Yes

Barbiturate

Relief of the symptomatic complex of tension or muscle contraction headache

C-III

D

Porphyria; hypersensitivity to butalbital or any component

Administer with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. May be habit-forming.

>10%:

Central nervous system: Dizziness, lightheadedness, drowsiness, "hangover" effect

Gastrointestinal: Nausea, heartburn, stomach pains, dyspepsia, epigastric discomfort

1% to 10%:

Central nervous system: Confusion, mental depression, unusual excitement, nervousness, faint feeling, headache, insomnia, nightmares, fatigue

Dermatologic: Skin rash

Gastrointestinal: Constipation, vomiting, gastrointestinal ulceration

Hematologic: Hemolytic anemia

Neuromuscular & skeletal: Weakness

Respiratory: Troubled breathing

Miscellaneous: Anaphylactic shock

Symptoms of barbiturate overdose include unsteady gait, slurred speech, confusion, respiratory depression, hypotension, and coma. Treatment is supportive.

Barbiturates are enzyme inducers. patients should be monitored when these drugs are started or stopped for a decreased or increased therapeutic effect respectively.

Increased toxicity when combined with other CNS depressants, benzodiazepine, valproic acid, chloramphenicol, or antidepressants; respiratory and CNS depression may be additive. MAOIs may prolong the effect of butalbital compound; barbiturates inhibit the hypoprothombinemic response to warfarin.

Adults: Oral: 1-2 tablets or capsules every 4 hours; not to exceed 6/day

Drowsiness is common; may cause depression, nervousness, insomnia, and nightmares; rare reports of hallucinations

Rare reports of agranulocytosis; use caution with clozapine and carbamazepine; CNS depressant effects of psychotropics may be enhance by barbiturates; enzyme induction effects of barbiturates may decrease effects of psychotropics

No information available to require special precautions

No effects or complications reported

If self-administered, use exactly as directed (do not increase dose or frequency); may cause physical and/or psychological dependence. Take with food or milk. While using this medication, do not use alcohol and other prescription or OTC medications (especially sedatives, tranquilizers, antihistamines, or pain medications) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). May cause dizziness, lightheadedness, confusion, or drowsiness (use caution when driving, climbing stairs, or changing position - rising from sitting or lying to standing, or when engaging in tasks requiring alertness until response to drug is known); heartburn or epigastric discomfort (frequent mouth care, frequent sips of fluids, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, or dietary fruit and fiber may help). Report chest pain or palpitations; persistent dizziness; confusion, nightmares, excitation, or changes in mentation; shortness of breath or difficulty breathing; skin rash; unusual bleeding or bruising; or unusual fatigue and weakness. Pregnancy/breast-feeding precautions: Do not get pregnant while taking this medication; use appropriate barrier contraceptive measures. Do not breast-feed.

Raise bed rails; initiate safety measures; aid with ambulation

Monitor for CNS depression

Capsule:

Amaphen®, Anoquan®, Endolor®, Esgic®, Femcet®, G-1®, Medigesic®, Repan®, Two-Dyne®: Butalbital 50 mg, caffeine 40 mg, and acetaminophen 325 mg

Axocet®; Phrenilin Forte®: Butalbital 50 mg and acetaminophen 650 mg

Triapin®: Butalbital 50 mg and acetaminophen 325 mg

Tablet:

Esgic®, Fioricet®, Repan®: Butalbital 50 mg, caffeine 40 mg, and acetaminophen 325 mg

Phrenilin®: Butalbital 50 mg and acetaminophen 325 mg

Sedapap-10®: Butalbital 50 mg and acetaminophen 650 mg