Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.Īutonomic Nervous System: dry mouth, hyperhidrosis. Call your doctor if you took more than the recommended dose.Īll adverse events tabulated below are classified as infrequent.Ĭentral Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Do not take more than 4000 milligrams of acetaminophen per day.If you develop signs of allergy such as a rash or difficulty breathing stop taking butalbital, acetaminophen, and caffeine tablets, USP and contact your healthcare provider immediately.Do not take butalbital, acetaminophen, and caffeine tablets, USP if you are allergic to any of its ingredients.Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.įor information on use in geriatric patients, see PRECAUTIONS/Geriatric Use. Such tasks should be avoided while taking this product.Īlcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product, and should be avoided.īutalbital may be habit-forming. This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells. This falls within the range of plasma protein binding (20%-45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5-20 mcg/mL. Of the material excreted in the urine, 32% is conjugated. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2, 3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.Įlimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. Barbiturates in general may appear in breast milk and readily cross the placental barrier. Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body.
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