BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE 325 mg/1
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE · CAPSULE · Amneal Pharmaceuticals of New York, LLC
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is a prescription capsule containing butalbital, aspirin, caffeine and codeine phosphate at 325 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals of New York, LLC.
Key Facts
- Brand Name
- BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE
- Generic Name
- BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE
- NDC Code (Product)
69238-1993- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Strength
- 325 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- DEA Schedule
- Schedule III (Controlled)
- Application #
- ANDA074951
- Drug Class
- Anti-Inflammatory Agents; Non-Steroidal [CS]
- Marketing Start
- 04/01/2019
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, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate. BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is a combination of butalbital, a barbiturate, aspirin, a nonsteroidal anti-inflammatory drug, 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 analgesics and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain ( 1 , 5.1 ). BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE should not be used for an extended period of time unless the pain r…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Periodically reassess patients receiving BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse ( 2.1 , 5.1 ) 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, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE. Consider prescribing naloxone based on the patient's r…
Contraindications
4 CONTRAINDICATIONS BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is contraindicated for: All children younger than 12 years of age [see Warnings and Precautions ( 5.6 ) ] Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy[see Warnings and Precautions ( 5.6 ) ]. BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions ( 5.9 ) ] 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 ) ] Hypersensitivity or intolerance to aspirin, caffeine, butalbital, or codeine. Hemophilia [see Warnings and Precautions ( 5.19 ) ] Reye's Syndrome [ see Warnings and Precautions ( 5.20 ) ] Known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) [see Warnings and Precautions…
Drug Interactions
7 DRUG INTERACTIONS Table 2 includes clinically significant drug interactions with BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE. Table 2: Clinically Significant Drug Interactions With BUTALBITAL, ASPIRIN, CAFFEINE And CODEINE PHOSPHATE Inhibitors of CYP3A4 Clinical Impact: The concomitant use of BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE 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, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is achieved. 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 a CYP3A4 inhibitor is…
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 (( 5.2 ) Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions ( 5.3 ) Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions ( 5.6 ) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.4 ) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.8 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.11 ) ] Severe Hypotension [see Warnings and Precautions ( 5.12 ) ] Risks of Use in Patients with Gastrointestinal Conditions Including Peptic Ulcer Disease [see Warnings and Precautions ( 5.14 ) ] Increased Risk of Seizures in Patients with Seizure Disorders [see Warnings and Precautions ( 5.15 ) ] Withdrawal [see Warnings and Precautions ( 5.16 ) ] Coagulation Abnormalities and Bleeding Risks [see Warnings and Precautions ( 5.19 ) ] Reye's Synd…
Frequently Asked Questions
What is BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE used for?
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE contains BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE. It is a capsule taken oral. Consult your doctor for specific uses.
Is BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE a controlled substance?
Yes, BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE?
The generic name for BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE. There are 2 other brand versions of BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE.
What is the NDC code for BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE 325 mg/1?
The NDC (National Drug Code) for BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE 325 mg/1 is 69238-1993, listed by Amneal Pharmaceuticals of New York, LLC.