Butalbital-Aspirin-Caffeine

Butalbital-Aspirin-Caffeine is a prescription medication used to treat tension headaches.

• Butalbital-Aspirin-Caffeine is available under the following different brand names: Fiorinal 

Common side effects of Butalbital-Aspirin-Caffeine include:

Drowsiness,

• Dizziness,
• Lightheadedness,
• Intoxicated feeling,
• Nausea, and
• Abdominal pain

Serious side effects of Butalbital-Aspirin-Caffeine include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Slow breathing with long pauses,
• Blue-colored lips,
• Difficulty waking up,
• Noisy breathing,
• Sighing,
• Shallowing breathing,
• Breathing that stops during sleep,
• Slow heart rate,
• Weak pulse,
• Lightheadedness,
• Confusion,
• Unusual thoughts or behavior,
• Easy bruising,
• Unusual bleeding (nosebleeds, bleeding gums),
• Severe constipation,
• Bloody or tarry stools,
• Coughing up blood,
• Vomit that looks like coffee grounds,
• Nausea,
• Vomiting,
• Loss of appetite,
• Dizziness,
• Tiredness,
• Weakness,
• Agitation,
• Hallucinations,
• Fever,
• Sweating,
• Shivering,
• Fast heart rate,
• Muscle stiffness,
• Twitching,
• Loss of coordination, and
• Diarrhea

Rare side effects of Butalbital-Aspirin-Caffeine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet/Capsule: Schedule III

• 50 mg/325 mg/40 mg

Tension Headache

Adult dosage

• 1-2 tablets /capsules orally every 4 hours; not to exceed 6 tablets/capsules per day

Pediatric dosage

• Children below 16 years: Safety & efficacy not established
• Children above 16 years: As adults; 1-2 tablets /capsules orally every 4 hours; not to exceed 6 tablets/capsules per day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Butalbital-Aspirin-Caffeine has severe interactions with the following drugs:
  • abrocitinib
  • dichlorphenamide
  • doravirine
  • fostemsavir
  • isavuconazonium sulfate
  • isocarboxazid
  • linezolid
  • lonafarnib
  • lorlatinib
  • mavacamten
  • mifepristone
  • phenelzine
• Butalbital-Aspirin-Caffeine has serious interactions with at least 97 other drugs.
• Butalbital-Aspirin-Caffeine has moderate interactions with at least 618 other drugs.
• Butalbital-Aspirin-Caffeine has minor interactions with at least 253 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity or intolerance to aspirin, caffeine, or butalbital
• Patients with a hemorrhagic diathesis (.g, hemophilia, hypoprothrombinaemia, von Willebrand’s disease thrombocytopenia, thrombasthenia, and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency, and severe liver damage)
• Patients with the syndrome of nasal polyps, angioedema, and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory drugs
• Peptic ulcer or other serious gastrointestinal lesions.
• Patients with porphyria 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Butalbital-Aspirin-Caffeine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Butalbital-Aspirin-Caffeine?”

Cautions

• Caution in patients with a history of GI bleeding, alcoholism, or bleeding disorders
• Avoid driving a car or operating machinery
• void in severe renal impairment (. e, CrCl below 10 mL/min)
• 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 bleeding time
• Butalbital is habit-forming and potentially abusable; consequently, extended use 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
• Avoid the use of NSAIDs in pregnant women at about 30 weeks gestation and later; NSAIDs, increase the risk of premature closure of fetal ductus arteriosus at approximately this gestational age
• Therapy should be prescribed with caution for certain special-risk patients such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, coagulation disorders, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison’s disease, or prostatic hypertrophy
• Aspirin should be used with caution in patients on anticoagulant therapy and patients with underlying hemostatic defects, and extreme caution in the presence of a peptic ulcer
• Precautions should be taken when administering salicylates to persons with known allergies
• Hypersensitivity to aspirin is particularly likely in patients with nasal polyps, and relatively common in those with asthma
• Oligohydramnios/neonatal renal impairment
  • Use of NSAIDs at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment; these adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation
  • Oligohydramnios is often, but not always, reversible with treatment discontinuation; complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation
  • In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required
  • If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit therapy to the lowest effective dose and shortest duration possible
  • Consider ultrasound monitoring of amniotic fluid if treatment extends beyond 48 hours; discontinue therapy if oligohydramnios occurs and follow up according to clinical practice
• Overuse of barbiturate-containing medications
  • Based on the American Academy of Neurology guidelines, limit and carefully monitor r use of butalbital-containing agents
  • Don’t use opioid or butalbital treatment for migraine except as a last resort
  • Any use of barbiturates and opiates was associated a with increased risk of transformed migraine after adjusting for covariates
  • Limit and carefully monitor their use (butalbital-containing agents) based on overuse, medication overuse headache, and withdrawal concerns
• Drug reaction with eosinophilia and systemic symptoms
• Drug Reactions reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
• Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
• Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
• Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately

Pregnancy and Lactation

• 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
• Use of NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment
• Because of these risks, limit the dose and duration of drug combination between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy
• Use of NSAIDs, including drug combination, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus
• Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment
• If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to the lowest effective dose and shortest duration possible; if drug combination treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue drug use, and follow up according to clinical practice
• Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
• Lactation
  • 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 the potential for serious adverse reactions in nursing infants from drug combination, a decision should be made whether to discontinue nursing or discontinue the drug, considering the importance of the drug to mother.