Long-Term Use of Ultracet and Aceclofenac: Risks and Considerations - Pharmacology

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Hello Dr.
Hou, I am 155 cm tall and weigh 41 kg.
I sought medical attention due to severe upper back pain and am currently taking Ultracet (tramadol 37.5 mg + acetaminophen 325 mg) at a dosage of 4 tablets per day, along with "Tonec" (aceclofenac 100 mg) at a dosage of 2 tablets per day, which I have been taking for 5 months.
Could you please advise if long-term use of these medications could be harmful? Thank you.

Mei, 40~49 year old female. Ask Date: 2008/04/30

Dr. Hou Fangmin reply Pharmacology


Hello: The maximum single dose of Ultracet is one to two tablets every four to six hours as needed for pain relief, with a maximum of eight tablets per day.
This medication is not recommended for patients with severe liver dysfunction.
It is intended for short-term use, with a total prescription duration of less than five to seven days! Common side effects occur in the central nervous system and gastrointestinal system, which may include nausea, dizziness, drowsiness, diarrhea, insomnia, and dyspepsia.
The side effects of Aceclofenac (NSAID) are mostly mild and reversible upon discontinuation, including gastrointestinal disturbances such as dyspepsia, abdominal pain, nausea, and diarrhea; dizziness may occur occasionally; skin reactions may include itching and erythema; abnormal liver enzyme levels may be reported, and there are occasional reports of elevated creatinine levels.
It may cause renal function impairment, and special caution is required for patients with mild renal or cardiac insufficiency, as well as the elderly.
If liver function is abnormal or deteriorating, or if symptoms of liver disease persist or if there is an increase in eosinophils or skin rash, this medication must be discontinued immediately.
In patients with porphyria, this medication may trigger hepatitis.
This medication also inhibits platelet aggregation.
Long-term use requires regular monitoring of liver and kidney function as well as blood counts.
Please use this medication according to your physician's instructions and discuss with your doctor how long you should use it.

Reply Date: 2008/04/30

More Info


Long-term use of medications like Ultracet (which combines tramadol and acetaminophen) and Aceclofenac (a non-steroidal anti-inflammatory drug, or NSAID) can raise several concerns regarding safety and potential side effects. Given your current regimen of Ultracet at a dosage of four tablets per day and Aceclofenac at two tablets per day for five months, it is essential to consider the implications of prolonged use of these medications.

Ultracet (Tramadol and Acetaminophen)
Ultracet is a combination medication that contains tramadol, an opioid analgesic, and acetaminophen, a non-opioid pain reliever. While tramadol can be effective for managing moderate to severe pain, its long-term use can lead to several issues:
1. Dependence and Tolerance: Prolonged use of tramadol can lead to physical dependence, where the body becomes accustomed to the drug, requiring higher doses to achieve the same pain relief. This can increase the risk of withdrawal symptoms if the medication is suddenly discontinued.

2. Side Effects: Common side effects of tramadol include dizziness, nausea, constipation, and drowsiness. Long-term use may exacerbate these effects and lead to more severe complications, such as seizures, especially if the dosage exceeds recommended levels.

3. Liver Health: Acetaminophen, when taken in high doses or for extended periods, can cause liver damage. Since you are taking four tablets daily, it is crucial to ensure that the total daily dose of acetaminophen does not exceed the recommended limit (typically 3,000 to 4,000 mg for adults, depending on individual health factors).

4. Kidney Function: Both tramadol and acetaminophen can affect kidney function, particularly in individuals with pre-existing conditions. Regular monitoring of liver and kidney function is advisable during long-term therapy.

Aceclofenac
Aceclofenac is an NSAID used to relieve pain and inflammation. While it can be effective, long-term use of NSAIDs carries its own set of risks:
1. Gastrointestinal Issues: Prolonged use of NSAIDs can lead to gastrointestinal problems, including ulcers, bleeding, and perforation of the stomach or intestines. These risks are heightened in older adults or those with a history of gastrointestinal issues.

2. Kidney Damage: NSAIDs can impair kidney function, especially in individuals with existing kidney disease or those taking other medications that affect renal function. Regular monitoring of kidney function is essential.

3. Cardiovascular Risks: Long-term NSAID use has been associated with an increased risk of cardiovascular events, such as heart attack and stroke, particularly in individuals with pre-existing heart conditions.

4. Liver Function: Although less common, NSAIDs can also affect liver function. Monitoring liver enzymes may be necessary, especially if you experience symptoms like jaundice or unexplained fatigue.

Recommendations
Given your current medication regimen and the duration of use, it is crucial to consult with your healthcare provider. They can assess your overall health, review your medications, and determine if any adjustments are necessary. Regular monitoring of liver and kidney function, as well as a review of your pain management strategy, is essential to minimize risks.

Additionally, consider discussing alternative pain management strategies, such as physical therapy, acupuncture, or non-pharmacological approaches, which may help alleviate your back pain without the risks associated with long-term medication use.

In summary, while Ultracet and Aceclofenac can be effective for pain management, their long-term use should be approached with caution. Regular medical supervision, monitoring for side effects, and exploring alternative treatments are key to ensuring your safety and well-being.

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