What should I Know Regarding Pregnancy, Nursing and Administering Combiflex ES Tablet 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 Contraindicated or Not Recommended: FDA CATEGORY C;SALICYLATES NOT RECOMMENDED ESPECIALLY IN 3RD TRIMESTER/NEAR TERM
  • Only When Necessary: REPORTS OF MISCARRIAGE,POOR FETAL GROWTH POSSIBLY ASSOC W/HIGH DOSES OF CAFFEINE
  • Only When Necessary: INSUFFICIENT HUMAN & ANIMAL DATA. FDA CATEGORY C IN MULTI-INGREDIENT PRODUCTS

If you are NURSING

  • Precaution: INSUFFICIENT DATA AVAIL. MAY POSSIBLY CAUSE SEDATION/ANTIMUSCARINIC EFFECTS.
  • Precaution: HIGH DOSES MAY CAUSE HYPERACTIVITY AND WAKEFULNESS IN INFANT.
  • Absolute Contraindication: ONE REPORT OF METABOL ACIDOSIS W/ASA;RISK OF REYE'S SYN W/VIRAL ILLNESS/FEVER
  • No Known Risk: LOW LEVELS EXCRETED WITH LOW RISK FOR ADVERSE EFFECTS IN INFANT

If you are an adult over 60

  • management or monitoring precaution: General-Elderly have a higher incidence of systemic toxicities. Dose reduction may be needed.
  • management or monitoring precaution: Neuro/Psych-Anticholinergic effects may cause sedation, worsen cognitive impairment and increase fall risk. Non-sedating agents preferred. Gastrointestinal-May cause or worsen pre-existing constipation. Genitourinary-Best avoided in patients with urinary retention from any cause.
  • management or monitoring precaution: Hepatic-Elderly are more susceptible to hepatotoxicity. Strict adherence to a maximum daily dose of 3000mg is advised.

Giving Combiflex ES Tablet to a child under 12

  • management or monitoring precaution: Use weight based dosing in children less than 12 years.
  • management or monitoring precaution: Adverse CNS effects of insomnia, restlessness, nervousness, and mild delirium, more severe in children.
  • Severe Precaution: Do not use in viral illness (influenza, varicella) due to possible increased risk of Reye syndrome. Consult clinician prior to use.
  • Contraindication: Possible CNS excitation and seizure risk in newborns.
  • management or monitoring precaution: Caution in: seizure disorder, cardiovascular disease, or in premature neonates with renal or hepatic impairment.

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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.