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 narcotic analgesic and acetaminophen combinations, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to acetaminophen or to a narcotic analgesic. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—

• For acetaminophen : Although studies on birth defects with acetaminophen have not been done in pregnant women, it has not been reported to cause birth defects or other problems.
• For narcotic analgesics : Although studies on birth defects with narcotic analgesics have not been done in pregnant women, they have not been reported to cause birth defects. However, hydrocodone caused birth defects in animal studies when very large doses were used. Codeine did not cause birth defects in animals, but it caused slower development of bones and other toxic or harmful effects in the fetus. Pentazocine and propoxyphene did not cause birth defects in animals. There is no information about whether dihydrocodeine or oxycodone causes birth defects in animals.
  Too much use of a narcotic during pregnancy may cause the fetus to become dependent on the medicine. This may lead to withdrawal side effects in the newborn baby. Also, some of these medicines may cause breathing problems in the newborn baby if taken just before or during delivery.
• For caffeine : Studies in humans have not shown that caffeine (contained in some of these combination medicines) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).

Breast-feeding—Acetaminophen, codeine, and propoxyphene pass into the breast milk. It is not known whether other narcotic analgesics pass into the breast milk. However, these medicines have not been reported to cause problems in nursing babies.

Children—Breathing problems may be especially likely to occur when narcotic analgesics are given to children younger than 2 years of age. These children are usually more sensitive than adults to the effects of narcotic analgesics. Also, unusual excitement or restlessness may be more likely to occur in children receiving these medicines.

Acetaminophen has been tested in children and has not been shown to cause different side effects or problems in children than it does in adults.

Older adults—Elderly people are especially sensitive to the effects of narcotic analgesics. This may increase the chance of side effects, especially breathing problems, during treatment.

Acetaminophen 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 a narcotic analgesic and acetaminophen combination, it is especially important that your health care professional know if you are taking any of the following:

• Carbamazepine (e.g., Tegretol)—Propoxyphene may increase the blood levels of carbamazepine, which increases the chance of serious side effects

• Central nervous system (CNS) depressants or
• 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) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Taking these medicines together with a narcotic analgesic may increase the chance of serious side effects

• Naltrexone (e.g., Trexan)—Naltrexone keeps narcotic analgesics from working to relieve pain; people taking naltrexone should take pain relievers that do not contain a narcotic

• Zidovudine (e.g., AZT, Retrovir)—Acetaminophen may increase the blood levels of zidovudine, which increases the chance of serious side effects

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

• Alcohol and/or other drug abuse, or history of, or
• Brain disease or head injury or
• Colitis or
• Convulsions (seizures), history of, or
• Emotional problems or mental illness or
• Emphysema, asthma, or other chronic lung disease or
• Hepatitis or other liver disease or
• Kidney disease or
• Underactive thyroid—The chance of serious side effects may be increased

• Enlarged prostate or problems with urination or
• Gallbladder disease or gallstones—Some of the effects of narcotic analgesics may be especially serious in people with these medical problems

• Heart disease—Caffeine (present in some of these combination medicines) can make some kinds of heart disease worse