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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
For butalbital: Although butalbital often causes drowsiness, some children become excited after taking it.
For aspirin: Do not give a medicine containing aspirin to a child with 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.
For caffeine: There is no specific information comparing use of caffeine in children up to 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults.
For butalbital: Confusion, depression, or excitement may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of butalbital.
For aspirin: Elderly patients are more sensitive than younger adults to the effects of aspirin. This may increase the chance of side effects during treatment.
For codeine: Breathing problems may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of codeine.
For caffeine: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of caffeine in the elderly with use in other age groups.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Influenza Virus Vaccine, Live
Using this medicine 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.
- Alteplase, Recombinant
- Beta Glucan
- Chloral Hydrate
- Clopidogrel Hydrogen Sulfate
- Dabigatran Etexilate
- Morphine Sulfate Liposome
- Reteplase, Recombinant
- Sodium Oxybate
- Varicella Virus Vaccine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Enalapril Maleate
- Ethacrynic Acid
- Valproic Acid
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.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse (or history of) or
- Drug abuse or dependence (or history of)—Dependence on butalbital and/or codeine may develop.
- Asthma, especially if occurring together with other 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
- Enlarged prostate or problems with urination or
- Gallbladder disease or gallstones or
- Hyperactivity (in children) or
- Kidney disease or
- Liver disease—The chance of serious side effects may be increased.
- Diabetes mellitus (sugar diabetes) or
- Mental depression or
- Overactive thyroid or
- Porphyria (or history of)—Butalbital can make these conditions worse.
- Gout—Aspirin can make this condition worse and can also lessen the effects of some medicines used to treat gout.
- Heart disease (severe)—The caffeine in the butalbital, aspirin, and codeine combination can make some kinds of heart disease worse.
- Hemophilia or other bleeding problems or
- Vitamin K deficiency—Aspirin increases the chance of serious bleeding.
- Stomach ulcer, especially with a history of bleeding, or other stomach problems—Aspirin can make your condition worse.