Author: Charles Frank

Esgic Butalbital, Acetaminophen and Caffeine Capsules: Side Effects, Uses, Dosage, Interactions, Warnings

Chances are that you’ve experienced its characteristic pain in your neck, head, or behind your eyes. It can also feel like someone put a band around your head and is pulling it tight. Headaches are common sources of pain that affect nearly every person on the planet at some point.

Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it. Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.

Is butalbital-acetaminophen-caffeine available as a generic drug?

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. Do not use Esgic if you have taken an MAO inhibitor in the past 14 days. Do not use this medcine if you have used an MAO inhibitor in the past 14 days.

1. Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain caffeine or ingredients that cause drowsiness.
2. Different medications have different amounts of acetaminophen but generally the same amount of butalbital and caffeine.
3. Keep the medication in a place where others cannot get to it.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Stop taking Esgic and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If your headache pain is especially bad or continues to occur over a long period, healthcare professionals may sometimes prescribe a medication that contains acetaminophen, caffeine, and butalbital.

Also keep in mind that certain beverages (such as coffee, colas, tea, energy drinks) contain caffeine. Ask your pharmacist about using those products safely. 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. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms. 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.

Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient. Caffeine, barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal. 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.

This drug can speed up the removal of other drugs from your body, which may affect how they work. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided. No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.

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Esgic® Capsules (butalbital, acetaminophen and caffeine capsules USP 50 mg/325 mg/40 mg) are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. During pregnancy, Esgic should be taken only if prescribed. All the drugs in Esgic pass into breast milk, and breastfeeding while taking Esgic is not recommended. Withdrawal symptoms may occur if you suddenly stop taking Esgic.

If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Use Esgic (Oral) exactly as directed on the label, or as prescribed by your doctor.

Nursing Mothers

Do not use in larger or smaller amounts or for longer than recommended. Acetaminophen, butalbital, and caffeine may also be used for purposes not listed in this medication guide. Butalbital is a barbiturate, which is a controlled substance that has a sedating effect on your brain. It’s better at relieving psychological tension and anxiety than the other two ingredients alone. This medication may interfere with certain medical/lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Side Effects for Esgic

Check the label to see if a medicine contains acetaminophen or APAP. Butalbital is habit-forming and can lead to rebound headaches. Therefore, Esgic should be restricted to intermittent use, not more than 2 days per week. Butalbital is also a sedative and is not recommended for use in patients prone to depression.

Esgic is a combination medicine used to treat tension headaches that are caused by muscle contractions. Esgic is a combination of acetaminophen, caffeine and butalbital. It is used primarily for the treatment of episodic, not daily, headache problems. It may work well for moderate and severe tension-type headache, but it is less effective for migraine. Small amounts of barbiturates and caffeine can make it into breast milk. Talk with a healthcare professional if you plan to breastfeed or chestfeed.

That means that there’s a low to moderate risk of dependence or overuse. A doctor may prescribe BAC to help relieve symptoms of tension headaches. They may also prescribe the combination to treat migraine, though it’s not Food and Drug Administration (FDA)-approved for this use. Different medications have different amounts of acetaminophen but generally the same amount of butalbital and caffeine. The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur.