• Mild to moderate pain.
• Antitussive (in smaller doses).

Contraindicated in:

• Hypersensitivity
• Significant respiratory depression
• Acute or severe bronchial asthma (in unmonitored setting or in absence of resuscitative equipment)
• Known or suspected GI obstruction (including paralytic ileus)
• Concurrent use of MAO inhibitors (or use within the past 14 days)
• Ultra-rapid CYP2D6 metabolizers of codeine
• Lactation: Lactation
• Pedi: Children <12 yr, children <18 yr following tonsillectomy and/or adenoidectomy, and children 12–18 yr who are postoperative; have obstructive sleep apnea, obesity, or severe pulmonary disease, neuromuscular disease; or are taking other medications that cause respiratory depression (↑ risk of respiratory depression and death).

Use Cautiously in:

• Head trauma
• ↑ intracranial pressure
• Severe renal impairment
• Severe hepatic impairment
• Severe pulmonary disease
• Hypothyroidism
• Adrenal insufficiency
• Alcoholism
• Prostatic hyperplasia
• Undiagnosed abdominal pain
• OB: Has been used during labor; respiratory depression may occur in the newborn
• Geri: Older adults may be more susceptible to CNS depression and constipation (dose ↓ required).

CV: hypotension, bradycardia.

Derm: flushing, sweating.

EENT: blurred vision, diplopia, miosis.

GI: constipation, nausea, vomiting.

GU: urinary retention.

Neuro: confusion, sedation, dysphoria, euphoria, floating feeling, hallucinations, headache, unusual dreams.

Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA [CSA] AND SLEEP-RELATED HYPOXEMIA).

Misc: physical dependence, psychological dependence, tolerance.

Drug-Drug:

• MAO inhibitors ↑ risk of adverse reactions; concurrent use or use within previous 14 days contraindicated.
• Additive CNS depression with alcohol, antidepressants, antihistamines, benzodiazepines, and sedative/hypnotics.
• CYP3A4 inhibitors, including erythromycin, clarithromycin, ketoconazole, itraconazole, and protease inhibitors may ↑ levels and risk of respiratory depression.
• CYP3A4 inducers may ↓ levels and effectiveness.
• CYP2D6 inhibitors, including amiodarone and quinidine may ↓ analgesic effects.
• Mixed agonist/antagonist analgesics, including nalbuphine or butorphanol and partial agonist analgesics, including buprenorphine, may ↓ meperidine's analgesic effects and/or precipitate opioid withdrawal in physically dependent patients.
• Drugs that affect serotonergic neurotransmitter systems, including tricyclic antidepressants, SSRIs, SNRIs, MAO inhibitors, TCAs, tramadol, trazodone, mirtazapine, 5–HT₃ receptor antagonists, linezolid, methylene blue, and triptans ↑ risk of serotonin syndrome.

Drug-Natural Products:

• Concomitant use of kava-kava, valerian, skullcap, chamomile, or hops can ↑ CNS depression.

(Generic available)

• Tablets: 15 mg; 30 mg; 60 mg;
• Oral solution: 25 mg/5 mL;

• PO (Adults): Analgesic: 15–60 mg every 4 hr as needed (not to exceed 360 mg/day). Antitussive: 10–20 mg every 4–6 hr as needed (not to exceed 120 mg/day). Antidiarrheal : 30 mg up to 4 times daily.

• Binds to opiate receptors in the CNS. Alters the perception of and response to painful stimuli while producing generalized CNS depression.
• Decreases cough reflex.
• Decreases GI motility.

• Decreased severity of pain.
• Suppression of the cough reflex.

Therapeutic Classification: allergy, cold and cough remedies, antitussives, opioid analgesics

Pharmacologic Classification: opioid agonists

Absorption: 50% absorbed from the GI tract.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Mostly metabolized by the liver via the CYP2D6 isoenzyme); 10% converted to morphine;the CYP2D6 enzyme system exhibits genetic polymorphism (some patients [1–10% Whites, 3% African Americans, 16–28% North Africans/Ethiopians/Arabs] may be ultra-rapid metabolizers and may have ↑ morphine concentrations and an ↑ risk of adverse effects); 5–15% excreted unchanged in urine.

Half-life: 2.5–4 hr.

Schedule II (C-II)
Schedule III (C-III)
Schedule IV (C-IV)
Schedule V (C-V)(depends on content)

(analgesia)

• Instruct patient on how and when to ask for and take pain medication. Do not stop abruptly without consulting health care professional.
• Advise patient that codeine is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed.
• REMS: Instruct patient on risk of addiction, abuse, and misuse, which could lead to death. Discuss safe use, risks, and proper storage and disposal of opioid analgesics with patients and caregivers with each Rx. The Patient Counseling Guide is available at OpioidAnalgesicREMSPCG. Advise patient not to share codeine with others and to protect from theft or misuse.
• Advise patient that codeine is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed. Store out of sight and reach of children, and in a location not accessible by others.
• Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose. Inform patients and caregivers about various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (by prescription, directly from a pharmacist, or as part of a community-based program).
• May cause drowsiness or dizziness. Advise patient to call for assistance when ambulating or smoking. Caution ambulatory patient to avoid driving or other activities requiring alertness until response to medication is known.
• Advise patient to change positions slowly to minimize orthostatic hypotension.
• Caution patient to avoid concurrent use of alcohol or other CNS depressants with this medication.
• Encourage patient to turn, cough, and breathe deeply every 2 hr to prevent atelectasis.
• Advise patient that good oral hygiene, frequent mouth rinses, and sugarless gum or candy may decrease dry mouth.
• Rep: Advise patient to notify health care professional if pregnancy is planned or suspected, or if breast feeding. Inform patient of potential for neonatal opioid withdrawal syndrome with prolonged use during pregnancy. Monitor neonate for signs and symptoms of withdrawal symptoms (irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight); usually occur the first days after birth. Monitor infants exposed to codeine through breast milk for excess sedation and respiratory depression.

KOE-deen

NDC Code^*

• 0054- West-Ward Pharmaceuticals Corp.
  • 0054-0243- Codeine sulfate
    • 0054-0243-24- 10 BLISTER PACK in 1 BOX (0054-0243-24) > 10 TABLET in 1 BLISTER PACK

• 0054- West-Ward Pharmaceuticals Corp.
  • 0054-0244- Codeine sulfate
    • 0054-0244-24- 10 BLISTER PACK in 1 BOX (0054-0244-24) > 10 TABLET in 1 BLISTER PACK

• 0054- West-Ward Pharmaceuticals Corp.
  • 0054-0244- Codeine sulfate
    • 0054-0244-25- 100 TABLET in 1 BOTTLE (0054-0244-25)

• 0054- West-Ward Pharmaceuticals Corp.
  • 0054-0245- Codeine sulfate
    • 0054-0245-25- 100 TABLET in 1 BOTTLE (0054-0245-25)

• 0527- Lannett Company, Inc.
  • 0527-1698- Codeine Sulfate
    • 0527-1698-01- 100 TABLET in 1 BOTTLE (0527-1698-01)

• 0527- Lannett Company, Inc.
  • 0527-1698- Codeine Sulfate
    • 0527-1698-91- 4 BLISTER PACK in 1 CARTON (0527-1698-91) > 25 TABLET in 1 BLISTER PACK

• 0527- Lannett Company, Inc.
  • 0527-1699- Codeine Sulfate
    • 0527-1699-01- 100 TABLET in 1 BOTTLE (0527-1699-01)

• 0527- Lannett Company, Inc.
  • 0527-1727- Codeine Sulfate
    • 0527-1727-91- 4 BLISTER PACK in 1 CARTON (0527-1727-91) > 25 TABLET in 1 BLISTER PACK