Skip to content

Esgic Plus for migraine treatment

Product Name Price Order link
Butalbital/APAP/Caffeine 50/500/40 mg (Esgic Plus) – 30 Tabs $65 Buy
Butalbital/APAP/Caffeine 50/500/40 mg (Esgic Plus) – 60 Tabs $75 Buy
Butalbital/APAP/Caffeine 50/500/40 mg (Esgic Plus) – 90 Tabs $89 Buy
Butalbital/APAP/Caffeine 50/325/40 mg (Generic Fioricet) – 30 Tabs $65 Buy
Butalbital/APAP/Caffeine 50/325/40 mg (Generic Fioricet) – 90 Tabs $85 Buy
Tramadol ( Generic Ultram ) 50 mg – 30 Tabs $65 Buy
Tramadol ( Generic Ultram ) 50 mg – 90 Tabs $75 Buy
Tramadol ( Generic Ultram ) 50 mg – 180 Tabs $99 Buy
Tramadol APAP 37.5/325 mg – 30 Tabs $97 Buy
Tramadol APAP 37.5/325 mg – 90 Tabs $159 Buy
Tramadol APAP 37.5/325 mg – 180 Tabs $189 Buy

Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle  contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

The combination of acetaminophen, butalbital, and caffeine is used to treat  tension headaches that are caused by muscle contractions.

Acetaminophen, butalbital, and caffeine may also be used for purposes not  listed in this medication guide.

 

Each Esgic Plus Tablets contains:

Butalbital ……………….50 mg  (Warning: May be habit-forming.)

Acetaminophen ……..500 mg

Caffeine ………………….40 mg

In addition, each Esgic Plus capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Capsule shell composed of gelatin (silicon dioxide and sodium lauryl sulfate are added as manufacturing aides to the gelatin), titanium dioxide, D&C Red #33, D&C Yellow #10 and FD&C Red #3. Imprinting ink composed of ammonium hydroxide, simethicone, isopropyl alcohol, n-butyl alcohol, pharmaceutical glaze, (modified) in SD-45 propylene glycol, and titanium dioxide.

Acetaminophen is a pain reliever and fever reducer. Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in lood vessels to improve blood flow. The combination of acetaminophen, butalbital, and caffeine is used to treat tension headaches that are caused by muscle contractions.

Pharmacokinetics

The behavior of the individual components is described below.

Butalbital

Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.

Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5 (3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.

The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5 to 20 mcg/mL. 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.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed thoughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug .

 

 Caffeine

Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.

Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. 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 .

What should I discuss with my healthcare provider before taking Esgic-Plus (acetaminophen, butalbital, and caffeine)?

Butalbital may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

You should not take this medication if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.

Before using acetaminophen, butalbital, and caffeine, tell your doctor if you are allergic to any drugs, or if you have:

  • kidney disease,
  • liver disease; or
  • a history of mental illness or suicidal thoughts.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. It is not known whether acetaminophen, butalbital, and caffeine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Acetaminophen, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Side Effects of Esgic-Plus

Esgic-Plus

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Esgic-Plus:

Dizziness; drowsiness; intoxicated feeling; lightheadedness; nausea.

Seek medical attention right away if any of these SEVERE side effects occur when using Esgic-Plus:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; seizures; severe drowsiness; shortness of breath; slurred speech; stomach pain; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

 

 

Esgic-Plus (acetaminophen, butalbital, and caffeine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • feeling light-headed or short of breath;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • drowsiness;
  • dizziness, confusion or lightheadedness;
  • dry mouth;
  • nausea, vomiting, stomach pain, loss of appetite;
  • feeling anxious or jittery;
  • drunk feeling; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Esgic-Plus (acetaminophen, butalbital, and caffeine)?

The following drugs can interact with acetaminophen, butalbital, and caffeine. Tell your doctor if you are using any of these:

  • an antibiotic;
  • a blood thinner such as warfarin (Coumadin);
  • isoniazid;
  • zidovudine (Retrovir, AZT);
  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
  • gout medications such as probenecid (Benemid) or sulfinpyrazone;
  • an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
  • steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or
  • an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen, butalbital, and caffeine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

What should I avoid while taking Esgic-Plus (acetaminophen, butalbital, and caffeine)?

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. Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by butalbital. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor’s advice, and never take more than 2 grams (2000 mg) of acetaminophen per day. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice.

Side Effects by Body System – for Healthcare Professionals

 

Nervous system

Nervous system side effects including drowsiness, lightheadedness, dizziness, sedation, and an intoxicated feeling have been reported frequently from the use of butalbital.  Headache and seizures have been reported infrequently.  Mental confusion, excitement, or depression have also been reported due to either intolerance (primarily in elderly or debilitated patients) or due to an overdose of butalbital.

 

General

General side effects including caffeinism have been reported.  Consumption of higher doses of caffeine (>600 mg/day) has been reported to have lead to caffeinism.  Caffeinism is a syndrome characterized by anxiety, restlessness, and sleep disorders (similar to anxiety states).  It has also been reported that chronic, heavy caffeine ingestion may be associated with depression.  Caffeine may cause anxiety and panic in panic disorder patients and may aggravate PMS.

 

Hepatic

Hepatic side effects including severe and sometimes fatal dose dependent hepatitis has been reported with the use of acetaminophen in alcoholic patients.  Hepatotoxicity has been increased during fasting.

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen.  In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person.  However, hepatotoxicity has been reported following smaller doses.  Glutathione concentrations may be repleted by the antidote N-acetylcysteine.  One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.
In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered.  None of the 306 patients died.
One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis.  The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.
Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.
A 19-year-old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.

 

Gastrointestinal

Gastrointestinal side effects are rare with acetaminophen use, except in alcoholics and after overdose.  Nausea, vomiting, and abdominal pain have been reported frequently with the use of butalbital.  In clinical trials of caffeine citrate, five cases of necrotizing enterocolitis were reported among the 46 infants exposed to the caffeine citrate injection.

 

Renal

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases.  A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.
A recent case-control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two pills per day.

Renal side effects are rare with acetaminophen and include acute tubular necrosis and interstitial nephritis.  Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.

 

Hypersensitivity

Hypersensitivity side effects including anaphylaxis and fixed drug eruptions have been reported rarely in association with acetaminophen use.

 

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported.  Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.

 

Dermatologic

Dermatologic side effects including acetaminophen associated bullous erythema and purpura fulminans have been reported.  Erythematous skin rashes associated with acetaminophen have been reported rarely.

 

Respiratory

Respiratory side effects including dyspnea have been reported frequently with the use of butalbital.  A case of acetaminophen-induced eosinophilic pneumonia has also been reported.

 

Cardiovascular

Two cases hypotension have been reported following the administration of acetaminophen.  Both patients experienced significant decreases in blood pressure.  One of the two patients required pressor agents to maintain adequate mean arterial pressures.  Neither episode was associated with symptoms of anaphylaxis.  Neither patient was rechallenged after resolution of the initial episode.

Cardiovascular side effects including several cases of hypotension have been reported following the administration of acetaminophen.