Author: Charles Frank

Esgic Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

This falls within the range of plasma protein binding (20% to 45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells (See OVERDOSE for toxicity information.). Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock. Consequently, the extended use of this product is not recommended. Esgic may interact with monoamine oxidase (MAO) inhibitors, other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants. Tell your doctor all medications and supplements you use.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine. Children younger than 18 years should not use products that contain codeine. Some children are more sensitive to codeine and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section).

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. Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours). Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butalbital, acetaminophen, and caffeine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving butalbital, acetaminophen, and caffeine combination. Appropriate studies have not been performed on the relationship of age to the effects of butalbital, acetaminophen, and caffeine combination in children younger than 12 years of age. This medication passes into breast milk and may have undesirable effects on a nursing infant, such as unusual sleepiness, difficulty feeding, trouble breathing, or unusual limpness. Do not increase your dose or use this drug more often or for longer than prescribed, because your risk of side effects may increase.

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests. 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. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

FDA Drug Information

This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. This medicine is available only with your doctor’s prescription. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. You should not use Esgic if you are allergic to it, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other opioids.

Codeine is an opioid pain reliever that acts on certain centers in the brain to give you pain relief. Acetaminophen helps to decrease the pain from the headache. Butalbital is a sedative which helps to decrease anxiety and cause sleepiness and relaxation. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Since Esgic is used when needed, you may not be on a dosing schedule. 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.

Side Effects

Other medications can affect the removal of this product from your body, which may affect how this product works. 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. Certain beverages (such as coffee, colas, tea) may also contain caffeine.

1. This medication can cause side effects that may impair your thinking or reactions.
2. Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.
3. Get medical help right away if you take too much acetaminophen (overdose), even if you feel well.
4. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist.

It consists of a fixed combination of butalbital, acetaminophen and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood. Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. 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. 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.

What should I avoid while taking acetaminophen, butalbital, and caffeine?

This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5 to 20 mcg/mL.

More about Esgic-Plus (acetaminophen / butalbital / caffeine)

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. Some patients may be sensitive to the caffeine component. Esgic-Plus has a similar combination of drugs as Esgic, but with a greater amount of the analgesic acetaminophen. Acetaminophen is used to relieve pain and reduce fever in patients.

Generic Name(S): butalbital-acetaminop-caf-cod

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law. Do not use Esgic if you have taken an MAO inhibitor in the past 14 days.

If you notice other effects not listed above, contact your doctor or pharmacist. Esgic® Capsules should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.