Is Vicodin the Right Choice for This Patient?

Scott Lothian, RPh

Disclosures

November 19, 2010

Question

My patient is a 76-year-old woman with a fractured shoulder who takes hydrocodone 5 mg/acetaminophen 500 mg (Vicodin®), 2 tablets every 4-6 hours as needed. She has many comorbidities. Is this dosage appropriate, or too high?

Response from Scott Lothian, RPh
Clinical Pharmacist, Oncology & Pain Management; Analyst, Clinical Information Services, Northwestern Memorial Hospital, Chicago, Illinois

Without a patient history and a full description of the quality and quantity of pain this patient is experiencing, it is impossible to determine the appropriateness of this pain regimen for this particular patient. Besides the obvious clinical question, "What else is she taking?" there certainly are other factors that you would want to know, such as what makes her pain better or worse, and what medications or other treatments have made a difference in the past.

Aside from any issues around opioid therapy, however, this patient has a very real risk of overdosing on acetaminophen (APAP) if she is taking the maximum prescribed amount.

The APAP dosage rules are[1,2]:

  • Patients should not take more than 4 g/day;

  • Patients should take less than 4 g/day if taking it for a prolonged period of time;

  • Elderly patients should reduce these limits to 3 g/day, or 2 g/day if taking it chronically; and

  • Patients with liver insufficiency or a history of alcohol abuse should limit daily intake to 2 g and should not use APAP chronically (conflicting data exist on this point, but there are no studies of chronic use of APAP daily limits in this population).

With the pain regimen described above, the prescriber may intend that the patient take 1 tablet every 4 hours, or 2 tablets every 6 hours, but in the real world, patients may take the maximum amount (2 tablets every 4 hours), which would mean 12 tablets and 6 g of APAP per day.

This patient should be monitored for average daily use, extent of control, and side effects to fully assess her pain regimen. If she is taking 4-6 tablets a day, is well controlled, and has no hindering side effects, then she should slowly taper her use as she gets better. (Note that she should be taking something to treat and prevent constipation while on opioid therapy, such as senna/ docusate.)

However, if she is taking 6 tablets daily and is not well controlled, she should be reassessed for a change in therapy. If her pain is expected to last less than 1 month, the physician may want to continue the current dosing. But if the pain lasts longer than this, she could be assessed for baseline sustained-release therapy to allow her to get through the day without taking medicine every 4 hours; this would also reduce her daily APAP intake.

In the end, this is about pain control with reasonable use:

  • As a patient, you do not want to have to take pain medicine every 4 hours for an extended time and constantly be reminded of your pain if you are even a little late with your dose; and

  • As a prescriber you do not want your patient taking more than the allowed amount of APAP in a day -- certainly not 6 g/day as is possible in this patient.

For combination APAP products, the following daily dosage limits are for healthy adults and are based on APAP content, not on opioid limits:

  • Vicodin ES® (hydrocodone/APAP 750 mg) -- 5 tablets;

  • Vicodin® (hydrocodone/APAP 500 mg) -- 8 tablets;

  • Norco® (hydrocodone/APAP 325 mg) -- 12 tablets;

  • Tylenol® with Codeine (codeine/APAP 300 mg) -- 12 tablets; and

  • Percocet® (oxycodone/APAP 325 mg) -- 12 tablets.

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