Caffeine - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Caffeine. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ASCOMP WITH CODEINE Addiction, Abuse, and Misuse Because the use of ASCOMP with Codeine 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 [see Warnings and Precautions ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of ASCOMP with Codeine, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of ASCOMP with Codeine are essential [see Warnings and Precautions ] . Accidental Ingestion Accidental ingestion of even one dose of ASCOMP with Codeine, especially by children, can result in a fatal overdose of aspirin, butalbital, caffeine, and codeine phosphate [see Warnings and Precautions ] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of ASCOMP with Codeine and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions , Drug Interact
5 WARNINGS AND PRECAUTIONS 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.
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate closely, particularly during initiation and titration.
Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid.
Severe Hypotension : Regularly evaluate during dose initiation and titration.
Avoid use of ASCOMP with Codeine in patients with circulatory shock.
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness : Regularly evaluate for sedation and respiratory depression.
Avoid use of ASCOMP with Codeine in patients with impaired consciousness or coma.
Fetal Toxicity : Limit use of NSAIDs, including ASCOMP with Codeine, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction.
Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. ( 5.17 , 8.1 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) : Discontinue and evaluate clinically.
5.1 Addiction, Abuse, and Misuse ASCOMP with Codeine contains codeine.
Codeine in combination with butalbital, aspirin, and caffeine is a Schedule III controlled substance.
As ASCOMP with Codeine contains butalbital and codeine, it exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence ] .
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed ASCOMP with Codeine.
Addiction can occur at recommended dosages and if the drug is misused or abused.
The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy.
In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see Adverse Reactions ] .
Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing ASCOMP with Codeine, and reassess all patients receiving ASCOMP with Codeine for the development of these behaviors and conditions.
Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).
The potential for these risks should not, however, prevent the proper management of pain in any given patient.
Patients at increased risk may be prescribed opioids such as ASCOMP with Codeine, but use in such patients necessitates intensive counseling about the risks and proper use of ASCOMP with Codeine along with frequent reevaluation for signs of addiction, abuse, and misuse.
Consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration , Warnings and Precautions ].
Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use.
Consider these risks when prescribing or dispensing ASCOMP with Codeine.
Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and proper disposal of unused drug.
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