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Pronunciation:

(byoo TAL bi tal, a seet a MIN oh fen, & KAF een)

U.S. Brand Names:

Anolor 300; Dolgic® LQ; Dolgic® Plus; Esgic®; Esgic-Plus™; Fioricet®; Medigesic®; Repan®; Zebutal™

Synonyms:

Acetaminophen, Butalbital, and Caffeine

Generic Available:

Yes: Excludes elixir

Use:

Relief of the symptomatic complex of tension or muscle contraction headache

Pregnancy Risk Factor:

Pregnancy Implications:

Reproduction studies have not been conducted with this combination. The FDA pregnancy classification for most other barbiturates is Category D. Withdrawal seizures were reported in an infant 2 days after birth following maternal use of a butalbital product during the last 2 months of pregnancy; butalbital levels were measured in the infants serum. In general, barbiturates cross the placenta and distribute in fetal tissue. Teratogenic effects have been reported with 1st trimester exposure. Exposure during the third trimester may lead to symptoms of acute withdrawal following delivery; symptoms may be delayed up to 14 days. Refer to individual monographs for specific information related to acetaminophen and caffeine.

Lactation:

Enters breast milk/not recommended

Contraindications:

Hypersensitivity to butalbital, acetaminophen, caffeine, or any component of the formulation; porphyria

Warnings/Precautions:

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; not recommended for extended use. Use caution with acute abdominal conditions, severe hepatic or renal impairment, or the elderly. Safety and efficacy in children <12 years of age have not been established.

Adverse Reactions:

Note: Specific percentages not reported.

Frequently observed:

Central nervous system: Dizziness, drowsiness, lightheadedness, sedation

Gastrointestinal: Abdominal pain, nausea, vomiting

Respiratory: Dyspnea

Miscellaneous: Intoxicated feeling

Infrequently observed:

Cardiovascular: Tachycardia

Central nervous system: Agitation, confusion, depression, euphoria, excitement, faintness, fever, headache, seizure

Dermatologic: Hyperhidrosis, pruritus

Endocrine & metabolic: Hot spells

Gastrointestinal: Constipation, dysphagia, heartburn, flatulence, xerostomia

Neuromuscular & skeletal: Leg pain, muscle fatigue, numbness, paresthesia

Ocular: Heavy eyelids

Otic: Earache, tinnitus

Renal: Diuresis

Respiratory: Nasal congestion

Miscellaneous: Allergic reaction, high energy, shaky feeling, sluggishness

Overdosage/Toxicology:

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

Symptoms of acetaminophen overdose include hepatic necrosis, transient azotemia, renal tubular necrosis with acute toxicity, anemia, and GI disturbances with chronic toxicity. Treatment consists of acetylcysteine. Therapy should be initiated based upon laboratory analysis suggesting a high probability of hepatotoxic potential. Activated charcoal is very effective at binding acetaminophen.

Drug Interactions:

Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C8/9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)

Caffeine: Substrate of CYP1A2 (major), 2C8/9 (minor), 2D6 (minor), 2E1 (minor), 3A4 (minor); Inhibits CYP1A2 (weak), 3A4 (moderate)

See individual monographs for Acetaminophen and Caffeine. For butalbital, refer to Phenobarbital monograph.

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Stability:

Store at room temperature below 30°C (86°F). Protect from moisture.

Mechanism of Action:

Butalbital is a short- to intermediate-acting barbiturate. Barbiturates depress the sensory cortex, decrease motor activity, alter cerebellar function, and produce drowsiness, sedation, hypnosis, and dose-dependent respiratory depression.

Acetaminophen inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center

Caffeine increases levels of 3'5' cyclic AMP by inhibiting phosphodiesterase; CNS stimulant which increases medullary respiratory center sensitivity to carbon dioxide, stimulates central inspiratory drive, and improves skeletal muscle contraction (diaphragmatic contractility)

Pharmacodynamics/Kinetics:

Also see individual monographs for Acetaminophen and Caffeine.

Absorption: Butalbital: Well absorbed

Protein binding: Butalbital: 45%

Half-life elimination: Butalbital: 35 hours

Excretion: Butalbital: Urine (59% to 88% as unchanged drug and metabolites)

Dosage:

Adults: Oral: 1-2 tablets or capsules (or 15-30 mL elixir) every 4 hours; not to exceed 6 tablets or capsules (or 180 mL elixir) daily

Dosing interval in renal or hepatic impairment: Should be reduced

Test Interactions:

Acetaminophen may produce false positive tests for urinary 5-hydroxyindoleacetic acid.

Patient Education:

If self-administered, use exactly as directed; do not increase dose or frequency. Drug 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); or constipation (increased exercise, fluids, fruit, or fiber may help). Report chest pain or palpitations; persistent dizziness; confusion, nightmares, excitation, or changes in mentation; shortness of breath or respiratory difficulty; skin rash; unusual bleeding or bruising; or unusual fatigue and weakness.

Nursing Implications:

Raise bed rails; initiate safety measures; aid with ambulation

Monitor for CNS depression

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

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

Mental Health: Effects on Psychiatric Treatment:

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

Dosage Forms:

Capsule:

Anolor 300, Esgic®, Medigesic®: Butalbital 50 mg, caffeine 40 mg, and acetaminophen 325 mg

Dolgic® Plus: Butalbital 50 mg, caffeine 40 mg, and acetaminophen 750 mg

Esgic-Plus™, Zebutal™: Butalbital 50 mg, caffeine 40 mg, and acetaminophen 500 mg

Elixir (Dolgic® LQ): Butalbital 50 mg, caffeine 40 mg, and acetaminophen 325 mg per 15 mL (480 mL) [contains alcohol 7%; fruit flavor]

Tablet: Butalbital 50 mg, caffeine 40 mg, and acetaminophen 325 mg; butalbital 50 mg, caffeine 40 mg, and acetaminophen 500 mg

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

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