Esgic Tablets Description. Butalbital, acetaminophen and caffeine are supplied in tablet form for oral administration. Esgic Tablets - Clinical Pharmacology.
Butalbital, acetaminophen and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
It has the following structural formula:. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate acting barbiturate.
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.
Esgic Capsules (butalbital, acetaminophen and caffeine capsules USP 50 mg/325 mg/40 mg) are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Autonomic Nervous System: dry mouth, hyperhidrosis.
The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells (See OVERDOSAGE for toxicity information). This falls within the range of plasma protein binding (20% to 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 to 20 mcg/mL.
All adverse events tabulated below are classified as infrequent.
Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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If any of these effects persist or worsen, l your doctor or pharmacist promptly. Nausea, vomiting, abdominal pain, constipation, dry mouth, shaking (tremor), shortness of breath, increased urination, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Canada residents can call a provincial poison control center.
Physician reviewed Esgic patient information - includes Esgic description, dosage and directions.
It may increase your risk of liver damage while taking acetaminophen. Avoid drinking alcohol.
Pregnancy Category C Risk cannot be ruled out.
If you use butalbital while you are pregnant, your baby could become dependent on the drug. It is not known whether this medicine will harm an unborn baby. This can cause life-threatening withdrawal symptoms in the baby after it is born. l your doctor if you are pregnant or plan to become pregnant. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.
Check the label to see if a medicine contains acetaminophen or APAP.
Consumer information about the medication BUTALBITAL/ACETAMINOPHEN/CAFFEINE - ORAL (Esgic, Fioricet), includes side effects, drug interactions.
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