Dosing & Uses
Dosage Forms & Strengths
capsule: Schedule V
2 capsules PO q4hr prn
Safety and efficacy not established
Frequency Not Defined
- Stomach pain
- Tinnitus (high or chronic dose)
Black Box Warnings
Postoperative pain in children
- Deaths have occurred in children with obstructive sleep apnea who receive codeine for postoperative pain following tonsillectomy and/or adenoidectomy
- Codeine is converted to morphine by the liver; these children had evidence of being ultra-rapid metabolizers (via CYP2D6) of codeine, which is an inherited (genetic) ability that causes codeine to be converted rapidly into life-threatening or fatal amounts of morphine (see Pharmacology)
Any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitation equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus
Postoperative use in children following tonsillectomy and/or adenoidectomy (see Black Box Warnings)
May impair mental/physical abilities required for hazardous tasks (eg, driving, operating machinery)
May cause respiratory depression
Caution is used with head injury or increased ICP
May cause hypotension
Dihydrocodeine can produce drug dependence
Caution in elderly or debilitated patients, or in patients with following conditions: adrenocortical insufficiency (Addison disease), asthma, central nervous system depression or coma, chronic obstructive pulmonary disease, decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis), delirium tremens, head injury, hypotension, increased intracranial pressure, myxedema or hypothyroidism, prostatic hypertrophy or urethral stricture, and toxic psychosis
Use opioids with caution with MAOIs
Caution with a history of drug abuse
Gastrointestinal bleeding; particular caution in patients with history of GI bleed, alcoholism, or bleeding disorders
Avoid with active peptic ulcer disease
Avoid in severe renal impairment (ie, CrCl <10 mL/min)
Avoid in severe hepatic impairment
Caffeine may produce CNS/CV stimulation and GI irritation
Pregnancy & Lactation
Pregnancy Category: D; avoid aspirin during pregnancy, particularly in third trimester because of risk for premature closure of the ductus arteriosus
Lactation: Distributed in breast milk in small amounts, caution advised
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Dihydrocodeine: Semisynthetic opioid agonist analgesic related to codeine
Aspirin: Acts on hypothalamus to produce antipyresis; anti-inflammatory properties attributed to prostaglandin synthetase inhibition resulting in decreased formation of thromboxane A2
Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches
10% of codeine is metabolized to morphine by CYP2D6; the active morphine metabolite has a higher affinity for opioid receptors
CYP2D6 poor metabolizers may not achieve adequate analgesia
Ultra-rapid metabolizers (up to 7% of Caucasians and up to 30% of Asian and African populations) may have increased toxicity due to rapid conversion
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.