What should I Know Regarding Pregnancy, Nursing and Administering Sudafed PE Severe Cold Tablet to Children or the Elderly?
If you are PREGNANT
- FDA B (no known animal fetal risk. Unknown human fetal risk):
- No Known Fetal/Neonatal Risk:
- Requires a Risk/Benefit Assessment:
If you are NURSING
- No Known Risk: LOW LEVELS EXCRETED WITH LOW RISK FOR ADVERSE EFFECTS IN INFANT
- Precaution: ORAL BIOAVAILABILITY LOW; INFANT EXPOSURE MAY BE MINIMAL
- Precaution: LIMITED DATA SUGGEST INCREASED DROWSINESS, AND IRRITABILITY
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. Maximum of 25mg/day. Cardiovascular-May cause orthostatic hypotension at higher doses. 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 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 Sudafed PE Severe Cold Tablet to a child under 12
- management or monitoring precaution: Use weight based dosing in children less than 12 years.
- Contraindication: Do not use unless as directed by clinician consultation. Risk of adverse CNS effects include sedation or paradoxical excitation.
- Contraindication: Possible risk of CNS excitation, convulsions in newborns.
- Contraindication: Risk of CNS excitation. Do not use age <6 years without clinician consult.
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.