What should I Know Regarding Pregnancy, Nursing and Administering Zebutal 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
- Only When Necessary: CASE REPORT OF NEONATAL WITHDRAWAL SEIZURES WITH BUTALBITAL COMBO PRODUCT
- Only When Necessary: REPORTS OF MISCARRIAGE,POOR FETAL GROWTH POSSIBLY ASSOC W/HIGH DOSES OF CAFFEINE
If you are NURSING
- Precaution: HIGH DOSES MAY CAUSE HYPERACTIVITY AND WAKEFULNESS IN INFANT.
- Precaution: POSSIBILITY OF CENTRAL NERVOUS SYSTEM DEPRESSION IN NURSING INFANT.
- 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-Not recommended in the elderly due to sedation which may predispose to falls. May exacerbate depression. Renal-Renal excretion may increase adverse events with renal impairment. Monitor renal function.
- 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 Zebutal 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: Safety and effectiveness not established age < 12 years.
- management or monitoring precaution: Caution in: seizure disorder, cardiovascular disease, or in premature neonates with renal or hepatic impairment.
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.