Annoxen-S

Each tablet contains Naproxen sodium 275 mg equivalent to Naproxen 250 mg.

Pharmacology: Pharmacodynamics: Naproxen is a non-steroidal anti-inflammatory drugs (NSAIDs), a propionic acid derivative, with anti-inflammatory, analgesic, and antipyretic effects. The onset of pain relief is more rapid with Naproxen sodium than Naproxen therefore Naproxen sodium is recommended for the management of acute painful conditions. It inhibits synthesis of prostaglandins as with other similar agents. Naproxen reversibly inhibits yclooxygenase-1 and 2 (COX-1 and 2) enzymes, which results in decreased formation of prostaglandin precursors; has anti-pyretic, analgesic, and anti-inflammatory properties.
Pharmacokinetics: Oral bioavailability of Naproxen is 95%. Peak plasma concentrations of the Naproxen occur in 1-2 hours following oral administration of Naproxen sodium tablet. Onset of pain relief occurs within 30 minutes in patients receiving Naproxen sodium tablet. Duration of action is 7-12 hours. It is more than 99% bound to plasma protein. Naproxen diffuses into synovial fluid; it crosses the placenta and is distributed into breast milk in small amounts. The plasma elimination half-life is about 12 to 17 hours.
Naproxen is metabolized by liver. About 95% of a dose is excreted in urine as Naproxen (less than 1%) and 6-desmethylnaproxen (less than 1%) and their conjugates (66-92%). Less than 3% of a dose appears in the feces.

Naproxen sodium is indicated for the treatment of mild to moderate pain, symptomatic management of musculoskeletal and joint disorders such as: Bursitis and tendonitis; Acute musculoskeletal pain; Rheumatoid arthritis; Osteoarthritis; Ankylosing spondylitis; Acute gouty arthritis; Postoperative pain, pain associated with dental surgery, postpartum pain; Headache; Toothache; Antipyretic; Dysmenorrhoea; Migraine treatment in adults; Migraine prophylaxis; Juvenile arthritis.

Administration: Administer with food, milk, or antacid to decrease GI adverse effect.
Dosages: Bursitis, tendonitis and acute musculoskeletal pain: Naproxen sodium 2 tablets initially, followed by 1 tablet every 6-8 hours or followed by 2 tablets every 12 hours; maximum daily dose of 5 tablets on the first day and 4 tablets thereafter.
Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: Naproxen sodium 2 to 4 tablets daily either as a single dose or in 2 divided doses. Dosage may be increased up to 6 tablets daily for a period of up to 6 months.
Acute gouty arthritis: Naproxen sodium 3 tablets initially, followed by 1 tablet every 6-8 hours until the attack has subsided.
Postoperative pain, pain associated with dental surgery and postpartum pain: Naproxen sodium 2 tablets initially, followed by 1 tablet every 6-8 hours.
Headache, toothache, fever, dysmenorrhoea and acute pain: Naproxen sodium 2 tablets initially, followed by 1 tablet every 6-8 hours, up to maximum daily dose of 5 tablets on the first day and 4 tablets thereafter.
Juvenile arthritis: Naproxen sodium 10 mg/kg daily in 2 divided doses, up to 15 mg/kg daily dose (maximum of 1 g daily).
Migraine treatment in adults: Naproxen sodium 3 tablets at the first symptom of an impending attack. An additional dose of Naproxen sodium 1-2 tablets can be taken throughout the day, if necessary, but not before half an hour after the initial dose.
Prophylaxis of migraine: Naproxen sodium 2 tablets given twice daily. If no improvement is seen within 4-6 weeks, the drug should be discontinued.
Elderly: Consider a lower dose. Caution is advised when high doses are required and some adjustment of dose may be required.

Overdose and Treatment: Patients with overdosage may experience effects including nausea and vomiting, headache, dizziness, drowsiness, epigastric pain, abdominal discomfort, indigestion, alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis and apnea.
There are no specific antidotes. In acute Naproxen overdosage, general measures should include immediately emptying the stomach by inducing emesis or by gastric lavage, followed by initiation of supportive and symptomatic treatment.

Patients with known hypersensitivity to the Naproxen and Naproxen sodium, including in whom attacks of asthma, angioedema, urticaria, or rhinitis have been participated by aspirin or any other.
Patients with active peptic ulceration.
Patients with severe heart failure.
Treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
Naproxen is contraindicated in children under 2 years of age.
Not recommended in patients with baseline creatinine clearance less than 30 ml/min.

1. It is contraindicated in patients with hypersensitivity to Naproxen and Naproxen sodium, or patients with asthma, urticaria or acute nasal cavity inflammation after taking aspirin or NSAIDs.
2. Avoid the drug during pregnancy in last trimester, unless prescribed by a physician.
3. It is contraindicated in patients with gastrointestinal hemorrhage or gastrointestinal perforation.
4.It is contraindicated in patients with severe hepatic or renal impairment.
5. It is contraindicated in patients with dengue hemorrhagic fever.
6. This drug may increase the risk of gastrointestinal hemorrhage or ulceration.
7. This drug may increase the risk of ischemic stroke and ischemic heart disease, especially with high dose and long term use of Naproxen.
8. This drug may cause an adverse effect of edema; use with caution in patients with heart disease and renal impairment.
9. Use with caution in patients with hypertension or elderly.
10. This drug may affect the platelet aggregation; avoid use in patients suspected with dengue hemorrhagic fever, or platelet disorders from other causes.

1. NSAIDs cause an increased risk of serious gastrointestinal adverse events including irritation, inflammation, ulceration, bleeding and perforation of the stomach or intestinal tract. These events may occur any time during therapy and without warning and use NSAIDs with caution in patients with a history of GI disease (ulcer or bleeding), risk for serious events is greater in elderly patients.
2. Use with caution in patients with: Impaired renal function, Dehydration, Heart failure, Liver dysfunction.
3. Use with caution in patients taken with: Diuretics, ACE inhibitors, ARBs.
Use in the Elderly: The elderly are at greater risk of renal toxicity and hyperkalemia.

Pregnancy Consideration: (Pregnancy category: C): Safe use of the drug during pregnancy has not been established. It is recommended not to use in pregnancy. Avoid NSAIDs including Naproxen in the last trimester of pregnancy as premature closure of ductus arteriosus, affecting the lung and heart function of the fetus, may occur. Except only when the potentials benefit justifies the possible risks to the fetus.
Lactation Consideration: The drug is distributed into breast milk in small amount. Because of the potential for adverse effects from Naproxen in infants, it is not recommended to use in nursing mothers. A decision should be made whether to discontinue nursing or the drug.

Common: Central nervous system: dizziness, drowsiness, headache, lightheadedness, vertigo.
Respiratory: dyspnea.
Ocular: visual disturbances.
Otic: hearing disturbances, tinnitus.
Cardiovascular: palpitations, edema.
Gastrointestinal: abdominal pain, diarrhea, nausea, vomiting, constipation, dyspepsia/indigestion, heartburn, stomatitis, flatulence, ulcer.
Hepatic: liver function test abnormalities/elevations.
Genitourinary: abnormal renal function.
Dermatologic: pruritus, increase sweating, skin eruption.
Endocrine and metabolic: fluid retention.
Hematologic: anemia, bleeding time increased, ecchymoses, hemolysis.
Miscellaneous: diaphoresis, thirst.
Rare but important or Life-threatening: Hallucination; Erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis; Melena, gastrointestinal bleeding, hematemesis, ulcerative stomatitis; Hypoglycemia/hyperglycemia, hyperkalemia, menstrual disorder; Muscle weakness, paresthesia; Agranulocytosis, thrombocytopenia, hematolytic anemia, eosinophilia, lymphadenopathy; Asthma, pneumonitis; Respiratory depression; Arrhythmia, congestive heart failure, vasculitis, myocardial infarction; Renal failure, cystitis, bleeding/hemorrhage, proteinuria; Blurred vision, conjunctivitis; Hepatitis, jaundice, liver failure; Anaphylaxis/anaphylactoid reaction, angioedema; Sepsis, seizure, syncope.

Anticoagulants, hydantoins, NSAIDs, sulfonamides or sulfonylurea: Naproxen is highly bound to plasma albumin. It thus has a theoretical potential for interaction with other albumin-bound drugs such as anticoagulants, hydantoins, NSAIDs, sulfonamides or sulfonylurea. Concomitant use of Naproxen with any of these drugs should be observed for adjustment of dose.
Selective serotonin reuptake inhibitors (SSRIs): Concomitant use of Naproxen with any of SSRIs (such as fluoxetine, paroxetine, sertraline) increases the risk of GI events.
Probenecid: The excretion of Naproxen is delayed by probenecid which inhibits the formation of glucuronide conjugates of Naproxen, as well as inhibits its renal clearance, and results in raised plasma concentration of Naproxen.
Anticoagulants and thrombolytic agents: Concomitant use of Naproxen with any of anticoagulant (such as warfarin) or thrombolytic agents (such as alteplase) increases the risk of GI bleeding.
Methotrexate: Naproxen increases plasma concentration of methotrexate and thus enhances its toxicity.
ACE inhibitors and angiotensin II receptor antagonists (ARBs): Concomitant use of NSAIDs with any ACE inhibitors (such as captopril, enalapril, lisinopril) and ARBs (such as losartan, valsartan, candesartan, irbesartan) may reduce the blood pressure response to anti-hypertensive drugs.
Beta-adrenergic blocking agents, including propranolol: Naproxen may interfere with the antihypertensive effects of beta-adrenergic blocking agents (such as propranolol, atenolol, metoprolol).
Diuretics: Concomitant use of Naproxen with any diuretics (such as furosemide, HCTZ, spironolactone) should be monitored for signs of renal failure and efficacy of the diuretic.
Sucralfate, cholestyramine: Concomitant use of Naproxen with any of these drugs may result in delayed absorption of Naproxen.

Store below 30°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

D