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Drug Catalog - Product Detail

NAPROXEN SUSP 125MG/5ML(SOL) 473ML

NDC Mfr Size Str Form
70868-0200-16 KEY THERAPEUTICS 473 125MG/5ML NA
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Description
DESCRIPTION Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen Suspension is available as a light orange-colored opaque oral suspension containing 125 mg/5 mL of naproxen in a vehicle containing sucrose, magnesium aluminum silicate, sorbitol solution and sodium chloride (39 mg/5 mL, 1.5 mEq), methylparaben, fumaric acid, FD&C Yellow No. 6, imitation pineapple flavor, imitation orange flavor and purified water. The pH of the suspension ranges from 2.2 to 3.7. Chemical Structure
How Supplied
HOW SUPPLIED Naproxen Suspension 125 mg/5 mL (contains 39 mg sodium per 5 mL): Available as light orange colored, pineapple-orange flavored suspension in 1 pint (473 mL) light-resistant bottles (NDC 70868-200-16). Store at 15° to 30°C (59° to 86°F); avoid excessive heat, above 40°C (104°F). Dispense in light-resistant containers. Keep out of reach of children. Shake gently before use.
Indications & Usage
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Naproxen Suspension and other treatment options before deciding to use Naproxen Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ) . Naproxen Suspension is indicated: For the relief of the signs and symptoms of rheumatoid arthritis For the relief of the signs and symptoms of osteoarthritis For the relief of the signs and symptoms of ankylosing spondylitis For the relief of the signs and symptoms of juvenile rheumatoid arthritis Naproxen Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. Naproxen Suspension is also indicated: For relief of the signs and symptoms of tendonitis For relief of the signs and symptoms of bursitis For relief of the signs and symptoms of acute gout For the management of pain For the management of primary dysmenorrhea
Dosage and Administration
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of Naproxen Suspension and other treatment options before deciding to use Naproxen Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ) . After observing the response to initial therapy with Naproxen Suspension, the dose and frequency should be adjusted to suit an individual patient's needs. Different dose strengths and formulations (ie, tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation. Although Naproxen Suspension and other formulations of naproxen and naproxen sodium all circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 30 minutes in patients taking naproxen sodium and within 1 hour in patients taking naproxen (see CLINICAL PHARMACOLOGY ) . The recommended strategy for initiating therapy is to choose a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS; Hepatotoxicity , and Renal Toxicity and Hyperkalemia and PRACAUTIONS; Geriatric Use ) . Geriatric Patients Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose. Patients With Moderate to Severe Renal Impairment Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS; Renal Toxicity and Hyperkalemia ) . Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis Naproxen Suspension 250 mg (10 mL) twice daily or 375 mg (15 mL) twice daily or 500 mg (20 mL) twice daily Naproxen Suspension should be shaken gently before use. During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary. In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see CLINICAL PHARMACOLOGY ) . Juvenile Rheumatoid Arthritis The use of Naproxen Suspension is recommended for juvenile arthritis in children 2 years or older because it allows for more flexible dose titration based on the child's weight. In pediatric patients, doses of 5 mg/ kg/day produced plasma levels of naproxen similar to those seen in adults taking 500 mg of naproxen (see CLINICAL PHARMACOLOGY ) . The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (i.e., 5 mg/kg given twice a day). A measuring cup marked in 1/2 teaspoon and 2.5 milliliter increments is provided with the Naproxen Suspension. The following table may be used as a guide for dosing of Naproxen Suspension. Patient's Weight Dose Administered as 13 kg (29 lb) 62.5 mg, twice daily 2.5 mL, twice daily 25 kg (55 lb) 125 mg, twice daily 5.0 mL, twice daily 38 kg (84 lb) 187.5 mg, twice daily 7.5 mL, twice daily Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis The recommended starting dose of Naproxen Suspension is 500 mg (20 mL), followed by 250 mg (10 mL) every 6 to 8 hours as required. The total daily dose should not exceed 1250 mg (50 mL) (see CLINICAL PHARMACOLOGY , INDICATIONS AND USAGE ) . Acute Gout The recommended starting dose is 750 mg of Naproxen Suspension followed by 250 mg every 8 hours until the attack has subsided (see CLINICAL PHARMACOLOGY ) .