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Pope Francis Visits Benedict XVI,Tells Him 'We're Brothers'
The two men in white embraced and showed one another the deference owed a pope in ways that surely turned Vatican protocol upside down: A reigning pope telling a retired one, "We are brothers," and insisting that they pray side-by-side during a date to discuss the future of the Catholic Church.
Pope Francis traveled Saturday from the Vatican to this hilltown south of Rome to have lunch with his predecessor, Benedict XVI, an historic and potentially problematic melding of the papacies that has never before confronted the church.
In a season of extraordinary moments, starting with Benedict's resignation and climaxing with the election of the first Latin American pope, Saturday's encounter provided perhaps the most enduring images of this papal transition as popes present and past embraced, prayed and broke bread together.
"It was a moment of great communion in the church," said the Vatican spokesman, the Rev. Federico Lombardi. "The spiritual union of these two people is truly a great gift and a promise of serenity for the church."
Benedict, 85, has been living at the papal retreat in Castel Gandolfo since he stepped down Feb. 28 and became the first pope to resign in 600 years. From the moment he was elected, Francis, 76, made clear he would go visit him, refusing in a way to let Benedict remain "hidden from the world" as he had intended.
Wearing a white quilted jacket over his white cassock to guard against the spring chill, Benedict greeted Francis on the helipad of the Castel Gandolfo gardens as soon as the papal helicopter landed. They embraced and clasped hands. And in a series of gestures that followed, Benedict made clear that he considered Francis to be pope while Francis made clear he considered his predecessor to be very much a revered brother and equal.
Traveling from the helipad to the palazzo, Benedict gave Francis the seat on the right-hand side of the car, the traditional place of the pope, while Benedict sat on the left. When they entered the chapel inside the palazzo to pray, Benedict tried to direct Francis to the papal kneeler in the front, but Francis refused.
Taking Benedict's hands and drawing him near, Francis said, "No, we are brothers," Lombardi said. The two used a longer kneeler in the pews and prayed side-by-side, the papal kneeler facing the altar left vacant.
It was a gesture that, 10 days into Francis' papacy, is becoming routine: a shunning of the trappings of the papacy in favor of a collegial and simple style that harks back to his Jesuit roots and ministry in the slums of Buenos Aires.
Francis also brought a gift for Benedict, an icon of the Madonna.
"They told me it's the Madonna of Humility," Francis told Benedict. "Let me say one thing: When they told me that, I immediately thought of you, at the many marvelous examples of humility and gentleness that you gave us during your pontificate."
Benedict replied: "Grazie, grazie."
Outside the villa, the main piazza of Castel Gandolfo was packed with well-wishers bearing photos of both popes and chanting "Francesco! Francesco!" But the crowd soon dissipated after Francis' helicopter left 2.5 hours later, without either pope coming to the balcony as many had hoped.
The Vatican downplayed the remarkable reunion in keeping with Benedict's desire to stay out of the spotlight so as not to interfere with his successor's papacy. There was no live coverage by Vatican television, and only a short video and still photos were released after the meeting. No details of the pair's private talks or lunch were released.
All of which led to enormous speculation about what these two men in white might have said to one another. That the former Cardinal Jorge Mario Bergoglio was second only to Cardinal Joseph Ratzinger in the 2005 conclave that elected Ratzinger pope — considered then to be the "anti-Ratzinger" candidate — only added to the popular imagination about what two men with such radically different styles, backgrounds and priorities might have chatted about over lunch.
Perhaps during their primo, or pasta course, they discussed the big issues facing the church: the rise of secularism in the world, the drop in priestly vocations in Europe, the competition that the Catholic Church faces in Latin America and Africa from evangelical Pentecostal movements.
During their secondo, or second course of meat or fish, they may have discussed more pressing issues about Francis' new job: Benedict left a host of unfinished business on Francis' plate, including the outcome of a top-secret investigation into the leaks of papal documents last year that exposed corruption and mismanagement in the Vatican administration. Francis might have wanted to sound Benedict out on his ideas for management changes in the Holy See administration, a priority given the dysfunctional government he has inherited.
Benedict's resignation — and his choices about his future — have raised the not-insignificant question of how the Catholic Church will deal with the novel situation of having one reigning and one retired pope living side-by-side.
Before Benedict announced his decision to be known as "emeritus pope" and "Your Holiness," one of the Vatican's leading canon lawyers, the Jesuit Rev. Gianfranco Ghirlanda, penned an article suggesting that such a title would be inappropriate for Benedict since in renouncing the papacy he had "lost all the power of primacy" conferred on him by his election. The Vatican had originally said Benedict would likely be known as "emeritus bishop of Rome" precisely to avoid confusion with the new pope.
But Benedict went ahead with the title and chose to keep wearing the white cassock of the papacy, albeit without the sash and cape worn by Francis, leading to questions about both his own influence on the future pontiff and whether Catholics more favorable to his traditional style might try to undermine his successor's authority and agenda by keeping their allegiance to the old pope.
Clearly aware of that potential, Benedict in his last meeting with his cardinals on Feb. 28 pledged his "unconditional reverence and obedience" to the then-unknown future pope, who was nevertheless in the room.
Lombardi said he understood Benedict had repeated that pledge of obedience to Francis on Saturday. Asked how the popes addressed one another, Lombardi demurred, saying he didn't think they addressed one another as "Your Holiness" or "Pope," saying the exchange was too familiar and warm for such titles.
The two men couldn't be more different in style and background: The Argentine-born Francis has made headlines with his simple gestures — no papal regalia, simple black shoes, paying his own hotel bill — and basic message that a pope's job is to protect the poor.
As archbishop of Buenos Aires, the man now known as Pope Francis worked in the slums, celebrating Masses for prostitutes and drug addicts. He plans to celebrate Holy Thursday Mass this week at a juvenile detention center, where he will wash the feet of 12 inmates in a show of humility echoing that of Jesus.
The German-born Benedict is an academic, one of the world's leading theologians who spent more than 30 years in the frescoed halls of the Vatican where he was first its chief doctrinal watchdog and then its pope. His primary concern was to remind Christians in Europe of their faith and bring back a more traditional Catholic identity, and with it the brocaded style of the papacy. His Holy Thursday Masses included the traditional foot-washing, but it involved clerics at the St. John Lateran basilica.
While there is a difference in style, there is a "radical" convergence in their spirituality, according to Civilta Cattolica, the Italian Jesuit magazine whose articles are approved by the Vatican before publication.
"They are two figures of the highest spirituality, whose relationship with life is completely anchored in God," the magazine wrote. "This radicalness is shown in Pope Benedict's shy and kind bearing, and in Pope Francis it is revealed by his immediate sweetness and spontaneity."


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Label: NAPROXEN tablet
Contains inactivated NDC Code(s)
NDC Code(s): 33261-081-02, 33261-081-15, 33261-081-20, 33261-081-24, view more33261-081-30, 33261-081-60, 33261-081-90, 33261-128-02, 33261-128-30, 33261-128-60 - Packager: Aidarex Pharmaceuticals LLC
- This is a repackaged label.
- Source NDC Code(s): 53746-188, 53746-190
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated January 17, 2014
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Cardiovascular Risk
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fate. This risk may increase with duration of use. Patient with cardiovascular disease or risk factor for cardiovascular disease may be at great risk (see WARNINGS).
- Naproxen as Naproxen Tablets, USP is contraindicated for the treatment of peri0operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
- NSAIDs cause increased risk of serious gastrointestinal adverse event including, 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).
Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.
The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure:
Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3.
Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.
Naproxen Tablets, USP are available as white tablets containing 250 mg of naproxen, white tablets containing 375 mg of naproxen and white tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are Croscarmellose Sodium, Povidone and Magnesium Stearate.
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. The mechanism of action of the naproxen anion, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.
Naproxen is rapidly and completely absorbed from the gastrointestinal tract with an in vivo bioavailability of 95%. The different dosage forms of naproxen are bioequivalent in terms of extent of absorption (AUC) and peak concentration (Cmax); however, the products do differ in their pattern of absorption. These differences between naproxen products are related to both the chemical form of naproxen used and its formulation. Even with the observed differences in pattern of absorption, the elimination half-life of naproxen is unchanged across products ranging from 12 to 17 hours. Steady-state levels of naproxen are reached in 4 to 5 days, and the degree of naproxen accumulation is consistent with this half-life. This suggests that the differences in pattern of release play only a negligible role in the attainment of steady-state plasma levels.
Immediate Release
After administration of Naproxen Tablets, USP, peak plasma levels are attained in 2 to 4 hours.
Naproxen has a volume of distribution of 0.16 L/kg. At therapeutic levels naproxen is greater than 99% albumin bound. At doses of naproxen greater than 500 mg/day there is less than proportional increase in plasma levels due to an increase in clearance caused by saturation of plasma protein binding at higher doses (average trough Css 36.5, 49.2, and 56.4 mg/L with 500, 1000 and 1500 mg daily doses of naproxen, respectively). The naproxen anion has been found in milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma (see PRECAUTIONS: Nursing Mothers).
Naproxen is extensively metabolized in the liver to 6-0-desmethyl naproxen, and both parent and metabolites do not induce metabolizing enzymes. Both naproxen and 6-0-desmethyl naproxen are further metabolized to their respective acylglucuronide conjugated metabolites.
The clearance of naproxen is 0.13 mL/min/kg. Approximately 95% of the naproxen from any dose is excreted in the urine, primarily as naproxen (<1%), 6-0-desmethyl naproxen (<1%) or their conjugates (66% to 92%). The plasma half-life of the naproxen anion in humans ranges from 12 to 17 hours. The corresponding half-lives of both naproxen's metabolites and conjugates are shorter than 12 hours, and their rates of excretion have been found to coincide closely with the rate of naproxen disappearance from the plasma. Small amounts, 3% or less of the administered dose, are excreted in the feces. In patients with renal failure metabolites may accumulate (see WARNINGS: Renal Effects).
Special Populations
Geriatric Patients
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly, although the unbound fraction is < 1% of the total naproxen concentration. Unbound trough naproxen concentrations in elderly subjects have been reported to range from 0.12% to 0.19% of total naproxen concentration, compared with 0.05% to 0.075% in younger subjects. The clinical significance of this finding is unclear, although it is possible that the increase in free naproxen concentration could be associated with an increase in the rate of adverse events per a given dosage in some elderly patients.
Pharmacokinetic differences due to race have not been studied.
Hepatic Insufficiency
Naproxen pharmacokinetics has not been determined in subjects with hepatic insufficiency.
Renal Insufficiency
Naproxen pharmacokinetics has not been determined in subjects with renal insufficiency. Given that naproxen, its metabolites and conjugates are primarily excreted by the kidney, the potential exists for naproxen metabolites to accumulate in the presence of renal insufficiency. Elimination of naproxen is decreased in patients with severe renal impairment. Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects).
General Information
Naproxen has been studied in patients with rheumatoid arthritis, osteoarthritis, juvenile arthritis, ankylosing spondylitis, tendonitis and bursitis, and acute gout. Improvement in patients treated for rheumatoid arthritis was demonstrated by a reduction in joint swelling, a reduction in duration of morning stiffness, a reduction in disease activity as assessed by both the investigator and patient, and by increased mobility as demonstrated by a reduction in walking time. Generally, response to naproxen has not been found to be dependent on age, sex, severity or duration of rheumatoid arthritis.
In patients with osteoarthritis, the therapeutic action of naproxen has been shown by a reduction in joint pain or tenderness, an increase in range of motion in knee joints, increased mobility as demonstrated by a reduction in walking time, and improvement in capacity to perform activities of daily living impaired by the disease.
In a clinical trial comparing standard formulations of naproxen 375 mg bid (750 mg a day) vs 750 mg bid (1500 mg/day), 9 patients in the 750 mg group terminated prematurely because of adverse events. Nineteen patients in the 1500 mg group terminated prematurely because of adverse events. Most of these adverse events were gastrointestinal events.
In clinical studies in patients with rheumatoid arthritis, osteoarthritis, and juvenile arthritis, naproxen has been shown to be comparable to aspirin and indomethacin in controlling the aforementioned measures of disease activity, but the frequency and severity of the milder gastrointestinal adverse effects (nausea, dyspepsia, heartburn) and nervous system adverse effects (tinnitus, dizziness, lightheadedness) were less in naproxen-treated patients than in those treated with aspirin or indomethacin.
In patients with ankylosing spondylitis, naproxen has been shown to decrease night pain, morning stiffness and pain at rest. In double-blind studies the drug was shown to be as effective as aspirin, but with fewer side effects.
In patients with acute gout, a favorable response to naproxen was shown by significant clearing of inflammatory changes (e.g., decrease in swelling, heat) within 24 to 48 hours, as well as by relief of pain and tenderness.
Naproxen has been studied in patients with mild to moderate pain secondary to postoperative, orthopedic, postpartum episiotomy and uterine contraction pain and dysmenorrhea. Onset of pain relief can begin within 1 hour in patients taking naproxen. Analgesic effect was shown by such measures as reduction of pain intensity scores, increase in pain relief scores, decrease in numbers of patients requiring additional analgesic medication, and delay in time to remedication. The analgesic effect has been found to last for up to 12 hours.
Naproxen may be used safely in combination with gold salts and/or corticosteroids; however, in controlled clinical trials, when added to the regimen of patients receiving corticosteroids, it did not appear to cause greater improvement over that seen with corticosteroids alone. Whether naproxen has a "steroid-sparing" effect has not been adequately studied. When added to the regimen of patients receiving gold salts, naproxen did result in greater improvement. Its use in combination with salicylates is not recommended because there is evidence that aspirin increases the rate of excretion of naproxen and data are inadequate to demonstrate that naproxen and aspirin produce greater improvement over that achieved with aspirin alone. In addition, as with other NSAIDS, the combination may result in higher frequency of adverse events than demonstrated for either product alone.
In 51Cr blood loss and gastroscopy studies with normal volunteers, daily administration of 1000 mg of naproxen as 1000 mg of Naproxen Tablets, USP has been demonstrated to cause statistically significantly less gastric bleeding and erosion than 3250 mg of aspirin.
Geriatric Patients
The hepatic and renal tolerability of long-term naproxen administration was studied in two double-blind clinical trials involving 586 patients. Of the patients studied, 98 patients were age 65 and older and 10 of the 98 patients were age 75 and older. Naproxen was administered at doses of 375 mg twice daily or 750 mg twice daily for up to 6 months. Transient abnormalities of laboratory tests assessing hepatic and renal function were noted in some patients, although there were no differences noted in the occurrence of abnormal values among different age groups.
Carefully consider the potential benefits and risks of Naproxen Tablets, USP and other treatment options before deciding to use Naproxen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen as Naproxen Tablets, USP is indicated:
- For the relief of the signs and symptoms of rheumatoid arthritis
- For the relief of the signs and symptoms of osteoarthritis
- For the relief of the signs and symptoms of ankylosing spondylitis
- For the relief of the signs and symptoms of juvenile arthritis
- For relief of the signs and symptoms of tendonitis
- For relief of the signs and symptoms of bursitis
- For relief of the signs and symptoms of acute gout
- For the management of pain
- For the management of primary dysmenorrhea
Naproxen Tablets, USP are contraindicated in patients with known hypersensitivity to naproxen.
Naproxen Tablets, USP 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 WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: Preexisting Asthma).
Naproxen Tablets, USP are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
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 Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation).
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).
NSAIDs, including Naproxen Tablets, USP, can lead to onset of new hypertension or worsening of preexisting 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 Naproxen Tablets, USP, 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.
Congestive Heart Failure and Edema
Fluid retention, edema, and peripheral edema have been observed in some patients taking NSAIDs. Naproxen Tablets, USP should be used with caution in patients with fluid retention, hypertension, or heart failure.
Gastrointestinal Effects- Risk of Ulceration, Bleeding, and Perforation
NSAIDs, including Naproxen Tablets, USP, 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. The utility of periodic laboratory monitoring has not been demonstrated, nor has it been adequately assessed. Only 1 in 5 patients who develop a serious GI adverse event on NSAID therapy is symptomatic.
NSAIDs should be prescribed 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 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.
Renal Effects
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, hypovolemia, heart failure, liver disfunction, salt depletion, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of nonsteroidal anti-inflammatory drug therapy is usually followed by recovery to the pretreatment state (see WARNINGS: Advanced Renal Disease).
Advanced Renal Disease
No information is available from controlled clinical studies regarding the use of Naproxen Tablets, USP in patients with advanced renal disease. Therefore, treatment with Naproxen Tablets, USP is not recommended in these patients with advanced renal disease. If Naproxen Tablets, USP therapy must be initiated, close monitoring of the patient's renal function is advisable.
Anaphylactoid Reactions
As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Naproxen Tablets, USP. Naproxen Tablets, USP 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 CONTRAINDICATIONS and PRECAUTIONS: Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs.
Skin Reactions
NSAIDs, including Naproxen Tablets, USP, 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, Naproxen Tablets, USP should be avoided because it may cause premature closure of the ductus arteriosus.
Naproxen-containing products such as Naproxen Tablets, USP, and other naproxen products should not be used concomitantly since they all circulate in the plasma as the naproxen anion.
Naproxen Tablets, USP 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 and the patient should be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.
Patients with initial hemoglobin values of 10 g or less who are to receive a long-term therapy should have hemoglobin values determined periodically.
The pharmacological activity of Naproxen Tablets, USP in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, noninflammatory painful conditions.
Because of adverse eye findings in animal studies with drugs of this class, it is recommended that ophthalmic studies be carried out if any change or disturbance in vision occurs.
Hepatic Effects
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Naproxen Tablets, USP. Hepatic abnormalities may be the result of hypersensitivity rather than direct toxicity. These laboratory abnormalities may progress, may remain essentially unchanged, or may be transient with continuing therapy. The SGPT (ALT) test is probably the most sensitive indicator of liver dysfunction. 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 more severe hepatic reaction while on therapy with Naproxen Tablets, USP.
If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Naproxen Tablets, USP should be discontinued.
Chronic alcoholic liver disease and probably other diseases with decreased or abnormal plasma proteins (albumin) reduce the total plasma concentration of naproxen, but the plasma concentration of unbound naproxen is increased. Caution is advised when high doses are required and some adjustment of dosage may be required in these patients. It is prudent to use the lowest effective dose.
Hematological Effects
Anemia is sometimes seen in patients receiving NSAIDs, including Naproxen Tablets, USP. 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 Naproxen Tablets, USP, 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 Naproxen Tablets, USP who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
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, Naproxen Tablets, USP should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.
Information for Patients
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.
1. Naproxen Tablets, USP, 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 WARNINGS: Cardiovascular Effects).
2. Naproxen Tablets, USP, like other NSAIDs, can 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 signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS: Gastrointestinal Effects- Risk of Ulceration, Bleeding, and Perforation).
3. Naproxen Tablets, USP, 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 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.
4. Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.
5. 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.
6. 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 WARNINGS).
7. In late pregnancy, as with other NSAIDs, Naproxen Tablets, USP should be avoided because it may cause premature closure of the ductus arteriosus.
8. Caution should be exercised by patients whose activities require alertness if they experience drowsiness, dizziness, vertigo or depression during therapy with naproxen.
Laboratory Tests
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, Naproxen Tablets, USP should be discontinued.
Drug Interactions
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.
Antacids and Sucralfate
Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen.
When naproxen as Naproxen Tablets, USP is administered with aspirin, its protein binding is reduced, although the clearance of free Naproxen Tablets, USP is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of naproxen and aspirin is not generally recommended because of the potential of increased adverse effects.
As with other NSAIDs, concomitant administration of cholestyramine can delay the absorption of naproxen.
Clinical studies, as well as postmarketing observations, have shown that Naproxen Tablets, USP 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, the patient should be observed closely for signs of renal failure (see WARNINGS: Renal Effects), as well as to assure diuretic efficacy.
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.
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Naproxen and other nonsteroidal anti-inflammatory drugs have been reported to reduce the tubular secretion of methotrexate in an animal model. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
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. No significant interactions have been observed in clinical studies with naproxen and coumarin-type anticoagulants. However, caution is advised since interactions have been seen with other nonsteroidal agents of this class. The free fraction of warfarin may increase substantially in some subjects and naproxen interferes with platelet function.
Other Information Concerning Drug Interactions
Naproxen is highly bound to plasma albumin; it thus has a theoretical potential for interaction with other albumin-bound drugs such as coumarin-type anticoagulants, sulphonylureas, hydantoins, other NSAIDs, and aspirin. Patients simultaneously receiving naproxen and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required.
Naproxen and other nonsteroidal anti-inflammatory drugs can reduce the antihypertensive effect of propranolol and other beta-blockers.
Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly.
Drug/Laboratory Test Interactions
Naproxen may decrease platelet aggregation and prolong bleeding time. This effect should be kept in mind when bleeding times are determined.
The administration of naproxen may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-di-nitrobenzene used in this assay. Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that therapy with naproxen be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used.
Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).
A 2-year study was performed in rats to evaluate the carcinogenic potential of naproxen at rat doses of 8, 16, and 24 mg/kg/day (50, 100, and 150 mg/m2). The maximum dose used was 0.28 times the systemic exposure to humans at the recommended dose. No evidence of tumorigenicity was found.
Teratogenic Effects
Pregnancy Category C
Reproduction studies have been performed in rats at 20 mg/kg/day (125 mg/m2/day, 0.23 times the human systemic exposure), rabbits at 20 mg/kg/day (220 mg/m2/day, 0.27 times the human systemic exposure), and mice at 170 mg/kg/day (510 mg/m2/day, 0.28 times the human systemic exposure) with no evidence of impaired fertility or harm to the fetus due to the drug. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Naproxen Tablets, USP should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects
There is some evidence to suggest that when inhibitors of prostaglandin synthesis are used to delay preterm labor there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus and intracranial hemorrhage. Naproxen treatment given in late pregnancy to delay parturition has been associated with persistent pulmonary hypertension, renal dysfunction and abnormal prostaglandin E levels in preterm infants. 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.
Labor and Delivery
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. Naproxen-containing products are not recommended in labor and delivery because, through its prostaglandin synthesis inhibitory effect, naproxen may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage. The effects of Naproxen Tablets, USP on labor and delivery in pregnant women are unknown.
Nursing Mothers
The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma. Because of the possible adverse effects of prostaglandin-inhibiting drugs on neonates, use in nursing mothers should be avoided.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
Geriatric Use
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Experience indicates that geriatric patients may be particularly sensitive to certain adverse effects of nonsteroidal anti-inflammatory drugs. Elderly or debilitated patients seem to tolerate peptic ulceration or bleeding less well when these events do occur. Most spontaneous reports of fatal GI events are in the geriatric population (see WARNINGS).
Naproxen is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Geriatric patients may be at greater risk for the development of a form of renal toxicity precipitated by reduced prostaglandin formation during administration of nonsteroidal anti-inflammatory drugs (see WARNINGS: Renal Effects).
Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.
A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg naproxen compared to those taking 750 mg naproxen (see CLINICAL PHARMACOLOGY).
In controlled clinical trials with about 80 pediatric patients and in well monitored, open-label studies with about 400 pediatric patients with juvenile arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were increased, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.
In patients taking naproxen in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:
Gastrointestinal (GI) Experiences, including: heartburn1, abdominal pain1, nausea1, constipation1, diarrhea, dyspepsia, and stomatitis
Central Nervous System: headache1, dizziness1, drowsiness1, lightheadedness, vertigo
Dermatologic: pruritus (itching)1, skin eruptions1, ecchymoses1, sweating, purpura
Special Senses: tinnitus1, visual disturbances, hearing disturbances
Cardiovascular: edema1, palpitations.
General: dyspnea1, thirst
In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.
Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting
General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes
The following are additional adverse experiences reported in <1% of patients taking naproxen during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.
Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)
Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema
Gastrointestinal: gastrointestinal bleeding and/or perforation, hematemesis, pancreatitis, vomiting, colitis, nonpeptic gastrointestinal ulceration, ulcerative stomatitis, peptic ulceration
Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some cases have been fatal)
Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia
Metabolic and Nutritional: hyperglycemia, hypoglycemia
Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions
Respiratory: eosinophilic pneumonitis, asthma
Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythemia multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematosus, Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.
Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema
Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine
Reproduction (female): infertility
In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients.
Body as a Whole: fever infection, sepsis, anaphylactic reactions, appetite changes, death
Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction
Gastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation
Hepatobiliary: hepatitis, liver failure
Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia
Metabolic and Nutritional: weight changes
Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations
Respiratory: asthma, respiratory depression, pneumonia
Dermatologic: exfoliative dermatitis
Special Senses: blurred vision, conjunctivitis
Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuria
1 Incidence of reported reaction between 3% and 9%. Those reactions occuring in less than 3% of the patients are unmarked.
Significant naproxen overdosage may be characterized by lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation or vomiting. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following a NSAID overdose. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine or hemoperfusion may not be useful due to high protein binding.
Carefully consider the potential benefits and risks of Naproxen Tablets, USP and other treatment options before deciding to use Naproxen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with Naproxen Tablets, USP, the dose and frequency should be adjusted to suit an individual patient's needs.
Different dose strengths and formulations (i.e., tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation.
Although naproxen tablets, naproxen suspension, naproxen delayed-release tablets, and naproxen sodium tablets all circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 1 hour in patients taking naproxen.
The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS and PRECAUTIONS).
Geriatric Patients
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Patients With Moderate to Severe Renal Impairment
Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects).
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis
Naproxen Tablets, USP 250 mg twice daily or 375 mg twice daily or 500 mg twice daily During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary.
In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see CLINICAL PHARMACOLOGY).
Acute Gout
The recommended starting dose is 750 mg of Naproxen Tablets, USP followed by 250 mg every 8 hours until the attack has subsided.
Naproxen Tablets, USP:
250 mg: white, round, biconvex, debossed with "IP 188" on obverse and "250" on the reverse. Packaged in bottles of 30, 60 and 120.
500 mg: white, capsule-shaped, biconvex, debossed with "IP 190" on obverse and "500" on the reverse. Packaged in bottles of 15, 20, 24, 30, 60, 90 and 120.
Store at 15°-30°C (59°-86°F) in well-closed containers; dispense in light-resistant containers.
Rx only
Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788
Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880Rev. 10-2008
Medication Guide
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication 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"
- drinking alcohol
- longer use
- older age
- smoking
- having poor health
NSAID medicines should only be used:
- exactly as prescribed
- for the shortest time needed
- at the lowest dose possible for your treatment
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 by pregnant women late in their 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
- slurred speech
- chest pain
- swelling of the face or throat
- weakness in one part or side of your body
Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:
- nausea
- vomit blood
- more tired or weaker than usual
- there is blood in your bowel movement or it is black and sticky like tar
- itching
- unusual weight gain
- your skin or eyes look yellow
- skin rash or blisters with fever
- stomach pain
- swelling of the arms and legs, hands and feet
- flu-like symptoms
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 (overthe-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 Cataflam, Voltaren, Arthrotec (combined with misoprostol) Diflunisal Dolobid Etodolac Lodine, Lodine XL Fenoprofen Nalfon, Nalfon 200 Flurbiprofen 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-Naprosyn, Naprelan, Naprapac (copackaged with lansoprazole) Oxaprozin Daypro Piroxicam Feldene Sulindac Clinoril Tolmetin Tolectin, Tolectin DS, Tolectin 600 * Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
naproxen tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-128(NDC:53746-188) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN 250 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONES (UNII: FZ989GH94E) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code IP188;250 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33261-128-02 120 in 1 BOTTLE, PLASTIC 2 NDC:33261-128-30 30 in 1 BOTTLE, PLASTIC 3 NDC:33261-128-60 60 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075927 02/18/2010 NAPROXEN
naproxen tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-081(NDC:53746-190) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN 500 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONES (UNII: FZ989GH94E) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 16mm Flavor Imprint Code IP190;500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33261-081-02 120 in 1 BOTTLE, PLASTIC 2 NDC:33261-081-15 15 in 1 BOTTLE, PLASTIC 3 NDC:33261-081-20 20 in 1 BOTTLE, PLASTIC 4 NDC:33261-081-24 24 in 1 BOTTLE, PLASTIC 5 NDC:33261-081-30 30 in 1 BOTTLE, PLASTIC 6 NDC:33261-081-60 60 in 1 BOTTLE, PLASTIC 7 NDC:33261-081-90 90 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075927 02/18/2010 Labeler - Aidarex Pharmaceuticals LLC (801503249)

subset: commoncrawl


text:
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For concerns regarding packages in transit, please refer to your local USPS office, as Fan Treasures can only track it with you.
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text:
Item Description -
* Painting Size (inch) :- 3 * 4
* Original/Reproduction :- Original
* Style :- Miniature
* Region of Origin:- Rajasthan (INDIA)
*Painting Surface:- Paper
*Quantity Type:- Single Piece Work
Product Description –
This is a very fine piece of Art painted on Synthetic Ivory. It is very rare find piece like this online but at ARTUDAIPUR we sell the best Miniature at the best prices. In the Painting, you can see a Beautiful KingFisher Bird painted with very delicate work with squirrel hair brush on Faux Synthetic Ivory. Only Natural Colors and Squirrel hair brushes are used to paint this masterpiece.
· About US
We at ARTUDAIPUR , provide you with the best quality of Artwork. All our art work are of supreme quality and are painted with only squirrel hair brushes. All the surfaces that we paint on are accepted worldwide. We are creating and dealing in the Art line for the past 35 years.All the art work that we have are genuine and the material that we paint on vary. We use a mixture of Natural Stone colors and Vegetable Colors, depending on the need of painting. Also physically we are located in Udaipur, Rajasthan (India).
Shipping Policy and Handling Time –
We ship our Art Works worldwide through India Economy Post and Fedex.
Normal Shipping we Provide is through India Post, but if you need the Artwork early then there would be
additional charges as then we would need to send through FedEx.
- Also the Art work would be shipped within 24 hours of Cleared Payment.
· Returns
We accept returns within 14 days of buyer receiving the Art work.


text:
Andrew Marshall, son of William Marshall, was born in St Ives in 1952. Although he didn't start potting until he was in his twenties, he grew up in an environment dominated by ceramics, and was no stranger to the Leach Pottery as a child.
In 1977 he helped in the building of his father's double-chamber kiln. Andrew pots mainly in red earthenware but is known to work in stoneware and porcelain. He uses local St Erth sand in his body clay as grog and mixes natural materials with St Erth clay for his slips and glazes.
Andrew draws on Japanese and Korean work for his inspiration; he quotes the Japanese potter Rosanjin as his most important single influence.


text:
The fastest oversized pulley wheel system in the world is also available for SRAM Rival & Force 1 Type 3 derailleurs.
Featuring 14-tooth (upper) and 18-tooth (lower) pulleys with a narrow-wide profile, the OSPW X System for SRAM Rival & Force 1 Type 3 is available fitted with CeramicSpeed standard or coated bearings, with up to a 6-year warranty. The unique narrow-wide tooth profile of the pulleys ensures durable chain retention.
The system is fitted with a custom-designed, strong carbon fiber pulley cage assembly for outstanding durability and light weight. The cage design allows you to choose between two spring tension settings to customize performance and reduce chain drag. We recommend initial setup in the lower spring tension. This has been designed to leave the clutch mechanism fully functional for chain retention.
In the event that the low spring tension does not provide adequate shift quality on very rough roads, you can increase it to the high-spring tension, which corresponds to the factory settings.
Thanks to the high-quality CeramicSpeed Bearings inside, your product will benefit from a 3-5 times longer lifespan than stock, and it has been tested to deliver 30-40% less friction than conventional systems.
This product is completely developed and handbuilt in Denmark, including the top quality CeramicSpeed Bearings inside.
The OSPW X System for SRAM Rival & Force 1 Type 3 is compatible with SRAM Rival or Force 1X 11-speed with Type 3 clutch, regardless of the cage length. Note that the cage lock must be in the 8 o'clock position, not the 5 o'clock position. This product is NOT compatible with Type 2.1 clutch derailleurs.
In The Box:
- A complete 14-tooth/18-tooth OSPW X System for SRAM 1x
- CeramicSpeed bearing oil in 15ml dropper bottle
- Sticker Sheet


text:
Calvinist Corner | www.mslick.com |
2 Chronicles 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 1 And Solomon the son of David was strengthened in his kingdom, and the LORD his God was with him, and magnified him exceedingly. 2 Then Solomon spake unto all Israel, to the captains of thousands and of hundreds, and to the judges, and to every governor in all Israel, the chief of the fathers. 3 So Solomon, and all the congregation with him, went to the high place that was at Gibeon; for there was the tabernacle of the congregation of God, which Moses the servant of the LORD had made in the wilderness. 4 But the ark of God had David brought up from Kirjathjearim to the place which David had prepared for it: for he had pitched a tent for it at Jerusalem. 5 Moreover the brasen altar, that Bezaleel the son of Uri, the son of Hur, had made, he put before the tabernacle of the LORD: and Solomon and the congregation sought unto it. 6 And Solomon went up thither to the brasen altar before the LORD, which was at the tabernacle of the congregation, and offered a thousand burnt offerings upon it. 7 In that night did God appear unto Solomon, and said unto him, Ask what I shall give thee. 8 And Solomon said unto God, Thou hast shewed great mercy unto David my father, and hast made me to reign in his stead. 9 Now, O LORD God, let thy promise unto David my father be established: for thou hast made me king over a people like the dust of the earth in multitude. 10 Give me now wisdom and knowledge, that I may go out and come in before this people: for who can judge this thy people, that is so great? 11 And God said to Solomon, Because this was in thine heart, and thou hast not asked riches, wealth, or honour, nor the life of thine enemies, neither yet hast asked long life; but hast asked wisdom and knowledge for thyself, that thou mayest judge my people, over whom I have made thee king: 12 Wisdom and knowledge is granted unto thee; and I will give thee riches, and wealth, and honour, such as none of the kings have had that have been before thee, neither shall there any after thee have the like. 13 Then Solomon came from his journey to the high place that was at Gibeon to Jerusalem, from before the tabernacle of the congregation, and reigned over Israel. 14 And Solomon gathered chariots and horsemen: and he had a thousand and four hundred chariots, and twelve thousand horsemen, which he placed in the chariot cities, and with the king at Jerusalem. 15 And the king made silver and gold at Jerusalem as plenteous as stones, and cedar trees made he as the sycomore trees that are in the vale for abundance. 16 And Solomon had horses brought out of Egypt, and linen yarn: the king's merchants received the linen yarn at a price. 17 And they fetched up, and brought forth out of Egypt a chariot for six hundred shekels of silver, and an horse for an hundred and fifty: and so brought they out horses for all the kings of the Hittites, and for the kings of Syria, by their means. Return to Bible Online Calvinist Corner |


text: After spearheading the industrial revolution 2.0 , the industrial technology blitz, Tunisia is all set to become a major industrial power worldwide. Investments are on the upswing with regards to science, research and development, and much more in an effort to catch up with the huge leaps made in the fields of Healthcare, Architecture the booming economy in general. This effectively necessitates the need for a platform to host events, seminars and workshops to shine a light on the relevant industry specific points. The MC : Main Conference provides information and logistics from A to Z with regards toany and all of your seminar related queries.


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text:
The Voice of a Suffering Individual*
1I am one who has known affliction
under the rod of God's anger,a
2One whom he has driven and forced to walk
in darkness, not in light;
3Against me alone he turns his hand—
again and again all day long.
4He has worn away my flesh and my skin,
he has broken my bones;b
5He has besieged me all around
with poverty and hardship;
6He has left me to dwell in dark places
like those long dead.c
7He has hemmed me in with no escape,
weighed me down with chains;
8Even when I cry for help,
he stops my prayer;d
9He has hemmed in my ways with fitted stones,
and made my paths crooked.
10He has been a bear lying in wait for me,
a lion in hiding!e
11He turned me aside and tore me apart,
leaving me ravaged.f
12He bent his bow, and set me up
as a target for his arrow.g
13He pierced my kidneys
with shafts from his quiver.h
14I have become a laughingstock to all my people,
their taunt all day long;i
15He has sated me with bitterness,
filled me with wormwood.j
16He has made me eat gravel,
trampled me into the dust;
17My life is deprived of peace,
I have forgotten what happiness is;
18My enduring hope, I said,
has perished before the LORD.
19The thought of my wretched homelessness
is wormwood and poison;
20Remembering it over and over,
my soul is downcast.
21But this I will call to mind;*
therefore I will hope:
22The LORD's acts of mercy are not exhausted,
his compassion is not spent;k
23They are renewed each morning—
great is your faithfulness!
24The LORD is my portion, I tell myself,
therefore I will hope in him.l
25The LORD is good to those who trust in him,
to the one that seeks him;m
26It is good to hope in silence
for the LORD's deliverance.
27It is good for a person, when young,
to bear the yoke,
28To sit alone and in silence,
when its weight lies heavy,
29To put one's mouth in the dust—*
there may yet be hope—
30To offer one's cheek to be struck,
to be filled with disgrace.n
31For the Lord does not
reject forever;o
32Though he brings grief, he takes pity,
according to the abundance of his mercy;p
33He does not willingly afflict
or bring grief to human beings.q
34That someone tramples underfoot
all the prisoners in the land,
35Or denies justice to anyone
in the very sight of the Most High,
36Or subverts a person's lawsuit—
does the Lord not see?
37Who speaks so that it comes to pass,
unless the Lord commands it?
38Is it not at the word of the Most High
that both good and bad take place?r
39What should the living complain about?
about their sins!
40* Let us search and examine our ways,
and return to the LORD!s
41Let us lift up our hearts as well as our hands
toward God in heaven!
42We have rebelled and been obstinate;
you have not forgiven us.
43You wrapped yourself in wrath and pursued us,
killing without pity;t
44You wrapped yourself in a cloud,
which no prayer could pierce.
45You have made us filth and rubbish
among the peoples.u
46They have opened their mouths against us,
all our enemies;
47Panic and the pit have been our lot,
desolation and destruction;v
48* My eyes stream with tears over the destruction
of the daughter of my people.w
49My eyes will flow without ceasing,
without rest,
50Until the LORD from heaven
looks down and sees.
51I am tormented by the sight
of all the daughters of my city.
52Without cause, my enemies snared me
as though I were a bird;
53They tried to end my life in the pit,
pelting me with stones.
54The waters flowed over my head:
and I said, "I am lost!"x
55I have called upon your name, O LORD,y
from the bottom of the pit;
56You heard me call, "Do not let your ear be deaf
to my cry for help."
57You drew near on the day I called you;
you said, "Do not fear!"
58You pleaded my case, Lord,
you redeemed my life.
59You see, LORD, how I am wronged;
do me justice!z
60You see all their vindictiveness,
all their plots against me.
61You hear their reproach, LORD,
all their plots against me,
62The whispered murmurings of my adversaries,
against me all day long;
63Look! Whether they sit or stand,
I am the butt of their taunt.
64Give them what they deserve, LORD,
according to their deeds;
65Give them hardness of heart;
your curse be upon them;a
66Pursue them in wrath and destroy them
from under the LORD's heaven!
* [3:1–66] This chapter is focused less on the destruction of Jerusalem than are chaps. 1 and 2 and more on the suffering of an individual. The identity of the individual is never given, and one probably should not search for a specific identification of the speaker. The figure of the representative sufferer makes concrete the pain of the people in a way similar to the personification of Zion as a woman in chaps. 1 and 2. Indeed, in vv. 40–48 the individual voice gives way to a communal voice, returning in vv. 49–66 to the individual sufferer.
* [3:21–24] In the midst of a description of suffering, the speaker offers this brief but compelling statement of hope in God's ultimate mercy. It is a hard-won and precarious hope, nearly submerged by the volume and intensity of the surrounding lament, but it is hope nonetheless.
* [3:29] To put one's mouth in the dust: a sign of humiliation and submission; cf. v. 16; Ps 72:9.
* [3:40–66] The plural voice in this lament suggests that a communal lament begins here; it then continues in the singular voice in vv. 55–66.
* [3:48–51] These verses are more appropriate on the lips of the poet, who speaks of "my city" (v. 51). Daughters of my city: here as elsewhere "daughter" may refer to villages dependent on a larger city.
d. [3:8] Ps 18:41; 22:2; 88:14–15.
k. [3:22] 1 Sm 20:15; Neh 9:31.
p. [3:32] 1 Sm 2:6–7; Tb 13:2; Is 54:8.
u. [3:45] 1 Cor 4:13.
v. [3:47] Is 24:17–18; Jer 48:43–44.
w. [3:48] Lam 1:16; 2:11; Jer 8:23; 9:17.
x. [3:54] Ps 69:2–3; 88:8; Jon 2:4.
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Polychromos colour pencil
267 pine green
Product details
- High-quality acid-free pigments in bright colours, unsurpassed lightfastness
- Soft, vibrant colour laydown
- Water-resistant and smudge-proof
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- Colour 267 pine green
Polychromos colour pencil, 267 pine green
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Timber from certified sustainable forestry (e.g. FSC, PEFC, SFI) order
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Inspiration from artists
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Carl Webster Accessibility Statement
Carl Webster is committed to facilitating the accessibility and usability of its website, carlwebster.com, for everyone. Carl Webster aims to comply with all applicable standards, including the World Wide Web Consortium's Web Content Accessibility Guidelines 2.0 up to Level AA (WCAG 2.0 AA). Carl Webster is proud of the efforts that we have completed and that are in-progress to ensure that our website is accessible to everyone.
If you experience any difficulty in accessing any part of this website, please feel free to email us at firstname.lastname@example.com and we will work with you to provide the information or service you seek through an alternate communication method that is accessible for you consistent with applicable law (for example, through telephone support).
June 23, 2020
Figure 27
Carl Webster is an independent consultant specializing in Citrix, Active Directory, and technical documentation. Carl (aka "Webster") serves the broader Citrix community by writing articles (see CarlWebster.com) and by being the most active person in the Citrix Zone on Experts Exchange. Webster has a long history in the IT industry beginning with mainframes in 1977, PCs and application development in 1986, and network engineering in 2001. He has worked with Citrix products since 1990 with the premiere of their first product – the MULTIUSER OS/2.
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Welcome to the Big Spring SDA Church in Big Spring, TX. We are a Christian community and would love to have you join our family. Please join us for Bible study, worship, and prayer.
Big Spring SDA Church
About Seventh-day Adventists®
The Seventh-day Adventist Church is a mainstream Protestant church with approximately 19 million members worldwide, including more than one million members in North America. The Seventh-day Adventist Church seeks to enhance quality of life for people everywhere and to let people know that Jesus is coming again soon.
Adventists believe a Trinity of three persons—the Father, the Son, and the Holy Spirit—make up one God. They made salvation possible when Jesus, the Son, came to earth as a baby in Bethlehem and lived a sinless life in accordance with the Father's will. When Jesus was crucified for the sins of the people of the world and arose from the dead on the third day, victory was won for everyone.
When He returned to heaven following the resurrection, Jesus left the Holy Spirit to serve as our Comforter and Counselor. He promised to return to earth a second time to complete His plan of salvation and take His people to heaven. Adventists are among the believers who look forward to that day.
Adventists believe that God is concerned with the quality of human life, and that everything—the way we live, eat, speak, think, treat each other, and care for the world around us—is part of His plan. Our families, our children, our jobs, our talents, our money, and our time are all important to Him.
Find out more


text:
Jay W. Lorsch
Harvard Business School (411005-PDF-ENG)
August 30, 2010
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Saul. 1There was a powerful man from Benjamin named Kish, who was the son of Abiel, son of Zeror, son of Becorath, son of Aphiah, a Benjaminite.a 2He had a son named Saul, who was a handsome young man. There was no other Israelite more handsome than Saul; he stood head and shoulders above the people.b
The Lost Donkeys. 3Now the donkeys of Saul's father, Kish, had wandered off. Kish said to his son Saul, "Take one of the servants with you and go out and hunt for the donkeys." 4So they went through the hill country of Ephraim, and through the land of Shalishah. Not finding them there, they continued through the land of Shaalim without success. They also went through the land of Benjamin, but they failed to find the animals. 5When they came to the land of Zuph, Saul said to the servant who was with him, "Come, let us turn back, lest my father forget about the donkeys and become anxious about us." 6The servant replied, "Listen! There is a man of God in this city, a man held in high esteem; everything he says comes true. Let us go there now! Perhaps he can advise us about the journey we have undertaken." 7c But Saul said to his servant, "If we go, what can we offer the man? The food in our bags has run out; we have no present to give the man of God. What else do we have?" 8Again the servant answered Saul, "I have a quarter shekel of silver.* If I give that to the man of God, he will advise us about the journey." 9d (In former times in Israel, anyone who went to consult God used to say, "Come, let us go to the seer." For the one who is now called prophet was formerly called seer.) 10Saul then said to his servant, "You are right! Come on, let us go!" So they headed toward the city where the man of God lived.
Meeting the Young Women. 11e As they were going up the path to the city, they met some young women coming out to draw water and they asked them, "Is the seer in town?" 12f The young women answered, "Yes, there—straight ahead. Hurry now; just today he came to the city, because the people have a sacrifice today on the high place.* 13When you enter the city, you may reach him before he goes up to the high place to eat. The people will not eat until he arrives; only after he blesses the sacrifice will the invited guests eat. Go up immediately, for you should find him right now."
Saul Meets Samuel. 14So they went up to the city. As they entered it—there was Samuel coming toward them on his way to the high place. 15The day before Saul's arrival, the LORD had revealed to Samuel:g 16At this time tomorrow I will send you a man from the land of Benjamin whom you are to anoint as ruler of my people Israel. He shall save my people from the hand of the Philistines. I have looked upon my people; their cry has come to me.h 17When Samuel caught sight of Saul, the LORD assured him: This is the man I told you about; he shall govern my people. 18Saul met Samuel in the gateway and said, "Please tell me where the seer lives." 19Samuel answered Saul: "I am the seer. Go up ahead of me to the high place and eat with me today. In the morning, before letting you go, I will tell you everything on your mind. 20As for your donkeys that were lost three days ago, do not worry about them, for they have been found. Whom should Israel want if not you and your father's family?" 21Saul replied: "Am I not a Benjaminite, from the smallest of the tribes of Israel,* and is not my clan the least among the clans of the tribe of Benjamin? Why say such things to me?"i
The Meal.* 22Samuel then took Saul and his servant and brought them into the room. He seated them at the head of the guests, of whom there were about thirty. 23He said to the cook, "Bring the portion I gave you and told you to put aside." 24So the cook took up the leg and what went with it, and placed it before Saul. Samuel said: "This is a reserved portion that is set before you. Eat, for it was kept for you until this time; I explained that I was inviting some guests." Thus Saul dined with Samuel that day. 25When they came down from the high place into the city, a mattress was spread for Saul on the roof, 26and he slept there.
Saul's Anointing. At daybreak Samuel called to Saul on the roof, "Get up, and I will send you on your way." Saul got up, and he and Samuel went outside the city together. 27As they were approaching the edge of the town, Samuel said to Saul, "Tell the servant to go on ahead of us, but you stay here for a moment, that I may give you a word from God."
* [9:8] A quarter shekel of silver: about a tenth of an ounce of silver.
* [9:12] On the high place: the local sanctuary on the top of a hill, where the sacrifice was offered and the sacrificial meal eaten.
* [9:21] Smallest of the tribes of Israel: Saul's objection is a common element in call narrative, e.g., Ex 3:11; 4:10; Jgs 6:15.
* [9:22–24] At this ritual meal, Samuel treats the youthful Saul as if he were already king. Saul receives the part of the sacrificed animal reserved for the priest and his family, perhaps the sheep's fat tail. Legal texts (Ex 29:22; Lv 3:9; 7:3–4) require the priest to burn this portion of the sheep on the altar.
a. [9:1] 1 Sm 14:51; 1 Chr 8:33.
b. [9:2] 1 Sm 10:23; 16:12.
c. [9:7–8] Nm 22:7; 1 Kgs 14:3; 2 Kgs 4:42; 5:15; 8:8–9.
e. [9:11] Gn 24:11–14; Ex 2:16.
f. [9:12] 1 Sm 7:17; 16:2, 5; 20:6, 29; Dt 12:13; 1 Kgs 3:2, 4.
g. [9:15] Acts 13:21.
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