DESCRIPTION
id: c55d8e69-8b9e-4d95-bcb4-10299b91ad98
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of non-steroidal anti-inflammatory drugs.
The chemical name for naproxen, USP is (+)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the following structural formula:
C14H14O3 M.W. 230.26
Naproxen, USP is a practically 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, USP at pH 7.4 is 1.6 to 1.8.
Naproxen Delayed-Release Tablets USP are available as enteric-coated, white to off-white tablets containing 375 mg or 500 mg of naproxen, USP for oral administration. The inactive ingredients are: antifoam DC 1510, corn starch, croscarmellose sodium, FD&C Blue # 2 Aluminum Lake, magnesium stearate, methacrylic acid copolymer-dispersion, povidone, propylene glycol, shellac, talc, titanium dioxide, and triethyl citrate. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4.
INDICATIONS AND USAGE
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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Carefully consider the potential benefits and risks of Naproxen Delayed-Release Tablets USP and other treatment options before deciding to use Naproxen Delayed-Release Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Naproxen Delayed-Release Tablets USP are 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 arthritis
Naproxen, USP as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight.
Naproxen Delayed-Release Tablets USP are not recommended for initial treatment of acute pain because the absorption of naproxen, USP is delayed compared to absorption from other naproxen-containing products (see
CLINICAL PHARMACOLOGY
and
DOSAGE AND ADMINISTRATION
).
CONTRAINDICATIONS
id: 89e01053-9045-4d27-b278-c31341e7d115
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Naproxen delayed-release tablets are contraindicated in patients with known hypersensitivity to naproxen and naproxen sodium.
Naproxen delayed-release tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS,
Anaphylactoid Reactions
and PRECAUTIONS,
Preexisting Asthma
).
Naproxen delayed-release tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see
WARNINGS
).
ADVERSE REACTIONS
id: c1042e00-b067-4f5f-80e8-6204530867fd
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.
A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg naproxen compared to those taking 750 mg naproxen (see
CLINICAL PHARMACOLOGY
).
In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with juvenile arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were increased, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.
In patients taking naproxen in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:
Gastrointestinal (GI) Experiences, including: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis
Central Nervous System: headache*, dizziness*, drowsiness*, lightheadedness, vertigo
Dermatologic: pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpura
Special Senses: tinnitus*, visual disturbances, hearing disturbances
Cardiovascular: edema*, palpitations
General: dyspnea*, thirst
* Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.
In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.
Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting
General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes
The following are additional adverse experiences reported in < 1% of patients taking naproxen during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.
Body as a Whole:
anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)
Cardiovascular:
congestive heart failure, vasculitis, hypertension, pulmonary edema
Gastrointestinal:
inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, perforation and obstruction of the upper or lower gastrointestinal tract. Esophagitis, stomatitis, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease).
Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some cases have been fatal)
Hemic and Lymphatic:
eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia
Metabolic and Nutritional:
hyperglycemia, hypoglycemia
Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions
Respiratory:
eosinophilic pneumonitis, asthma
Dermatologic:
alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematosus, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.
Special Senses:
hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema
Urogenital:
glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine
Reproduction (female):
infertility
In patients taking NSAIDs, the following adverse experiences have also been reported in < 1% of patients.
Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death
Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction
Gastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation
Hepatobiliary: hepatitis, liver failure
Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia
Metabolic and Nutritional: weight changes
Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations
Respiratory: asthma, respiratory depression, pneumonia
Dermatologic: exfoliative dermatitis
Special Senses: blurred vision, conjunctivitis
Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuria
DOSAGE AND ADMINISTRATION
id: d0dffc53-ae69-4f9c-b36f-a67902d4fca9
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Carefully consider the potential benefits and risks of Naproxen Delayed-Release Tablets and other treatment options before deciding to use Naproxen Delayed-Release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
After observing the response to initial therapy with Naproxen Delayed-Release Tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
Different dose strengths and formulations (i.e., tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation.
Although naproxen tablets, naproxen suspension, Naproxen Delayed-Release Tablets, and naproxen sodium tablets 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. Because Naproxen Delayed-Release Tablets dissolve in the small intestine rather than in the stomach, the absorption of the drug is delayed compared to the other naproxen formulations (see
CLINICAL PHARMACOLOGY
).
The recommended strategy for initiating therapy is to choose a formulation and 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
and
PRECAUTIONS
).
HOW SUPPLIED
id: 6c21c2b8-2438-4f20-894e-1099e2054185
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Naproxen Delayed-Release Tablets USP are supplied as follows:
375 mg: White to off-white, capsule-shaped, enteric-coated, unscored tablets imprinted on one side in blue ink with “93-5”. They are available in bottles of 60.
500 mg: White to off-white, capsule-shaped, enteric-coated, unscored tablets imprinted on one side in blue ink with “93-6”. They are available in bottles of 30 and 60 tablets.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured In Israel By:
TEVA PHARMACEUTICAL IND. LTD.
Jerusalem, 91010, Israel
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
Rev. I 3/2013
Principal Display Panel
id: c74b8af6-46d7-4706-bdb2-065a573dea8a
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Principal Display Panel
id: 64be756b-cb44-4558-ac6e-edcd3190e3ec
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
