Pill with imprint 1378 is White, Round and has been identified as Acetaminophen, Butalbital and Caffeine 325 mg / 50 mg / 40 mg. It is supplied by Zydus Pharmaceuticals (USA) Inc.
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).
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Acetaminophen, Butalbital and Caffeine
- Imprint
- 1378
- Strength
- 325 mg / 50 mg / 40 mg
- Color
- White
- Size
- 11.00 mm
- Shape
- Round
- Availability
- Prescription only
- Drug Class
- Analgesic combinations
- Pregnancy Category
- C – Risk cannot be ruled out
- CSA Schedule
- Not a controlled drug
- Labeler / Supplier
- Zydus Pharmaceuticals (USA) Inc.
- Manufacturer
- Nesher Pharmaceuticals (USA) LLC
- National Drug Code (NDC)
- 70710-1378
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:
- 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.
- 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.
- 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:
- Increased tolerance: Over time, individuals may need higher doses of Fioricet to achieve the same pain relief or euphoric effects.
- 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.
- Cravings: Individuals may experience intense cravings for Fioricet, leading to continued use despite negative consequences.
- Social or occupational problems: Dependence on Fioricet can interfere with daily functioning, relationships, and work or school responsibilities.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
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- 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 acetaminophen, butalbital, and caffeine.
- 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.
- Other Narcotic Analgesics: Fioricet may interact with other narcotic pain medications. Be cautious if you’re using opioids or other similar drugs.
- Alcohol: Avoid alcohol while taking Fioricet. Combining alcohol with Fioricet can increase the risk of side effects and sedation.
- 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.
- 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.
- 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:
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- 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:
- 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.
- 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.
- 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.
- 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.
Zydus Pharmaceuticals (USA) Inc
Zydus Pharmaceuticals (USA) Inc. is the American subsidiary of Zydus Cadila, a global pharmaceutical company based in India. Here’s an overview of Zydus Pharmaceuticals (USA) Inc.:
- Parent Company: Zydus Cadila is one of the leading pharmaceutical companies in India, with a presence in over 50 countries worldwide. It is part of the Zydus Group, a diversified conglomerate with interests in pharmaceuticals, healthcare, biotechnology, consumer products, and more.
- Establishment: Zydus Pharmaceuticals (USA) Inc. was established to serve as the U.S. arm of Zydus Cadila’s operations. It operates as a fully integrated pharmaceutical company, engaged in the development, manufacturing, marketing, and distribution of generic pharmaceuticals in the United States.
- Product Portfolio: Zydus Pharmaceuticals (USA) Inc. offers a wide range of generic pharmaceutical products across various therapeutic categories, including cardiovascular, central nervous system, gastrointestinal, respiratory, oncology, dermatology, and more. Their portfolio includes both oral solid dosage forms (tablets, capsules) and injectable formulations.
- Manufacturing Facilities: Zydus Cadila operates state-of-the-art manufacturing facilities in India that comply with international quality standards, including Good Manufacturing Practices (GMP). These facilities produce active pharmaceutical ingredients (APIs) and finished dosage forms for domestic and international markets, including the United States.
- Regulatory Compliance: Zydus Pharmaceuticals (USA) Inc. adheres to strict regulatory standards set forth by the U.S. Food and Drug Administration (FDA) and other regulatory agencies. They ensure that their products meet quality, safety, and efficacy requirements, and undergo rigorous testing and inspection processes.
- Research and Development: Zydus Cadila invests significantly in research and development (R&D) to develop new generic formulations, innovative drug delivery technologies, and complex generic products. They focus on bringing affordable and high-quality medications to patients while addressing unmet medical needs.
- Market Presence: Zydus Pharmaceuticals (USA) Inc. has a strong presence in the U.S. generic pharmaceutical market, supplying products to wholesalers, pharmacies, hospitals, and other healthcare providers. They are committed to expanding their market share and portfolio of products to better serve patients and healthcare professionals in the United States.