The Medical Problems That can Affect the use of Fioricet

The presence of other medical problems may affect the use of Fioricet.

Fioricet Interaction
Fioricet Interaction

Make sure you tell your doctor if you have any other medical problems, especially:

    • Addison’s disease (an adrenal problem) or
    • Alcohol abuse, or history of or
    • Brain problems (eg, tumor, increased intracranial pressure) or
    • Breathing or lung problems (eg, COPD, hypercapnia, hypoxia, sleep apnea) or
    • Cor pulmonale (serious heart condition) or
    • Depression, or history of or
    • Drug abuse or dependence, or history of or
    • Enlarged prostate or
    • Head injury, history of or
    • Hypothyroidism (underactive thyroid) or
    • Obesity (overweight) or
    • Trouble urinating or
    • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
    • Gallbladder problems or Hypotension (low blood pressure) or
    • Pancreatitis (swelling of the pancreas) or
    • Seizures, or history of—Use with caution. May make these conditions worse.
    • Kidney disease or
    • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
    • Lung or breathing problems (eg, asthma, respiratory depression), severe or
    • Porphyria (enzyme problem) or
    • Stomach or bowel blockage (including paralytic ileus) or
    • Surgery (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with these conditions.
  • Do not Take Fioricet if you are taking following drugs:
      • doravirine
      • fostemsavir
      • isavuconazonium sulfate
      • isocarboxazid
      • linezolid
      • lonafarnib
      • lorlatinib
      • mavacamten
      • phenelzine

Who cannot Buy Fioricet Online ?

Black Box Warnings

Contains acetaminophen

Hepatotoxicity may occur with acetaminophen doses that exceed 4 g/day; take into account all acetaminophen-containing products the patient is taking, including PRN doses and OTC products

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplantation or death

New dosage limit allows no more than 325 mg/dosage unit for prescription medications that contain acetaminophen

Healthcare professionals can direct patients to take 1 or 2 tablets, capsules, or other dosage units of a prescription product containing 325 mg of acetaminophen up to 6 times daily (12 dosage units) and still not exceed the maximum daily dose of acetaminophen (ie, 4 g/day)

Who cannot Buy Fioricet Online ?

    • If you have liver, kidney, or heart diseases, please donot take fioricet. Because fioricet contains barbiturate butalbital, it can cross the placental barrier;
    • We donot suggest you order fioricet online if you are pregnant or or in breast feeding period.   If you are pregnant, please go to your street doctors and let them to check whether you are OK to take fioricet;
    • If you are addictive to alcohol or other pain killer medicines, please donot buy fioricet online, you must find a street doctor to solve your addictive first before you order fioricet, or buy fioricet online;
    • You must complete the health questionnaires very carefull because the US licensed doctors and pharmacists will review your health questionnaires to approve your prescription or not;
    • All online pharmacies share the same blacklist. If you have paid bounced checks to any online pharmacy and you will be blacklisted by all online pharmacies. You are not allowed to order Fioricet Online;
    • We will not send you Fioricet or  Gabapentin if you have suicide thoughts

For more detail fioricet prescription instruction, you can check Wiki Fioricet. The pharmacy will also send you a instruction on fioricet usage and introduction. Please be very careful to take the fioricet within the max dosage. Never exceed the max dosages. Or you will be seriously damaged.

In some cases, Fioricet can interact with other drugs and create an adverse reaction or serious side effects. Fioricet should not be combined with any other drugs that contain butalbital, acetaminophen and caffeine to avoid accidental overdose.

Fioricet with Codeine should not be taken in combination with serotonergic drugs, like some types of antidepressants or anxiety medications.

Fioricet may also have a negative interaction with other medications that have a sedating effect. Combining sedatives can slow breathing and heart rate to dangerous levels. It’s important to disclose all medications to your doctor to avoid risks of drug interactions.

 

 

Fioricet Drug Interaction

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.

Acetaminophen, butalbital, and caffeine is a combination medicine 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.

Who should not use butalbital-acetaminophen-caffeine?

BAC is not for everyone. Your doctor may not prescribe BAC if:

  • You’re allergic to acetaminophen, butalbital, or caffeine.
  • You’re taking certain other medications, especially:
      • blood thinners such as warfarin (Coumadin)
      • some antidepressants
      • antihistamines
      • pain medications
      • sedatives, sleeping pills, or tranquilizers
      • certain vitamins
  • You’re already taking medication that includes acetaminophen. Too much of this drug can damage your liver.
  • You have or had liver disease, porphyria, or depression.
  • You’re pregnant, plan to become pregnant, or are nursing.
  • You drink alcohol, which adds to the drowsiness that BAC can cause.
  • You’re a child. Experts don’t yet knowTrusted Source the effects of this medication on developing brains.

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.

Fioricet Interaction
Fioricet Interaction

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.

    • Furazolidone
    • Iproniazid
    • Isocarboxazid
    • Linezolid
    • Methylene Blue
    • Moclobemide
    • Nalmefene
    • Naltrexone
    • Nialamide
    • Phenelzine
    • Procarbazine
    • Rasagiline
    • Riociguat
    • Safinamide
    • Selegiline
    • Toloxatone
    • Tranylcypromine

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.

  • Acepromazine
  • Alfentanil
  • Almotriptan
  • Alprazolam
  • Amifampridine
  • Amineptine
  • Amiodarone
  • Amitriptyline
  • Amitriptylinoxide
  • Amobarbital
  • Amoxapine
  • Amphetamine
  • Amprenavir
  • Anileridine
  • Anisindione
  • Aprepitant
  • Aprobarbital
  • Aripiprazole
  • Armodafinil
  • Asenapine
  • Atazanavir
  • Baclofen
  • Benperidol
  • Benzhydrocodone
  • Benzphetamine
  • Boceprevir
  • Bosentan
  • Bromazepam
  • Bromopride
  • Brompheniramine
  • Buprenorphine
  • Bupropion
  • Buspirone
  • Butabarbital
  • Butorphanol
  • Cannabidiol
  • Capmatinib
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Carphenazine
  • Cetirizine
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Cimetidine
  • Cinacalcet
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clomipramine
  • Clonazepam
  • Clopidogrel
  • Clorazepate
  • Clozapine
  • Cobicistat
  • Cocaine
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Cyclosporine
  • Dantrolene
  • Darunavir
  • Delavirdine
  • Desipramine
  • Desmopressin
  • Desvenlafaxine
  • Dexamethasone
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Dezocine
  • Diazepam
  • Dibenzepin
  • Dichloralphenazone
  • Dicumarol
  • Difenoxin
  • Dihydrocodeine
  • Diltiazem
  • Diphenhydramine
  • Diphenoxylate
  • Dolasetron
  • Donepezil
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Doxylamine
  • Dronedarone
  • Droperidol
  • Duloxetine
  • Efavirenz
  • Eletriptan
  • Enflurane
  • Enzalutamide
  • Erythromycin
  • Escitalopram
  • Esketamine
  • Eslicarbazepine Acetate
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Etonogestrel
  • Etravirine
  • Fentanyl
  • Flibanserin
  • Fluconazole
  • Flunitrazepam
  • Fluoxetine
  • Fluphenazine
  • Flurazepam
  • Fluspirilene
  • Fluvoxamine
  • Fosamprenavir
  • Fosaprepitant
  • Fosnetupitant
  • Fosphenytoin
  • Fospropofol
  • Frovatriptan
  • Gabapentin
  • Gabapentin Enacarbil
  • Givosiran
  • Granisetron
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Hydroxyzine
  • Idelalisib
  • Imatinib
  • Imipramine
  • Indinavir
  • Iobenguane I 131
  • Isoflurane
  • Isoniazid
  • Itraconazole
  • Ivacaftor
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Ketoconazole
  • Lasmiditan
  • Lemborexant
  • Levomilnacipran
  • Levorphanol
  • Lisdexamfetamine
  • Lithium
  • Lofepramine
  • Lofexidine
  • Lomitapide
  • Lopinavir
  • Lorazepam
  • Lorcaserin
  • Lormetazepam
  • Loxapine
  • Lumacaftor
  • Meclizine
  • Medazepam
  • Melitracen
  • Melperone
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methamphetamine
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Metoclopramide
  • Mibefradil
  • Midazolam
  • Mifepristone
  • Milnacipran
  • Mirabegron
  • Mirtazapine
  • Mitotane
  • Modafinil
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Nafcillin
  • Nalbuphine
  • Naratriptan
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nevirapine
  • Nicomorphine
  • Nifedipine
  • Nilotinib
  • Nitrazepam
  • Nitrous Oxide
  • Nortriptyline
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxcarbazepine
  • Oxycodone
  • Oxymorphone
  • Ozanimod
  • Palbociclib
  • Palonosetron
  • Papaveretum
  • Paregoric
  • Paroxetine
  • Peginterferon Alfa-2b
  • Pentazocine
  • Pentobarbital
  • Perampanel
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenindione
  • Phenobarbital
  • Phenprocoumon
  • Phenytoin
  • Piperacetazine
  • Piperaquine
  • Pipotiazine
  • Piritramide
  • Pixantrone
  • Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
  • Posaconazole
  • Prazepam
  • Prednisone
  • Pregabalin
  • Primidone
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propofol
  • Protriptyline
  • Quazepam
  • Quetiapine
  • Quinidine
  • Quinine
  • Ramelteon
  • Ranitidine
  • Ranolazine
  • Remifentanil
  • Remoxipride
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Rizatriptan
  • Rolapitant
  • Saquinavir
  • Scopolamine
  • Secobarbital
  • Sertindole
  • Sertraline
  • Sibutramine
  • Sodium Oxybate
  • St John’s Wort
  • Sufentanil
  • Sulpiride
  • Sumatriptan
  • Suvorexant
  • Tapentadol
  • Telaprevir
  • Telithromycin
  • Temazepam
  • Terbinafine
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioridazine
  • Tianeptine
  • Tilidine
  • Tizanidine
  • Tolonium Chloride
  • Topiramate
  • Tramadol
  • Trazodone
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Trimipramine
  • Tryptophan
  • Ulipristal
  • Venlafaxine
  • Verapamil
  • Vilazodone
  • Voriconazole
  • Vortioxetine
  • Zaleplon
  • Ziprasidone
  • Zolmitriptan
  • Zolpidem
  • Zopiclone
  • Zotepine

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

Other 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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol
  • Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Cabbage
  • Ethanol

What other Drugs Will Affect Acetaminophen, Butalbital, Caffeine ?

Do not take acetaminophen, butalbital, caffeine, and codeine with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Use Cautiously in:

    • History of suicide attempt or drug addiction
    • Chronic alcohol use
    • Severe hepatic or renal impairment
    • Severe cardiovascular disease
    • Patients concomitantly receiving other CNS depressants
    • OB:   Safety not established in pregnancy
    • Pedi:  Children <12 yr (safety and effectiveness not established);
    • Geri:  Appears on Beers list. Geriatric patients are at ↑ risk for side effects (dosage ↓ recommended).

Tell your doctor about all other medicines you use, especially:

    • glycopyrrolate (Robinul);
    • mepenzolate (Cantil);
    • ciprofloxacin (Cipro);
    • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
    • bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
    • a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva);
    • irritable bowel medications such as dicyclomine (Bentyl) or hyoscyamine (Anaspaz, Cystospaz, and others); or
    • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).

This list is not complete and other drugs may interact with acetaminophen, butalbital, caffeine, and codeine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Blue Fioricet – Lannett Co Inc Generic Fioricet Pill Identification: LCI | 1695

Butal/APAP/Caf 50-325-40mg Tab Lannett Co Inc Pill Identification: LCI | 1695
Butal/APAP/Caf 50-325-40mg Tab
Lannett Co Inc
Pill Identification: LCI | 1695

Lannett Company is a Generic Pharmaceutical Manufacturing and Development Company.

Founded in 1942, Lannett Company, Inc. is a leading manufacturer of over 100 unique pharmaceutical product families that save and enhance people’s lives. We are a US-based company, with our headquarters in Trevose, PA, and top-notch facilities for research and development, manufacturing, packaging, business, and distribution in three states including Pennsylvania, Indiana, and New York.

Their Top Products:

  • Lamivudine
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Their Fioricet ( Butalbital APAP Caffeine ) Prescription

FIoricet Butalbital APAP Caffeine - Lannett
FIoricet Butalbital APAP Caffeine – Lannett

Their Prescription Introduction:

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- butalbital, acetaminophen, and caffeine tablet 
Lannett Company, Inc.

———-

Butalbital, Acetaminophen, and Caffeine Tablets, USP
50 mg/325 mg/40 mg

Butalbital, Acetaminophen, and Caffeine Tablets, USP
50 mg/325 mg/40 mg

Rx only

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.

DESCRIPTION

Butalbital, Acetaminophen, and Caffeine Tablets, USP are supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:

Butalbital, USP . . . . . . . . . .50 mg

Acetaminophen, USP . . . . .325 mg

Caffeine, USP . . . . . . . . . . .40 mg

Inactive Ingredients: microcrystalline cellulose, crospovidone, croscarmellose sodium, corn starch, stearic acid, colloidal silicon dioxide, magnesium stearate, and FD&C Blue No. 1.

Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula:
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:

CLINICAL PHARMACOLOGY

This combination drug product is intended as a treatment for tension headache.

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.

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 0.5-20 mcg/mL. This falls within the range of plasma protein binding (20%-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 OVERDOSAGE for toxicity information.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout 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.

See OVERDOSAGE for toxicity information.

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.

See OVERDOSAGE for toxicity information.

INDICATIONS AND USAGE

Butalbital, acetaminophen, and caffeine tablets, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

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.

CONTRAINDICATIONS

This product is contraindicated under the following conditions:

– Hypersensitivity or intolerance to any component of this product
– Patients with porphyria.

WARNINGS

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

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.

Serious Skin Reactions

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. Patients should be informed about the signs of serious reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Hypersensitivity/anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue butalbital, acetaminophen, and caffeine tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe butalbital, aceta­minophen, and caffeine tablets, USP for patients with acetaminophen allergy.

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

PRECAUTIONS

General

Butalbital, acetaminophen, and caffeine tablets, USP 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.

Information for Patients/Caregivers

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.

Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product, and should be avoided.

Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

For information on use in geriatric patients, see PRECAUTIONS/Geriatric Use.

  • Do not take butalbital, acetaminophen, and caffeine tablets, USP if you are allergic to any of its ingredients.
  • If you develop signs of allergy such as a rash or difficulty breathing stop taking butal­bital, acetaminophen, and caffeine tablets, USP and contact your healthcare provider immediately.
  • Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

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-hydroxyindoleacetic acid.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C:

Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen, and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.

Nonteratogenic Effects

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. Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Nursing Mothers

Caffeine, barbiturates, and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen, and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Geriatric Use

Clinical studies of butalbital, acetaminophen, and caffeine tablets, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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.

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.

The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage 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 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. 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.

OVERDOSAGE

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 include 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 necrosis, 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. In adults hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.

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

Treatment

A single or multiple 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.

DOSAGE AND ADMINISTRATION

One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.

Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed “1695” on one side and “LCI” on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05).

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

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

CIB70307C

Rev. 07/20

PRINCIPAL DISPLAY PANEL – 50 mg/325 mg/40 mg Tablet Bottle Label

NDC 0527-1695-01

Butalbital,
Acetaminophen,
and Caffeine
Tablets, USP

50 mg/325 mg/40 mg

Rx Only

100 Tablets

Lannett

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE
butalbital, acetaminophen, and caffeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1695
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL – UNII:KHS0AZ4JVK) BUTALBITAL 50 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN – UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE – UNII:3G6A5W338E) CAFFEINE 40 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Product Characteristics
Color BLUE (Light-blue, speckled) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code LCI;1695
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0527-1695-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/13/2012
2 NDC:0527-1695-05 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/13/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200243 09/13/2012
Labeler – Lannett Company, Inc.
(002277481)
Establishment
Name Address ID/FEI Business Operations
Lannett Company, Inc. 829757603 ANALYSIS(0527-1695)
Establishment
Name Address ID/FEI Business Operations
Lannett Company, Inc. 006422406 LABEL(0527-1695) , MANUFACTURE(0527-1695) , PACK(0527-1695)

Revised: 7/2020

Lannett Company, Inc.

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Fioricet is a pain reliever and sedative medication to relieve mild to moderate pain and tension headaches.

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Information About Fioricet :

Fioricet – Important note : The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of Fioricet is safe, appropriate, or effective for you. Consult your healthcare professional before using Fioricet.

BUTALBITAL/ACETAMINOPHEN/CAFFEINE – ORAL (byou-TAL-bih-tall/uh-seet-uh-MEE-no-fen/kaff-EEN)

Fioricet common brand names : Esgic, Fioricet

Fioricet uses :

Fioricet is a pain reliever and sedative. It is used to relieve mild to moderate pain and tension headaches.

How to use Fioricet :

To prevent upset stomach, take Fioricet with food or milk. Pain medications work best in preventing pain before it occurs. Once the pain becomes intense, the medication is not as effective in relieving it. Take Fioricet as prescribed. Do not increase your dose of Fioricet or take it more frequently without your doctor’s approval.

Fioricet side effects :

Fioricet may cause the following side effects the first few days as your body adjusts to the medication:

  • lightheadedness;
  • dizziness;
  • drowsiness;
  • stomach upset;
  • nausea;
  • sleeping disturbances.

If these symptoms persist or become bothersome, inform your doctor. Notify your doctor immediately if you develop a rapid/ irregular heartbeat.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include :

  • rash;
  • itching;
  • swelling;
  • severe dizziness;
  • trouble breathing.

If you notice other effects of Fioricet not listed above, contact your doctor or pharmacist.

Fioricet precautions :

Tell your doctor your medical history, especially of :

  • serious liver disease;
  • alcohol or narcotic dependence;
  • emotional/mental conditions;
  • heart disease (arrhythmias, recent MI);
  • stomach/intestinal ulcers;
  • any allergies.

Acetaminophen may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Check with your doctor or pharmacist for more information.

To prevent oversedation, avoid using alcohol and other sedative type medications while taking Fioricet. Fioricet may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages.

Fioricet contains caffeine. Avoid drinking large amounts of caffeinated beverages while taking this medication as excessive nervousness and irritability can occur.

Fioricet should be used during pregnancy only if clearly needed. Small amounts of this medication appear in breast milk. Consult your doctor before breast-feeding.

Fioricet – Drug interactions :

Tell your doctor of all prescription and nonprescription drugs you may use, especially of: “blood thinners” Tell your doctor or pharmacist of all prescription and nonprescription drugs you may use that cause drowsiness such as :

  • medicine for sleep (e.g., sedatives);
  • tranquilizers;
  • anti-anxiety drugs (e.g., diazepam);
  • narcotic pain relievers (e.g., codeine);
  • psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline);
  • anti-seizure drugs (e.g., carbamazepine);
  • muscle relaxants;
  • antihistamines that cause drowsiness (e.g., diphenhydramine).

Because Fioricet contains acetaminophen, check with your doctor or pharmacist before taking other medications containing acetaminophen which is commonly found in nonprescription pain relievers and cough-and-cold products. Read labels carefully to check ingredients.

Fioricet may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. Do not start or stop any medicine without doctor or pharmacist approval.

Fioricet overdose :

If Fioricet overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of Fioricet overdose may include :

  • vomiting;
  • unusual drowsiness;
  • lack of feeling alert;
  • slow or shallow breathing;
  • cold or clammy skin;
  • loss of consciousness;
  • dark urine;
  • stomach pain;
  • extreme fatigue.

Fioricet – Missed dose :

If you miss Fioricet dose, take it as soon as remembered; do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not “double-up” the Fioricet dose to catch up.

Fioricet storage :

Store Fioricet at room temperature away from moisture and sunlight. Do not store Fioricet in the bathroom.