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Naproxen information from DrugsUpdate  

See Available Brands of Naproxen in India

P - Contraindicated in pregnancy
L - Caution when used during lactation
FI - Food *
LI - Lab *

Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.

Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

Pharmacodynamics

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.

Pharmacokinetics

Naproxen has anti-inflammatory, analgesic, antipyretic actions. It reduces prostaglandin synthesis by inhibiting the enzyme cyclooxygenase. It also inhibits platelet aggregation.

Onset
Analgesic: 1 hour; anti-inflammatory: Approx 2 weeks.

Duration
Analgesic: ≤7 hours; anti-inflammatory: ≤12 hours.

Absorption
Readily absorbed from the GI tract (oral); peak plasma concentrations after 2-4 hours. Well absorbed rectally.

Distribution
Diffuses into synovial fluid; crosses the placenta; enters breast milk. Protein-binding: 99%.

Excretion
Via urine (as unchanged drug and metabolites), faeces; 13 hours (elimination half-life).

Naproxen Indications / Naproxen Uses

Information Not Available

Naproxen Adverse Reactions / Naproxen Side Effects

Oedema, palpitation, dizziness, drowsiness, headache, light headedness, vertigo, pruritus, skin eruption, ecchymosis, purpura, rash, fluid retention, abdominal pain, constipation, nausea, heartburn, diarrhoea, dyspepsia, stomatitis, flatulence, gross bleeding/perforation, indigestion, ulcers, vomiting, abnormal renal function, haemolysis, anaemia, increased bleeding time, elevated LFTs, visual disturbances, tinnitus, hearing disturbances, dyspnoea, diaphoresis, thirst.

Potentially Fatal: Anaphylactic/anaphylactoid reactions. Exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).

Precautions

Naproxen Oral Suspension should not be used concomitantly with other Naproxen products (such as Naproxen sodium) since they all circulate in plasma as the Naproxen anion.

Naproxen Oral Suspension 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 long-term therapy should have hemoglobin values determined periodically.

The pharmacological activity of Naproxen Oral Suspension 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.

Overdosage
Symptoms: Drowsiness, heartburn, vomiting, CNS depression, leukocytosis, renal failure. Management: Supportive and symptomatic.

Special Precautions

Pre-existing CV risk factors or disease e.g. fluid retention, CHF, hypertension. History of GI disease (bleeding or ulcers). Other forms of asthma. Hepatic impairment; closely monitor patients with any abnormal LFT. Renal impairment. Elderly. Lactation.

Other Drug Interactions

Antihypertensive effects of hypotensive agents may be reduced. May increase ciclosporin levels. Increased risk of seizures with fluoroquinolones. May reduce efficacy of diuretics. May diminish the cardioprotective effect of acetylated salicylates. Alcohol may enhance gastric mucosal irritation. Increased serum levels with probenecid.

Potentially Fatal: Increased risk of GI ulceration with corticosteroids. May increase lithium levels/toxicity. Severe bone marrow suppression, aplastic anaemia and GI toxicity may occur with methotrexate. Increased risk of bleeding with anticoagulants (e.g. warfarin, heparin, LMWHs) and antiplatelet agents (e.g. ticlopidine, clopidogrel, aspirin, abciximab, dipyridamole, eptifibatide, tirofiban). Absorption may be reduced with colestyramine (and other bile acid sequestrants).

Other Interactions

Food Interaction
Rate of absorption may be reduced with food. Avoid herbs/food with antiplatelet activity e.g. alfalfa, anise, bilberry, grapeseed, green tea, bladderwrack, turmeric, bromelain, cat's claw, celery, ginkgo biloba, coleus, cordyceps, dong quai, evening primrose, feverfew, fenugreek, garlic, ginger, red clover, horse chestnut, ginseng, guggul, horse chestnut seed, horseradish, licorice, prickly ash, reishi, sweet clover, white willow.

Dosage

Oral
Rheumatic disorders
Adult: 0.5-1 g as a single dose or in 2 divided doses, up to 1.5 g daily for patients who can tolerate lower doses, for up to 6 months, if required.
Elderly: Consider dose reductions; use lowest possible effective dose.

Oral
Juvenile idiopathic arthritis
Child: ≥2 years: 5-7.5 mg/kg bid. Max: 1 g/day.

Oral

Dysmenorrhoea
Adult: Initially, 500 mg followed by 250 mg every 6-8 hours. Max: 1.25 g on the 1st day and 1 g thereafter.
Elderly: Consider dose reductions; use lowest possible effective dose.

Oral
Acute musculoskeletal disorders
Adult: Initially, 500 mg followed by 250 mg every 6-8 hours. Max: 1.25 g on the 1st day and 1 g thereafter.
Elderly: Consider dose reductions; use lowest possible effective dose.

Oral
Acute gout
Adult: Initially, 750 mg followed by 250 mg every 8 hours.
Elderly: Consider dose reductions; use lowest possible effective dose.

Oral
Acute migraine attacks
Adult: 750 mg at the onset of attack, followed after at least ½ an hour by further doses of 250-500 mg daily. Max: 1250 mg daily.
Elderly: Consider dose reductions; use lowest possible effective dose.

Food(before/after)

Should be taken with food

List of Contraindications

Naproxen and Pregnancy

Contraindicated in pregnancy

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

In 3rd trimester or near delivery.

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Naproxen and Lactation

Caution when used during lactation

Naproxen and Children

Safety and efficacy in children younger than 2 years of age not established (Rx); do not give to children younger than 12 years of age except under the advice and supervision of a health care provider (OTC).

Naproxen and Geriatic

Increased risk of adverse reactions

Naproxen and Other Contraindications

Hypersensitivity. Aspirin or NSAID allergy. Perioperative pain in the setting of CABG surgery. Pregnancy (3rd trimester)

Storage

Oral
Store at 15-30°C (59-86°F).

Lab interference

Oral
Store at 15-30°C (59-86°F).

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