Ascomp with Codeine

Warning

Risk of addiction, abuse, and misuse, as well as respiratory depression, especially in children and adolescents

Contraindications

• Children under 12 years old
• Children under 18 years old after 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

Adverse Reactions

• Nausea and/or abdominal pain
• Drowsiness
• Dizziness
• Constipation
• Pruritus

General Guidance

Dose adjustments may be necessary for geriatric patients, patients with renal or hepatic impairment, and patients taking other medications that interact with Ascomp with Codeine

Pregnancy

• Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome
• Aspirin use at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus

Nursing Mothers

• Ascomp with Codeine is not recommended for nursing mothers, as it may cause respiratory depression in the infant

Pediatric Use

• Ascomp with Codeine is contraindicated in children under 12 years old and in children under 18 years old after tonsillectomy and/or adenoidectomy
• Life-threatening respiratory depression and death have occurred in children who received codeine

Geriatric Use

• Elderly patients may have increased sensitivity to Ascomp with Codeine
• Titrate the dosage of Ascomp with Codeine slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression