Aspirin, ASA; Butalbital; Caffeine Contraindications and Precautions
- acute bronchospasm
- agranulocytosis
- anemia
- angioedema
- asthma
- barbiturate hypersensitivity
- coma
- ethanol intoxication
- hemophilia
- hepatic disease
- hepatic encephalopathy
- hepatitis
- hypoprothrombinemia
- nasal polyps
- peptic ulcer disease
- porphyria
- salicylate hypersensitivity
- tartrazine dye hypersensitivity
- thrombocytopenia
- urticaria
- vitamin K deficiency
- von Willebrand’s disease
- abrupt discontinuation
- acid/base imbalance
- acute myocardial infarction
- alcoholism
- angina
- anticoagulant therapy
- ascites
- bone marrow suppression
- breast-feeding
- carbamazepine hypersensitivity
- cardiac arrhythmias
- cardiac disease
- children
- chronic obstructive pulmonary disease (COPD)
- CNS depression
- coagulopathy
- dehydration
- depression
- diabetes mellitus
- driving or operating machinery
- elderly
- esophagitis
- exfoliative dermatitis
- G6PD deficiency
- gastritis
- GI bleeding
- GI disease
- gout
- head trauma
- heart failure
- hemolytic anemia
- hydantoin hypersensitivity
- hypertension
- hypotension
- hypothyroidism
- hypovolemia
- immunosuppression
- infants
- infection
- intramuscular injections
- labor
- mental status changes
- metabolic acidosis
- metabolic alkalosis
- myocardial infarction
- neutropenia
- NSAID hypersensitivity
- osteomalacia
- osteoporosis
- pain
- pregnancy
- prostatic hypertrophy
- pulmonary disease
- pulmonary edema
- renal disease
- renal failure
- renal impairment
- respiratory acidosis
- respiratory alkalosis
- respiratory depression
- Reye’s syndrome
- seizure disorder
- seizures
- sleep apnea
- status asthmaticus
- status epilepticus
- substance abuse
- suicidal ideation
- surgery
- systemic lupus erythematosus (SLE)
- thrombolytic therapy
- thrombotic thrombocytopenic purpura (TTP)
- thyroid disease
- tobacco smoking
- urethral stricture
Aspirin, ASA; Butalbital; Caffeine Contraindications and Precautions
NOTE: This monograph discusses the use of aspirin; ASA; butalbital; caffeine combination products. Clinicians may wish to consult the individual monographs for more information about the specific contraindications and precautions for each agent.
Aspirin; ASA; butalbital; caffeine should not be used in patients with barbiturate hypersensitivity, salicylate hypersensitivity, tartrazine dye hypersensitivity or hypersensitivity to any of the other product components. The risk of cross-sensitivity with other nonsteroidal antiinflammatory drugs is significantly greater with aspirin than other salicylates; avoid use in patients with a known NSAID hypersensitivity. Patients with aspirin-induced allergic reactions (e.g. angioedema, urticaria) to aspirin are at risk of developing bronchoconstriction or anaphylaxis and should not receive aspirin. Aspirin; ASA; butalbital; caffeine should not be used in patients with a history of aspirin-induced asthma or acute bronchospasm. Aspirin containing products should be used with caution in patients with preexisting asthma since there is a higher risk for aspirin sensitivity (aspirin triad). This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Emergency help should be sought in cases where an anaphylactoid reaction occurs.
Aspirin; ASA; butalbital; caffeine should not be used in patients with porphyria because it may trigger symptoms of the disease. Barbiturates can stimulate the accumulation of porphyrin precursors.
Barbiturates can also cause severe and potentially fatal reactions that are preceded by skin eruptions. Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of adverse hematologic, hypersensitivity, or other adverse reactions to barbiturate or other anticonvulsants. Skin reactions can precede potentially fatal hypersensitivity reactions; exfoliative dermatitis has resulted in fatalities. Hypersensitivity reactions to barbiturates have been reported in patients who previously experienced hydantoin hypersensitivity (e.g., phenytoin) or carbamazepine hypersensitivity. Estimates of cross-sensitivity vary, but may range from 30 - 80%. There is no way to predict with certainty which patients will exhibit cross-sensitivity.
Aspirin; ASA; butalbital; caffeine should be used with caution in patient with mental status changes such as major depression or suicidal ideation due to exacerbation of these conditions by the CNS depressant effects. Aspirin; ASA; butalbital; caffeine should be prescribed cautiously to certain high risk patients such as elderly or debilitated patients, patients with cardiac disease (e.g., angina, cardiac arrhythmias, hypertension, hypotension, or immediately following an acute myocardial infarction) because of possible adverse hemodynamic effects. The risk of an aspirin-induced GI bleed is greater in the elderly. Elderly patients may experience increased side effects such as excitement, confusion or depression. In cases where an overdose of a barbiturate has occurred, symptoms may include: confusion, hypotension, incoherent speech, nystagmus, and tachycardia. According to US federal OBRA regulations, butalbital is not to be used in a nursing home patient, unless started before admission to the nursing home, or given as a single dose for a medical or dental procedure. Discontinuation should be gradually attempted at least twice in one year before discontinuation is considered ‘clinically contraindicated.’
The respiratory effects of salicylates may contribute to serious acid/base imbalance in patients with underlying acid/base disorders (e.g., metabolic acidosis, metabolic alkalosis, respiratory acidosis, or respiratory alkalosis) or in overdose situations. Patients who are unable to compensate for salicylate-induced metabolic acidosis (i.e., respiratory response to CO2 is depressed) will develop respiratory acidosis and increased levels of plasma CO2. Because butalbital can cause dose-dependent respiratory depression, it should be used cautiously in patients with pulmonary disease states causing respiratory depression, dyspnea, severe pulmonary insufficiency or airway obstruction. Barbiturates should be avoided in patients with bronchopneumonia. Use with close supervision in patients with sleep apnea or chronic obstructive pulmonary disease (COPD) asthmatic disease or status asthmaticus.
Aspirin; ASA; butalbital; caffeine should be used carefully in patients with diabetes mellitus, inflammatory bowel disease, prostatic hypertrophy, urethral stricture or thyroid disease (i.e., hypothyroidism). Aspirin-butalbital-caffeine should be used with caution in patients with renal disease, renal impairment and with extreme caution, if at all, in patients with advanced, chronic renal failure since metabolites of aspirin, including salicylic acid, are renally excreted. In addition, these patients may be at increased risk of developing salicylate-induced nephrotoxicity. Aspirin-butalbital-caffeine should be used cautiously in patients with renal disease or systemic lupus erythematosus (SLE) due to the risk of decreased glomerular filtration rate in these patients.
Since aspirin inhibits platelet aggregation and increases bleeding time, aspirin, ASA; butalbital; caffeine may interact with anticoagulant therapy or thrombolytic therapy (see Drug interactions). Butalbital may decrease the effect of oral coumarin anticoagulants (e.g., warfarin, see Drug Interactions) and necessitate coumarin dosage adjustment for optimal effect. Conversely, when the drug is discontinued, the dose of the anticoagulant may have to be decreased.
Since aspirin inhibits platelet aggregation and increases bleeding time, aspirin, ASA; butalbital; caffeine should not be used in patients with coagulopathy, hemophilia, hypoprothrombinemia, von Willebrand’s disease, thrombocytopenia, severe liver disease, vitamin K deficiency, aplastic anemia, agranulocytosis, pancytopenia, or thrombotic thrombocytopenic purpura (TTP). Aspirin, ASA; butalbital; caffeine should be used with caution in patients with immunosuppression or neutropenia following myelosuppressive chemotherapy. Aspirin may mask signs of infection, such as fever and pain, in patients with bone marrow suppression or immunosuppression.
Since aspirin inhibits platelet aggregation and increases bleeding time, aspirin, ASA; butalbital; caffeine should not be used in patients with severe hepatic disease or hepatitis. Because barbiturates may impair the ability of the liver to metabolize ammonia, barbiturates are best avoided in patients with hepatic encephalopathy. Note that barbiturates are hepatic enzyme inducers and patients should be monitored for altered drug levels and therapeutic effects as indicated (see Drug Interactions).
Aspirin can induce gastric or intestinal ulceration that can occasionally be accompanied by iron-deficiency anemia or other anemia from the resultant blood loss. Aspirin-butalbital-caffeine should not be used in patients with peptic ulcer disease and should be used cautiously, if at all, in patients with a history of or active GI disease including erosive gastritis, esophagitis, GI bleeding, or previous NSAID-induced bleeding. Such patients should be monitored closely, with special caution in tobacco smoking patients or in patients with alcoholism. All patients receiving chronic treatment should be routinely monitored for potential GI ulceration and bleeding. Aspirin; butalbital; caffeine should generally be discontinued at least 1 week before surgery to minimize postoperative bleeding.
Because salicylates may cause or aggravate hemolysis in patients with G6PD deficiency, some reference texts state that aspirin should be used cautiously in these patients. If hemolytic anemia occurs in patients receiving aspirin, it almost always occurs in G6PD-deficient individuals.
Aspirin; ASA; butalbital; caffeine can cause CNS depression and should be used with caution in patients with head trauma and avoided in coma. The CNS depressant effects of butalbital may further obscure the clinical course of head injury patients. Butalbital may cause blurred vision, drowsiness, or dizziness, especially with initial use. Patients should use caution when driving or operating machinery until they are aware of the effects of the drug. Ethanol intoxication or concomitant use of other sedating drugs can magnify CNS depression and is best avoided. Avoid use of butalbital in patients with chronic alcohol abuse; seizure activity may be induced.
Aspirin; ASA; butalbital; caffeine combinations are classified as FDA pregnancy-risk category C (D if used for prolonged periods or in high doses at term) and should be used during pregnancy only if the benefits to the mother outweigh the potential risks to the fetus. All three components cross the placenta. Because regular use of full-dose aspirin late in pregnancy may result in constriction or premature closure of the fetal ductus arteriosus, aspirin should be avoided during the third trimester of pregnancy. Fetal and newborn effects from aspirin exposure in utero may include increased perinatal mortality, intrauterine growth retardation, congenital salicylate intoxication, or depressed albumin-binding capacity. Full doses of aspirin administered to pregnant women near term have been associated with toxicities such as hemorrhage, premature closure of the ductus arteriosus, pulmonary hypertension, prolonged gestation, and prolonged labor. There have been reports of physical abnormalities in infants correlating to exposure to barbiturates in utero. Additionally, a retrospective study revealed that in utero exposure to barbiturates was associated with intelligence deficits. Repeated use of butalbital during the third trimester can also cause physical dependence in the neonate. A withdrawal seizure has been reported in a 2-day old infant whose mother had been taking a butalbital-containing medication during the last 2 months of her pregnancy. If the mother used butabarbital late in pregnancy, newborns should also be carefully observed for signs of ventilatory depression, particularly if the infant is premature. There is no established use for butalbital during labor or obstetrical delivery. Neonatal arrhythmias (e.g., tachycardia, premature atrial contractions) and tachypnea have been reported when caffeine was consumed during pregnancy in amounts > 500 mg/day. Caffeine withdrawal in the neonate after birth may account for these symptoms. Fatal arrhythmias in neonates with caffeine use by the mother have also been reported. Females should be warned of the potential adverse effects on the fetus should pregnancy occur while taking aspirin; ASA; butalbital; caffeine combinations .
Aspirin; ASA; butalbital; caffeine components may all be excreted to some extent into breast milk. Salicylates are excreted into breast milk and could cause adverse hematologic effects in newborns. The American Academy of Pediatrics recommends that aspirin be used cautiously during breast-feeding. Chronic barbiturate use while breast-feeding may cause dependence in the neonate. Caffeine can accumulate in the neonate, leading to insomnia, irritability or poor feeding. The chronic use of aspirin; ASA; butalbital; caffeine during breast-feeding is not recommended.
The safety and efficacy of aspirin, ASA; butalbital; caffeine combinations have not been established in children. Aspirin has been associated with the occurrence of Reye’s syndrome when given to children with varicella (i.e., chickenpox) or influenza. Although a causal relationship has not been confirmed, most authorities advise against the use of aspirin in children with varicella, influenza, or other viral illnesses.
Aspirin; ASA; butalbital; caffeine combinations should be prescribed with caution to patients with known substance abuse because of the potential for psychological and/or physical dependence to butalbital; prolonged therapy is not recommended. Patients with a previous history of substance abuse may be at increased risk. Avoid abrupt discontinuation of butalbital after prolonged use to limit drug withdrawal and/or seizure onset. Sudden, abrupt discontinuation of butalbital in epileptic patients may precipitate acute seizures, status epilepticus, or other seizure disorder.
Use aspirin; ASA; butalbital; caffeine with caution in patients with low bone density. There may be an increased risk of osteopenia/osteoporosis with long-term barbiturate therapy. Osteomalacia has been noted in patients using barbiturates who have end-stage kidney disease.
In patients with gout, aspirin may increase serum uric acid levels, resulting in hyperuricemia, and interfere with the efficacy of uricosuric agents.
Intramuscular injections should be administered cautiously to patients receiving products that contain aspirin. IM injections may cause bleeding, bruising, or hematomas due to aspirin-induced inhibition of platelet aggregation.
Sodium-restricted patients or patients with hypovolemic states (e.g., ascites, dehydration, heart failure, high blood pressure, or hypovolemia) may be more susceptible to adverse renal effects of products that contain aspirin. In patients with carditis, high doses of salicylates may precipitate congestive heart failure or pulmonary edema.
[ Last revised: 11/24/2003 2:34:00 PM ]
References
. Reinisch JM, Sanders SA, Mortensen EL et al. In utero exposure to phenobarbital and intelligence deficits in adult men. JAMA 1995;274:1518 - 25.
. Holmes LB, Harvey EA, Coull BA, et al. The teratogenecity of anticonvulsant drugs. N Engl J Med 2001;344:1132 - 8.
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