Yes

Barbiturate

Relief of the symptomatic complex of tension or muscle contraction headache

C-III

C/D (if used for long periods or in high doses near end of pregnancy)

Porphyria; hypersensitivity to butalbital or any component

Use with extreme caution in the presence of peptic ulcer or coagulation abnormality - can produce psychological/physical drug dependence. Children and teenagers should not use this product.

>10%:

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

Gastrointestinal: Heartburn, stomach pains, dyspepsia, epigastric discomfort, nausea

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

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

Take as directed; do not exceed prescribed amount. Avoid alcohol, aspirin or aspirin-containing medications, or any OTC medications unless approved by prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake) to prevent constipation. You may experience drowsiness, impaired judgment or coordination; use caution when driving or engaging in tasks that require alertness until response to drug is known. Small frequent meals may help reduce GI upset. Report any ringing in ears; abdominal pain; easy bruising or bleeding; blood in urine; severe weakness; acute unresolved dizziness or confusion, nervousness, nightmares, insomnia; or skin rash. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Raise bed rails; initiate safety measures; aid with ambulation; children and teenagers should not use for chickenpox or flu symptoms before a physician is consulted about Reye's syndrome (Fiorinal®)

Monitor for CNS depression

Capsule: (Fiorgen PF®, Fiorinal®, Isollyl Improved®, Lanorinal®, Marnal®): Butalbital 50 mg, caffeine 40 mg, and aspirin 325 mg

Tablet:

Fiorinal®, Isollyl Improved®, Lanorinal®, Marnal®: Butalbital 50 mg, caffeine 40 mg, and aspirin 325 mg