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    Butalbital Compound Tablet

    precautions

    What should I know regarding pregnancy, nursing and administering Butalbital Compound Tablet to children or the elderly?

    If you are:

    Pregnant:

    Only When Necessary: CASE REPORT OF NEONATAL WITHDRAWAL SEIZURES WITH BUTALBITAL COMBO PRODUCT

    FDB Contraindicated or Not Recommended: NO FDA CATEGORY; NOT RECOMMENDED ESPECIALLY IN 3RD TRIMESTER OR NEAR TERM

    Only When Necessary: REPORTS OF MISCARRIAGE,POOR FETAL GROWTH POSSIBLY ASSOC W/HIGH DOSES OF CAFFEINE

    Nursing:

    Precaution: HIGH DOSES MAY CAUSE HYPERACTIVITY AND WAKEFULNESS IN INFANT.

    Precaution: POSSIBILITY OF CENTRAL NERVOUS SYSTEM DEPRESSION IN NURSING INFANT.

    Absolute Contraindication: ONE REPORT OF METABOLIC ACIDOSIS; RISK OF REYE'S SYND IN VIRAL ILLNESS.

    An adult over 60:

    management or monitoring precaution: Neuro/Psych-Avoid in elderly with insomnia due to CNS stimulation effects.

    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.

    Giving Butalbital Compound tablet to a child under 12:

    management or monitoring precaution: Adverse CNS effects of insomnia, restlessness, nervousness, and mild delirium, more severe in children.

    Severe Precaution: Reye syndrome risk with viral illness, fever, and/or flu symptoms.

    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.

    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, expect 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.

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