Butalbital, Acetaminophen, Caffeine and Codeine Phosphate 325 mg/1
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate · CAPSULE · Hikma Pharmaceuticals USA Inc.
This prescription medication combines a barbiturate, pain reliever, stimulant, and opioid to treat moderate pain, often used for tension headaches and migraines. It works by reducing pain signals in the brain while the caffeine enhances the pain-relieving effects of the other ingredients.
Key Facts
- Brand Name
- Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
- Generic Name
- Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
- NDC Code (Product)
0054-3000- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 325 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- ANDA215138
- Drug Class
- Barbiturate [EPC]; Central Nervous System Stimulant [EPC]
- Marketing Start
- 05/09/2022
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 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsule 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 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules 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. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids and butalbital,…
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 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules. 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 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules 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 treatmen…
Contraindications
4 CONTRAINDICATIONS Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are 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) ] . Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are 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 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules Porphyria Children younger than 12 years of age. ( 4 ) Post-operative mana…
Drug Interactions
7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Table 1: Clinically Significant Drug Interactions with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules Inhibitors of CYP3A4 Clinical Impact: The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules 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 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules 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…
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 clinical stu…
Frequently Asked Questions
What is Butalbital, Acetaminophen, Caffeine and Codeine Phosphate used for?
This prescription medication combines a barbiturate, pain reliever, stimulant, and opioid to treat moderate pain, often used for tension headaches and migraines. It works by reducing pain signals in the brain while the caffeine enhances the pain-relieving effects of the other ingredients.
Is Butalbital, Acetaminophen, Caffeine and Codeine Phosphate a controlled substance?
Yes, Butalbital, Acetaminophen, Caffeine and Codeine Phosphate is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Butalbital, Acetaminophen, Caffeine and Codeine Phosphate?
The generic name for Butalbital, Acetaminophen, Caffeine and Codeine Phosphate is Butalbital, Acetaminophen, Caffeine and Codeine Phosphate. There are no other listed brand versions of Butalbital, Acetaminophen, Caffeine and Codeine Phosphate.
What is the NDC code for Butalbital, Acetaminophen, Caffeine and Codeine Phosphate 325 mg/1?
The NDC (National Drug Code) for Butalbital, Acetaminophen, Caffeine and Codeine Phosphate 325 mg/1 is 0054-3000, listed by Hikma Pharmaceuticals USA Inc..
Other Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)