Anaprox DS is a nonsteroidal anti-inflammatory drug (NSAID). Anaprox DS works by reducing hormones that cause inflammation and pain in the body.
Anaprox DS is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.
The delayed-release or extended-release tablets are slower-acting forms of Anaprox DS that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms of Anaprox DS will not work fast enough to treat acute pain.
Anaprox DS may also be used for purposes not listed in this medication guide.
Anaprox DS indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Carefully consider the potential benefits and risks of Anaprox DS, EC-Anaprox DS or Anaprox DS Suspension and other treatment options before deciding to use Anaprox DS, EC-Anaprox DS or Anaprox DS Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Anaprox DS as Anaprox DS, EC-Anaprox DS or Anaprox DS 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 arthritis
Anaprox DS as Anaprox DS Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.
Anaprox DS as Anaprox DS and Anaprox DS 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
EC-Anaprox DS is not recommended for initial treatment of acute pain because the absorption of Anaprox DS is delayed compared to absorption from other Anaprox DS-containing products.
How should I use Anaprox DS?
Use Anaprox DS sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Anaprox DS sustained-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Anaprox DS sustained-release tablets refilled.
Swallow Anaprox DS sustained-release tablets whole. Do not break, crush, or chew before swallowing.
Take Anaprox DS sustained-release tablets by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
Take Anaprox DS sustained-release tablets with a full glass of water (8 oz [240 mL]) as directed by your doctor.
If you take antacids, cholestyramine, or sucralfate, ask your doctor or pharmacist how to take them with Anaprox DS sustained-release tablets.
If you miss a dose of Anaprox DS sustained-release tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Anaprox DS sustained-release tablets.
Uses of Anaprox DS in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Anaprox DS is used to relieve mild to moderate pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation.
If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.
This form of Anaprox DS is absorbed slowly and should not be used for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist about using a different form of this drug or other medications for quick relief of pain.
How to use EC-Anaprox DS
Read the Medication Guide provided by your pharmacist before you start using Anaprox DS and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually twice daily with or without food. Swallow this medication whole. Do not break, crush, or chew the tablets. Doing so can release the drug too quickly, increasing the risk of side effects. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug.
The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than directed. For ongoing conditions such as arthritis, continue taking this medication as directed by your doctor.
For certain conditions (such as arthritis), it may take up to two weeks of taking this drug regularly until you get the full benefit.
Tell your doctor if your condition does not improve or if it worsens.
Anaprox DS description
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Each tablet contains Naproxen 200 mg and sodium 20 mg. It also contains the following inactive ingredients: Povidone, microcrystalline cellulose, talc, magnesium stearate, purified water and Opadry (blue) in the coating. It is lactose- and gluten-free.
The sodium content of Anaprox DS is low, similar to a slice of wheat bread.
Anaprox DS dosage
Usual Adult Dose for Ankylosing Spondylitis:
Initial: 250 mg to 500 mg (Anaprox DS) or 275 mg to 550 mg (Anaprox DS sodium) orally twice a day. The initial dose for Anaprox DS sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.
Maintenance: May be increased to a daily maximum of 1500 mg (Anaprox DS) or 1650 mg (Anaprox DS sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Anaprox DS sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.
Usual Adult Dose for Osteoarthritis:
Initial: 250 mg to 500 mg (Anaprox DS) or 275 mg to 550 mg (Anaprox DS sodium) orally twice a day. The initial dose for Anaprox DS sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.
Maintenance: May be increased to a daily maximum of 1500 mg (Anaprox DS) or 1650 mg (Anaprox DS sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Anaprox DS sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.
Usual Adult Dose for Rheumatoid Arthritis:
Initial: 250 mg to 500 mg (Anaprox DS) or 275 mg to 550 mg (Anaprox DS sodium) orally twice a day. The initial dose for Anaprox DS sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.
Maintenance: May be increased to a daily maximum of 1500 mg (Anaprox DS) or 1650 mg (Anaprox DS sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Anaprox DS sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.
Usual Adult Dose for Acute Gout:
750 mg (Anaprox DS) or 825 mg (Anaprox DS sodium) orally one time, followed by 250 mg (Anaprox DS) or 275 mg (Anaprox DS sodium) every 8 hours until the gouty attack has resolved, usually 2 to 3 days. The recommended dose of Anaprox DS sodium controlled-release is two to three 500 mg tablets (1000 to 1500 mg) orally on the first day, followed by two 500 mg tablets (1000 mg) orally daily until the attack has subsided.
Usual Adult Dose for Bursitis:
550 mg Anaprox DS sodium orally once, followed by 550 mg Anaprox DS sodium every 12 hours, or 275 mg (Anaprox DS sodium)/250 mg (Anaprox DS) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Anaprox DS sodium or 1000 mg Anaprox DS. The recommended initial dose of Anaprox DS sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).
Usual Adult Dose for Tendonitis:
550 mg Anaprox DS sodium orally once, followed by 550 mg Anaprox DS sodium every 12 hours, or 275 mg (Anaprox DS sodium)/250 mg (Anaprox DS) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Anaprox DS sodium or 1000 mg Anaprox DS. The recommended initial dose of Anaprox DS sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).
Usual Adult Dose for Dysmenorrhea:
550 mg Anaprox DS sodium orally once, followed by 550 mg Anaprox DS sodium every 12 hours, or 275 mg (Anaprox DS sodium)/250 mg (Anaprox DS) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Anaprox DS sodium or 1000 mg Anaprox DS.
Over-the-counter preparation: Anaprox DS sodium 220 mg orally every 8 hours as needed. Do not exceed 2 caplets in any 8- to 12-hour period.
The recommended initial dose of Anaprox DS sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).
Usual Adult Dose for Pain:
550 mg Anaprox DS sodium orally once, followed by 550 mg Anaprox DS sodium every 12 hours, or 275 mg (Anaprox DS sodium)/250 mg (Anaprox DS) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Anaprox DS sodium or 1000 mg Anaprox DS.
Over-the-counter preparation: Anaprox DS sodium 220 mg orally every 8 hours as needed. Do not exceed 2 caplets in any 8- to 12-hour period.
The recommended initial dose of Anaprox DS sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).
Usual Geriatric Dose for Pain:
Over-the-counter preparation - 220 mg (Anaprox DS sodium) orally every 12 hours or 250 mg (Anaprox DS) orally every 8 hours as needed.
Usual Pediatric Dose for Fever:
Dosage guidelines are based on Anaprox DS:
Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours.
Usual Pediatric Dose for Pain:
Dosage guidelines are based on Anaprox DS:
Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours.
Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:
Dosage guidelines are based on Anaprox DS:
Greater than or equal to 2 years: 5 mg/kg orally twice a day. Maximum dose: 1000 mg/day.
The use of NSAIDs in patients who are receiving ACE inhibitors may potentiate renal disease states.
In vitro studies have shown that Anaprox DS anion, because of its affinity for protein, may displace from their binding sites other drugs which are also albumin-bound.
Theoretically, the Anaprox DS anion itself could likewise be displaced. Short-term controlled studies failed to show that taking the drug significantly affects prothrombin times when administered to individuals on coumarin-type anticoagulants. Caution is advised nonetheless, since interactions have been seen with other nonsteroidal agents of this class. Similarly, patients receiving the drug and a hydantoin, sulfonamide or sulfonylurea should be observed for signs of toxicity to these drugs.
Concomitant administration of Anaprox DS and aspirin is not recommended because Anaprox DS is displaced from its binding sites during the concomitant administration of aspirin, resulting in lower plasma concentrations and peak plasma levels.
The natriuretic effect of furosemide has been reported to be inhibited by some drugs of this class. Inhibition of renal lithium clearance leading to increases in plasma lithium concentrations has also been reported. DL Anaprox DS and other NSAIDs can reduce the antihypertensive effect of propranolol and other beta-blockers.
Probenecid given concurrently increases Anaprox DS anion plasma levels and extends its plasma half-life significantly.
Caution should be used if Anaprox DS is administered concomitantly with methotrexate. DL Anaprox DS, Anaprox DS sodium and other NSAIDs have been reported to reduce the tubular secretion of methotrexate in an animal model, possibly increasing the toxicity of methotrexate.
Drug/Laboratory Test Interactions
DL Anaprox DS may decrease platelet aggregation and prolong bleeding time. This effect should be kept in mind when bleeding times are determined. The administration of Anaprox DS may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-dinitrobenzene used in this assay. Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that therapy with Anaprox DS be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used.
DL Anaprox DS may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).
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 Anaprox DS compared to those taking 750 mg Anaprox DS.
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 Anaprox DS, 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 Anaprox DS in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:
The following are additional adverse experiences reported in <1% of patients taking Anaprox DS 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)
Gastrointestinal: inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, perforation and obstruction of the upper and lower gatrointestinal 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 causes have been fatal)
Anaprox DS, EC-Anaprox DS and Anaprox DS Suspension are contraindicated in patients with known hypersensitivity to Anaprox DS and Anaprox DS sodium.
Anaprox DS, EC-Anaprox DS and Anaprox DS Suspension 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.
Anaprox DS, EC-Anaprox DS and Anaprox DS Suspension are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
DailyMed. "NAPROXEN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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