Table of Contents
What is Naproxen?
Naproxen is an active ingredient used for the treatment of mild pain to moderate, fever, inflammation and stiffness. The product ingredient is Naproxen Sodium.
The brand names of Naproxen in the United States are: Aleve, Naprosyn, Anaprox, Naproxen Sodium DS.
Mechanism of action (MOA) of Naproxen
Inhibits prostaglandin synthetase.
Therapeutic Indications, Uses and Benefits of Naproxen
- Symptomatic treatment of mild-moderate pain.
- Febrile states.
- Rheumatoid arthritis, juvenile rheumatoid arthritis, osteoporosis, acute episodes of gout, ankylosing spondylitis, rheumatoid syndromes, dysmenorrhea, musculoskeletal disorders with pain and inflammation.
- Symptomatic treatment of acute migraine attacks.
- Primary or secondary menorrhagia to an intrauterine device.
– Rheumatoid arthritis, osteoporosis, osteoarthritis, ankylosing spondylitis: initial: 250-500 mg/12 h, or 500-1,000 mg/day (single dose/night), or 550/12 h or 550-1100 mg (single dose).
Maintenance: 500-1,000 mg/day. Severe pain, morning stiffness and previously treated with another NSAID: start at 750-1,000 mg/day.
– Acute gout: start with 750 mg, at 8 a.m. 500 mg; continue with 250 mg/8 h until remission, or 825 mg, followed by 275 mg/8 h until the attack has subsided.
– Dysmenorrhoea: start with 500-550 mg and continue with 250-275 mg/6-8 h.
– Acute inflammatory musculoskeletal alterations: start with 500 mg, continue with 250 mg/6-8 h; max. 1,250 mg/day.
– Mild-moderate pain, fever: 200 mg/8-12 h or start with 400 mg and 200 mg at 12 h if necessary.
– Acute migraine attacks: 825 mg at the 1st symptom, and ½ h after 275 mg.
– Primary or secondary menorrhagia to an intrauterine device: 825-1375 mg/day in two intakes 1st day of menstruation, follow 4 following days with 550-1,100 mg/day.
Children, juvenile rheumatoid arthritis: 10 mg/kg/day at 12-hour intervals.
Kidney failure, heart failure, liver failure, reduce dose.
Mode of administration of Naproxen
Administer whole, with milk or food, especially if digestive discomfort is noted.
Contraindications with Naproxen
- Hypersensitivity to naproxen, history of severe allergic reactions to ASA or other NSAIDs.
- History of or with asthma, rhinitis, hives, nasal polyps, angioedema, ulcerative colitis.
- Severe renal insufficiency, Severe hepatic insufficiency.
- Children under 2 years old.
- History of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
- Active or recurrent peptic ulcer/gastrointestinal bleeding (two or more different episodes of proven ulceration or bleeding). Severe heart failure.
- Third trimester of gestation.
Warnings and Precautions with Naproxen
- Liver failure, kidney failure, and the elderly (maintain min. effective dose).
- History of ulcerative colitis, Crohn’s disease (exacerbates these pathologies).
- History of high blood pressure and/or heart failure.
- Risk of gastrointestinal bleeding, ulcer or perforation is greater when increasing doses of NSAIDs are used in patients with a history of ulcer and the elderly.
- Assess risk/benefit in: high blood pressure, CHF, established coronary artery disease, peripheral artery disease and/or cerebrovascular disease, also assess long-term treatment with known cardiovascular risk factors (high blood pressure, hyperlipidemia, diabetes mellitus, smokers).
- Risk of skin reactions at the start of treatment.
- Masks symptoms of infections.
- Renal, hepatic and haematological control.
- Interrupt if visual disturbances appear.
- Alters female fertility.
- Risk of anaphylactic reactions (without previous exposure or with a history of angioedema, asthma, rhinitis, nasal polyps, asthma, urticaria).
Contraindicated in severe liver failure.
Caution in hepatic insufficiency.
Contraindicated in severe renal failure.
Caution in renal insufficiency.
Interactions with Naproxen
- Power toxicity of: methotrexate.
- Inhibits natriuretic effect of: furosemide.
- Reduces antihypertensive effect of: ß-blockers.
- Increases plasma concentrations of: lithium, hydantoins, anticoagulants, sulfonamides, digoxin.
- Increases risk of renal insufficiency with: ACEI.
- Plasma concentration increased by: probenecid.
- Risk of gastrointestinal bleeding with: selective COX-2 and SSRI inhibitors.
- Pharmacodynamic clinical data suggest that concomitant use of naproxen with AAS for more than one consecutive day may inhibit the antiplatelet effect of AAS at low doses and this inhibition may persist for several days after completion of naproxen treatment. The clinical relevance of this interaction is unknown.
- Lab: adrenal function assessment test. Urinary tests of ac. 5-hydroxy- indolacetic and 17-ketosteroids. Bleeding time may be prolonged. May produce an increase in blood urea nitrogen concentrations, as well as serum creatinine and potassium concentrations. It may cause a decrease in creatinine clearance. Liver function tests: may increase transaminase activity values.
Pregnancy and Naproxen
Not recommended in the first and second trimester of pregnancy unless absolutely necessary.
Contraindicated third trimester of pregnancy, due to premature closure of the ductus arteriosus, increased risk of maternal-fetal haemorrhage and possible decrease in uterine contractility.
Avoid. About 1% is excreted in breast milk.
Not recommended during lactation.
Effects on driving ability
Some patients experience drowsiness, dizziness, vertigo, insomnia, or depression during treatment.
Those affected by these or similar effects should be cautious about engaging in activities that require close attention.
Adverse reactions and side effects of Naproxen
Oral: peptic ulcers, perforation or gastrointestinal bleeding, epigastric pain, headaches, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, mane, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease; moderate peripheral edema, high blood pressure, ringing in the ears, vertigo, drowsiness.
Rectal: tenesmus, proctitis, vaginal bleeding or sensation of discomfort, pain, burning or itching.
⭐⭐⭐⭐⭐ VIDEO OF NAPROXEN/ALEVE (DRUG).
Source: The content of this active ingredient has been written taking into account the clinical and molecular information of all medicines authorised and marketed in the United States under the Unique Ingredient Identifier (UNII) by the Substance Registration System (SRS) of the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP).
In order to know in detail the information authorized by the FDA for each drug, you should consult the corresponding medication guide authorized by the FDA.