Butalbital, Acetaminophen, Caffeine, and Codeine (Oral Route)

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Before Using

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:

Allergies

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.

Pediatric

• For butalbital: Although barbiturates such as butalbital often cause drowsiness, some children become excited after taking them.
• For acetaminophen: Acetaminophen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.
• 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.

Geriatric

• For butalbital: Certain side effects, such as confusion, excitement, or mental depression, may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of the butalbital in this combination medicine.
• For acetaminophen: 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.
• 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.
• 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.

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

• Naltrexone

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.

• Adinazolam
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Anisindione
• Aprobarbital
• Bromazepam
• Brotizolam
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Dezocine
• Diazepam
• Dicumarol
• Estazolam
• Ethchlorvynol
• Fentanyl
• Flunitrazepam
• Flurazepam
• Halazepam
• Hydrocodone
• Hydromorphone
• Ketazolam
• Levorphanol
• Lorazepam
• Lormetazepam
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nitrazepam
• Nordazepam
• Opium
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Phenindione
• Phenobarbital
• Phenprocoumon
• Prazepam
• Primidone
• Propoxyphene
• Quazepam
• Quetiapine
• Remifentanil
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Triazolam

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.

• Acenocoumarol
• Cannabis
• Carbamazepine
• Imipramine
• Isoniazid
• Phenytoin
• Prednisone
• Warfarin
• Zidovudine

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.

Using this medicine with any of the following is usually not recommended, 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.

• Ethanol

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.

• Cabbage
• Ethanol

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 codeine may develop; also, acetaminophen may cause liver damage in people who abuse alcohol

• Asthma (or history of), emphysema, or other chronic lung disease 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
• Hepatitis or other liver disease or
• Hyperactivity (in children) or
• Kidney disease—The chance of serious side effects may be increased

• Type 2 diabetes mellitus or
• Mental depression or
• Overactive thyroid or
• Porphyria (or history of)—Butalbital can make these conditions worse

• Heart disease (severe)—The caffeine can make some kinds of heart disease worse

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