What should I Know Regarding Pregnancy, Nursing and Administering Colrex Compound Capsule to Children or the Elderly?

If you are PREGNANT

  • FDB Only When Necessary: AVAILABLE DATA SUGGEST NO KNOWN RISK; OTC PRODUCT, NO FDA PREGNANCY WARNINGS
  • FDB Only When Necessary: INSUFFICIENT DATA AVAILABLE; NEONATE RISK OF SEIZURES;AVOID DURING 3RD TRIMESTER
  • Only When Necessary: NEONATAL WITHDRAWAL/RESP.DEPRESS. W/CHRONIC OR HIGH DOSE; SMALL TERATOGENIC RISK
  • Only When Necessary: EVIDENCE FOR MALFORMATIONS; CAN REDUCE UTERINE BLOOD FLOW CAUSING FETAL HYPOXIA

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: ORAL BIOAVAILABILITY LOW; INFANT EXPOSURE MAY BE MINIMAL
  • Precaution: INSUFFICIENT DATA AVAILABLE; MAY CAUSE SEDATION AND INHIBIT LACTATION

If you are an adult over 60

  • 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.
  • management or monitoring precaution: Pulmonary-Life threatening respiratory depression is more likely to occur with high doses, SR products, cachexia, or debilitation due to altered pharmacokinetics with poor fat stores, muscle wasting, or altered clearance. Monitor closely at initiation and with 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: 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 Colrex Compound Capsule to a child under 12

  • Severe Precaution: Not recommended in children under 6 years unless clinician consultation.
  • Contraindication: Possible paradoxical CNS excitation. Seizure risk in newborns.
  • Severe Precaution: Contraindicated for pain management post-surgical tonsillectomy and or adenoidectomy. Respiratory depression and death reported in CYP2D6 ultra-rapid metabolizer patients post tonsillectomy or adenoidectomy. Avoid in patient with obesity, obstructive sleep apnea, asthma or other underlying breathing problem.
  • 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.
  • Contraindication: Risk of CNS excitation. Do not use age <6 years without clinician consult.

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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.