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Drug Interactions between Aflaxen and Goody's Body Pain

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

naproxen aspirin

Applies to: Aflaxen (naproxen) and Goody's Body Pain (acetaminophen / aspirin)

GENERALLY AVOID: The antiplatelet and cardioprotective effect of low-dose aspirin may be antagonized by coadministration of some nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen has been specifically implicated, and there is evidence that others including indomethacin, naproxen, and tiaprofenic acid may also interact. The mechanism is competitive inhibition of platelet cyclooxygenase by certain NSAIDs, which, unlike aspirin, bind reversibly at the active site of the enzyme and cause a temporary rather than persistent depression of thromboxane formation and thromboxane-dependent platelet function. Unpublished single-dose trials with ibuprofen 400 mg indicate that interference with aspirin's antiplatelet activity, as measured by thromboxane B2 (TXB2) levels and platelet activation studies, occurs when ibuprofen is taken within 8 hours before or 30 minutes after dosing of immediate-release aspirin. One study showed that the antiplatelet effect of enteric-coated low-dose aspirin is attenuated when ibuprofen 400 mg is dosed 2, 7, and 12 hours after aspirin. In contrast, a placebo-controlled study found no clinically significant reduction of TXB2 inhibition when ibuprofen (400 mg three times a day) was coadministered with chewable, immediate-release aspirin (81 mg once a day) for 10 days in healthy volunteers. There are no clinical endpoint studies conducted specifically to evaluate the interaction. A retrospective study of 7107 heart patients discharged from hospitals between 1989 and 1997 with aspirin prescriptions found that those also taking ibuprofen were twice as likely to die during the study period as those taking aspirin alone or with other NSAIDs or acetaminophen. That translates to 12 extra deaths (3 heart-related deaths) a year for every 1000 patients treated. A subgroup analysis from a 5-year randomized, double-blind, placebo-controlled trial of 325 mg aspirin use on alternate days among 22,071 apparently healthy U.S. male physicians with prospective observational data on use of NSAIDs found that regular (>= 60 days/year) but not intermittent (1 to 59 days/year) use of NSAIDs inhibited the clinical benefits of aspirin on first myocardial infarction (MI). Specifically, regular users of NSAIDs in the aspirin group had a greater than 2-fold increased risk of MI, while regular users of NSAIDs in the placebo group had a nonsignificantly reduced risk of MI. There was no association between intermittent use of NSAIDs and subsequent development of MI among aspirin or placebo recipients.

MONITOR: The combined use of aspirin with NSAIDs in general may increase the potential for serious gastrointestinal (GI) toxicity, including inflammation, bleeding, ulceration, and perforation. Pharmacokinetically, aspirin at anti-inflammatory dosages or higher has been shown to decrease the plasma concentrations of many NSAIDs, including indomethacin and naproxen.

MANAGEMENT: Until more information is available, patients receiving low-dose aspirin for cardioprotection should avoid the regular use of NSAIDs including ibuprofen, indomethacin, naproxen, and tiaprofenic acid. Occasional, single use may be acceptable, as the risk from any attenuation of the antiplatelet effect of low-dose aspirin is likely to be minimal given the long-lasting effect of aspirin on platelets. If routine NSAID therapy is necessary, diclofenac may be a viable alternative. In the retrospective study implicating ibuprofen, 75 mg twice daily of delayed-release diclofenac did not interfere with the antiplatelet activity of aspirin. Other noninterfering alternatives for pain include acetaminophen, celecoxib, or narcotic analgesics. In any case, caution is advised whenever aspirin is combined with a NSAID due to the potential for additive GI toxicity. Patients should be advised to take the medications with food and to immediately report signs and symptoms of GI ulceration and bleeding such as abdominal pain, bloating, sudden dizziness or lightheadedness, nausea, vomiting, hematemesis, anorexia, and melena.

References

  1. Livio M, Del Maschio A, Cerletti C, de Gaetano G "Indomethacin prevents the long-lasting inhibitory effect of aspirin on human platelet cyclo-oxygenase activity." Prostaglandins 23 (1982): 787-96
  2. Furst DE, Sarkissian E, Blocka K, et al. "Serum concentrations of salicylate and naproxen during concurrent therapy in patients with rheumatoid arthritis." Arthritis Rheum 30 (1987): 1157-61
  3. Kwan KC, Breault GO, Davis RL, et al. "Effects of concomitant aspirin administration on the pharmacokinetics of indomethacin in man." J Pharmacokinet Biopharm 6 (1978): 451-76
  4. Rubin A, Rodda BE, Warrick P, Gruber CM Jr, Ridolfo RS "Interactions of aspirin with nonsteroidal antiinflammatory drugs in man." Arthritis Rheum 16 (1973): 635-45
  5. Brooks PM, Walker JJ, Bell MA, Buchanan WW, Rhymer AR "Indomethacin--aspirin interaction: a clinical appraisal." Br Med J 3 (1975): 69-11
  6. Muller FO, Hundt HK, Muller DG "Pharmacokinetic and pharmacodynamic implications of long-term administration of non-steroidal anti-inflammatory agents." Int J Clin Pharmacol Biopharm 15 (1977): 397-402
  7. Pawlotsky Y, Chales G, Grosbois B, Miane B, Bourel M "Comparative interaction of aspirin with indomethacin and sulindac in chronic rheumatic diseases." Eur J Rheumatol Inflamm 1 (1978): 18-20
  8. Segre EJ, Chaplin M, Forchielli E, Runkel R, Sevelius H "Naproxen-aspirin interactions in man." Clin Pharmacol Ther 15 (1973): 374-9
  9. Grennan DM, Ferry DG, Ashworth ME, Kenny RE, Mackinnnon M "The aspirin-ibuprofen interaction in rheumatoid arthritis." Br J Clin Pharmacol 8 (1979): 497-503
  10. Schafer AI "Effects of nonsteroidal antiinflammatory drugs on platelet function and systemic hemostasis." J Clin Pharmacol 35 (1995): 209-19
  11. Catella-Lawson F, Reilly MP, Kapoor SC, et al. "Cyclooxygenase inhibitors and the antiplatelet effects of aspirin." N Engl J Med 345 (2001): 1809-17
  12. Wilner KD, Rushing M, Walden C, et al. "Celecoxib does not affect the antiplatelet activity of aspirin in healthy volunteers." J Clin Pharmacol 42 (2002): 1027-30
  13. MacDonald TM, Wei L "Effect of ibuprofen on cardioprotective effect of aspirin." Lancet 361 (2003): 573-4
  14. Kurth T, Glynn RJ, Walker AM, et al. "Inhibition of clinical benefits of aspirin on first myocardial infarction by nonsteroidal antiinflammatory drugs." Circulation 108 (2003): 1191-5
  15. Bates ER, Mukherjee D, Lau WC "Drug-drug interactions involving antiplatelet agents." Eur Heart J 24 (2003): 1707-9
  16. Kimmel SE, Berlin JA, Reilly M, et al. "The effects of nonselective non-aspirin non-steroidal anti-inflammatory medications on the risk of nonfatal myocardial infarction and their interaction with aspirin." J Am Coll Cardiol 43 (2004): 985-90
  17. Cryer B, Berlin RG, Cooper SA, Hsu C, Wason S "Double-blind, randomized, parallel, placebo-controlled study of ibuprofen effects on thromboxane B(2) concentrations in aspirin-tereated healthy adult volunteers." Clin Ther 27 (2005): 185-91
  18. Capone ML, Sciulli MG, Tacconelli S, et al. "Pharmacodynamic interaction of naproxen with low-dose aspirin in healthy subjects." J Am Coll Cardiol 45 (2005): 1295-301
  19. "Concomitant use of ibuprofen and aspirin." J Pain Palliat Care Pharmacother 21 (2007): 73-4
  20. Gladding PA, Webster MW, Farrell HB, Zeng IS, Park R, Ruijne N "The antiplatelet effect of six non-steroidal anti-inflammatory drugs and their pharmacodynamic interaction with aspirin in healthy volunteers." Am J Cardiol 101 (2008): 1060-3
  21. FDA. U.S. Food and Drug Administration "Information for healthcare professionals: concomitant use of ibuprofen and aspirin. New information [9/2006] - concomitant use of ibuprofen and aspirin. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm125222." (2010):
  22. Rao GH, Johnson GG, Reddy KR, White JG "Ibuprofen protects platelet cycloosygenase from irreversible inhibition by aspirin." Arteriosclerosis 3 (1983): 383-8
View all 22 references

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Drug and food interactions

Major

acetaminophen food

Applies to: Goody's Body Pain (acetaminophen / aspirin)

GENERALLY AVOID: Chronic, excessive consumption of alcohol may increase the risk of acetaminophen-induced hepatotoxicity, which has included rare cases of fatal hepatitis and frank hepatic failure requiring liver transplantation. The proposed mechanism is induction of hepatic microsomal enzymes during chronic alcohol use, which may result in accelerated metabolism of acetaminophen and increased production of potentially hepatotoxic metabolites.

MANAGEMENT: In general, chronic alcoholics should avoid regular or excessive use of acetaminophen. Alternative analgesic/antipyretic therapy may be appropriate in patients who consume three or more alcoholic drinks per day. However, if acetaminophen is used, these patients should be cautioned not to exceed the recommended dosage (maximum 4 g/day in adults and children 12 years of age or older).

References

  1. Kaysen GA, Pond SM, Roper MH, Menke DJ, Marrama MA "Combined hepatic and renal injury in alcoholics during therapeutic use of acetaminophen." Arch Intern Med 145 (1985): 2019-23
  2. O'Dell JR, Zetterman RK, Burnett DA "Centrilobular hepatic fibrosis following acetaminophen-induced hepatic necrosis in an alcoholic." JAMA 255 (1986): 2636-7
  3. Seeff LB, Cuccherini BA, Zimmerman HJ, Adler E, Benjamin SB "Acetaminophen hepatotoxicity in alcoholics." Ann Intern Med 104 (1986): 399-404
  4. Thummel KE, Slattery JT, Nelson SD "Mechanism by which ethanol diminishes the hepatotoxicity of acetaminophen." J Pharmacol Exp Ther 245 (1988): 129-36
  5. McClain CJ, Kromhout JP, Peterson FJ, Holtzman JL "Potentiation of acetaminophen hepatotoxicity by alcohol." JAMA 244 (1980): 251-3
  6. Kartsonis A, Reddy KR, Schiff ER "Alcohol, acetaminophen, and hepatic necrosis." Ann Intern Med 105 (1986): 138-9
  7. Prescott LF, Critchley JA "Drug interactions affecting analgesic toxicity." Am J Med 75 (1983): 113-6
  8. "Product Information. Tylenol (acetaminophen)." McNeil Pharmaceutical PROD (2002):
  9. Whitcomb DC, Block GD "Association of acetaminopphen hepatotoxicity with fasting and ethanol use." JAMA 272 (1994): 1845-50
  10. Bonkovsky HL "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301
  11. Nelson EB, Temple AR "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301
  12. Zimmerman HJ, Maddrey WC "Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure." Hepatology 22 (1995): 767-73
View all 12 references

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Moderate

naproxen food

Applies to: Aflaxen (naproxen)

GENERALLY AVOID: The concurrent use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) and ethanol may lead to gastrointestinal (GI) blood loss. The mechanism may be due to a combined local effect as well as inhibition of prostaglandins leading to decreased integrity of the GI lining.

MANAGEMENT: Patients should be counseled on this potential interaction and advised to refrain from alcohol consumption while taking aspirin or NSAIDs.

References

  1. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn PROD (2002):

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Moderate

aspirin food

Applies to: Goody's Body Pain (acetaminophen / aspirin)

GENERALLY AVOID: The concurrent use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) and ethanol may lead to gastrointestinal (GI) blood loss. The mechanism may be due to a combined local effect as well as inhibition of prostaglandins leading to decreased integrity of the GI lining.

MANAGEMENT: Patients should be counseled on this potential interaction and advised to refrain from alcohol consumption while taking aspirin or NSAIDs.

References

  1. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn PROD (2002):

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Minor

aspirin food

Applies to: Goody's Body Pain (acetaminophen / aspirin)

One study has reported that coadministration of caffeine and aspirin lead to a 25% increase in the rate of appearance and 17% increase in maximum concentration of salicylate in the plasma. A significantly higher area under the plasma concentration time curve of salicylate was also reported when both drugs were administered together. The exact mechanism of this interaction has not been specified. Physicians and patients should be aware that coadministration of aspirin and caffeine may lead to higher salicylate levels faster.

References

  1. Yoovathaworn KC, Sriwatanakul K, Thithapandha A "Influence of caffeine on aspirin pharmacokinetics." Eur J Drug Metab Pharmacokinet 11 (1986): 71-6

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Therapeutic duplication warnings

Therapeutic duplication is the use of more than one medicine from the same drug category or therapeutic class to treat the same condition. This can be intentional in cases where drugs with similar actions are used together for demonstrated therapeutic benefit. It can also be unintentional in cases where a patient has been treated by more than one doctor, or had prescriptions filled at more than one pharmacy, and can have potentially adverse consequences.

Duplication

Nonsteroidal anti-inflammatories

Therapeutic duplication

The recommended maximum number of medicines in the 'nonsteroidal anti-inflammatories' category to be taken concurrently is usually one. Your list includes two medicines belonging to the 'nonsteroidal anti-inflammatories' category:

  • Aflaxen (naproxen)
  • Goody's Body Pain (acetaminophen/aspirin)

Note: In certain circumstances, the benefits of taking this combination of drugs may outweigh any risks. Always consult your healthcare provider before making changes to your medications or dosage.

See also

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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