Butalbital, Aspirin, Cafeine, And Codeine Phosphate
Generic Name: butalbital, aspirin, cafeine, and codeine phosphate
Brand Names:
Ascomp With Codeine
11 DESCRIPTION Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is supplied in capsule form for oral administration. Each capsule contains the following active ingredients: Butalbital, USP…………………50mg Aspirin, USP……………………325mg Caffeine, USP…………………..40mg Codeine phosphate, USP………30mg Butalbital (5-allyl-5-isobutylbarbituric acid) is a short-to intermediate-acting barbiturate.
Overview
11 DESCRIPTION Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is supplied in capsule form for oral administration. Each capsule contains the following active ingredients: Butalbital, USP…………………50mg Aspirin, USP……………………325mg Caffeine, USP…………………..40mg Codeine phosphate, USP………30mg Butalbital (5-allyl-5-isobutylbarbituric acid) is a short-to intermediate-acting barbiturate.
Uses
1 INDICATIONS AND USAGE Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [ see Warnings and Precautions (5.1) ], reserve opioid analgesics, including Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Dosage
2 DOSAGE AND ADMINISTRATION Periodically reassess patients receiving Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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. ( 2.1 ) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose.
Side Effects
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 )] Neonatal Opioid Withdrawal Syndrome [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 ( 5.6 ) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.8 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.11 ) ] Severe Hypotension [see Warnings and Precau...
Interactions
7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP. Table 1: Clinically Significant Drug Interactions with Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP Inhibitors of CYP3A4 Clinical Impact: The concomitant use of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 Phosphat...
Warnings
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES, USP Addiction, Abuse, and Misuse Because the use of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death , a ssess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and condition... 5 WARNINGS AND PRECAUTIONS Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.8 ) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate closely, particularly during initiation and titration. ( 5.9 ) Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid. ( 5.11 ) Severe Hypotension : Regularly evaluate during dose initiation and titration. 4 CONTRAINDICATIONS Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 ) ].
Pregnancy
8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.4 )] . Use of NSAIDs, including aspirin, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP have a plain blue opaque cap with a yellow opaque body imprinted with "B 074" in black ink. They are available in bottles of 100 capsules [NDC 79739-6094-1] and 500 capsules [NDC 79739-6094-5]. Store and Dispense Store below 25°C (77°F) in a tight, light-resistant container.
Frequently Asked Questions
What is Butalbital, Aspirin, Cafeine, And Codeine Phosphate used for?▼
1 INDICATIONS AND USAGE Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [ see Warnings and Precautions (5.1) ], reserve opioid analgesics, including Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
What are the side effects of Butalbital, Aspirin, Cafeine, And Codeine Phosphate?▼
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 )] Neonatal Opioid Withdrawal Syndrome [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 ( 5.6 ) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.8 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.11 ) ] Severe Hypotension [see Warnings and Precau...
Can I take Butalbital, Aspirin, Cafeine, And Codeine Phosphate during pregnancy?▼
8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.4 )] . Use of NSAIDs, including aspirin, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
What are the important warnings for Butalbital, Aspirin, Cafeine, And Codeine Phosphate?▼
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES, USP Addiction, Abuse, and Misuse Because the use of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death , a ssess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and condition... 5 WARNINGS AND PRECAUTIONS Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.8 ) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate closely, particularly during initiation and titration. ( 5.9 ) Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid. ( 5.11 ) Severe Hypotension : Regularly evaluate during dose initiation and titration. 4 CONTRAINDICATIONS Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 ) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.