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

If you are pregnant

  • Not Recommended:
  • Not Recommended:

    • If you are nursing

  • Precaution: INSUFFICIENT HUMAN DATA AVAILABLE
  • Precaution: INSUFFICIENT HUMAN DATA AVAILABLE; MAY REDUCE MILK PRODUCTION

    • If you are an adult over 60

  • management or monitoring precaution: Neuro/Psych-Anticholinergic effects may cause sedation, worsen cognitive impairment and increase fall risk. 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: Risk for sedation, worsening confusion, falls, urinary retention or constipation.

    • Pediatric use

  • Severe Precaution: Risk of respiratory and CNS depression, atropinism in Down's syndrome. No safety and efficacy established age < 13 years.
  • Severe Precaution: Risk of respiratory and CNS depression. Contraindicated age < 6 years.
  • Severe Precaution: Monitor for respiratory and CNS depression, atropinism in Down's syndrome.
  • Severe Precaution: Infants and children are more sensitive to anticholinergic and adverse effects. Adverse CNS effects onset may be sooner and with lower dose. Caution in children with spastic paralysis.
    • Full Drug Information

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

    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.