butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule
Generic Name: BUTALBITAL, ASPIRIN, AND CAFFEINE
Brand Name: Butalbital, Aspirin, and Caffeine
- Substance Name(s):
- BUTALBITAL
- CAFFEINE
- ASPIRIN
WARNINGS
Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions.
It should be ascertained if the patient is allergic to aspirin, although a specific history of allergy may be lacking.
Significant bleeding can result from aspirin therapy in patients with peptic ulcer or other gastrointestinal lesions, and in patients with bleeding disorders.
Aspirin administered preoperatively may prolong the bleeding time.
Butalbital is habit-forming and potentially abusable.
Consequently, the extended use of Butalbital, Aspirin, and Caffeine Capsules, USP is not recommended.
Results from epidemiologic studies indicate an association between aspirin and Reye’s Syndrome.
Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.
DRUG INTERACTIONS
Drug Interactions The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
In patients receiving concomitant corticosteroids and chronic use of aspirin, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Butalbital, Aspirin, and Caffeine Capsules, USP may enhance the effects of: Oral anticoagulants, causing bleeding by inhibiting prothrombin formation in the liver and displacing anticoagulants from plasma protein binding sites.
Oral antidiabetic agents and insulin, causing hypoglycemia by contributing an additive effect, if dosage of Butalbital, Aspirin, and Caffeine Capsules, USP exceeds maximum recommended daily dosage.
6-mercaptopurine and methotrexate, causing bone marrow toxicity and blood dyscrasias by displacing these drugs from secondary binding sites, and, in the case of methotrexate, also reducing its excretion.
Non-steroidal anti-inflammatory agents, increasing the risk of peptic ulceration and bleeding by contributing additive effects.
Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
Butalbital, Aspirin, and Caffeine Capsules, USP may diminish the effects of: Uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout.
Aspirin competes with these agents for protein binding sites.
OVERDOSAGE
The toxic effects of acute overdosage of Butalbital, Aspirin, and Caffeine Capsules, USP are attributable mainly to its barbiturate component, and, to a lesser extent, aspirin.
Because toxic effects of caffeine occur in very high dosages only, the possibility of significant caffeine toxicity from Butalbital, Aspirin, and Caffeine Capsules, USP overdosage is unlikely.
Signs and Symptoms Symptoms attributable to acute barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; hypovolemic shock.
Symptoms attributable to acute aspirin poisoning include hyperpnea; acid-base disturbances with development of metabolic acidosis; vomiting and abdominal pain; tinnitus; hyperthermia; hypoprothrombinemia; restlessness; delirium; convulsions.
Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium; tachycardia and extrasystoles.
Treatment Treatment consists primarily of management of barbiturate intoxication and the correction of the acid-base imbalance due to salicylism.
Vomiting should be induced mechanically or with emetics in the conscious patient.
Gastric lavage may be used if the pharyngeal and laryngeal reflexes are present and if less than 4 hours have elapsed since ingestion.
A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and when necessary to provide assisted respiration.
Diuresis, alkalinization of the urine, and correction of electrolyte disturbances should be accomplished through administration of intravenous fluids such as 1% sodium bicarbonate in 5% dextrose in water.
Meticulous attention should be given to maintaining adequate pulmonary ventilation.
The value of vasopressor agents such as Norepinephrine or Phenylephrine Hydrochloride in treating hypotension is questionable since they increase vasoconstriction and decrease blood flow.
However, if prolonged support of blood pressure is required, Norepinephrine Bitartrate (Levophed®) may be given I.V.
with the usual precautions and serial blood pressure monitoring.
In severe cases of intoxication, peritoneal dialysis, hemodialysis, or exchange transfusion may be lifesaving.
Hypoprothrombinemia should be treated with Vitamin K, intravenously.
Up-to-date information about the treatment of overdose can often be obtained from a Certified Regional Poison Control Center.
Telephone numbers of Certified Regional Poison Control Centers are listed in the Physicians’ Desk Reference®.
Toxic and Lethal Doses (for adults) Butalbital: toxic dose 1 g (20 capsules) Aspirin: toxic blood level greater than 30 mg/100 mL; lethal dose 10-30 g Caffeine: toxic dose 1 g (25 capsules)
DESCRIPTION
Butalbital, Aspirin, and Caffeine Capsules, USP is supplied in capsule form for oral administration.
Each capsule contains the following active ingredients: butalbital, USP .
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50 mg aspirin, USP.
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325 mg caffeine, USP .
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40 mg Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate.
It has the following structural formula: C11H16N2O3 molecular weight 224.26 Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory.
It has the following structural formula: C9H8O4 molecular weight 180.16 Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant.
It has the following structural formula: C8H10N4O2 molecular weight 194.19 Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, and talc.
Gelatin capsules contain D&C Yellow No.
10, FD&C Green No.
3, and gelatin.
The capsules are printed with edible ink containing red iron oxide.
Butalbital structural formula.
Aspirin structural formula.
Caffeine structural formula.
HOW SUPPLIED
Butalbital, Aspirin, and Caffeine Capsules, USP Green cap with a yellow body.
Cap is imprinted with “WATSON” in red.
Body is imprinted with “3219” in red.
Bottles of 30 are supplied with child-resistant closures.
Store and Dispense Below 25°C (77°F); tight container.
Protect from moisture.
Rx only Address medical inquiries to: WATSON Medical Communications P.O.
Box 1953 Morristown, NJ 07962-1953 800-272-5525 Watson Laboratories, Inc.
Corona, CA 92880 USA Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Revised: June 2009 190110 S0609
INDICATIONS AND USAGE
INDICATIONS Butalbital, Aspirin, and Caffeine Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of Butalbital, Aspirin, and Caffeine Capsules, USP in the treatment of multiple recurrent headaches is unavailable.
Caution in this regard is required because butalbital is habit-forming and potentially abusable.
PEDIATRIC USE
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
PREGNANCY
Usage in Pregnancy Teratogenic Effects: Pregnancy Category C .
Animal reproduction studies have not been conducted with Butalbital, Aspirin, and Caffeine Capsules, USP.
It is also not known whether Butalbital, Aspirin, and Caffeine Capsules, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Butalbital, Aspirin, and Caffeine Capsules, USP 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 2 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.
Studies of aspirin use in pregnant women have not shown that aspirin increases the risk of abnormalities when administered during the first trimester of pregnancy.
In controlled studies involving 41,337 pregnant women and their offspring, there was no evidence that aspirin taken during pregnancy caused stillbirth, neonatal death or reduced birth weight.
In controlled studies of 50,282 pregnant women and their offspring, aspirin administration in moderate and heavy doses during the first four lunar months of pregnancy showed no teratogenic effect.
Therapeutic doses of aspirin in pregnant women close to term may cause bleeding in mother, fetus, or neonate.
During the last 6 months of pregnancy, regular use of aspirin in high doses may prolong pregnancy and delivery.
NUSRING MOTHERS
Nursing Mothers Aspirin, caffeine, and barbiturates are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known.
Because of potential for serious adverse reactions in nursing infants from Butalbital, Aspirin, and Caffeine Capsules, USP, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
INFORMATION FOR PATIENTS
Information for Patients Patients should be informed that Butalbital, Aspirin, and Caffeine Capsules, USP contains aspirin and should not be taken by patients with an aspirin allergy.
Butalbital, Aspirin, and Caffeine Capsules, USP may impair the mental and/or physical abilities required for performance of potentially hazardous tasks such as driving a car or operating machinery.
Such tasks should be avoided while taking Butalbital, Aspirin, and Caffeine Capsules, USP.
Alcohol and other CNS depressants may produce an additive CNS depression when taken with Butalbital, Aspirin, and Caffeine Capsules, USP and should be avoided.
Butalbital may be habit-forming.
Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
DOSAGE AND ADMINISTRATION
One or 2 capsules every 4 hours.
Total daily dose should not exceed 6 capsules.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.