BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE WITH CODEINE CIIIPHOSPHATE CAPSULES

Rx Only

Rev. 07/07

Butalbital, acetaminophen, caffeine, and codeine phosphate is supplied in capsule form for oral administration. Each capsule contains:

Codeine Phosphate, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30 mg (1/2 gr)

Butalbital, USP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 mg

Acetaminophen, USP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .325 mg

Caffeine, USP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40 mg

In addition, each capsule contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Sodium Lauryl Sulfate, and Sodium Starch Glycolate.

Capsule shell contains: FD&C Blue #2, FD&C Red #3, Gelatin, Red Iron Oxide, Titanium Dioxide, and Yellow Iron Oxide. The imprinting ink contains Titanium Dioxide.

Codeine phosphate [morphine-3-methyl ether phosphate (1:1) (salt) hemihydrate, anhydrous], is a narcotic analgesic and antitussive. It has the following structural formula:

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

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:

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

Butalbital, acetaminophen, caffeine, and codeine phosphate is a combination drug product intended as a treatment for tension headache.

Butalbital, acetaminophen, caffeine, and codeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of butalbital, acetaminophen, caffeine, and codeine phosphate in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.

Butalbital, acetaminophen, caffeine, and codeine phosphate is contraindicated under the following conditions:

• Hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine.
• Patients with porphyria.

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.

Butalbital and codeine are both habit-forming and potentially abusable. Consequently, the extended use of butalbital, acetaminophen, caffeine, and codeine phosphate is not recommended.

Frequently Observed: The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed: All adverse events tabulated below are classified as infrequent.

Central Nervous: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, exclient or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.

The following adverse reactions have been voluntarily reported as temporally associated with butalbital, aspirin, caffeine, and codeine phosphate, a related product containing aspirin, butalbital, caffeine, and codeine.

Central Nervous: abuse, addiction, anxiety, disorientation, hallucination, hyperactivity, insomnia, libido decrease, nervousness, neuropathy, psychosis, sexual activity increase, slurred speech, twitching, unconsciousness, vertigo.

Autonomic Nervous: epistaxis, flushing, miosis, salivation.

Gastrointestinal: anorexia, appetite increased, diarrhea, esophagitis, gastroenteritis, gastrointestinal spasms, hiccup, mouth burning, pyloric ulcer.

Cardiovascular: chest pain, hypotensive reaction, palpitations, syncope.

Skin: erythema, erythema multiforme, exfoliative dermatitis, hives, rash, toxic epidermal necrolysis.

Urinary: kidney impairment, urinary difficulty.

Miscellaneous: allergic reaction, anaphylactic shock, cholangiocarcinoma, drug interaction with erythromycin (stomach upset), edema.

The following adverse drug events may be borne in mind as potential effects of the components of butalbital, acetaminophen, caffeine, and codeine phosphate. Potential effects of high dosage are uled in the OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

Codeine: nausea, vomiting, drowsiness, lightheadedness, constipation, pruritus.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported for Butalbital, Acetaminophen, and Caffeine Tablets, USP.

Following an acute overdosage of butalbital, acetaminophen, caffeine, and codeine phosphate, toxicity may result from the barbiturate, the codeine, or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.

•  Butalbital: toxic dose 1 g                      (20 capsules)
•  Acetaminophen: toxic dose 10 g        (30 capsules)
•  Caffeine: toxic dose 1 g                       (25 capsules)
•  Codeine: toxic dose 240 mg               (8 capsules)

one or two capsule every four hours. Total daily dosage should not exceed 6 capsules.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

Butalbital, Acetaminophen, Caffeine with Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg are supplied as No. 0 blue/grey capsules printed “West-ward 3000” in white ink and are available in:

•  Bottles of 30 capsules.
•  Bottles of 100 capsules.
•  Bottles of 500 capsules.

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

*Levophed is a registered Trademark of Sanofi Winthrop Pharmaceuticals.

Manufactured By:
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
Revised July 2003