Fioricet with Codeine 300 mg/1
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate · CAPSULE · Actavis Pharma, Inc.
Fioricet with Codeine is a capsule containing butalbital, acetaminophen, caffeine, and codeine phosphate at 300 mg/1, taken oral. Manufactured by Actavis Pharma, Inc..
Key Facts
- Brand Name
- Fioricet with Codeine
- Generic Name
- Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
- NDC Code (Product)
52544-082- Manufacturer
- Actavis Pharma, Inc.
- Strength
- 300 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- ANDA076560
- Drug Class
- Barbiturate [EPC]; Central Nervous System Stimulant [EPC]
- Marketing Start
- 07/29/2013
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE FIORICET with CODEINE is indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions ( 5.1 )], reserve FIORICET with CODEINE for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. FIORICET with CODEINE is a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve FIORICET with CODEINE for use in patients for whom alternative t…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ( 2.1 ) Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. ( 2.1 ) Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with FIORICET with CODEINE. Consider prescribing naloxone based on the patient’s risk factors for overdose. ( 2.2 , 5.1 , 5.3 , 5.4 ) Initiate treatment with one or two capsules every 4 hours as needed for pain. Total daily dosage should not exceed 6 capsules. ( 2.3 ) Do not abruptly discontinue FIORICET with CODEINE in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide ( 2.4 ). 2.1 Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5 )]. Initiate the dosing regimen for each patient …
Contraindications
4 CONTRAINDICATIONS FIORICET with CODEINE is contraindicated for: All children younger than 12 years of age [see Warnings and Precautions ( 5.5 )] . Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions ( 5.5 )] . FIORICET with CODEINE is also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions ( 5.3 )] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.9 )] Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions ( 5.10 ), Drug Interactions ( 7 )] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.14 )] Known intolerance or hypersensitivity to acetaminophen, caffeine, butalbital, or codeine or to the components of FIORICET with CODEINE Porphyria Children younger than 12 years of age. ( 4 ) Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. ( 4 ) Significant respiratory depressio…
Drug Interactions
7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with FIORICET with CODEINE. Table 1: Clinically Significant Drug Interactions with FIORICET with CODEINE Inhibitors of CYP3A4 Clinical Impact: The concomitant use of FIORICET with CODEINE with CYP3A4 inhibitors may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of FIORICET with CODEINE is achieved [see Warnings and Precautions ( 5.7 )] . After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [see Clinical Pharmacology ( 12.3 )] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to codeine. Intervention: If concomitant use with CYP3A4 inhibitor is necessary, consider dosage reduction of FIORICET with CODEINE until stable drug e…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.3 )] Interactions with Benzodiazepines and other CNS Depressants [see Warnings and Precautions ( 5.4 )] Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions ( 5.5 )] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.6 )] Hepatotoxicity [see Warnings and Precautions ( 5.8 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.11 )] Severe Hypotension [see Warnings and Precautions ( 5.12 )] Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.14 )] Seizures [see Warnings and Precautions ( 5.15 )] Withdrawal [see Warnings and Precautions ( 5.16 )] Serious Skin Reactions [see Warnings and Precautions ( 5.18 )] Anaphylaxis [see Warnings and Precautions ( 5.19 )] The following adverse reactions associated with the use of butalbital, acetaminophen, caffeine, and codeine phosphate were identified in…
Frequently Asked Questions
What is Fioricet with Codeine used for?
Fioricet with Codeine contains Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate. It is a capsule taken oral. Consult your doctor for specific uses.
Is Fioricet with Codeine a controlled substance?
Yes, Fioricet with Codeine is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Fioricet with Codeine?
The generic name for Fioricet with Codeine is Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate. There are 3 other brand versions of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate.
What is the NDC code for Fioricet with Codeine 300 mg/1?
The NDC (National Drug Code) for Fioricet with Codeine 300 mg/1 is 52544-082, listed by Actavis Pharma, Inc..