Generic

Naproxen Sodium

Indications

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis, and acute gout are among the conditions for which naproxen is prescribed. It’s also used to treat pain and dysmenorrhea in women with primary dysmenorrhea.

Pharmacology

Naproxen is an anti-inflammatory, analgesic, and antipyretic non-steroidal anti-inflammatory medication (NSAID). It is quickly absorbed from the gastrointestinal system and has a bioavailability of 95%.

Dosage & Administration

Naproxen Tablet-

• Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
• Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
• Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.

Naproxen Suspension-

• For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.

Naproxen Gel-

• Is to be applied 2-6 times a day as required and is not recommended for use in children.

Interaction

• ACE inhibitors: ACE inhibitors have a reduced antihypertensive impact.
• Naproxen absorption is slowed by antacids and sucralfate.
• Aspirin increases the risk of side effects.
• Furosemide and Thiazides’ natriuretic effects are reduced by diuretics.
• Methotrexate: increases Methotrexate toxicity.
• Warfarin raises the risk of gastrointestinal bleeding.
• SSRIs (Selective Serotonin Reuptake Inhibitors) raise the risk of gastrointestinal bleeding.

Contraindications

Patients who have a known hypersensitivity to naproxen should avoid using it. Patients who have had asthma, urticaria, or allergic-type responses after taking aspirin or other NSAIDs should not use it. In the situation of coronary artery bypass graft (CABG) surgery, it is contraindicated for the management of perioperative discomfort.

Side Effect

The following are the most often reported adverse effects:

• Heartburn, stomach discomfort, nausea, diarrhea, and dyspepsia are all symptoms of gastrointestinal problems.
• Headache, vertigo, and sleepiness are symptoms of the Central Nervous System.
• Pruritus (itching) and purpura are two dermatological conditions.
• Edema and palpitation are symptoms of cardiovascular disease.
• Other symptoms include visual and auditory problems.

Pregnancy & Lactation

US FDA pregnancy category of Naproxen is C. So, Naproxen should be avoided in pregnancy & lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Precautions & Warnings

Before taking naproxen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), blood disorders (such as anemia), bleeding/clotting problems, growths in the nose (nasal polyps), heart disease (such as previous heart attack), high blood pressure, liver disease, stroke, swelling (edema, fluid retention), stomach/intestinal/esophagus problems (such as bleeding, heartburn, ulcers).

Kidney problems can sometimes occur with the use of NSAID medications, including naproxen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).

Therapeutic Class

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Storage Conditions

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Pharmaceutical Name

Drug International Ltd.