Capacet

Capacet is part of the drug class:

• Anilides

Butalbital, acetaminophen and caffeine are supplied in capsule form for oral administration.

Each capsule contains:

Butalbital ................... 50 mg

Warning: May be habit-forming.

Acetaminophen ........ 325 mg

Caffeine ...................... 40 mg

In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose with capsule shell composed of gelatin and titanium dioxide.

Imprinting ink composed of n-butyl alcohol, pharmaceutical glaze modified in SD-45, propylene glycol, methanol, alcohol, titanium dioxide, D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.

Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula:

C11H16N2O3  MW = 224.26

Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

C8H9NO2 MW = 151.16

Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula:

C8H10N4O2 MW = 194.19

Applies to acetaminophen / butalbital / caffeine: oral capsule, oral liquid, oral tablet

Nervous system

Butalbital/Acetaminophen/Caffeine:
Common (1% to 10%): Drowsiness, lightheadedness, dizziness, sedation
Uncommon (0.1% to 1%): Headache, shaky feeling, tingly, fainting, numbness, seizures, mental confusion, excitement or depression due to intolerance

Caffeine:
Frequency not reported: Tremor[Ref]

General

The most frequently reported adverse events have included drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.[Ref]

Hepatic

Acetaminophen:
Frequency not reported: Liver failure[Ref]

Acute liver failure has been reported with acetaminophen use; many case have been associated with use at doses in excess of 4 g/day, and often involving more than 1 acetaminophen-containing product.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, abdominal pain
Uncommon (0.1% to 1%): Dry mouth, difficulty swallowing, heartburn, flatulence, constipation[Ref]

Renal

Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Diuresis

Caffeine:
Frequency not reported: Nephrotoxicity[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions
Postmarketing reports: Anaphylaxis

Acetaminophen:
Postmarketing reports: Anaphylaxis[Ref]

Hematologic

Acetaminophen:
Frequency not reported: Thrombocytopenia, agranulocytosis[Ref]

Dermatologic

Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Hyperhidrosis, pruritus
Frequency not reported: Toxic epidermal necrolysis, erythema multiforme

Acetaminophen:
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
Frequency not reported: Rash[Ref]

Several cases of dermatologic reactions including toxic epidermal necrolysis and erythema multiforme have been reported.[Ref]

Respiratory

Common (1% to 10%): Shortness of breath
Uncommon (0.1% to 1%): Nasal congestion[Ref]

Cardiovascular

Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Tachycardia

Caffeine:
Frequency not reported: Cardiac stimulation[Ref]

Other

Common (1% to 10%): Intoxicated feeling
Uncommon (0.1% to 1%): Fatigue, high energy, heavy eyelids, sluggishness, hot spells, fever, earache, tinnitus[Ref]

Metabolic

Caffeine:
Frequency not reported: Hyperglycemia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Leg pain, muscle fatigue[Ref]

Psychiatric

Butalbital/Acetaminophen/Caffeine:
Uncommon (0.1% to 1%): Agitation, euphoria

Caffeine:
Frequency not reported: Irritability, dependence[Ref]

Some side effects of Capacet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.