What should I Know Regarding Pregnancy, Nursing and Administering Novadyne Solution to Children or the Elderly?

If you are PREGNANT

  • Requires a Risk/Benefit Assessment:
  • Requires a Risk/Benefit Assessment:
  • Requires a Risk/Benefit Assessment:
  • Requires a Risk/Benefit Assessment:
  • Requires a Risk/Benefit Assessment:

If you are NURSING

  • Precaution: RESP DEP POSS IN INFANT,NON-OPIOID ALT REC, OR USE LOW DOSE SHORTEST DURATION
  • Precaution: ORAL BIOAVAILABILITY LOW; INFANT EXPOSURE MAY BE MINIMAL
  • Precaution: MAY DECREASE MILK SUPPLY AND CAUSE IRRITABILITY
  • Precaution: INSUFFICIENT HUMAN DATA AVAILABLE
  • Precaution: INSUFFICIENT DATA AVAILABLE; MAY CAUSE SEDATION AND INHIBIT LACTATION

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: 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: Neuro/Psych-Anticholinergic effects may cause sedation, worsen cognitive impairment and increase fall risk. Non-sedating antihistamine preferred. Gastrointestinal-May cause or worsen pre-existing constipation. Genitourinary-Best avoided in patients with urinary retention from any cause.

Giving Novadyne Solution to a child under 12

  • Severe Precaution: Risk of CNS depression and paradoxical excitation. Consult healthcare provider for age< 6 years.
  • Severe Precaution: No established efficacy for cough and cold products age < 2 years. Do not use unless directed by clinician consultation.
  • Contraindication: Possible paradoxical CNS excitation. Seizure risk in newborns.
  • Contraindication: Not indicated for symptoms of cough and cold in pediatrics. Risk of slowed or difficult breathing and respiratory depression. Death reported in CYP2D6 ultra-rapid metabolizers post tonsillectomy or adenoidectomy.
  • Contraindication: Risk of serious and life-threatening adverse effects of CNS depression or excitation. Not recommended age <2 years. Avoid using with underlying asthma.
  • Contraindication: Risk of CNS excitation. Do not use age <6 years without clinician consult.
  • Contraindication: High risk of adverse CNS effects. Not recommended for use age < 6 years.
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