Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1600
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Naprosyn (Tablet)
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Carefully consider the potential benefits and risks
of NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension
and other treatment options before deciding to use NAPROSYN, EC-NAPROSYN,
ANAPROX, ANAPROX DS and NAPROSYN Suspension. Use the lowest effective
dose for the shortest duration consistent with individual patient
treatment goals . After
observing the response to initial therapy with NAPROSYN, EC-NAPROSYN,
ANAPROX, ANAPROX DS or NAPROSYN Suspension, the dose and frequency
should be adjusted to suit an individual patient's needs. Different dose strengths and
formulations (ie, tablets, suspension) of the drug are not necessarily
bioequivalent. This difference should be taken into consideration
when changing formulation. Although
NAPROSYN, NAPROSYN Suspension, EC-NAPROSYN, ANAPROX and ANAPROX DS
all circulate in the plasma as naproxen, they have pharmacokinetic
differences that may affect onset of action. Onset of pain relief
can begin within 30 minutes in patients taking naproxen sodium and
within 1 hour in patients takingnaproxen. Because EC-NAPROSYN dissolves
in the small intestine rather than in the stomach, the absorption
of the drug is delayed compared to the other naproxen formulations
(see CLINICAL
PHARMACOLOGY). 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 .<br/>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.<br/>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) . Rheumatoid Arthritis,
Osteoarthritis and Ankylosing Spondylitis To maintain the integrity of the enteric coating,
the EC-NAPROSYN tablet should not be broken, crushed or chewed during
ingestion. NAPROSYN Suspension should be shaken gently before use. 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
adifference in response .<br/>Juvenile Arthritis: The use of NAPROSYN Suspension is recommended for
juvenile arthritis in children 2 years or older because it allows
for more flexible dose titration based on the child's weight. In pediatric
patients, doses of 5 mg/kg/day produced plasma levels of naproxen
similar to those seen in adults taking 500 mg of naproxen . The recommended total daily dose
of naproxen is approximately 10 mg/kg given in 2 divided doses (ie,
5 mg/kg given twice a day). A measuring cup marked in 1/2 teaspoon
and 2.5 milliliter increments is provided with the NAPROSYN Suspension.
The following table may be used as a guide for dosing of NAPROSYN
Suspension:<br/>Management of Pain, Primary
Dysmenorrhea, and Acute Tendonitis and Bursitis: The recommended starting dose is 550 mg of naproxen
sodium as ANAPROX/ANAPROX DS followed by 550 mg every 12 hours or
275 mg every 6 to 8 hours as required. The initial total daily dose
should not exceed 1375 mg of naproxen sodium. Thereafter, the total
daily dose should not exceed 1100 mg of naproxen sodium. Because the
sodium salt of naproxen is more rapidly absorbed, ANAPROX/ANAPROX
DS is recommended for the management of acute painful conditions when
prompt onset of pain relief is desired. NAPROSYN may also be used
but EC-NAPROSYN is not recommended for initial treatment of acute
pain because absorptionof naproxen is delayed compared to other naproxen-containing
products (see CLINICAL PHARMACOLOGY,INDICATIONS
AND USAGE).<br/>Acute Gout: The recommended starting dose is 750 mg of NAPROSYN
followed by 250 mg every 8 hours until the attack has subsided. ANAPROX
may also be used at a starting dose of 825 mg followed by 275 mg every
8 hours. EC-NAPROSYN is not recommended because of the delay in absorption
(see CLINICAL
PHARMACOLOGY).
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Naproxen is a proprionic acid derivative related
to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are
(S)-6-methoxy-��-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-��-methyl-2-naphthaleneacetic
acid, sodium salt, respectively. Naproxen and naproxen sodium have
the following structures, respectively: Naproxen has
a molecular weight of 230.26 and a molecular formula of CHO. Naproxen sodium has a molecular weight
of 252.23 and a molecular formula of CHNaO. 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 sodium is a white to creamy white, crystalline solid,
freely soluble in water at neutral pH. NAPROSYN
(naproxen tablets) is available as yellow tablets containing 250 mg
of naproxen, pink tablets containing 375 mg of naproxen and yellow
tablets containing 500 mg of naproxen for oral administration. The
inactive ingredients are croscarmellose sodium, iron oxides,
povidone and magnesium stearate. EC-NAPROSYN
(naproxen delayed-release tablets) is available as enteric-coated
white tablets containing 375 mg of naproxen and 500 mg of naproxen
for oral administration. The inactive ingredients are croscarmellose
sodium, povidone and magnesium stearate. The enteric coating dispersion
contains methacrylic acid copolymer, talc, triethyl citrate, sodium
hydroxide and purified water. The dissolution of this enteric-coated
naproxen tablet is pH dependent with rapid dissolution above pH 6.
There is no dissolution below pH 4. ANAPROX
(naproxen sodium tablets) is available as blue tablets containing
275 mg of naproxen sodium and ANAPROX DS (naproxen sodium tablets)
is available as dark blue tablets containing 550 mg of naproxen sodium
for oral administration. The inactive ingredients are magnesium stearate,
microcrystalline cellulose, povidone and talc. The coating suspension
for the ANAPROX 275 mg tablet may contain hydroxypropyl methylcellulose
2910, Opaspray K-1-4210A, polyethylene glycol 8000 or Opadry YS-1-4215.
The coating suspension for the ANAPROX DS 550 mg tablet may contain
hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene
glycol 8000 or Opadry YS-1-4216. NAPROSYN (naproxen
suspension) is available as a light orange-colored opaque oral suspension
containing 125 mg/5 mL of naproxen in a vehicle containing sucrose,
magnesium aluminum silicate, sorbitol solution and sodium chloride
(39 mg/5 mL, 1.5 mEq), methylparaben, fumaric acid, FD&C Yellow
No. 6, imitation pineapple flavor, imitation orange flavor and purified
water. The pH of the suspension ranges from 2.2 to 3.7.
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Pharmacodynamics: Naproxen is a nonsteroidal anti-inflammatory drug
(NSAID) with analgesic and antipyretic properties. The sodium salt
of naproxen has been developed as a more rapidly absorbed formulation
of naproxen for use as an analgesic. 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.<br/>Pharmacokinetics: Naproxen and naproxen sodium are rapidly and completely
absorbed from the gastrointestinal tract with an in vivo bioavailability
of 95%. The different dosage forms of NAPROSYN are bioequivalent in
terms of extent of absorption (AUC) and peak concentration (C); 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.<br/>Absorption:<br/>Distribution: 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
C36.5, 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 the milk of lactating women at a concentration equivalent
to approximately 1% of maximum naproxen concentration in plasma (see PRECAUTIONS: Nursing
Mothers).<br/>Metabolism: 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.<br/>Excretion: 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 .<br/>Special Populations:
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NAPROSYN Tablets: 250 mg: round, yellow, biconvex, engraved with NPR LE 250 on one
side and scored on the other. Packaged in light-resistant bottles
of 100. 100's (bottle):
NDC 0004-6313-01. 375 mg: pink, biconvex oval,
engraved with NPR LE 375 on one side. Packaged in light-resistant
bottles of 100. 100's
(bottle): NDC 0004-6314-01. 500 mg: yellow,
capsule-shaped, engraved with NPR LE 500 on one side and scored on
the other. Packaged in light-resistant bottles of 100. 100's (bottle): NDC 0004-6316-01. Store at 15��to 30��C (59��to 86��F)
in well-closed containers; dispense in light-resistant containers. NAPROSYN Suspension: 125 mg/5 mL (contains 39 mg sodium, about 1.5 mEq/teaspoon): Available
in 1 pint (473 mL) light-resistant bottles (NDC 0004-0028-28). Store at 15��to 30��C (59��to 86��F);
avoid excessive heat, above 40��C (104��F). Dispense in light-resistant
containers. Shake gently before use. EC-NAPROSYN Delayed-Release Tablets: 375
mg: white, oval biconvex coated tablets imprinted with NPR-EC 375
on one side. Packaged in light-resistant bottles of 100. 100's (bottle): NDC 0004-6415-01. 500 mg: white, oblong coated tablets, imprinted with NPR-EC
500 on one side. Packaged in light-resistant bottles of 100. 100's (bottle): NDC 0004-6416-01. Store at 15��to 30��C (59��to 86��F)
in well-closed containers; dispense in light-resistant containers. ANAPROX Tablets: Naproxen
sodium 275 mg: light blue, oval-shaped, engraved with NPS-275 on one
side. Packaged in bottles of 100. 100's
(bottle): NDC 0004-6202-01. Store at 15��to 30��C (59��to 86��F) in well-closed containers. ANAPROX DS Tablets: Naproxen sodium 550 mg: dark blue, oblong-shaped, engraved with NPS
550 on one side and scored on both sides. Packaged in bottles of 100. 100's (bottle): NDC 0004-6203-01. Store at 15��to 30��C (59��to 86��F)
in well-closed containers. Revised: September
2007
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Cardiovascular Risk:<br/>Gastrointestinal Risk:
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Symptoms and Signs: 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. Because
naproxen sodium may be rapidly absorbed, high and early blood levels
should be anticipated. A few patients have experienced convulsions,
but it is not clear whether or not these were drug-related. It is
not known what dose of the drug would be life threatening. The oral
LDof the drug is 543 mg/kg in rats, 1234 mg/kg in mice,
4110 mg/kg in hamsters, and greater than 1000 mg/kg in dogs.<br/>Treatment: 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 usefuldue to high protein binding.
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naproxen
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Naprosyn (Tablet)
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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 . 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: heartburn, abdominal pain, nausea, constipation, diarrhea, dyspepsia,
stomatitis Central
Nervous System: headache, dizziness, drowsiness, lightheadedness,
vertigo Dermatologic: pruritus (itching), skin eruptions, ecchymoses, sweating, purpura Special Senses: tinnitus, visual disturbances, hearing disturbances Cardiovascular: edema, palpitations General: dyspnea, 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, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's
disease), nonpeptic gastrointestinal ulceration, ulcerative stomatitis,
esophagitis, 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, erythema multiforme, erythema nodosum, fixed drug eruption,
lichen planus, pustular reaction, systemic lupus erythematoses, bullous
reactions, including 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
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Carefully consider the potential benefits and risks
of NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension
and other treatment options before deciding to use NAPROSYN, EC-NAPROSYN,
ANAPROX, ANAPROX DS or NAPROSYN Suspension. Use the lowest effective
dose for the shortest duration consistent with individual patient
treatment goals . Naproxen as
NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension
is indicated: Naproxen as NAPROSYN Suspension is recommended for
juvenile rheumatoid arthritis in order to obtain the maximum dosage
flexibility based on the patient's weight. Naproxen
as NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension is also indicated: EC-NAPROSYN is not recommended for initial treatment
of acute pain because the absorption of naproxen is delayed compared
to absorption from other naproxen-containing products .
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Naprosyn
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