Butalbital

Mechanism-of-action class: Neurotransmitter Transporter Interactions.

• Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable.ICD-10: R51.9

• This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product Patients with porphyria.contraindicated

1 or 2 capsules every 4 hours as needed. 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 is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is high in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well. Serious skin reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

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 System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital. Autonomic Nervous System: 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. Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported. The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section. Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis. Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

Pregnancy Teratogenic Effects Pregnancy Category C: Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen, and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed. Nonteratogenic Effects Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital- containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Metabolism

The behavior of the individual components is described below. Butalbital Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body.

Following an acute overdosage of butalbital, acetaminophen, and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation. Signs and Symptoms Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock. In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles. Treatment A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.

• Dec 28, 1981ANDAANDA086996Sandoz
• Nov 9, 1984ANDAANDA088616Actavis Labs Ut Inc
• Mar 17, 1986ANDAANDA089007Dr Reddys Labs Sa
• Jan 21, 1987ANDAANDA089175Mikart
• Jul 30, 1992NDANDA020232Actavis Labs Ut Inc
• Oct 26, 1992ANDAANDA089987Mikart
• Aug 31, 1998ANDAANDA074951Stevens J
• Nov 30, 2001ANDAANDA075231Lgm Pharma

1. 1Headache1,34312%
2. 2Nausea1,0629.1%
3. 3Drug Ineffective9818.4%
4. 4Fatigue9187.9%
5. 5Pain8617.4%
6. 6Migraine7936.8%
7. 7Diarrhoea6325.4%
8. 8Dizziness6095.2%
9. 9Dyspnoea5134.4%
10. 10Vomiting5134.4%
11. 11Anxiety4794.1%
12. 12Fall4443.8%
13. 13Malaise4293.7%
14. 14Depression4253.7%
15. 15Insomnia4063.5%

The 2 most recently updated of 2 ClinicalTrials.gov registrations naming Butalbital as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Idiopathic Intracranial Hypertension Treatment Trial
  Completed · Phase 2 · Phase 3 · Interventional · 165 enrolled · St. Luke's-Roosevelt Hospital Center
  NCT01003639updated 2018-12-12
• TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults
  Completed · Phase 3 · Interventional · 375 enrolled · GlaxoSmithKline
  NCT00573170updated 2010-12-29

Frequently asked questions

How does Butalbital work?

Mechanism-of-action class: Neurotransmitter Transporter Interactions.

What is Butalbital used for?

According to FDA labeling, Butalbital carries indications including: Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Butalbital?

Butalbital is classified as Barbiturate, Neurotransmitter Transporter Interactions, Decreased Organized Electrical Activity.

What are the brand names for Butalbital?

Butalbital is marketed under brand names including Allzital, Ascomp, Bupap, Capacet, Esgic, Fioricet, Fioricet with Codeine, Marten-Tab.

What are the contraindications for Butalbital?

Butalbital labeling lists contraindications including: This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product Patients with porphyria.. Always consult the full prescribing information and a clinician.