Acetaminophen, Butalbital, Caffeine and Codeine

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy,, reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Butalbital, a barbiturate, is a GABA A receptor agonist and may inhibit excitatory AMPA receptors. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions. Caffeine is a methylxanthine and CNS stimulant. The exact mechanism with respect to the indication is not clear, however, the effects of caffeine may be due to antagonism of adenosine receptors. Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic properties of codeine have been speculated to come from its conversion to morphine, although the exact mechanism of analgesic action remains unknown.

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available.

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are contraindicated for: All children younger than 12 years of age Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are also contraindicated in patients with: Significant respiratory depression Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days Known or suspected gastrointestinal obstruction, including paralytic ileus Known intolerance or hypersensitivity to acetaminophen, caffeine, butalbital, or codeine or to the components of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules Porphyria Children younger than 12 years of age.

Boxed warning: Addiction, Abuse, and Misuse Because the use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions. Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation.

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse Life-Threatening Respiratory Depression Interactions with Benzodiazepines and other CNS Depressants Neonatal Opioid Withdrawal Syndrome Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children Hepatotoxicity Opioid-Induced Hyperalgesia and Allodynia Adrenal Insufficiency Severe Hypotension Gastrointestinal Adverse Reactions Anaphylaxis Seizures Withdrawal Serious Skin Reactions The following adverse reactions associated with the use of butalbital, acetaminophen, caffeine, and codeine phosphate were identified in clinical studies or post-marketing reports.

Table 1 includes clinically significant drug interactions with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Table 1: Clinically Significant Drug Interactions with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules Inhibitors of CYP3A4 Clinical Impact: The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules with CYP3A4 inhibitors may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is achieved.

Store below 30°C (86°F), and dispense in a tight container. Store Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules securely and dispose of properly.