A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Naprosyn Patient, Information, Instructions - Naproxen
Naprosyn Patient, Information, Instructions - Naproxen
INFORMATION FOR PATIENTS
Naproxen, in NAPROSYN, EC- NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension,
like other drugs of this class, is not free of side effects. The side effects
of these formulations of naproxen can cause discomfort and, rarely, there are
more serious side effects, such as gastrointestinal bleeding, which may result
in hospitalization and even fatal outcomes.
NSAIDs ( Nonsteroidal Anti- Inflammatory Drugs) are often essential agents
in the management of arthritis and have a major role in the treatment of pain,
but they also may be commonly employed for conditions that are less serious.
Physicians may wish to discuss with their patients the potential risks ( see
WARNINGS, PRECAUTIONS
and ADVERSE REACTIONS)
and likely benefits of naproxen treatment, particularly when it is used for
less serious conditions where treatment without NSAIDs may represent an acceptable
alternative to both the patient and physician.
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 ulceration and bleeding
can occur without warning symptoms, physicians should follow patients chronically
treated with naproxen for signs and symptoms of ulceration and bleeding and
should inform them of the importance of this follow- up and what they should
do if certain signs and symptoms do appear ( see WARNINGS:
Risk of GI Ulcerations, Bleeding and Perforation With NSAID Therapy ).
Drug Interactions: The use of NSAIDs in patients who are receiving
ACE inhibitors may potentiate renal disease states ( see PRECAUTIONS:
Renal Effects ).
In vitro studies have shown that naproxen anion, because of its affinity for
protein, may displace from their binding sites other drugs that are also albumin-
bound ( see CLINICAL PHARMACOLOGY:
Pharmacokinetics ).
Theoretically, the naproxen anion itself could likewise be displaced. Short-
term controlled studies failed to show that taking the drug significantly affects
prothrombin times when administered to individuals on coumarin- type anticoagulants.
Caution is advised nonetheless, since interactions have been seen with other
nonsteroidal agents of this class. Similarly, patients receiving the drug and
a hydantoin, sulfonamide or sulfonylurea should be observed for signs of toxicity
to these drugs ( see CLINICAL STUDIES:
General Information ).
Concomitant administration of naproxen and aspirin is not recommended because
naproxen is displaced from its binding sites during the concomitant administration
of aspirin, resulting in lower plasma concentrations and peak plasma levels.
The natriuretic effect of furosemide has been reported to be inhibited by some
drugs of this class. Inhibition of renal lithium clearance leading to increases
in plasma lithium concentrations has also been reported. Naproxen and other
nonsteroidal anti- inflammatory drugs can reduce the antihypertensive effect
of propranolol and other betablockers.
Probenecid given concurrently increases naproxen anion plasma levels and extends
its plasma half- life significantly.
Caution should be used if naproxen is administered concomitantly with methotrexate.
Naproxen, naproxen sodium and other nonsteroidal anti- inflammatory drugs have
been reported to reduce the tubular secretion of methotrexate in an animal model,
possibly increasing the toxicity of methotrexate.
Due to the gastric pH elevating effects of H 2 - blockers, sucralfate and intensive
antacid therapy, concomitant administration of EC- NAPROSYN is not recommended.
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- hydroxycorticosteroid
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).
Carcinogenesis: 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/ m 2 ). The maximum dose used was 0.28 times the systemic
exposure to humans at the recommended dose. No evidence of tumorigenicity was
found.
Pregnancy: Teratogenic Effects: Pregnancy Category B
. Reproduction studies have been performed in rats at 20 mg/ kg/ day ( 125
mg/ m 2 / day, 0.23 times the human systemic exposure), rabbits at 20 mg/ kg/
day ( 220 mg/ m 2 / day, 0.27 times the human systemic exposure), and mice at
170 mg/ kg/ day ( 510 mg/ m 2 / day, 0.28 times the human systemic exposure)
with no evidence of impaired fertility or harm to the fetus due to the drug.
There are no adequate and well- controlled studies in pregnant women. Because
animal reproduction studies are not always predictive of human response, naproxen
should not be used during pregnancy unless clearly needed.
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 effect of drugs of this class on the human fetal
cardiovascular system ( closure of ductus arteriosus), use during third trimester
should be avoided.
Nursing Mothers: The naproxen anion has been found in the milk
of lactating women at a concentration of approximately 1% of that found 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. Pediatric dosing recommendations
for juvenile arthritis are based on well- controlled studies ( see DOSAGE
AND ADMINISTRATION). There are no adequate effectiveness or dose- response
data for other pediatric conditions, but the experience in juvenile arthritis
and other use experience have established that single doses of 2.5 to 5 mg/
kg ( as naproxen suspension, see DOSAGE AND
ADMINISTRATION), with total daily dose not exceeding 15 mg/ kg/ day,
are well tolerated in pediatric patients over 2 years of age.
top
