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Human

NAPDAs™

Tablet

500 mg

GENERIC NAMENaproxen

MANUFACTURED BYEskayef Pharmaceuticals Ltd.

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Available Pack Sizes:1 Size

Purchase Option:Full Pack

Maximum Retail Price (MRP):

Quantity

৳ 126.00/ 10 x 4

(Unit: ৳ 14.00 / 1 Tablet)

16263

Composition

NAPDAS™ 500 Controlled Release Tablets: Each Controlled Release Tablet contains Naproxen Sodium USP equivalent to Naproxen 500 mg.

Description

NAPDAs™ is the preparation of naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPDAs™ tablets use the proprietary IPDAS* (Intestinal Protective Drug Absorption System) technology*. It is a rapidly disintegrating tablet system combining an immediate release component and a sustained release component of microparticles that are widely dispersed, allowing absorption of the active ingredient throughout the gastrointestinal (Gl) tract, maintaining blood levels over 24 hours. After oral administration, plasma levels of naproxen are detected within 30 minutes of dosing, with peak plasma levels occurring at approximately 5 hours after dosing.

Indications

Naproxen Sodium is indicated for the treatment of Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, Tendinitis, Bursitis, and Acute Gout. It is also indicated for the relief of mild to moderate pain, and the treatment of primary dysmenorrhea.

Dosage & Administration

Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. RA, OA, and AS: The dosage is two 375 mg or 500 mg tablets once daily, or one 750 mg tablet once daily. Management of Pain, PD, and Acute Tendinitis and Bursitis: The dosage is two 500 mg tablets once daily. For patients requiring greater analgesic benefit, two 750 mg tablets or three 500 mg tablets may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets. For the treatment of Acute Gout: The dosage is two to three 500 mg tablets once daily on the first day, followed by two 500 mg tablets once daily, until the attack has subsided.

Interaction

Monitor patients for bleeding who are taking Naproxen Sodium controlled release tablet with drugs that interfere with hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs) * Concomitant use of Naproxen Sodium controlled release tablet and analgesic doses of aspirin is not generally recommended. * Concomitant use of ACE Inhibitors and ARBs, or Beta-Blockers with Naproxen Sodium controlled release tablets may diminish the antihypertensive effect of these drugs. Monitor blood pressure. * Concomitant use of ACE Inhibitors and ARBs with Naproxen Sodium controlled release tablets in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function. * NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects. * Concomitant use of Digoxin with Naproxen Sodium controlled release tablets can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.

Overdose:

Significant over dosage of the drug may be characterized by drowsiness, heartburn, indigestion, and nausea or vomiting. It is not known what doses of the drug would be life threatening.

Contraindications

Known hypersensitivity to Naproxen Sodium.

History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

In the setting of CABG surgery.

Side Effects

The most frequent adverse events were headache (15%), followed by dyspepsia (14%), and flu syndrome (10%).

Pregnancy & Lactation

Use of NSAIDs including Naproxen Sodium controlled release tablets during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use in pregnant women starting at 30 weeks gestation. (third trimester). There is no adequate and well-controlled studies of Naproxen sodium controlled release tablet in pregnant women. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Naproxen Sodium controlled release tablets and any potential adverse effect on the breastfed infant from the Naproxen Sodium controlled release tablets or from the underlying maternal condition.

Precautions & Warnings

Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. Heart Failure and Edema: Avoid use of Naproxen Sodium in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Seek emergency help if an anaphylactic reaction occurs.

Storage Conditions

Do not store above 30°C temperature. Keep away from light and wet place. Keep out of reach of children.

NAPDAs™ • 10 x 4

৳ 126.00