TradeName :Napro-A.Naprox,Sonap,Naprosyn,Servinaprox(BD)
Naproxen USP
Naproxen USP is a nonsteroidal anti-inflammatory
drug (NSAID) with analgesic, anti-inflammatory and antipyretic properties.
Naproxen is a propionic acid derivative related to the arylacetic acid class of
drugs. The chemical name of naproxen is (+)-6-methoxyalpha-
methyl-2-naphthaleneacetic acid. Naproxen has been shown to have striking
anti-inflammatory properties when tested in human clinical studies and
classical animal test systems. In addition, it has marked analgesic and
antipyretic actions. It inhibits synthesis of prostaglandins.
Naproxen Presentation:
Naproxen USP250 Tablets: Each tablet contains
Naproxen USP 250 mg.
Naproxen USP500 Tablets: Each tablet contains Naproxen USP 500 mg.
Naproxen USP50 ml suspension: After reconstitution according to direction, each 5 ml suspension contains Naproxen Sodium USP powder equivalent to Naproxen 125 mg.
Naproxen USP500 Tablets: Each tablet contains Naproxen USP 500 mg.
Naproxen USP50 ml suspension: After reconstitution according to direction, each 5 ml suspension contains Naproxen Sodium USP powder equivalent to Naproxen 125 mg.
General Onset of pain relief can begin within 1 hour in patients
taking naproxen. A lower dose should be considered in patients with renal or
hepatic impairment or in elderly patients. Naproxen USPis not recommended in
patients with baseline creatinine clearance less than 10 ml/minute because
accumulation of naproxen metabolites has been seen in such patients. Naproxen
USPmay be given orally either in fasting state or with meals and/or antacids.
Dose in adults Chronic conditions: Osteoarthritis / Rheumatoid arthritis /
Ankylosing spondylitis / chronic pain states in which there is an inflammatory
component: The recommended dose of naproxen is Naproxen USP250 mg or 500 mg
taken twice daily (morning and evening), or a single daily dose of 500-1000 mg
given in the morning or evening, or 500 mg taken twice daily, or a single daily
dose of 1000 mg given in the evening. 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. In
patients who tolerate lower doses well, the dose may be increased to 1500 mg
per day when a higher level of anti-inflammatory/analgesic activity is
required. When treating patients with naproxen 1500 mg/day, the physician
should observe sufficient increased clinical benefit to offset the potential
increased risk (see Precautions). 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. Acute conditions:
Analgesia / Dysmenorrhoea / Acute musculoskeletal conditions/Acute pain states
in which there is an inflammatory component: The recommended starting dose is
Naproxen USP500 mg followed by Naproxen USP250 mg every 6-8 hours as required.
Naproxen Side Effects:-
Gastrointestinal: abdominal pain, constipation, diarrhea,
dyspepsia, heartburn, nausea, stomatitis. Central nervous system: dizziness,
drowsiness, headache, lightheadedness, vertigo. Dermatologic: ecchymoses,
itching (pruritus), purpura, skin eruptions, sweating.Special senses: hearing
disturbances, tinnitus, visual disturbances. Card
Use in Pregnancy and Lactation
Naproxen :-
Pregnancy: As with other drugs of this type, naproxen produces
delay in parturition in animals and also affects the human fetal cardiovascular
system (closure of ductus arteriosus). Therefore, naproxen should not be used
during pregnancy unless clearly needed.
Naproxen Drug Interaction :-
Concomitant administration of antacid or cholestyramine can delay
the absorption of naproxen , but does not affect its extent. Concomitant
administration of food can delay the absorption of naproxen, but does not
affect its extent. Naproxen is highly bound to plasma
Naproxen Over Dosage :-
If a patient ingest a large amount of naproxen, accidentally or
purposefully, the stomach should be emptied and the usual supportive measures
employed. Animal studies indicate that the prompt administration of 50-100 g of
activated charcoal as an aqueous slurry over 15 minutes within 2 hours of the
overdose would tend to reduce markedly the absorption of the drug. Hemodialysis
does not decrease the plasma concentration of naproxen because of the high
degree of its protein binding.
Storage
Naproxen USPStore at below 35°C.
The reconstituted suspension should be store in cool and dry place and used within 14 days after preparation.
Keep out of reach of children.
The reconstituted suspension should be store in cool and dry place and used within 14 days after preparation.
Keep out of reach of children.
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