Tramadol and Acetaminophen (Systemic)

Brand Names : Ultracet

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tramadol and acetaminophen, the following should be considered:

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to tramadol, other opioid analgesics or acetaminophen. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy - Tramadol and acetaminophen has not been studied in pregnant women. However, studies in animals have shown that tramadol and acetaminophen causes birth defects and other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Too much use of an opioid during pregnancy may cause the fetus to become dependent on the medicine. This may lead to withdrawal side effects in the newborn baby. Newborn seizures, symptoms of withdrawal from opioids, death of the fetus and still birth have been reported.

Breast-feeding - Tramadol and acetaminophen pass into breast milk and may cause unwanted side effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children - Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of tramadol and acetaminophen in children up to 16 years of age with use in other age groups.

Older adults - This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines - Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tramadol and acetaminophen, it is especially important that your health care professional know if you are taking any of the following:

Tramadol and acetaminophen
• Anticoagulants (e.g., Coumadin [blood thinners]) - Tramadol and acetaminophen may increase the amount of blood thinners in your blood, which can cause problems with bleeding.
• Alcohol and products with alcohol in them - Taking these medicines with tramadol and acetaminophen may cause problems with your liver.

For acetaminophen:

• Acetaminophen-containing products (e.g., Tylenol, Nyquil, Chlor-Trimeton Sinus) - Taking additional acetaminophen may increase the risk of liver problems.

For tramadol:
• Analgesics, opioid (e.g., codeine, morphine) or
• Antidepressants such as tricyclic antidepressants (e.g., amitriptyline [Elavil], doxepin [Sinequan]), and selective serotonin reuptake inhibitors (e.g., citalopram [Celexa], fluvoxamine [Luvox], sertraline [Zoloft]), and medicines with Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) or
• Neuroleptics (e.g., Thorazine, Prolixin) - Taking these medicines with tramadol may increase the possibility of seizures or convulsions.
• Alcohol and products with alcohol in them or
• Anesthetic medicines or
• Central nervous system (CNS) depressants such as , narcotic pain relievers (e.g., Codeine, Darvon), phenothiazines (e.g., Thorazine, Prolixin), sedative hypnotics (e.g., Valium, Xanax), tranquilizers (e.g., Ativan, Haldol - Taking these medicines with tramadol may increase the chance of serious side effects.
• Carbamazepine (e.g., Tegretol) - May decrease the blood levels of Tramadol, which increases the chance of serious side effects
• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) (taken currently or within the past 2 weeks) - Taking tramadol with these medicines may cause more of a chance for seizures. It may also cause high blood pressure, unusual heartbeats, or headache

• Selective serotonin reuptake inhibitors (SSRI) (citalopram [e.g., Celexa], fluvoxamine [e.g., Luvox], and sertraline [e.g., Zoloft] - Taking these medicines with tramadol and acetaminophen may increase the possibility of seizures or convulsions

Other medical problems - The presence of other medical problems may affect the use of tramadol and acetaminophen. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol and/or other drug abuse, or history of, or
• Convulsions (seizures), history of, or
• Head injury, or
• Hormonal problems or
• Infections of the central nervous system or
• Kidney disease or
• Liver disease, or
• Respiratory difficulty or troubled breathing, or
• Severe abdominal problems - The chance of serious side effects may be increased