What should I Know Regarding Pregnancy, Nursing and Administering VALPROATE SODIUM to Children or the Elderly?
If you are pregnant Not Recommended:
If you are nursing Precaution: LIMITED DATA SUGGEST MINIMAL AMNT EXCRETED;MONITOR INFANT FOR ADVERSE EFFECTS
If you are an adult over 60 management or monitoring precaution: Hepatic-Elderly may have slower metabolism and protein binding which requires dosage reduction. Monitor closely. Neuro/Psych-Use caution in elderly with a history of recurrent falls. Drug may produce somnolence, ataxia, impaired psychomotor function, syncope, and additional falls. Monitor fluid and nutritional intake and avoid dehydration. Musculoskeletal-Postmarketing reports of fractures, decreased bone mineral density, osteopenia, osteoporosis.
Pediatric use Severe Precaution: Risk of fatal hepatotoxicity, especially for younger children, children with POLG gene mutations, and children on multiple anticonvulsants. Monitor closely for liver impairment including non-specific symptoms (e.g., lethargy, facial edema, vomiting). Rare risk of severe pancreatitis. Adverse psychiatric changes (e.g. aggression, agitation, disturbance in attention, and learning disorders) may be more prevalent in pediatric patients compared to adults. Severe Precaution: Counsel post-menarche females on teratogenicity, appropriate contraception. Risk of fatal hepatotoxicity, especially in younger children, children with POLG gene mutations, children on multiple anticonvulsants. Monitor closely for liver impairment including non-specific symptoms (e.g., lethargy, facial edema, vomiting). Rare risk of severe pancreatitis. Psychiatric changes (e.g. aggression, agitation, disturbance in attention, learning disorders) may be more prevalent in children than adults. Severe Precaution: Risk of serious or fatal hepatotoxicity in age < 2 years, especially in children with congenital metabolic disorders, mental retardation, organic brain disease, and children taking multiple anticonvulsants. Contraindicated in patients suspected of having a mitochondrial disorder. Also reports of life-threatening pancreatitis. Use as single agent and monitor patients closely if used.
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.