Naprosyn (Generic Naproxen Sodium Tablets)

Naprosyn (Generic Naproxen Tablets)
© The Swiss Pharmacy

Naprosyn (Generic Naproxen Sodium Tablets) are
used for the treatment Of Rheumatoid Arthritis
(RA), Osteoarthritis (OA), Ankylosing Spondylitis
(AS), Tendinitis, Bursitis, Acute Gout, Primary
Dysmenorrhea (PD) and the Relief Of Mild To
Moderate Pain.

Naprosyn Tablets are
manufactured by RPG
Lifesciences Limited, India.
(Manufactured under license of
F. Hoffmann- La Roche Limited
Switzerland)

Chemical Structure

The active ingredient contained in
tablets is Naproxen Sodium.
Each Naprosyn tablet contains
Naproxen Sodium equivalent to 250 mg
or 500 mg of Naproxen.

Uses of Naprosyn 250 mg and 500 mg tablets:
Naprosyn (Generic Naproxen Sodium Tablets) is used for the
treatment of the signs and symptoms of osteoarthritis, rheumatoid
arthritisandankylosing spondylitis.
This medicine is also used for the relief of minor aches and pains
in muscles, bones and joints, mild to moderate pain accompanied
by inflammation in musculoskeletal injuries (sprains and
strains)and primary dysmenorrhea.

Recommended Adult Dosage
For most patients, the starting dose of
Naprosyn (Generic Naproxen Sodium Tablets) for the treatment of
Rheumatoid Arthritis, Osteoarthritis or Ankylosing Spondylitis is 250 mg
taken twice daily. The dose may be adjusted up or down depending on the
clinical response of the patient.
For the treatment of Polyarticular Juvenile Idiopathic Arthritis, the
recommended total daily dose of Naproxen is approximately 10 mg/kg
given in 2 divided doses. Dosing with Naprosyn tablets is not appropriate
for children weighing less than 50 kilograms.

Recommended Adult Dosage
Management of Pain, Primary Dysmenorrhea, and Acute
Tendinitis and Bursitis:
The recommended starting dose is two Naproxen Sodium
500 mg tablets (1,000 mg) once daily.
Thereafter, the total daily dose should not exceed two
Naproxen Sodium 500 mg tablets (1,000 mg).

Contraindications
➔Naprosyn tablets are contraindicated in patients with a known
hypersensitivity to Naproxen Sodium or any component of the tablet.
➔Naprosyn 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.
➔Naproxen tablets are contraindicated for the treatment of peri-
operative pain in the setting of coronary artery by-pass graft (CABG)
surgery.
➔Contraindicated in patients with active peptic ulcers, a history of
recurrent ulceration, or active gastrointestinal bleeding

Contraindications
➔Contraindicated in patients with inflammatory bowel disease.
➔Contraindicated in patients with severe liver impairment or active liver
disease.
➔Contraindicated in patients with severe renal impairment (creatinine
clearance less than 30 mL/min or 0.5 mL/sec) or deteriorating renal
disease (individuals with lesser degrees of renal impairment are at risk of
deterioration of their renal function when prescribed NSAIDs and must be
monitored)
➔Contraindicated in women in their third trimester of pregnancy because
of risk of premature closure of the ductus arteriosus and prolonged
parturition.

Storage Instructions
Naprosyn (Generic Naproxen Sodium
Tablets) have to be stored at controlled
room temperature i.e. from 20°C to 25°C
(68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

Warnings
Hepatotoxicity: Inform patients of warning signs and symptoms of
hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and
symptoms of liver disease develop.
Hypertension: Patients taking some antihypertensive medications may have impaired
response to these therapies when taking NSAIDs. Monitor blood pressure.
Heart Failure and Edema: Avoid use of Naprosyn (Generic Naproxen Sodium
Tablets) in patients with severe heart failure unless benefits are expected to outweigh
risk of worsening heart failure.
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment,
heart failure, dehydration, or hypovolemia. Avoid use of Naprosyn (Generic Naproxen
Sodium Tablets) in patients with advanced renal disease unless benefits are
expected to outweigh risk of worsening renal function.

Warnings
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
Exacerbation of Asthma Related to Aspirin Sensitivity: Naprosyn (Generic
Naproxen Sodium Tablets) is contraindicated in patients with aspirin-sensitive
asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
Serious Skin Reactions: NSAIDs, including Naproxen, 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 medicine should be
discontinued at the first appearance of skin rash or any other sign of
hypersensitivity.

Warnings
Premature Closure of Fetal Ductus Arteriosus: Avoid use in
pregnant women starting at 30 weeks gestation.
Hematologic Toxicity: Monitor hemoglobin or hematocrit in
patients with any signs or symptoms of anemia.
Gastrointestinal Bleeding, Ulceration, and Perforation: NSAIDs,
including Naproxen, cause serious gastrointestinal (GI) adverse events
including inflammation, bleeding, ulceration, and perforation of the
esophagus, stomach, small intestine, or large intestine, which can be
fatal.

Possible Side Effects
Most common Naproxen Sodium (Naprosyn tablets) side
effects were dyspepsia, abdominal pain, nausea,
headache, rash, ecchymosis, and edema.

Possible Side Effects
In patients taking Naproxen in clinical trials, the most frequently reported side
effects in approximately 1% to 10% of patients were:
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

Naprosyn Overdosage
Significant Naprosyn (Naproxen Sodium tablets) overdose
can be characterized by drowsiness, heartburn, indigestion,
nausea and vomiting.
A few patients have experienced convulsions but it is not
clear if these were Naproxen related.
Some cases with acute, reversible renal failure have been
described. It is not known what dose of the drug would be
life-threatening.

Treatment of Naprosyn Overdosage
Should a patient ingest a large quantity of Naproxen Sodium
(Naprosyn tablets) the stomach may be emptied and usual
supportive measures like administration of activated charcoal
employed.
Hemodialysis does not decrease the plasma concentration of
Naproxen because of the high degree of its protein binding.
There is no specific antidote.

Naprosyn Tablets During Pregnancy
Naproxen Sodium (Naprosyn Tablets) has been classified by the US
FDA as Pregnancy Category C.
Reproduction studies have been performed in rats at (0.23 times the
human systemic exposure), rabbits at (0.27 times the human
systemic exposure), and mice at (0.28 times the human systemic
exposure) with no evidence of impaired fertility or harm to the fetus
due to the medicine.
However, animal reproduction studies are not always predictive of
human response.

Naprosyn Tablets During Pregnancy
There are no adequate and well-controlled studies of Naproxen
Sodium (Naprosyn Tablets) in pregnant women.
Use of NSAIDs, including Naproxen Sodium, during the third
trimester of pregnancy increases the risk of premature closure of
the fetal ductus arteriosus.
Avoid use of NSAIDs, including Naproxen Sodium (Naprosyn
Tablets), in pregnant women starting at 30 weeks of gestation (third
trimester).

Naprosyn Tablets are manufactured by RPG
Lifesciences Limited, India.
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Naprosyn (Generic Naproxen Sodium Tablets)

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