Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. Tell your health care provider if you have the flu or chickenpox. Taking butalbital/aspirin/caffeine during certain viral infections may put you at risk for a rare but serious condition called Reye’s syndrome, especially if you are 18 years of age or younger. Do not take butalbital/aspirin/caffeine unless it has been prescribed to you by a health care provider. Butalbital, aspirin, and caffeine work in different ways to relieve a tension headache. Aspirin works by reducing inflammation and swelling.
The most common side effects of butalbital/acetaminophen/caffeine are listed below. Tell your health care provider if you have any of these side effects that bother you. This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention.
- Call your doctor for medical advice about side effects.
- But some states do classify BAC as a controlled substance.
- Stopping too quickly may cause serious side effects.
- Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days.
- 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.
When the body can not make heme properly, certain chemicals build up and cause nerve or skin problems. While less common, the most serious side effects of butalbital/aspirin/caffeine are described below, along with what to do if they happen. Caffeine has pain relieving properties and may boost the action of other pain relievers by mechanisms that are not well understood.
Butalbital/acetaminophen/caffeine has a boxed warning of liver toxicity if used in excessive amounts for prolonged periods. Acetaminophen dosage should not exceed 4000 mg per day to avoid acute liver injury. 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. The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness.
Your health care provider will advise you if you should take butalbital/aspirin/caffeine while you are pregnant or trying to get pregnant. Talk to your health care provider if you use or used to use street drugs or have or had a problem using alcohol or prescription medicines or live with someone with this problem. The most common side effects of butalbital/aspirin/caffeine are listed below. Other drugs may affect Esgic, including prescription and over-the-counter medicines, vitamins, and herbal products. It is not known whether this medicine will harm an unborn baby.
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Do not use Esgic if you have taken an MAO inhibitor in the past 14 days. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. Do not use this medcine if you have used an MAO inhibitor in the past 14 days. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.
Information for Patients/Caregivers
The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood. Do not take butalbital/aspirin/caffeine at 20 weeks or later in pregnancy without talking to your health care provider. Taking butalbital/aspirin/caffeine during this time may cause harm to an unborn baby and complications during delivery.
Although not all of these side effects may occur, if they do occur they may need medical attention. Ask your healthcare professional how you should dispose of any medicine you do not use. If you miss a dose of this medicine, take it as soon as possible.
However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Butalbital belongs to the group of medicines called esgic dosage barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.
How is butalbital/acetaminophen/caffeine supplied (dosage forms)?
The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. This drug can speed up the removal of other drugs from your body, which may affect how they work.
- Botox is used to treat chronic migraines, excessive sweating, bladder conditions, eye muscle …
- Butalbital/aspirin/caffeine can cause severe skin reactions called toxic epidermal necrolysis (TEN) and erythema multiforme that can lead to death if not treated.
- Butalbital is a barbiturate, which is a controlled substance that has a sedating effect on your brain.
- When the body can not make heme properly, certain chemicals build up and cause nerve or skin problems.
- Tell your health care provider if you have any of the following.
The lethal dose of a barbiturate is far less if alcohol is also ingested. 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.
Adverse Reactions/Side Effects
Caffeine is cleared through metabolism and excretion in the urine. Hepatic biotransformation prior to excretion, results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug (See OVERDOSE for toxicity information.). It consists of a fixed combination of butalbital, acetaminophen and caffeine.
What should I do if I accidentally use too much butalbital/acetaminophen/caffeine?
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. There are no known interactions between butalbital/acetaminophen/caffeine and foods or drinks. Butalbital/acetaminophen/caffeine can affect your alertness or coordination.
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Do not use extra medicine to make up the missed dose. Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. 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.
Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes). This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests. The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling. 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.