Generic Fioricet MIA 110 Pill – white oval, 14mm – Mikart, LLC and Chartwell RX

MIA Fioricet

Pill with imprint MIA 110 is White, Oval and has been identified as Acetaminophen, Butalbital and Caffeine 325 mg / 50 mg / 40 mg. It is supplied by Chartwell RX, LLC.

Acetaminophen/butalbital/caffeine is used in the treatment of Headache and belongs to the drug class analgesic combinations. Risk cannot be ruled out during pregnancy. Acetaminophen/butalbital/caffeine 325 mg / 50 mg / 40 mg is not a controlled substance under the Controlled Substances Act (CSA).

MIA Fioricet

Acetaminophen, Butalbital and Caffeine

Imprint
MIA 110
Strength
325 mg / 50 mg / 40 mg
Color
White
Size
14.00 mm
Shape
Oval
Availability
Prescription only
Drug Class
Analgesic combinations
Pregnancy Category
C – Risk cannot be ruled out
CSA Schedule
Not a controlled drug
Labeler / Supplier
Chartwell RX, LLC
Inactive Ingredients
microcrystalline cellulose, croscarmellose sodium, crospovidone, povidone, silicon dioxide, corn starch, stearic acid

Note: Inactive ingredients may vary.

Labelers / Repackagers

NDC Code Labeler / Repackager
46672-0053 Mikart, Inc.
51862-0540 Libertas Pharma
63874-0448 (Discontinued) Altura Pharmaceuticals Inc. (repackager)

What is Fioricet (Butalbital APAP Caffeine )?

Fioricet is a prescription medication primarily used to treat tension headaches. It contains a combination of three active ingredients:

  1. Acetaminophen (also known as paracetamol): This is a pain reliever and fever reducer commonly found in over-the-counter medications. It works by reducing the production of prostaglandins in the brain, which helps alleviate pain and lower fever.
  2. Butalbital: This is a barbiturate, a type of central nervous system depressant. It acts as a muscle relaxant and can also provide pain relief. It works by relaxing muscle contractions in the head, neck, and shoulders, which can contribute to tension headaches.
  3. Caffeine: Caffeine is a stimulant that is often included in headache medications because it can enhance the effectiveness of pain relievers. It helps to constrict blood vessels in the brain, which can reduce the intensity of headaches.

The combination of these three ingredients in Fioricet provides both pain relief and muscle relaxation, making it effective for relieving tension headaches. It’s typically available in tablet or capsule form and is taken orally. However, Fioricet contains butalbital, which is a barbiturate, and it has the potential for abuse and addiction. Therefore, it’s essential to use Fioricet only as prescribed by a healthcare professional and to follow their instructions carefully.

What You Should Know Before You Take Fioricet ?

Fioricet is a medication commonly prescribed for tension headaches. It contains a combination of three active ingredients: acetaminophen (paracetamol), butalbital, and caffeine. Here’s a detailed guide on how to take Fioricet:

1. Prescription: Fioricet is available only with a prescription from a healthcare provider. It’s essential to follow your doctor’s instructions carefully when taking this medication.

2. Dosage: The dosage of Fioricet will depend on your medical condition, response to treatment, and other medications you may be taking. Do not increase your dose or take it more frequently than prescribed, as this can increase the risk of side effects and dependency.

3. Administration: Fioricet is usually taken orally, with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

4. Timing: Take Fioricet as soon as you feel a tension headache starting. It’s most effective when taken at the first sign of a headache.

5. Frequency: Fioricet should not be taken more frequently than prescribed. Typically, it’s taken every 4 to 6 hours as needed for pain relief. Do not exceed the recommended dosage or take it for longer than prescribed.

6. Avoid Alcohol: Do not consume alcohol while taking Fioricet, as it can increase the risk of liver damage due to the acetaminophen component of the medication.

7. Withdrawal: If you have been using Fioricet regularly for an extended period, do not stop taking it suddenly without consulting your doctor. Abrupt discontinuation can lead to withdrawal symptoms such as headaches, nausea, and anxiety. Your doctor may need to taper your dose gradually to prevent withdrawal.

8. Overdose: Taking too much Fioricet can be dangerous and even life-threatening due to the butalbital component, which can cause respiratory depression in high doses. If you suspect an overdose, seek immediate medical attention or contact a poison control center.

9. Storage: Store Fioricet at room temperature away from moisture and heat. Keep it out of reach of children and pets.

10. Side Effects: Common side effects of Fioricet may include dizziness, drowsiness, nausea, vomiting, and upset stomach. If any of these side effects persist or worsen, notify your doctor promptly.

11. Precautions: Before taking Fioricet, inform your doctor if you have a history of liver disease, kidney disease, substance abuse, or if you are pregnant or breastfeeding. Fioricet may not be suitable for individuals with certain medical conditions or those taking specific medications.

12. Interaction: Fioricet can interact with other medications, including certain antidepressants, anticonvulsants, and blood thinners. Inform your doctor about all the medications you are currently taking to avoid potential drug interactions.

Fioricet Dependance

Fioricet, specifically because it contains butalbital, a barbiturate, has the potential for dependence and abuse. Butalbital is a central nervous system depressant that can produce feelings of relaxation and euphoria when taken in higher doses than prescribed or for longer periods than recommended.

Dependence on Fioricet can develop when the medication is taken regularly over an extended period. Physical dependence occurs when the body adapts to the presence of the drug and requires it to function normally. Psychological dependence can also develop, where individuals feel they need Fioricet to cope with daily life or to manage stress.

Signs of Fioricet dependence may include:

  1. Increased tolerance: Over time, individuals may need higher doses of Fioricet to achieve the same pain relief or euphoric effects.
  2. Withdrawal symptoms: If Fioricet is suddenly stopped or the dose is significantly reduced, withdrawal symptoms may occur. These can include anxiety, restlessness, tremors, insomnia, nausea, vomiting, abdominal cramps, and seizures in severe cases.
  3. Cravings: Individuals may experience intense cravings for Fioricet, leading to continued use despite negative consequences.
  4. Social or occupational problems: Dependence on Fioricet can interfere with daily functioning, relationships, and work or school responsibilities.
  5. Failed attempts to quit: Despite wanting to stop or cut back on Fioricet use, individuals may struggle to do so on their own.

Fioricet Addiction

Although it’s only a prescription headache medication, Fioricet has the potential to cause addiction. If a person follows their prescription guidelines and uses the medication correctly, the risks of addiction are low. However, if someone takes too much Fioricet, they may develop tolerance to its effects. A person with tolerance to a certain dose of Fioricet will require higher doses of the medication to alleviate their headaches.

When a person with tolerance starts to take more Fioricet, possibly by obtaining more prescriptions, they may eventually become dependent on it. In other words, they may feel unable to get through the day without taking Fioricet; if they stop, they will experience symptoms of withdrawal. These symptoms arise because their body has grown accustomed to Fioricet in high doses.

If a Fioricet-dependent person attempts to weather withdrawal alone, it’s likely they will take Fioricet again just to relieve the symptoms of withdrawal. This is a hallmark characteristic of addiction. Anyone who compulsively abuses Fioricet to avoid withdrawal likely has an addiction to Fioricet. Additionally, people with an addiction to Fioricet will experience cravings for the medication which further compel them to keeping using it.

Moreover, the ingredient Butalbital is an addictive substance in its own right. Butalbital can cause someone to get “high” because it’s a Central Nervous System (CNS) Depressant. Since Butalbital is part of Fioricet, it is possible for someone to abuse Fioricet as a recreational drug. At high doses, Fioricet can intoxicate a person in a manner similar to alcohol. People who abuse Fioricet for this purpose have as much of a risk of developing an addiction as they would have if they repeatedly used an illegal drug.

Here are some reasons why Fioricet can be addictive:

  1. Butalbital’s Effects: Butalbital is a central nervous system depressant that can produce feelings of relaxation and euphoria when taken in excess. These effects can be reinforcing and lead to continued use, even when not medically necessary.
  2. Tolerance Development: With regular use of Fioricet, individuals may develop tolerance, meaning they need higher doses of the medication to achieve the desired effects. This can lead to escalating doses and increased risk of addiction.
  3. Psychological Dependence: Over time, individuals may become psychologically dependent on Fioricet, feeling like they need it to cope with stress, manage emotions, or function in daily life.
  4. Withdrawal Symptoms: When someone who is dependent on Fioricet stops using it suddenly or tries to cut back, they may experience withdrawal symptoms. These can include anxiety, restlessness, tremors, insomnia, nausea, vomiting, abdominal cramps, and seizures in severe cases. The fear of experiencing these withdrawal symptoms can contribute to continued use of Fioricet, perpetuating the cycle of addiction.
  5. Behavioral Patterns: Addiction involves not only physical dependence but also behavioral patterns of use. Individuals may develop routines or rituals around taking Fioricet, and cravings for the drug can become powerful motivators for continued use.
  6. Co-occurring Factors: Factors such as genetics, environment, mental health conditions, and past experiences with substance abuse can also influence the likelihood of developing an addiction to Fioricet or any other medication.

The Symptoms Of Fioricet Withdrawal

In most cases, Fioricet withdrawal lasts anywhere from 8 hours to three days after the last dose. Withdrawal is the biggest obstacle to overcoming dependence on Fioricet, which is why rehab centers provide detox programs so that people can safely undergo the withdrawal cycle without the risk of relapse. According to research, it is best to undergo withdrawal under medical supervision because some withdrawal symptoms are dangerous.

Rebound headaches are the most common symptoms of Fioricet withdrawal. Other symptoms of withdrawal include:

    • Anxiety
    • Dizziness
    • Insomnia
    • Muscle spasms
    • Nausea and vomiting
    • Rapid emotional changes
    • Seizures (in rare cases)
    • Weakness

Generic Fioricet  Interactions

Fioricet is a combination medication that contains acetaminophenbutalbital, and caffeine.

  1. Monoamine Oxidase (MAO) Inhibitors: Avoid using Fioricet if you’ve taken an MAO inhibitor in the past 14 days. MAO inhibitors include drugs like isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. Combining Fioricet with MAO inhibitors can lead to dangerous interactions12.
  2. Other Narcotic Analgesics: Fioricet may interact with other narcotic pain medications. Be cautious if you’re using opioids or other similar drugs.
  3. Alcohol: Avoid alcohol while taking Fioricet. Combining alcohol with Fioricet can increase the risk of side effects and sedation.
  4. General Anesthetics and Tranquilizers: Fioricet may interact with general anesthetics and tranquilizers (such as chlordiazepoxide). These combinations can enhance sedation and affect your central nervous system.
  5. Other CNS Depressants: Fioricet can interact with other central nervous system (CNS) depressants. These include sedative-hypnotics and other medications that have a calming effect on the brain.
  6. Specific Medications: Some specific drugs that may interact with Fioricet include darunavir (used for HIV), sodium oxybate (used for narcolepsy), isoniazid (used for tuberculosis), ketoconazole and levoketoconazole (antifungal medications), lithium (used for bipolar disorder), and phenothiazines (such as chlorpromazine, used for various conditions).

Fioricet Dosage For Headaches

The dosage of Fioricet for headaches can vary depending on factors such as the severity of the headache, the individual’s response to the medication, and any other medical conditions they may have. It’s crucial to follow your healthcare provider’s instructions and the dosage guidelines provided on the prescription label. However, a typical dosage for tension headaches might be:

    • Fioricet tablet: 1 to 2 tablets every 4 hours as needed.
    • Fioricet capsule: 1 capsule every 4 hours as needed.

However, it’s essential to note that Fioricet contains acetaminophen (paracetamol), butalbital, and caffeine. Exceeding the recommended dosage can lead to acetaminophen overdose, which can cause liver damage or even be fatal. Therefore, it’s crucial to:

  1. Not Exceed the Recommended Dosage: Stick to the dosage prescribed by your healthcare provider. Do not take more Fioricet than directed, even if you feel your headache is not improving.
  2. Be Aware of Total Acetaminophen Intake: Keep track of the total amount of acetaminophen you consume from all sources (including other medications) to avoid exceeding the maximum daily limit, which is typically 4,000 milligrams for adults. Exceeding this limit can increase the risk of liver damage.
  3. Avoid Long-Term Use: Fioricet is not intended for long-term use due to the potential for dependence and other adverse effects. If you find yourself needing Fioricet frequently for headaches, consult your healthcare provider for alternative treatments and strategies to manage your headaches effectively.
  4. Consult Your Healthcare Provider: If you have any questions or concerns about the dosage or frequency of Fioricet for your headaches, or if you experience any side effects or worsening of symptoms, contact your healthcare provider for guidance.

Mikart, LLC

Mikart, LLC is a pharmaceutical contract development and manufacturing organization (CDMO) based in Atlanta, Georgia, USA. Here’s an overview of Mikart:

  1. Founding and History: Mikart was founded in 1975 and has since grown to become a leading provider of contract manufacturing and development services for the pharmaceutical industry.
  2. Services Offered: Mikart specializes in contract manufacturing, formulation development, analytical testing, and packaging services for pharmaceutical products. They offer comprehensive solutions for both oral solid dosage forms (tablets, capsules) and liquid formulations.
  3. Facilities: Mikart operates a state-of-the-art manufacturing facility in Atlanta, Georgia. The facility is equipped with modern manufacturing equipment and adheres to strict quality standards to ensure the production of high-quality pharmaceutical products.
  4. Capabilities: Mikart has expertise in various dosage forms, including immediate-release and controlled-release formulations. They provide services for both small-scale and large-scale production, accommodating the needs of different pharmaceutical clients.
  5. Regulatory Compliance: As a pharmaceutical manufacturer, Mikart is committed to maintaining high standards of quality, safety, and compliance with regulatory requirements. They undergo regular inspections by regulatory authorities, including the U.S. Food and Drug Administration (FDA), to ensure adherence to Good Manufacturing Practices (GMP) and other regulatory standards.
  6. Partnerships and Collaborations: Mikart collaborates with pharmaceutical companies of all sizes, from startups to multinational corporations, to support their product development and manufacturing needs. They work closely with their clients to develop customized solutions tailored to their specific requirements.
  7. Clientele: Mikart serves a diverse customer base, including brand-name pharmaceutical companies, generic drug manufacturers, biotechnology firms, and contract research organizations (CROs). They provide services across various therapeutic categories, including cardiovascular, central nervous system, gastrointestinal, oncology, and more.
  8. Acquisition by Aurobindo Pharma: In 2017, Mikart was acquired by Aurobindo Pharma USA Inc., a subsidiary of Aurobindo Pharma Limited, one of the leading pharmaceutical companies in India. The acquisition further strengthened Aurobindo’s presence in the U.S. market and expanded its capabilities in contract manufacturing and development.

Overall, Mikart, LLC is a reputable pharmaceutical contract development and manufacturing organization with extensive experience and expertise in providing high-quality services to the pharmaceutical industry. Their focus on quality, innovation, and customer satisfaction has made them a trusted partner for pharmaceutical companies seeking reliable manufacturing and development solutions.

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