How is Esgic Tablets Supplied

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container with a child-resistant closure.

Rx only

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Distributed by:

Mayne Pharma

Greenville, NC 27834

Code 687J00

Rev. 04/2017

ESGIC 
butalbital, acetaminophen and caffeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68308-220
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTALBITAL (BUTALBITAL) BUTALBITAL 50 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
CAFFEINE (CAFFEINE) CAFFEINE 40 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
POVIDONE
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape OVAL (CAPSULE SHAPED) Size 14mm
Flavor Imprint Code 535;11
Contains
Packaging
# Item Code Package Description
1 NDC:68308-220-01 100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089175 05/01/2014
Labeler – Mayne Pharma Inc. (867220261)

 

Mayne Pharma Inc.

Esgic Over-dosage and Treatment

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.

Signs and Symptoms

Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.

Treatment

A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

Esgic Abuse and Dependence

Butalbital: Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg.

As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller.

Buy Fioricet Online
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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.

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.

Esgic Adverse Reactions

Adverse Reactions

Frequently Observed

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed

All adverse events tabulated below are classified as infrequent.

Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous System: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

Frequently Observed

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed

All adverse events tabulated below are classified as infrequent.

Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous System: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions. Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.

The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dos age are listed in the OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

 

Drug Abuse And Dependence

Abuse and Dependee

Butalbital

Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. 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. 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.

DRUG INTERACTIONS

The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.

Butalbital, acetaminophen and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

Drug/Laboratory Test Interactions

Acetaminophen may produce false-positive test results for urinary 5-hydroxy-indoleacetic acid.

 

Gabapentin is the best substitute Prescription of tramadol

It is said Gabapentin is the best substitute of tramadol. Because tramadol is controlled after Aug 18, 2014. Some tramadol patients are changing their prescriptions from tramadol to Gabapentin.

Gabapentin is an anti-epileptic medication, also called an anticonvulsant. It affects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain. Gabapentin is used in adults to treat nerve pain caused by herpes virus or shingles (herpes zoster).

Fioricet Storage and Fioricet Interactions

Fioricet Storage

  • Keep out of the reach of children since overdose is especially dangerous in children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

How do I take Fioricet?

Fioricet should be taken exactly as prescribed by your physician. Do not take it in larger amounts or for longer than recommended. Follow the directions on your fioricet prescription label and tell your physician if the medicine seems to stop working as well in relieving your pain.  If Fioricet upsets your stomach take it with food or milk. An overdose of acetaminophen can cause serious harm and damage to your liver. The maximum amount of acetaminophen for an adult is 1 gram per dose and 4 grams per day. Taking more acetaminophen could cause damage to your liver.

Fioricet Interactions with other prescriptions

Fioricet Interaction with other drugs
Fioricet Interaction with other drugs

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Fioricet with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with acetaminophen, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

    • Riociguat

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

      • Alfentanil
      • Alprazolam
      • Amobarbital
      • Anisindione
      • Aprobarbital
      • Butabarbital
      • Carisoprodol
      • Chloral Hydrate
      • Chlordiazepoxide
      • Chlorzoxazone
      • Clarithromycin
      • Clonazepam
      • Clorazepate
      • Dantrolene
      • Darunavir
      • Diazepam
      • Dicumarol
      • Doxorubicin
      • Doxorubicin Hydrochloride Liposome
      • Esketamine
      • Estazolam
      • Ethchlorvynol
      • Etonogestrel
      • Flunitrazepam
      • Flurazepam
      • Halazepam
      • Imatinib
      • Iobenguane I 131
      • Isoniazid
      • Ketazolam
      • Lorazepam
      • Lormetazepam
      • Medazepam
      • Mephenesin
      • Mephobarbital
      • Meprobamate
      • Metaxalone
      • Methocarbamol
      • Methohexital
      • Midazolam
      • Nifedipine
      • Nitrazepam
      • Oxazepam
      • Peginterferon Alfa-2b
      • Pentobarbital
      • Phenindione
      • Phenobarbital
      • Phenprocoumon
      • Piperaquine
      • Pixantrone
      • Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
      • Prazepam
      • Primidone
      • Quazepam
      • Secobarbital
      • Sodium Oxybate
      • Temazepam
      • Thiopental
      • Trazodone
      • Triazolam
      • Ulipristal

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

      • Acenocoumarol
      • Cannabis
      • Carbamazepine
      • Fosphenytoin
      • Lixisenatide
      • Ospemifene
      • Phenytoin
      • Prednisone
      • Warfarin
      • Zidovudine

What you should know before you buy Fioricet Online ?

When you order fioricet generic, gabapentin online,  please remember to complete the health condition questionnaire very honestly and carefully.

It would be best if You already have the experience of taking fioricet from your local pharmacies and your local doctors have prescribed this medicine before. You should know the side effects and drug interaction before you order cheap fioricet online.

There are a lot of medicines contains acetaminophen, butalbital, caffeine. Please read carefully the pain relief medicines’ introduction. Never exceed the max dosages of acetaminophen, or butalbital.

fioricet

The acetaminophen (Paracetamol, tylenol, APAP) is very popular pain reliever. A lot of pain medicines contain apap. You must read the drug introduction very carefully if you are talking more than two medicines.

Our doctors will definitely check whether you are taking acetaminophen too much, but it is your own duty to guarantee all your medicines’ acetaminophen dosage never exceed the max dosage 3000mg per day.

Because Acetaminophen eliminates acetaminophen mainly through metabolism by the liver, which breaks this drug down and eventually moves it out of the body by way of the kidneys, Too much acetaminophen will damage your liver and kidneys.

You are not allowed to take fioricet if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications. Do not use Fioricet if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

We donot suggest you buy fioricet online if you are pregnant or breastfeeding. Because the butalbital in the fioricet can cross the placenta, you must go to a local doctor to check your health condition and buy fioricet under the doctor’s instruction.

If you have the experience of taking fioricet, and you know the fioricet side effects, and fioricet drug interaction, and fioricet caution, you have completed the health questionnaires correctly, you are safe to buy fioricet online.

You also need know to pay online fioricet pharmacy the money orders. We made our Fioricet prices the cheapest.  But we will lose a lot if you do not pick up your order after you have placed it.  All the orders must be paid by us before it is shipped.  If one order is returned, we have to pay a fine and disposal fee.  Returned prescriptions have no uses. That is why we hate the no-responsible guys who clicked and run away.

The pharmacy’s bank account will be flagged if they receives too many bounced checks.  Almost all online pharmacies do not cash personnel checks. If you pay postman the personnel check, the pharmacies may put your name into their blacklist.  We cannot control the blacklist, but we will not do business with a patient who has been blacklisted by two more pharmacies.

What is narcotic analgesic apap caffeine butalbital oral ?

What is the dosage for narcotic analgesic-apap-caffeine-butalbital-oral?

esgic plus
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Adults and children of 12 years of age and older

  • 50/325/40 mg tablets or capsules: Take 1 to 2 tablets by mouth every 4 hours. Maximum of 6 doses per day. Not to exceed 4000 mg of acetaminophen per day to avoid liver injury.
  • Dolgic Plus (50/750/40 mg): Take 1 tablet by mouth every 4 hours. Maximum of 5 tablets per day.
  • Alagesic LQ: Take 1 to 2 tablespoons (15-30 ml) by mouth every 4 hours. Maximum daily dose of 6 tablespoons (180 ml) per day.
  • Safe and effective use of butalbital/acetaminophen/caffeine is not established in children under 12 years of age.

Which drugs or supplements interact with narcotic analgesic-apap-caffeine-butalbital-oral?

Butalbital/acetaminophen/caffeine should not be used with MAOI (monoamine oxidase inhibitors) like phenelzine (Nardil) and selegiline (Emsam) because they can significantly increase central nervous system effects of butalbital and increased blood levels of caffeine.

Butalbital can increase the effects of narcotic pain killers, alcohol, sedative or hypnotic medications, and other medications that depress the central nervous system. Loss of consciousness, troubled breathing, lowered heart rate, coma, and in severe cases death can occur.

Fioricet Side Effects

Following the safety instructions and intake recommendations are important during your Fioricet course.

Fioricet Side Effects

Otherwise, a patient may face a risk of dangerous side effects.

Emergency medical help is required for people, who misuse or overuse the headache treatment and experience life-threatening allergic reactions. Thus, you should contact emergency care in case you have noticed swelling of the throat, lips, tongue, or face, breathing disorders, hives, itching or similar disorders.

In rare instances, the components of the drug may lead to fatal skin reactions. Therefore, following Fioricet dosing and individual prescription is inevitable.

Stop the medication intake and contact your healthcare specialist the moment you have any skin rash or redness that is rapidly spreading and triggering peeling and blistering.

We do not suggest you to take Fioricet or Gabapentinfor a long time, you need go to your local health professional to treat your pain without prescription. We think exercising is the best way to relieve your pain. Exercising is a very good methods.

Exercising can enhance your immune system and increase your muscle strength and make your nerve strong.
You can also take some nutrition from food.

A patient should stop Fioricet use and address the doctor in case he/she has got any of the following abnormalities:

  • Dark urine, jaundice, nausea, upper stomach discomfort or pain, decreased appetite, clay-colored stools;
  • Lightheadedness, confusion;
  • Seizures;
  • Problems breathing.

Apart from severe adverse reactions, a patient may suffer from mild to moderate disorders, with the most common being:

  • Insomnia;
  • Feeling drunk;
  • Restlessness or anxiety;
  • Dizziness and drowsiness, etc.

Contraindications, Warnings and Precautions for the Drug Use

Striving to avoid complications and health disorders, a patient should talk to the doctor beforehand, learning the specifications of Fioricet influence on the organism and safety of its course.

Fioricet is not approved for patients, who are sensitive to any of its ingredients, as well as the ones, who are diagnosed with Porphyria.

The medication is not likely to harm the health of an unborn or nursing child, but it can cause dependency in a fetus if used by a pregnant woman. Life-threatening withdrawal reactions may appear in such an instance.

To eliminate potential risks and get balanced intake recommendations, a patient should inform the doctor about underlying and accompanying disorders and abnormalities he/she has:

  • Liver disorders, cirrhosis;
  • Alcohol or drug addiction;
  • Stomach bleeding or ulcer;
  • Sleep apnea, asthma or similar breathing complications;
  • Kidney disorders;
  • Skin rash and others.

Fioricet side effects

Get emergency medical help if you have signs of an allergic reaction to Fioricet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

  • confusion, seizure (convulsions);
  • shortness of breath;
  • a light-headed feeling, like you might pass out; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
  • drowsiness, dizziness;
  • feeling anxious or restless;
  • drunk feeling; or
  • sleep problems (insomnia).

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.

Fioricet Interactions with Other Medications

It is also necessary to provide the medical specialist with details of any accompanying treatment courses you have.

Certain prescription and over-the-counter drugs, herbal supplements, minerals, and vitamins may interfere with Fioricet launching dangerous outcomes and unwanted reactions.

Fioricet combination with other remedies may promote sleepiness and trigger breathing abnormalities, leading to dangerous, sometimes even fatal outcomes. Tell your doctor if you have recently used any of the following drugs:

  • Narcotic pain medications;
  • Anxiety, seizure or depression treatments;
  • Sleeping pills;
  • MAOIs;
  • Sedatives and others.

The Mechanism of Action of Fioricet

The roles and interactions of the combination of acetaminophen, butalbital and caffeine in the treatment of tension headaches are not well understood. But the different mechanisms of action of acetaminophen, or butalbital, or caffeine are well understood.

The mechanism of action of acetaminophen

The mechanisms of action of acetaminophenAcetaminophen:  Acetaminophen acts primarily in the CNS and increases the pain threshold by inhibiting cyclooxygenase, an enzyme involved in prostaglandin (PG) synthesis. Paracetamol (acetaminophen) is generally considered to be a weak inhibitor of the synthesis of prostaglandins (PGs). However, the in vivo effects of paracetamol are similar to those of the selective cyclooxygenase-2 (COX-2) inhibitors. Paracetamol also decreases PG concentrations in vivo, but, unlike the selective COX-2 inhibitors, paracetamol does not suppress the inflammation of rheumatoid arthritis.  Acetaminophen inhibits both isoforms of central cyclooxygenase, COX-1 and COX-2.

Acetaminophen does not inhibit PG synthesis in peripheral tissues, which is the reason for its lack of peripheral anti-inflammatory effects. The antipyretic activity of acetaminophen is exerted by blocking the effects of endogenous pyrogen on the hypothalamic heat-regulating center by inhibiting PG synthesis. Heat is dissipated by vasodilatation, increased peripheral blood flow, and sweating.

The mechanism of action of butalbital

Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. The mechanism of action of barbiturate is listed below:

The mechanism of action of barbiturate

 

Butalbital:  Butalbital has generalized depressant effect on central nervous system and, in very high doses, has peripheral effects. Sedative-hypnotic effects of butalbital are similar to phenobarbital and may result from producing or enhancing the inhibitory affects of gamma-aminobutyric acid (GABA) in the thalamus. Barbiturates inhibit ascending conduction in the reticular formation, which interferes with conduction of impulses to the cortex causing sensory cortex depression, decreased motor activity, drowsiness, sedation and changes in cerebral function. Barbiturates also cause a nonselective depressant effect throughout the CNS and are capable of producing all types of CNS mood alterations. In addition, butalbital may exhibit anticonvulsant affects in high, anesthetic doses.

The mechanism of action of Caffeine

The mechanism of action of caffeine

Caffeine is thought to produce constriction of cerebral blood vessels and serves to counteract the sedative effect of butalbital.  Caffeine causes cerebral vasoconstriction, which decreases blood flow and oxygen tension. In combination with acetaminophen, caffeine may provide a quicker onset of action and enhance pain relief allowing for lower doses of analgesics. In some patients, caffeine relieves headaches by treating the effects of caffeine withdrawal.

Butalbital has a half-life of about 35 hours. Acetaminophen has a half-life of about 1.25 to 3 hours, but may be increased by liver damage and after an overdose. Caffeine has a half-life of about 2.5 to 4.5 hours.