NAPROXEN ORAL SUSPENSION 125 MG / 5 ML 473 ML
Generic: Naproxen
NAPROXEN ORAL SUSPENSION 125 MG / 5 ML 473 ML
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Identification
Naproxen
Naproxen
Acella Pharmaceuticals, LLC
HUMAN PRESCRIPTION DRUG
Administration
SUSPENSION
ORAL
NDA018965
Active Ingredients
| Ingredient | Strength |
|---|---|
| NAPROXEN | 125 mg/5mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Naproxen Suspension is indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea Naproxen Suspension is a non-steroidal anti-inflammatory drug indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Use the lowest effective dose for shortest duration consistent with individual patient treatment goals. ( 2 ) Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Naproxen Suspension 250 mg (10 mL) or 375 mg (15 mL) or 500 mg (20 mL) twice daily twice daily twice daily The dose may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for up to 6 months. Polyarticular Juvenile Idiopathic Arthritis Recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses. 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 (1/2 tsp) twice daily 25 kg (55 lb) 125 mg twice daily 5.0 mL (1 tsp) twice daily 38 kg (84 lb) 187.5 mg twice daily 7.5 mL (1 1/2 tsp) 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. Acute Gout The recommended starting dose is 750 mg (30 mL) of Naproxen Suspension followed by 250 mg (10 mL) every 8 hours until the attack has subsided. 2.1 General Dosing Instructions 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 and Precautions ( 5 ) ]. After observing the response to initial therapy with Naproxen Suspension, the dose and frequency should be adjusted to suit an individual patient’s needs. Always use a calibrated measuring device when administering Naproxen Suspension to ensure the dose is measured and administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half of a teaspoonful is to be measured. Given the variability of the household spoon measure, it is strongly recommended that caregivers obtain and use a calibrated measuring device. Health care providers should recommend an appropriate measuring device that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage. Naproxen-containing products such as Naproxen Suspension, and other naproxen products should not be used concomitantly since they all circulate in the plasma as the naproxen anion. 2.2 Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis The recommended dosage of Naproxen Suspension is shown in Table 1. Table 1: Recommended dosages of Naproxen Suspension Naproxen Suspension 250 mg (10 mL) or 375 mg (15 mL) or 500 mg (20 mL) twice daily twice daily 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. 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. 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. 2.3 Polyarticular Juvenile Idiopathic 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 ( 12 .3 ) ] 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 (1/2 tsp) twice daily 25 kg (55 lb) 125 mg twice daily 5.0 mL (1 tsp) twice daily 38 kg (84 lb) 187.5 mg twice daily 7.5 mL (1 1/2 tsp) twice daily 2.4 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). 2.5 Acute Gout The recommended starting dose is 750 mg (30 mL) of Naproxen Suspension followed by 250 mg (10 mL) every 8 hours until the attack has subsided. 2.6 Non-Interchangeability with Other Formulations of Naproxen Different dose strengths and formulations (e.g., tablets, suspension) of naproxen are not interchangeable. This difference should be taken into consideration when changing strengths or formulations.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 Cardiovascular Thrombotic Events ) ] GI Bleeding, Ulceration, and Perforation [ see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [ see Warnings and Precautions ( 5.3 Hepatotoxicity ) ] Hypertension [ see Warnings and Precautions ( 5.4 Hypertension ) ] Heart Failure and Edema [ see Warnings and Precautions ( 5.5 Heart Failure and Edema ) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 Renal Toxicity and Hyperkalemia ) ] Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] Hematologic Toxicity [ see Warnings and Precautions ( 5.11 ) ] Most common adverse reactions to naproxen were dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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. In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with polyarticular juvenile idiopathic arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were greater, 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 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of naproxen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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 erythematoses, 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
Information for Patients
17 PATIENT COUNSELING INFORMATION Advise the patient and caregiver to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers should be informed of the following information before initiating therapy with Naproxen Suspension and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [ see Warnings and Precautions ( 5.1 Cardiovascular Thrombotic Events ) ]. Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [ see Warnings and Precautions ( 5.2 ) ]. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop Naproxen Suspension and seek immediate medical therapy [ see Warnings and Precautions ( 5.3 Hepatotoxicity)]. Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [ see Warnings and Precautions ( 5.5 Heart Failure and Edema ) ]. Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.7 ) ]. Serious Skin Reactions Advise patients to stop Naproxen Suspension immediately if they develop any type of rash and to contact their healthcare provider as soon as possible [ see Warnings and Precautions ( 5.9 ) ]. Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including Naproxen Suspension, may be associated with a reversible delay in ovulation [ see Use in Specific Populations ( 8.3 ) ]. Fetal Toxicity Inform pregnant women to avoid use of Naproxen Suspension and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus [ see Warnings and Precautions ( 5.10 ) and Use in Specific Populations ( 8.1 ) ]. Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of Naproxen Suspension with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [ see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7 ) ]. Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia. Use of NSAIDS and Low-Dose Aspirin Inform patients not to use low-dose aspirin concomitantly with Naproxen Suspension until they talk to their healthcare provider [ see Drug Interactions ( 7 ) ]. Dosing Instructions Instruct patients on how to measure and take the correct dose of Naproxen Suspension and to always use a calibrated measuring device when administering Naproxen Suspension to ensure the dose is measured and administered accurately [ see Dosage and Administration ( 2.1 ) ]. If the prescribed concentration is changed, instruct patients on how to correctly measure the new dose to avoid errors. Made in Canada Distributed by: Acella Pharmaceutical, LLC Alpharetta, GA 30005 L-0291 Rev 1020-01 For more information call 1-800-541-4802 Revised: October 2020
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.