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Before Using

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Do not give a medicine containing aspirin to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because aspirin may cause a serious illness called Reye's syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.

The narcotic analgesic in this combination medicine can cause breathing problems, especially in 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.

Geriatric

Elderly people are especially sensitive to the effects of aspirin and of narcotic analgesics. This may increase the chance of side effects, especially breathing problems caused by narcotic analgesics, during treatment.

Pregnancy

For aspirin—Studies in humans have not shown that aspirin causes birth defects. However, studies in animals have shown that aspirin causes birth defects.

Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn baby. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these effects. However, regular use of aspirin late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn baby. Also, use of aspirin during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn baby.

Too much use of aspirin during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.

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 given in very large doses. Codeine did not cause birth defects in animals, but it caused slower development of bones and other toxic or harmful effects on 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).

Breastfeeding

Most of these combination medicines have not been reported to cause problems in nursing babies.

For aspirin, caffeine, propoxyphene—These medicines do pass into the breast milk.

For codeine and other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine)—Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects. A nursing mother should talk to her doctor if she has any questions about taking codeine or about how this medicine may affect her baby .

Drug Interactions

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Ketorolac

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Anisindione
• Beta Glucan
• Citalopram
• Clovoxamine
• Desvenlafaxine
• Dicumarol
• Duloxetine
• Eptifibatide
• Escitalopram
• Femoxetine
• Flesinoxan
• Fluoxetine
• Fluvoxamine
• Ginkgo
• Heparin
• Ketoprofen
• Methotrexate
• Milnacipran
• Nefazodone
• Paroxetine
• Phenindione
• Phenprocoumon
• Reteplase, Recombinant
• Sertraline
• Ticlopidine
• Varicella Virus Vaccine
• Venlafaxine
• Warfarin
• Zimeldine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol and/or other drug abuse, or history of, or
• Asthma, allergies, and nasal polyps (history of) or
• Brain disease or head injury or
• Colitis or
• Convulsions (seizures), history of, or
• Emphysema or other chronic lung disease or
• Kidney disease or
• Liver disease or
• Underactive thyroid—The chance of serious side effects may be increased.

• Overactive thyroid or
• Stomach ulcer or other stomach problems—Aspirin may make these conditions worse.

• Enlarged prostate or problems with urination or
• Gallbladder disease or gallstones—Narcotic analgesics have side effects that may be dangerous if these medical problems are present.

• Gout—Aspirin can make this condition worse and can also lessen the effects of some medicines used to treat gout.

• Heart disease—Large amounts of aspirin and caffeine (present in some of these combination medicines) can make some kinds of heart disease worse.

• Hemophilia or other bleeding problems or
• Vitamin K deficiency—Aspirin increases the chance of serious bleeding.

DR602297

Nov. 1, 2009

Source: Drug Information provided by: Micromedex

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