Medicamentos
Acetaminophen and Codeine Phosphate
Información de referencia, no reemplaza la indicación de tu médico. No empieces ni cambies este medicamento por tu cuenta.
Esta ficha incluye información en su idioma original (inglés), de la fuente FDA.
- Principio activo
- ACETAMINOPHEN AND CODEINE PHOSPHATE
- Vía de administración
- Oral
Indicaciones (para qué se usa)
INDICATIONS AND USAGE Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Posología (cómo se toma)
Consulta el prospecto y a tu médico.
Contraindicaciones (cuándo no usarlo)
CONTRAINDICATIONS Acetaminophen and codeine phosphate tablets are contraindicated for: • All children younger than 12 years of age (see WARNINGS ). • Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy ( see WARNINGS ) . Acetaminophen and codeine phosphate tablets are contraindicated in patients with: • Significant respiratory depression [ see WARNINGS ]. • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see WARNINGS ] . • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [ see WARNINGS ] . • Known or suspected gastrointestinal obstruction, including paralytic ileus [ see WARNINGS ] . • Hypersensitivity to codeine, acetaminophen, or any of the formulation excipients (e.g., anaphylaxis) [ see WARNINGS ] .
Efectos adversos
ADVERSE REACTIONS •The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see WARNINGS ] • Life-Threatening Respiratory Depression [see WARNINGS ] • Neonatal Opioid Withdrawal Syndrome [see WARNINGS ] • Ultra-rapid Metabolizers of Codeine [see WARNINGS ] • Interactions with CNS Depressants [see WARNINGS ] • Severe Hypotension [see WARNINGS ] • Gastrointestinal Adverse Reactions [see WARNINGS ] • Seizures [see WARNINGS ] • Withdrawal [see WARNINGS ] • Opioid-Induced Hyperalgesia and Allodynia [See Warnings ] The following adverse reactions associated with the use of codeine were identified in post marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions associated with codeine are respiratory depression and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest. The most frequently observed adverse reactions with codeine administration include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, sweating, and constipation. Other adverse reactions include allergic reactions, euphoria, dysphoria, , abdominal pain, pruritus, rash, thrombocytopenia, and agranulocytosis. Other less frequently observed adverse reactions expected from opioid analgesics, including acetaminophen and codeine phosphate tablets: Cardiovascular system: faintness, flushing, hypotension, palpitations, syncope Digestive System: abdominal cramps, anorexia, diarrhea, dry mouth, gastrointestinal distress, pancreatitis Nervous system: anxiety, drowsiness, fatigue, headache, insomnia, nervousness, shakiness, somnolence, vertigo, visual disturbances, weakness Skin and Appendages: rash, sweating, urticarial • Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. • Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. • Anaphylaxis : Anaphylaxis has been reported with ingredients contained in Acetaminophen and Codeine Phosphate Tablets. • Androgen deficiency : Cases of androgen deficiency have occurred with use of opioids for an extended period of time [see Clinical Pharmacology ]. · Hyperalgesia and Allodynia : Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings]. · Hypoglycemia : Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes). Opioid-induced esophageal dysfunction (OIED): Cases of OIED have been reported in patients taking opioids, and may occur more frequently in patients taking higher doses of opioid, and/or in patients taking opioids longer term [see WARNINGS ]. Adverse Reactions from Observational Studies A prospective, observational cohort study estimated the risks of addiction, abuse, and misuse in patients initiating long-term use of Schedule II opioid analgesics between 2017 and 2021. Study participants included in one or more analyses had been enrolled in selected insurance plans or health systems for at least one year, were free of at least one outcome at baseline, completed a minimum number of follow-up assessments, and either: 1) filled multiple extended-release/long-acting opioid analgesic prescriptions during a 90 day period (n=978); or 2) filled any Schedule II opioid analgesic for at least 70 of 90 days (n=1,244). Those included also had no dispensing of the qualifying opioids in the previous 6 months. Over 12 months: • approximately 1% to 6% of participants across the two cohorts newly met criteria for addiction, as assessed with two valid
Fuente de los datos: OpenFDA
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