What should I Know Regarding Pregnancy, Nursing and Administering P-Ephed-Codeine-Acetaminoph-GG Tablet to Children or the Elderly?

If you are PREGNANT

  • No Known Fetal/Neonatal Risk:
  • FDA C (unknown human fetal risk; assess risk/benefit):
  • FDA C (unknown human fetal risk; assess risk/benefit):
  • FDA C (unknown human fetal risk; assess risk/benefit):

If you are NURSING

  • Absolute Contraindication: CNS/RESPIRATORY DEPRESSION,APNEA POSSIBLE;CAUTION W/ FAST CYP2D6 METABOLIZER
  • No Known Risk: LOW LEVELS EXCRETED WITH LOW RISK FOR ADVERSE EFFECTS IN INFANT
  • Precaution: MAY DECREASE MILK SUPPLY, AND CAUSE IRRITABILITY
  • Precaution: INSUFFICIENT HUMAN DATA AVAILABLE

If you are an adult over 60

  • management or monitoring precaution: General-Consider adding naloxone Rx. Pulmonary-Life threatening respiratory depression risk with high doses, cachexia, or debilitation due to altered pharmacokinetics (poor fat stores, muscle wasting, or altered clearance). Monitor closely at initiation and dose titration. Neuro/Psych-Risk for increased confusion and delirium. May increase fall risk. Avoid treatment with 3 or more CNS active drugs. Gastrointestinal-Constipation risk. Urogenital-Urinary retention risk.
  • management or monitoring precaution: Cardiovascular-Elderly are more sensitive to tachycardia and hypertensive effects. May exacerbate symptomatic coronary insufficiency. Genitourinary-May cause urinary retention. Neuro/Psych-May worsen cognitive impairment in some elderly with dementia. Insomnia risk.
  • management or monitoring precaution: Hepatic-Elderly may be more susceptible to hepatotoxicity. Strict adherence to a maximum daily dose is recommended, and the maximum dose recommendation varies between 3000-3800 mg depending on strength used and source of the recommendation.

Giving P-Ephed-Codeine-Acetaminoph-GG Tablet to a child under 12

  • management or monitoring precaution: Use weight based dosing in children less than 12 years.
  • Severe Precaution: Risk of life-threatening respiratory depression, death. Risk highest with CYP2D6 ultra-rapid metabolizers and following a tonsillectomy and/or adenoidectomy. Use contraindicated post tonsillectomy and/or adenoidectomy. Avoid in patient with obesity, obstructive sleep apnea, asthma or other underlying breathing problem. With any opioid, access to naloxone for emergency reversal can mitigate risk from accidental ingestion/overdose.
  • management or monitoring precaution: Consult clinician for use in pediatrics age < 12 years.
  • Contraindication: Increased risk of CNS and respiratory depression. Contraindicated age < 12 years. Respiratory depression and death reported in CYP2D6 ultra-rapid metabolizers post tonsillectomy or adenoidectomy. Risk increases with obesity, asthma, obstructive sleep apnea or other underlying lung or breathing problem. With any opioid, access to naloxone for emergency reversal can mitigate risk from accidental ingestion/overdose.
  • Contraindication: High risk of adverse CNS effects. Not recommended for use age < 6 years.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.