatoes makes a hearty meal that doesn't take forever to cook, and this marinade is rich with flavor from fresh sprigs of rosemary and a unique blend of spices.
Click here for the Grilled Steak With Blue Cheese Potatoes recipe.Shutterstock
Bacon-Wrapped Grilled Peaches With Balsamic Glaze
The best way to make good use of summer peaches is probably a classic Southern peach pie, but this appetizer comes in at a close second. Wrap peaches in bacon and grill them to a crisp for a fun party appetizer your guests won't expect.
Click here for the Bacon-Wrapped Grilled Peaches With Balsamic Glaze recipe.Shutterstock
Super-Simple Whole Grilled Branzino
Grilling a whole fish may sound intimidating, but it's much simpler than you think. This recipe for branzino involves stuffing the fish with lemon for a low-effort way to add a lot of flavor. And it takes less than 20 minutes to make!
Click here for the Super-Simple Whole Grilled Branzino recipe.Shutterstock
Grilled Balsamic Eggplant, Peppers and Zucchini
Make the most of summer's fantastic produce with this side dish. Seasoning with balsamic vinegar adds a distinct flavor profile and the array of vegetables used in this will result in a colorful, beautiful-looking plate.
Click here for the Grilled Balsamic Eggplant, Peppers and Zucchini recipe.Peapod
Spatchcock Grilled Chicken With Beetroot Slaw
To spatchcock (or butterfly) a chicken is to remove the bird's backbone to allow it to lie flat on the grill and cook evenly. It may sound complicated, but this technique isn't as complicated as you may think. And of course, the perfect thing to balance out a juicy, tender steak is a light, crunchy slaw. This chicken pairs wonderfully with a beet slaw, but you can always pair it with one of our 15 best coleslaw recipes.
Click here for the Spatchcock Grilled Chicken With Beetroot Slaw recipe.Nando's PERi-PERi Sauce
Grilled Chipotle Orange Chicken
Making grilled chicken that isn't boring may sound like a lofty challenge, but this citrus-y recipe makes it easy. Dinner will be on the table in a flash, and you can bet it'll be both healthy and tasty.
Click here for the Grilled Chipotle Orange Chicken recipe.istockphoto.com
Grilled Lemon Pepper Shrimp Kabobs
All you need is a little zest from lemons, olive oil and salt to make these delicious and healthy shrimp skewers. Grill both shrimp and vegetables at the same time for a simple, healthy dish that takes almost zero effort.
Click here for the Grilled Lemon Pepper Shrimp Kabobs recipe.McCormick
Plancha-Grilled Barramundi With Charred Cauliflower, Pomegranate Gremolata, Pistachio and Basil
Pomegranate seeds and pistachios blend perfectly with flaky white fish in this chef-made recipe. Though it may sound complex, it's actually quite simple to make and will fool your guests into thinking you spent hours cooking dinner.
Click here for the Plancha-Grilled Barramundi With Charred Cauliflower, Pomegranate Gremolata, Pistachio and Basil recipe.Crave Fishbar
Why mess with a classic? Sometimes, you just really want a grilled burger. This recipe is all you need to make a restaurant-quality burger at home.
Click here for the Best Burger Recipe Ever.Istockphoto.com
Grilled Crescent Dogs
These make a fun spin on pigs in a blanket and an appetizer that people of all ages will want to devour. Cheese and hot dogs are wrapped in flaky crescent dough before they're grilled to melty, crispy perfection.
Click here for the Grilled Crescent Dogs recipe.Pillsbury
Grilled Spaghetti With a Grilled Chicken and Vegetable Skewer and a Simple Garlic and Herb Sauce
You probably never thought to grill spaghetti, but this recipe will have you wondering why not. After cooking grilled kebabs and a pot of fresh pasta (which is easier to mess up than you might think), the pasta is mixed with an olive oil blend and grilled over the hot flame.
Click here for the Grilled Spaghetti With a Grilled Chicken and Vegetable Skewer and a Simple Garlic and Herb Sauce.Barilla
Grilled Corn and Poblano Tacos
The fillings for these tacos are healthy and take just minutes to prepare. Get all the flavor of grilled corn and vegetables and stuff them into a taco with spicy salsa and cotija cheese. What's not to like?
Click here for the Grilled Corn and Poblano Tacos recipe.Istockphoto.com
Coffee and Chili Rubbed Steak Tip Skewers
Adding coffee to the rub of this steak gives it a rich, chocolatey flavor. Switch up your usual grilling methods with this new technique.
Click here for the Coffee and Chili Rubbed Steak Tip Skewers recipe.Community Coffee
Grilled Flat Iron Tortas
Grilled steak is great eaten on its own with some barbecue sides, but this recipe stuffs it into a hearty sandwich. This cut of steak is super flavorful but still lean, making it a great option to partner with avocado and other ingredients in this Mexican dish.
Click here for the Grilled Flat Iron Tortas recipe.Whole Foods Market
Grilled Eggplant, Tomato and Mozzarella Salad
Fresh basil, oregano and mozzarella bring Italian-inspired flavors to the table in this healthy side dish. Grilling the vegetables before tossing them into the salad gives them a unique smoky, charred flavor. It's the perfect thing to serve with burgers - here's how to make next-level burgers at home.
Click here for the Grilled Eggplant, Tomato and Mozzarella Salad recipe.
More from The Daily Meal:
15 Best Coleslaw Recipes
The Best Hot Dog in Every State
Barbecue Sides to Wow Your Guests At Your Summer Cookout
18 Foods You Should Never Serve at a Cookout
50 Cold Dishes for Hot Days


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Last weekend, when Europe announced that to bail out Cypriot banks, there would be a sizable one-off tax on all bank depositors, there was worry about bank runs elsewhere in Europe. Would depositors in Greece, Italy, and Spain start lining up to (further) move their assets into banks in more stable countries, for fear of a similar fate down the line?
So far that part of the story hasn't borne out. There are good reasons to think that mechanistically, Cyprus is a one-off. Other Eurozone countries don't have such gigantic banking sectors relative to GDP. And the notion that Cyprus is a haven for offshore Russian money is well understood.
But what is a real precedent here is Cyprus getting a tough deal because Angela Merkel is in a re-election fight, and playing tough with Cyprus is politically popular. Her coalition partners and opposition parties have made a big deal of not giving Cyprus a blank check.
So Cypriots are told: Tax your depositors or the ECB will let your banks collapse on Tuesday because of German politics.
And this is explosive.
The above picture is of supporters of Greece's Golden Dawn Party (which is basically a Neo-Nazi party) protesting in front of the German embassy in Athens last night, due to the treatment of Cyprus. The leftist Alexis Tsipras has also been making hay over the treatment of Cyprus, and is doing well in the polls, so this is a common point of agreement for the extreme right and the extreme left. The middle ground New Democracy party — the party with which the rest of Europe prefers to play ball — can only get squeezed.
Meanwhile, Italy faces the risk of another election sometime in the next few months. One of the most salient issues in the February election was the notion that the existing Mario Monti government was just a puppet for Germany and Brussels. Now imagine if elections are held tomorrow against the Cyprus backdrop. The parties that are simpatico with Brussels wouldn't do better.
With the ECB at the ready, there are good arguments that financial contagion will be limited regardless of what happens with Cyprus (if it takes the deal, if it goes bust, if it leaves the Eurozone, etc.). But with the economy going to garbage all over the place, this is a big shot in the arm to politicians and parties that are not going to be so friendly towards the status quo.


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- Home
- Our Departments
- Prince George's County Operations
- Parks & Recreation
- Parks & Facilities
- Trails
- Jug Bay Natural Area Trail
Jug Bay Natural Area Trail
- Boat Ramp
- Boat Tours
- Camping
- Canoe Rentals
- Canoe/Kayak Launch Area
- Fishing
- Horseback Riding Trails
- Kayak Rentals
- Observation Tower
- Pavilion
- Picnic Areas
- Restrooms
- Trails
OverviewJug Bay Natural Area is the headquarters for the Patuxent River Park, the largest freshwater tidal wetland in Maryland. Our amenities will give you a truly unique outdoor experience.
Amenities14 miles of scenic woodland trails for hikers, bicyclists, and horseback riders. The park offers a wide range of amenities for the public including:
- Guided trips
- Daily canoe and kayak rentals
- The park provides facilities for camping and picnics
- 2 fishing areas at Jug Bay that offer good tidal fishing year-round
- 2 standard boat ramps, but no overnight tie-ups or fuel facilities
- Waterfowl hunting permitted in designated areas
- A limited number of blind sites along the river are leased on a seasonal basis
- Educational programs
- American Indian Village
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In response I tweeted on Twitter, "One more reason that customers need the MCM program. I weep for our future."
77 Microsoft certifications I hold, I take Microsoft certifications seriously. As a Microsoft Gold Partner ExtraTeam does, as well, and makes its mark in the professional services industry by hiring the the most highly certified consultants and engineers in the industry.
Judging by the feedback I received to my tweet, I know that other IT Pros share my sense of frustration and dismay about the direction of Microsoft Learning.
Veronica Wei Sopher of Microsoft Learning responded to my tweet, genuinely asking for my feedback - so here it is:
- Take yourself seriously. "Sesame Street" style videos have no place in a professional certification program. As one person wrote, "The costumes? No names? This needs to feel more work related if the sound is muted." How do you think this looks to hiring managers? I can't imagine anything like this coming from the Cisco or CCISP certification programs.
- Be respectful and show ownership. Many IT Pros, such as myself, have invested significant amounts of time preparing for, taking exams, and maintaining their Microsoft certifications. Many do it on their own time and with their own money. It's embarrassing and insulting to all IT Pros to be associated with a program that makes fun of certifications and the process.
- Have integrity. Like other MCM candidates, I spent 21 days in Redmond learning 24x7 about Exchange in the MCM program and I'd do it again in a heartbeat. It was one of the best learning experiences of my life. That's why it was so disappointing when Microsoft Learning canceled the MCM program without any notice, even to the Exchange product group. When Tim Sneath canceled the program in September 2013, he told us that Microsoft Learning was looking into ways to revamp the program. It's been nearly a year later and we have heard absolutely nothing. At this time, the highest level of certification that IT Pros can achieve is an MCSE, which is pretty much worthless due to cheating and brain dumps. There has to be a better top-tier certification for Microsoft products than what is available now.
Have a comment? Please leave one below.


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Grammar nerds, this is figuratively going to make your heads explode. Google's Dictionary function, which provides definitions of words you search, now says literally means… figuratively. The No. 2 definition for literally, as noted by Rob Bricken on io9.com, reads:
"Used for emphasis or to express strong feeling while not being literally true."
So, literally means not literally – an Orwellian denial sure to drive English majors to write their righteous indignation. The problem is, there's no one to blame but ourselves. Google's Dictionary function explains:
The usage examples, images and web definitions on this page were selected automatically by a computer program. They do not necessarily reflect the views of Google Inc. or its employees.
Google is just reflecting this all-too-common error in semantics. But that raises a question: How can we nitpick popular usage if the world's most powerful reference site goes along with the crowd?
You could always wear your heart on your sleeve. (Not literally.) Shirt by Snorg Tees.


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The Dodd-Frank Act did not deal with them, and that's fine, because Congress now understands that private investors are unnecessary to the process.
There does not need to be a middleman to skim a profit from mortgage guarantees either. There is no natural law saying that private investors should participate in government mortgage guarantees while the taxpayers absorb the losses. Fannie was only privatized during the Johnson administration as a revenue gimmick.
As part of their conversion to agency status, Fannie and Freddie should auction off their portfolios of duff mortgages and dodgy mortgage-backed securities, with no guarantees for the bidders. This would have the salutary effect of setting a market price for this garbage, forcing the banks to mark their retained mortgages to market (so far they've marked down the dodgy securities). It would be the end of extend and pretend.
Yes, that would be a big balance sheet hit to the banks. Will marking their loan portfolios make banks insolvent? No, it will recognize the fact that some of them may already be insolvent. Without residential and commercial mortgage loans marked to market, bank financials are works of fiction, just like Japanese banks' financials were in the early '90s.
Yet Fannie and Freddie may have become tools of extend and pretend. Some observers believe that the government is trying to prop up insolvent banks by causing Fannie and Freddie to buy dodgy mortgage-backed securities from the banks at above-market prices, the way
Treasury Secretary Timothy Geithner denied this at the administration's Aug. 17 conference on what to do with Fannie and Freddie. He asked for a careful winding down of Fannie and Freddie's portfolios, which is code for propping up prices of duff loans.
Let's back up. Should the government guarantee mortgages at all? No, as an economic matter, but the middle class demands it. As long as politicians fight over middle-class votes, mortgages will be subsidized. The Obama administration reform proposal, due in January, is expected to include mortgage guarantees.
The tricky question is how to do it without unduly distorting allocation of capital and ensuring borrower suitability. Geithner advocates conflicting goals. Low mortgage rates are inconsistent with private sector mortgage provision. Affordable housing is inconsistent with a floor under house prices. People could afford to buy houses in a downturn if the government would let prices adjust. House prices have further to fall.
Fannie and Freddie were set up to provide a secondary market for mortgages so that mortgage lenders could make more of them. The guarantees were implicit, but in September 2008 they effectively became explicit. Fannie and Freddie now guarantee roughly half of all mortgages, and 95% of new mortgages.
Former St. Louis Fed President William Poole of the Cato Institute pointed out that Fannie and Freddie are no longer necessary for mortgage securitization. But his argument that Fannie and Freddie should be abolished is misplaced politically.
If mortgage finance was left entirely to the private sector, mortgages would be slightly more expensive and harder to get. It's horrible to agree with Geithner on anything, but he has the politics right on mortgage subsidies.
As USA Today recently pointed out, 30-year fixed-rate mortgages would not exist without government guarantees, because no sentient lender would take that bet. If the middle class is to be guaranteed this option--it is an option since equity builds so slowly--then government has to backstop it.
Historically, the government also subsidized mortgages by capping mortgage rates. The old "3-6-3 Club" guaranteed low mortgage rates for borrowers and profits for thrift institutions (the other 3 was for tee-off time). The S&L crisis can be partially attributed to the repeal of Regulation Q in 1979. Fannie's mortgage portfolio became what its officers called a bag of dead cats. No one suggests we go back to fixed mortgage rates.
As Poole observed, politics enter the decision about who should get a mortgage through government mortgage purchasing criteria. His point is amply illustrated by Congress allowing the FHA to insure $729,000 mortgages on $1-million apartments in Tempo, a 98-unit luxury condominium on Gramercy Park in Manhattan. Several other Manhattan luxury buildings have asked for mortgage guarantees.
The money spent guaranteeing larger-than-average mortgages could be better spent on housing for people who need it. The conforming mortgage guarantee limits should go back to the old limit, which was $275,000 a decade ago. We do not need to prop up the prices of expensive houses and Manhattan apartments.
Should we subsidize homeownership in any way? No. Ownership sticks around 67% in the U.S. and other developed countries, no matter how large or small the subsidies. Canada has the same level of ownership without a mortgage interest subsidy.
Mortgage guarantees are part of a huge web of subsidies, chief among which is the sacrosanct mortgage interest deduction, which costs more than $100 billion annually. Not only is it a regressive subsidy, but the cost of the deduction gets packed into the price of housing.
The annual cost of the mortgage interest deduction is twice the entire budget of the Home Affordable Modification Program, the Obama administration's slow-moving plan for mortgage relief for underwater borrowers. Since HAMP does not reduce principal, it might be more efficient to give a tax cut to hedge fund vultures who do. They are asking that the mortgage workout profits of their ostensibly foreign funds not be subject to U.S. tax.
The mortgage interest deduction should be repealed, and not replaced, as long as prices are falling. Another ill-advised tax subsidy is the exclusion from income of large amounts of capital gain on residences, which costs $15 billion annually. This should be left in place only for a short while, with a definite sunset date, to encourage people to take their money out of housing.
Subsidizing homeownership is bad capital allocation and bad housing policy. We would be better off if less capital were devoted to single-family housing. As Paul Krugman has often observed, buying and selling the existing housing stock is not productive economic activity.
While ownership may produce more stable communities, it has contributed to labor immobility. Economic research has shown that ownership prevents people who need jobs from leaving places like Detroit because they own houses, even though their employment chances would improve if they moved.
Housing policy ought to focus on poorer people who are more likely to be ill-housed. We spend four times as much money guaranteeing mortgages as we do building rental housing for poor people. The low-income housing credit is supposed to encourage construction, but the benefits mostly go to investors. Oh, but isn't that just warehousing the poor? Not if housing agencies are given power to kick people out.
Geithner gave lip service to affordable housing. For years, Fannie's political machine successfully conflated mortgage guarantees and outsized portfolio profits for private investors with homeownership and good housing policy. It's too bad that it took a financial meltdown to bust that myth.
Lee Sheppard is a contributing editor of Tax Notes, a Washington-based weekly tax journal. She writes a column for Forbes.
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Miu Miu Cardigans
After completing a PhD in political science, studying mime, and joining the Italian Communist Party, Miuccia Prada inherited her family's leather company and began designing handbags, debuting her first women's ready-to-wear collection in 1988. Since, Prada and her brand of intellectual, offbeat chic has transformed the business into one of the fashion industry's leading luxury houses. Taking its title from Miuccia's childhood nickname, Miu Miu was introduced in 1993 as the main line's playful sister brand. At once effervescent, demure, sensual, and rebellious, Miu Miu's designs uncover the many—and often contradictory—facets of modern femininity. Signature styles include crystal-embellished shoes, knit sweaters, and bejewelled collars, while leather handbags like the Matelasse, Ultimate, and Madras honor the Prada family's leatherworking heritage.
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