Hepatitis C Review - Acetaminophen -Tylenol
In 2011 Johnson & Johnson reduced the maximum daily dose of its Extra Strength Tylenol pain reliever, lowering the risk of accidental overdose from the drugs active ingredient acetaminophen.
Today on the blog those label changes are highlighted with the hepatitis C patient in mind.
Stay updated by viewing future articles related to - Acetaminophen Safety.
What We Know
Stay updated by viewing future articles related to - Acetaminophen Safety.
What We Know
For the average healthy person acetaminophen-Tylenol is a remarkably safe and effective drug when taken at the recommended dose, yet acetaminophen has caused hundreds of deaths per year.
Why?
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The Answer
In November of last year MSNBC author Rachel Rettner wrote an article about a study published in the British Journal of Clinical Pharmacology . The study found that "staggered overdoses" of acetaminophen were more deadly than single overdoses. The journalist explains:
The study looked at what are called "staggered overdoses," in which a person repeatedly exceeds the daily recommendation through small overdoses. This is in contrast to the more familiar single overdose, when a person takes too many pills at once.In the study, staggered overdoses of acetaminophen (which is found in Tylenol and other pain reliever's) were more deadly than single overdoses, even though people who experienced staggered overdoses typically took smaller total amounts of acetaminophen than those who experienced a single overdose.
Doctors may not identify staggered overdoses right away, researchers added. People with a staggered overdose may have levels of the drug in their blood below what a standard blood test would indicate as an overdose, even when their liver is badly damaged.
In a related article at TIME journalist Maia Szalavitz reported the highest health risks from "staggered overdose" were seen in older people and people who drink a lot of alcohol.
Heavy drinkers and older patients were at highest risk of staggered overdose. Alcohol alone can damage the liver and those who drink more than three drinks a day are advised not to use drugs that contain acetaminophen.
People who misuse opioid painkillers are also at risk of staggered acetaminophen overdose because common opioid drugs like Vicodin include it. While long-term users develop tolerance to the effects of the opioid component of these drugs, this does not affect the potential of acetaminophen to damage the liver.
In January of 2011 the FDA asked acetaminophen-manufacturers to lower the strength of acetaminophen in prescription drug products to 325 milligrams per pill. Although, MSNBC reported taking a pill of this dosage every four hours could still put a person at risk from "staggered overdose" from acetaminophen. As noted below Tylenol was not included in the FDA action.
The U.S. Food and Drug Administration (FDA) is asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen.
These actions will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen.Acetaminophen is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. It is one of the most commonly-used drugs in the United States. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet).OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. Additional safety measures relating to OTC acetaminophen products will be taken through separate action, such as a rulemaking as part of the ongoing OTC monograph proceeding for internal analgesic drug products.
Acetaminophen-ALT elevations in non-drinkers
I thought this was interesting, in 2010 a study published in "The Journal of Human Pharmacology and Drug Therapy" researchers found that daily use of acetaminophen - at the daily maximum dose of 4 g/day for 10 days causes asymptomatic ALT elevations in non-drinkers.
2010 Study/Full Text:
In conclusion, administration of the maximum daily recommended dose of acetaminophen, 4 g/day to healthy non-drinkers for more than 4 consecutive days is associated with asymptomatic ALT elevation in most subjects. ALT elevations are generally between 1.5 and 2 times their pre-treatment measurements are not accompanied by other laboratory findings or symptoms of liver injury and all ALT elevations resolved once acetaminophen administration was stopped.
Hepatitis C And Tylenol
Under the supervision of a doctor, and depending on the condition of the liver, people undergoing HCV therapy are often prescribed Tylenol for joint aches, pain and fever relief, without risk or complications.
Someone please tell me what is the recommended dose of Tylenol is for people with HCV ?
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The Recommended dose of acetaminophen (Tylenol®) for patients with hepatitis C
Tylenol Label Changes
The Maximum Recommended Dose For "Healthy Patients"
In the fall of 2011 new dosing instructions for TYLENOL were put in place by Johnson & Johnson. The maximum daily dose was changed from 8 pills (4,000 milligrams) per day to 6 pills (3,000 milligrams) per day. The drug company also changed the dosing interval from every 4-6 hours to every 6 hours.
*The 2011 label changes for extra strength Tylenol are listed below, the company says it will cut the maximum dosage of Regular Strength Tylenol and other acetaminophen-containing products in 2012..
* Patients with cirrhosis should avoid pain medications called “non‐steroidal antiinflammatories (NSAIDS)”
Please know with every mention of HCV therapy there are far too many people who have not benefited from new or old drugs that treat this virus. For these people who have advanced liver damage, managing pain or sleep aids can be a daily struggle. Check out the website for an article written by Jennifer Pate, covering the commonly used sleep medications in patients with liver disease
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Pain Medications In Patients With Cirrhosis
Medications
Patients with cirrhosis should avoid pain medications called “non‐steroidal antiinflammatories (NSAIDS)”. These include over‐the‐counter medications such as ibuprofen (Motrin, Advil), naprosyn (Aleve), as well as some prescription medications. Ask your doctor if any of your medications are NSAIDS.
For mild to moderate aches and pains, it is safe to use Tylenol (acetaminophen) at doses of 2,000 mg/day or less (no more than 6 regular strength or no more than 4 extra strength each day AND no more than 20 regular strength or no more than 15 extra strength each week). Some cold medicines and prescription pain medicines contain acetaminophen, so read the labels and make sure you don’t
take too much by mistake.
Medications - Decompensated Liver Disease
A 2011 review article published in the International Journal of Hepatology titled:
Extra Strength TYLENOL New dosing instructions
Once again the new dosing instructions reduce the maximum daily dose from 8 pills per day to 6 pills per day and change the dosing interval for Extra Strength TYLENOL® from every 4-6 hours to every 6 hours. These labeling changes will be consistent across all single-ingredient Extra Strength TYLENOL® products. We are working closely with other manufacturers of acetaminophen products to help ensure consistency in dosing instructions.
Changes affect the labels of the following Extra Strength TYLENOL® products
Extra Strength TYLENOL® Rapid Release Gels - 500 mg in each gelcap
Extra Strength TYLENOL® Caplets - 500 mg in each tablet
Extra Strength TYLENOL® EZ Tabs - 500 mg in each tablet
Extra Strength TYLENOL® Rapid Blast Liquid - 500 mg in each
15 mL = 1 tablespoon
*Regular strength Tylenol
*Consider a lower acetaminophen dose found in regular-strength Tylenol, which is 325 mg. It could be adequate enough to relieve minor pain or treatment side effects.
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| Regular strength Tylenol - 325 mg in each tablet |
Warnings
Regular strength Tylenol
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- child take more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
*Ask a doctor before use if the user has liver disease
Extra Strength TYLENOL
Caplets, Rapid Release Gels, EZ Tabs
Liver warning:
This product contains acetaminophen. The maximum daily dose of this product is 6 caplets, gelcaps, or tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Rapid Blast Liquid
Liver warning:
This product contains acetaminophen. The maximum daily dose of this product is 90 mL (6 TBSP) (3 FL OZ) (3,000 mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
****Ask a doctor before use if you have liver disease.
Today, more than 600 over-the-counter and prescription medicines contain acetaminophen.These include medicines to treat symptoms of allergies, cold and flu, and pain with trouble sleeping.
Some people accidentally exceed the recommended dose when taking multiple products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instructions. Acetaminophen –the active ingredient in TYLENOL®–is safe when used as directed, but when taken in overdose amounts, it can cause liver damage.
Some Common Medications That Contain Acetaminophen*
It’s important to be aware of the ingredients in all medications that you may be taking. Acetaminophen (APAP) is a common component of many different over-the-counter and prescription medications. You should not take two or more products that contain acetaminophen at the same time.
Taking more than the recommended dose (overdose) of acetaminophen may cause liver damage.
Some Common Prescription Drugs That Contain Acetaminophen*
- Darvocet®
- Endocet®
- Fioricet®
- Hycotab
- Hydrocet®
- Hydrocodone Bitartrate
- Lortab®
- Percocet®
- Phenaphen®
- Sedapap®
- Tapanol®
- Ultracet®
- Vicodin®
- Zydone®
Some Common Over-the-Counter Drugs That Contain Acetaminophen*
- Actifed®
- Anacin®
- Benadryl®
- Cepacol®
- Contac®
- Coricidin®
- Dayquil®
- Dimetapp®
- Dristan®
- Elixir®
- Excedrin®
- Feverall®
- Formula 44®
- Goody’s® Powders
- Liquiprin®
- Midol®
- Nyquil®
- Panadol®
- Robitussin®
- Saint Joseph® Aspirin-Free
- Singlet®
- Sinutab®
- Sudafed®
- Theraflu®
- Triaminic®
- TYLENOL® Brand Products
- Vanquish®
- Vicks®
- Zicam®
*This is NOT a complete list.
In addition to the new dosing instructions on the OTC label, the makers of TYLENOL® launched Get Relief Responsibly™, an initiative designed to educate consumers about the appropriate use of OTC and prescription medications, particularly those containing acetaminophen, and the importance of reading and following medication labels. As a part of this initiative, the makers of TYLENOL® have created a new website www.getreliefresponsibly.com. The site includes an interactive Acetaminophen Finder tool to help consumers identify products that contain acetaminophen and build a personal acetaminophen medication list to share with their healthcare provider or pharmacist.
Related Updates
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