NEWLY REFORMULATED VICODIN® LAUNCH ANNOUNCEMENT
 
Introduction of newly reformulated Vicodin®, Vicodin ES®, and
Vicodin HP® (hydrocodone bitartrate and acetaminophen tablets, USP)
         
     
     
  Dear Healthcare Provider:  
 

On January 13, 2011, the U.S. Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, including combination acetaminophen and opioid products, to no more than 325 mg per tablet, capsule, or other dosage unit. The FDA has stated that limiting the amount of acetaminophen per dosage unit in prescription products may reduce the risk of severe liver injury from acetaminophen overdosing.1 (Please visit the FDA website for more information on acetaminophen dosing: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm)

How is Abbott responding to the FDA guidance?
Abbott is complying with this directive more than 1 year ahead of the FDA's requested deadline of January 2014, and is now introducing new formulations of Vicodin, Vicodin ES, and Vicodin HP (hydrocodone bitartrate and acetaminophen tablets, USP).

What is the indication of the reformulated Vicodin?
The indication for the new Vicodin formulations has remained the same: Vicodin, Vicodin ES, and Vicodin HP (hydrocodone bitartrate and acetaminophen tablets, USP) are indicated for the relief of moderate to moderately severe pain.2

HEPATOTOXICITY: ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST CASES OF LIVER INJURY ARE ASSOCIATED WITH DOSES THAT EXCEED 4000 MG/DAY.

VICODIN, VICODIN ES, and VICODIN HP tablets are contraindicated in patients who have hypersensitivity to the drugs or their inactive ingredients. VICODIN formulations contain hydrocodone which is an opioid agonist and a schedule III controlled substance with an abuse liability and dependence. It may cause dose-related respiratory depression in sensitive patients and caution should be exercised when prescribing to elderly or debilitated patients. The concomitant use with other central nervous system (CNS) depressants and monoamine oxidase (MAO) inhibitors or tricyclic antidepressants may increase the effect of either drug. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent.

 
     
   
     
  What are the details about the new Vicodin?  
  Formulations:
The new Vicodin formulations contain 300 mg of acetaminophen per tablet, which is lower than the amount mandated by the FDA. The formulations are:
 Vicodin (hydrocodone bitartrate and acetaminophen tablets, USP) 5 mg/300 mg
 Vicodin ES (hydrocodone bitartrate and acetaminophen tablets, USP) 7.5 mg/300 mg
 Vicodin HP (hydrocodone bitartrate and acetaminophen tablets, USP) 10 mg/300 mg

Change to Generic:
The new Vicodin is being introduced as a branded generic product, which means that patients will pay a generic co-pay at the pharmacy.

Tablet Visual Appearance and Markings:
New Vicodin tablets will look slightly different than the original formulations. Both are white, capsule-shaped, scored tablets. However, new formulations of Vicodin, Vicodin ES, and Vicodin HP will show:

The original formulation did not have the strength debossed on the tablet.

Dosing:

*The total daily dosing regimen for the new Vicodin ES 7.5 mg/300 mg is slightly different from the previous product. The original 7.5 mg/750 mg version of Vicodin ES has a "not to exceed" total daily dose of 5 tablets.

How Supplied?
The reformulated Vicodin is available in bottles of 100 and 500 tablets for each strength. The new National Drug Code (NDC) associated with each strength is listed in the chart below:

Abbott is working with pharmacies to help ensure the availability of the new Vicodin formulations. Also, because Vicodin is still a CIII product, no samples will be available.
 
     
  What happened to the original Vicodin formulation?  
  Abbott discontinued manufacturing and distribution of its original formulations of Vicodin (Vicodin® 5 mg/500 mg, Vicodin ES® 7.5 mg/750 mg, and Vicodin HP® 10 mg/660 mg), which contained higher strengths of acetaminophen.

Abbott has been working with pharmacy wholesalers and pharmacies to process returns of the original Vicodin formulations, in order to minimize confusion or the potential for medication errors.
 
     
  How do I return the original formulation of Vicodin?  
  When returning the Vicodin formulations listed below, Abbott will issue credit to you through your wholesaler for full or partial bottles of product in original Abbott containers that have not expired. No special authorizations from Abbott are required.  
     
  Returns should be sent to:  
  GENCO
6101 North 64th Street
Milwaukee, WI 53218
 
   
  Patient Communication  
 
  The new formulations of Vicodin will be available on October 8th 2012.
Patients should not take more than 4000 mg of acetaminophen per day.
Patients should be instructed to call their physician if they have taken more than the recommended dose of acetaminophen.
 
     
  For More Information  
  Should you have any questions or require further information regarding Vicodin, the Abbott Medical Information Department may be reached at 1-800-633-9110 or via email at medinfo@abbott.com. You can also visit www.vicodin.com.  
     
  Indication2-5  
 

VICODIN® 5 mg/300 mg, VICODIN ES® 7.5 mg/300 mg, VICODIN HP® 10 mg/300 mg, VICODIN® 5 mg/500 mg, VICODIN ES® 7.5 mg/750 mg, and VICODIN HP® 10 mg/660 mg (hydrocodone bitartrate and acetaminophen tablets, USP) tablets are indicated for the relief of moderate to moderately severe pain.

 
     
  Important Safety Information2-5  
  BOXED WARNING
HEPATOTOXICITY: ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.
 
     
  CONTRAINDICATIONS  
  VICODIN, VICODIN ES, and VICODIN HP tablets are contraindicated in patients previously exhibiting hypersensitivity to hydrocodone or acetaminophen, and also in patients known to be hypersensitive to other opioids, as they may exhibit cross-sensitivity to hydrocodone.  
     
  WARNINGS  
  Controlled Substance: VICODIN, VICODIN ES, and VICODIN HP contain hydrocodone, which is an opioid agonist and a Schedule III controlled substance with an abuse liability.

Abuse and Dependence: VICODIN, VICODIN ES, and VICODIN HP can be abused in a manner similar to other opioid agonists, legal or illicit. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, these products should be prescribed and administered with caution.

Hypersensitivity/Anaphylaxis: There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.

Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression.

Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury or other intracranial pressure.

Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
 
     
  PRECAUTIONS  
  As with any narcotic, special caution should be used when prescribing hydrocodone to elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture. Caution should also be exercised with patients who are likely to take other acetaminophen-containing medications, antihistamines, antipsychotics, antianxiety agents, other narcotic analgesics, or other central nervous system (CNS) depressants (including alcohol) concomitantly. When combined therapy is contemplated, the dose of one or both agents should be reduced. Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery.

The use of monoamine oxidase (MAO) inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

VICODIN, VICODIN ES, and VICODIN HP tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. Administration to the mother during labor or shortly before delivery may result in some degree of respiratory depression in the newborn.
 
     
  ADVERSE REACTIONS  
  The most frequently reported adverse reactions include lightheadedness, dizziness, sedation, nausea, and vomiting. Prolonged administration may produce constipation.  
     
  DOSAGE AND ADMINISTRATION  
 
  VICODIN 5 mg/300 mg: The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.
VICODIN ES 7.5 mg/300 mg: The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
VICODIN HP 10 mg/300 mg: The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
 
     
  DOSAGE AND ADMINISTRATION  
 
  VICODIN 5 mg/500 mg: The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.
VICODIN ES 7.5 mg/750 mg: The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 5 tablets.
VICODIN HP 10 mg/660 mg: The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
 
     
  Reporting Adverse Events  
  You can assist us with monitoring the safety of Vicodin by reporting adverse events to Abbott at 1-800-633-9110. Alternatively, this information may be reported to the FDA's MedWatch reporting system by phone (1-800-FDA-1088), fax (1-800-FDA-0178), at www.fda.gov/medwatch, or mailed to MedWatch, HF-2, 5600 Fishers Lane, Rockville MD, 20852-9787.  
     
     
     
  Sincerely,  
  Michael Jones
Divisional Vice President and General Manager
Proprietary Pharmaceuticals
Mature Businesses
 
     
     
     
     
  References:  
  1. United States Department of Health and Human Services. Information by Drug Class: Acetaminophen. Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm. Accessed October 28, 2011. 2. Vicodin, Vicodin ES, Vicodin HP 5, 7.5, 10 mg (hydrocodone)/300 mg (acetaminophen) [package insert]. North Chicago, IL: Abbott Laboratories. 3. Vicodin 5 mg (hydrocodone)/500 mg (acetaminophen) [package insert]. North Chicago, IL: Abbott Laboratories. 4. Vicodin ES 7.5 mg (hydrocodone)/750 mg (acetaminophen) [package insert]. North Chicago, IL: Abbott Laboratories. 5. Vicodin HP 10 mg (hydrocodone)/660 mg (acetaminophen) [package insert]. North Chicago, IL: Abbott Laboratories.  
   
     
  Please see Full Prescribing Information including BOXED WARNING on hepatotoxicity.  
     
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Abbott Consumer Relations
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  This communication has been funded by Abbott Laboratories.
©2012 Abbott Laboratories   Abbott Park, IL 60064   084-824204   October 2012