What should I Know Regarding Pregnancy, Nursing and Administering Mygranol W/Codeine #3 Capsule to Children or the Elderly?

If you are PREGNANT

  • FDA C (unknown human fetal risk; assess risk/benefit):
  • Contraindicated:
  • FDA C (unknown human fetal risk; assess risk/benefit):
  • FDA C (unknown human fetal risk; assess risk/benefit):

If you are NURSING

  • Precaution: HIGH DOSES MAY CAUSE HYPERACTIVITY AND WAKEFULNESS IN INFANT.
  • Precaution: POSSIBILITY OF CENTRAL NERVOUS SYSTEM DEPRESSION IN NURSING INFANT.
  • Absolute Contraindication: ONE REPORT OF METABOLIC ACIDOSIS; RISK OF REYE'S SYND IN VIRAL ILLNESS.
  • Absolute Contraindication: CNS/RESPIRATORY DEPRESSION,APNEA POSSIBLE;CAUTION W/ FAST CYP2D6 METABOLIZER

If you are an adult over 60

  • management or monitoring precaution: General-Not recommended in the elderly due to sedation which may predispose to falls. May exacerbate depression. Renal-Renal excretion may increase adverse events with renal impairment. Monitor renal function.
  • 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.

Giving Mygranol W/Codeine #3 Capsule to a child under 12

  • 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.
  • Severe Precaution: Reye syndrome risk with viral illness, fever, and/or flu symptoms.
  • management or monitoring precaution: Caution in infants with seizure disorder, cardiovascular disease, renal impairment, or hepatic impairment.
  • management or monitoring precaution: Adverse CNS effects (e.g. insomnia, restlessness, nervousness, and mild delirium) may be more severe in children.
  • 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.
  • Severe Precaution: Safety and effectiveness not established age < 12 years.

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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.