How long did you take this medication to work?
What happens if I overdose Ameproxen?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.
Proper storage of Ameproxen tablets and capsules:
Store Ameproxen tablets and capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid temperatures above 104 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ameproxen tablets and capsules out of the reach of children and away from pets.
Overdose of Ameproxen in details
Symptoms and Signs
Significant Ameproxen overdosage may be characterized by lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation or vomiting. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Because Ameproxen sodium may be rapidly absorbed, high and early blood levels should be anticipated. A few patients have experienced convulsions, but it is not clear whether or not these were drug-related. It is not known what dose of the drug would be life threatening. The oral LD50 of the drug is 543 mg/kg in rats, 1234 mg/kg in mice, 4110 mg/kg in hamsters, and greater than 1000 mg/kg in dogs.
Patients should be managed by symptomatic and supportive care following a NSAID overdose. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of Ameproxen because of the high degree of its protein binding. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine or hemoperfusion may not be useful due to high protein binding.
What should I avoid while taking Ameproxen?
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Avoid taking aspirin while you are taking Ameproxen.
Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over the counter contain aspirin or other medicines similar to Ameproxen. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or Ameproxen.
Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb Ameproxen.
Ameproxen® (Ameproxen sodium controlled-release tablets) represents the first prescription product to offer convenient once-a-day dosing of Ameproxen, a medication long considered a standard in arthritis treatment. Ameproxen or Ameproxen sodium-based products account for nearly one in every five prescriptions written for non-steroidal anti-inflammatory drugs (NSAID) in the United States. (Ameproxen sodium, a sodium salt formulation of Ameproxen, provides for more rapid absorption./p>
Ameproxen tablets use a proprietary delivery system IPDAS™, (Intestinal Protective Drug Absorption System), a matrix of Ameproxen sodium with immediate and controlled-release components. Upon ingestion, and after rapid disintegration of the tablet matrix, an initial portion (approximately 30%) of the medication is released for rapid systemic absorption -- achieving onset of analgesic action within 30 minutes. In addition, a sustained-release component of microparticles provides an extended absorption phase that has wide GI dispersion, allowing gradual absorption throughout the GI tract, and prolongs therapeutic systemic levels of the drug, enabling 24-hour duration of action and once-a-day dosing/p>
Ameproxen has been used safely and effectively worldwide for 20 years and is one of the NSAIDs most widely used in the treatment of osteoarthritis and rheumatoid arthritis. Numerous clinical studies have demonstrated the efficacy and safety profile of Ameproxen. Ameproxen offers the same efficacy and safety profile with the added advantage of once-a-day dosing. The most frequent complaints relate to the gastrointestinal tract. Serious GI toxicity, such as perforation, ulceration or bleeding can occur in patients treated chronically with NSAID therapy. Please consult with your physician to see if Ameproxen may be right for you.
- Ameproxen® is marketed by Wyeth-Ayerst Labratories and not associated with Syntex Puerto Rico, Inc.
- Ameproxen is a registered trademark of Syntex Puerto Rico, Inc.
- IPDAS™ is a trademark of élan pharma ltd.
- Ameproxen® (Ameproxen sodium) Controlled Release Tabletstrong>Equivalent to 375 mg and 500 mg Ameproxen
What should I discuss with my healthcare provider before taking Ameproxen?
Some medical conditions may interact with Ameproxen enteric-coated tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, ulcerative colitis, Crohn disease)
- if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
- if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk of any of these diseases
- if you have poor health, dehydration or low fluid volume; low blood sodium levels; you are on a low-salt (sodium) diet; or you drink alcohol, smoke, or have a history of alcohol abuse
Some MEDICINES MAY INTERACT with Ameproxen enteric-coated tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), aspirin, corticosteroids (eg, prednisone), heparin, other NSAIDs (eg, ibuprofen), rivaroxaban, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased
- Probenecid because it may increase the risk of Ameproxen enteric-coated tablets's side effects
- H blockers (eg, ranitidine) or sucralfate because they may decrease Ameproxen enteric-coated tablets's effectiveness
- Bisphosphonates (eg, alendronate), cyclosporine, hydantoins (eg, phenytoin), lithium, methotrexate, quinolones (eg, ciprofloxacin), sulfonamides (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Ameproxen enteric-coated tablets
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Ameproxen enteric-coated tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ameproxen enteric-coated tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Ameproxen-containing products such as Ameproxen, EC-Ameproxen, Ameproxen SUSPENSION, ALEVE®, and other Ameproxen products should not be used concomitantly since they all circulate in the plasma as the Ameproxen anion.
Ameproxen, EC-Ameproxen and Ameproxen Suspension cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids and the patient should be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.
Patients with initial hemoglobin values of 10 g or less who are to receive long-term therapy should have hemoglobin values determined periodically.
The pharmacological activity of Ameproxen, EC-Ameproxen and Ameproxen Suspension in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, noninflammatory painful conditions.
Because of adverse eye findings in animal studies with drugs of this class, it is recommended that ophthalmic studies be carried out if any change or disturbance in vision occurs.
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Ameproxen, EC-Ameproxen and Ameproxen Suspension. Hepatic abnormalities may be the result of hypersensitivity rather than direct toxicity. These laboratory abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. The SGPT (ALT) test is probably the most sensitive indicator of liver dysfunction. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.
A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of more severe hepatic reaction while on therapy with Ameproxen, EC-Ameproxen or Ameproxen Suspension.
If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (eg, eosinophilia, rash, etc.), Ameproxen, EC-Ameproxen or Ameproxen Suspension should be discontinued.
Chronic alcoholic liver disease and probably other diseases with decreased or abnormal plasma proteins (albumin) reduce the total plasma concentration of Ameproxen, but the plasma concentration of unbound Ameproxen is increased. Caution is advised when high doses are required and some adjustment of dosage may be required in these patients. It is prudent to use the lowest effective dose.
Anemia is sometimes seen in patients receiving NSAIDs, including Ameproxen, EC-Ameproxen and Ameproxen Suspension. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Ameproxen, EC-Ameproxen and Ameproxen Suspension, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving either Ameproxen, EC-Ameproxen or Ameproxen Suspension who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, Ameproxen, EC-Ameproxen and Ameproxen Suspension should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.
Information for Patients
Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.
- Ameproxen, EC-Ameproxen and Ameproxen Suspension, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up.
- Ameproxen, EC-Ameproxen and Ameproxen Suspension, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up.
- Ameproxen, EC-Ameproxen and Ameproxen Suspension, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.
- Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.
- Patients should be informed of the warning signs and symptoms of hepatotoxicity (eg, nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
- Patients should be informed of the signs of an anaphylactoid reaction (eg, difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help.
- In late pregnancy, as with other NSAIDs, Ameproxen, EC-Ameproxen and Ameproxen Suspension should be avoided because it may cause premature closure of the ductus arteriosus.
- Caution should be exercised by patients whose activities require alertness if they experience drowsiness, dizziness, vertigo or depression during therapy with Ameproxen.
Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (eg, eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, Ameproxen, EC-Ameproxen and Ameproxen Suspension should be discontinued.
Drug InteractionsAngiotensin Converting Enzyme (ACE)-inhibitors/Angiotensin Receptor Blockers (ARBs)
NSAIDs may diminish the antihypertensive effect of ACE-inhibitors, ARBs, or beta-blockers (including propanolol).
Monitor patients taking NSAIDs concomitantly with ACE-inhibitors, ARBs, or beta blockers for changes in blood pressure.
In addition, in patients who are elderly, volume-depleted (including those on diuretic therapy), or have compromised renal function, co-administration of NSAIDs with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. Monitor these patients closely for signs of worsening renal function.
Antacids and Sucralfate
Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of Ameproxen.
When Ameproxen as Ameproxen, EC-Ameproxen or Ameproxen Suspension is administered with aspirin, its protein binding is reduced, although the clearance of free Ameproxen, EC-Ameproxen or Ameproxen Suspension is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Ameproxen and Ameproxen sodium and aspirin is not generally recommended because of the potential of increased adverse effects.
As with other NSAIDs, concomitant administration of cholestyramine can delay the absorption of Ameproxen.
Clinical studies, as well as postmarketing observations, have shown that Ameproxen, EC-Ameproxen and Ameproxen Suspension can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Ameproxen, Ameproxen sodium and other nonsteroidal anti-inflammatory drugs have been reported to reduce the tubular secretion of methotrexate in an animal model. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. No significant interactions have been observed in clinical studies with Ameproxen and coumarin-type anticoagulants. However, caution is advised since interactions have been seen with other nonsteroidal agents of this class. The free fraction of warfarin may increase substantially in some subjects and Ameproxen interferes with platelet function.
Selective Serotonin Reuptake Inhibitors (SSRIs)
There is an increased risk of gastrointestinal bleeding when selective serotonin reuptake inhibitors (SSRIs) are combined with NSAIDs. Caution should be used when NSAIDs are administered concomitantly with SSRIs.
Other Information Concerning Drug Interactions
Ameproxen is highly bound to plasma albumin; it thus has a theoretical potential for interaction with other albumin-bound drugs such as coumarin-type anticoagulants, sulphonylureas, hydantoins, other NSAIDs, and aspirin. Patients simultaneously receiving Ameproxen and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required.
Probenecid given concurrently increases Ameproxen anion plasma levels and extends its plasma half-life significantly.
Due to the gastric pH elevating effects of H2-blockers, sucralfate and intensive antacid therapy, concomitant administration of EC-Ameproxen is not recommended.
Drug/Laboratory Test Interaction
Ameproxen may decrease platelet aggregation and prolong bleeding time. This effect should be kept in mind when bleeding times are determined.
The administration of Ameproxen may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-di-nitrobenzene 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 Ameproxen be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used.
Ameproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).
A 2-year study was performed in rats to evaluate the carcinogenic potential of Ameproxen at rat doses of 8, 16, and 24 mg/kg/day (50, 100, and 150 mg/m2). The maximum dose used was 0.28 times the systemic exposure to humans at the recommended dose. No evidence of tumorigenicity was found.
Pregnancy Category C
Reproduction studies have been performed in rats at 20 mg/kg/day (125 mg/m2/day, 0.23 times the human systemic exposure), rabbits at 20 mg/kg/day (220 mg/m2/day, 0.27 times the human systemic exposure), and mice at 170 mg/kg/day (510 mg/m2/day, 0.28 times the human systemic exposure) with no evidence of impaired fertility or harm to the fetus due to the drug. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Ameproxen, EC-Ameproxen and Ameproxen Suspension should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
There is some evidence to suggest that when inhibitors of prostaglandin synthesis are used to delay preterm labor there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus and intracranial hemorrhage. Ameproxen treatment given in late pregnancy to delay parturition has been associated with persistent pulmonary hypertension, renal dysfunction and abnormal prostaglandin E levels in preterm infants. Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.
Labor and Delivery
In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. Ameproxen-containing products are not recommended in labor and delivery because, through its prostaglandin synthesis inhibitory effect, Ameproxen may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage. The effects of Ameproxen, EC-Ameproxen and Ameproxen Suspension on labor and delivery in pregnant women are unknown.
The Ameproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum Ameproxen concentration in plasma. Because of the possible adverse effects of prostaglandin-inhibiting drugs on neonates, use in nursing mothers should be avoided.
Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Pediatric dosing recommendations for juvenile arthritis are based on well-controlled studies. There are no adequate effectiveness or dose-response data for other pediatric conditions, but the experience in juvenile arthritis and other use experience have established that single doses of 2.5 to 5 mg/kg (as Ameproxen suspension, see DOSAGE AND ADMINISTRATION), with total daily dose not exceeding 15 mg/kg/day, are well tolerated in pediatric patients over 2 years of age.
Studies indicate that although total plasma concentration of Ameproxen is unchanged, the unbound plasma fraction of Ameproxen 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.
Experience indicates that geriatric patients may be particularly sensitive to certain adverse effects of nonsteroidal anti-inflammatory drugs. Elderly or debilitated patients seem to tolerate peptic ulceration or bleeding less well when these events do occur. Most spontaneous reports of fatal GI events are in the geriatric population.
Ameproxen is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Geriatric patients may be at a greater risk for the development of a form of renal toxicity precipitated by reduced prostaglandin formation during administration of nonsteroidal anti-inflammatory drugs.
What happens if I miss a dose of Ameproxen?
Since Ameproxen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
- 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).
- DrugBank. "NAPROXEN". http://www.drugbank.ca/drugs/DB00788 (accessed September 17, 2018).
- MeSH. "Gout Suppressants". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology