Ascomp with Codeine

BUTALBITAL, ASPIRIN, CAFEINE, AND CODEINE PHOSPHATE

Manufacturer: LGM PHARMA SOLUTIONS, LLC

Score: 144.0

Quick Summary

Ascomp with Codeine is a combination medication used for the management of tension headaches. It contains butalbital, aspirin, caffeine, and codeine phosphate. The medication works by relieving pain, reducing inflammation, and inducing relaxation. However, it has several important safety considerations, including the risk of addiction, respiratory depression, and interactions with other medications. The dosing recommendations vary based on the patient's condition and response to treatment, and special considerations are necessary for use in pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

Tension headaches
Pain relief
Inflammation reduction
Relaxation induction

Important Safety Information

Warning

Risk of addiction, respiratory depression, and interactions with other medications

Contraindications

Children under 12 years old
Post-operative management in pediatric patients younger than 18 years old following tonsillectomy and/or adenoidectomy
Significant respiratory depression
Acute or severe bronchial asthma
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
Known or suspected gastrointestinal obstruction
Hypersensitivity or intolerance to aspirin, caffeine, butalbital, or codeine

Adverse Reactions

Nausea
Vomiting
Drowsiness
Dizziness
Constipation
Pruritus

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with renal or hepatic impairment, and in geriatric patients

Tension headaches

Adult Dose

One or two capsules every 4 hours as needed for pain, with a total daily dose not exceeding 6 capsules

Pediatric Dose

Not recommended for pediatric patients under 12 years old

Special Population Considerations

Pregnancy

Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome
NSAIDs, including aspirin, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction

Nursing Mothers

Codeine is excreted in breast milk, and caution should be exercised when administering to nursing mothers

Pediatric Use

Not recommended for pediatric patients under 12 years old due to the risk of life-threatening respiratory depression
Avoid use in adolescents 12 to 18 years old with other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine

Geriatric Use

Elderly patients may have increased sensitivity to the medication, and dose selection should be cautious
Monitor renal function in elderly patients, as they may be more susceptible to adverse reactions