Adult Dosing

Mild to moderately severe pain

• 15-60 mg PO q4 hrs PRN
• Max: 360 mg/day
• Taper doses to prevent withdrawal signs and symptoms during cessation of therapy

Pediatric Dosing

Mild to moderately severe pain

• Children 2-16 yrs: 0.5 mg/kg (15 mg/m²) q4-6 hrs PRN

[Outline]

• Adult Dosing
• Pediatric Dosing

• Mild to moderately severe pain

• Hypersensitivity to any of the ingredients of the product
• Respiratory depression in the absence of resuscitative equipment
• Acute or severe bronchial asthma or hypercarbia
• Paralytic ileus

• Respiratory depression and death have been reported in children receiving codeine after tonsillectomy and/or adenoidectomy. These patients had an evidence of being ultra-rapid metabolizers of codeine resulting from a CYP2D6 polymorphism

Renal Dose Adjustment

• Renal impairment: Use lower doses or increase dosing intervals

Hepatic Dose Adjustment

• Hepatic impairment: Use lower doses or increase dosing intervals

See Supplemental Patient Information

• Respiratory depression and death have been reported in children receiving codeine after tonsillectomy and/or adenoidectomy. These patients had an evidence of being ultra-rapid metabolizers of codeine resulting from a CYP2D6 polymorphism (US Black Box warning)
• It may cause respiratory depression in elderly, debilitated patients, and those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction
• Similar to other opioids, it is a Schedule II controlled substance with an abuse liability
• If used in conjunction with alcohol, other opioids, or illicit drugs, it may result in additive CNS depressive effects, including respiratory depression, hypotension, profound sedation, coma, or death
• Avoid use in head injury, other intracranial lesions or a pre-existing intracranial hypertension, as it may exaggerate elevation of cerebrospinal fluid pressure
• Restrict use in patients whose ability to maintain blood pressure has already been compromised, as therapy may cause severe hypotension
• Avoid administration in patients with gastrointestinal obstruction, especially paralytic ileus because it diminishes propulsive peristaltic waves in the gastrointestinal tract and may prolong the obstruction
• Use with caution in patients with biliary tract disease, including acute pancreatitis, as it may cause spasm of the Sphincter of Oddi and diminish biliary and pancreatic secretions
• Administration may result in higher than expected serum morphine levels and overdose symptoms due to rapid conversion into its active metabolite, morphine, in individuals who are ultra-rapid CYP2D6 metabolizers
• Caution must be used with potentially hazardous activities such as driving and operating machinery

Cautions: Use cautiously in

• Severe renal impairment
• Severe hepatic impairment
• Elderly or debilitated pts
• GI obstruction
• Hypothyroidism
• Seizure disorder
• CNS depression
• Asthma
• COPD
• IBD
• Urethral stricture
• Pseudomembranous colitis
• Biliary disease
• Ultra-rapid CYP2D6 metabolizer
• GU obstruction
• Acute abdomen
• Prostatic hypertrophy
• Addison's disease
• Children <2 yrs

Supplemental Patient Information

• Advise patients to strictly follow prescription orders as directed by the physician
• Caution the patients about the potential for severe constipation while taking codeine sulfate; appropriate treatments including laxatives and/or stool softeners should be given from the onset of therapy
• Avoid abrupt discontinuation of the drug as it could precipitate withdrawal symptoms during cessation of therapy. Provide a dose schedule to accomplish an effective and safe tapering and a gradual discontinuation of the medication
• Advise women of childbearing potential who become or are trying to become pregnant to consult a physician before initiating or continuing therapy with codeine sulfate

Pregnancy Category:C

Breastfeeding: Safety conditional. Breastfeeding can cause infant drowsiness. Newborn infants seem to be particularly sensitive to the effects of even small dosages, particularly in the first week of life. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 09 December 2010 ). Maternal medication usually compatible with breastfeeding, no observable change was seen in the nursing infant while the mother was ingesting the compound. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 09 December 2010 ).According to the manufacturer's data, the risk of infant exposure through breast milk should be weighed against the benefits of breastfeeding for both the mother and the baby. Caution should be exercised when codeine is administered to a nursing woman

• CNS: Agitation, anxiety, insomnia, lethargy, lightheadedness, convulsions, disorientation, dizziness, drowsiness, headache, mental clouding, mood changes, impaired mental and physical performance, sedation, weakness, vertigo, nervousness, shakiness, somnolence, depression, increased ICP, seizures
• PSYCHIATRY: Dysphoria, euphoria, fear, mood changes, psychic dependence, anorexia, withdrawal if discontinued abruptly
• CV: Circulatory depression, fainting, orthostatic hypotension, bradycardia, cardiac arrest, palpitation, shock, syncope, tachycardia
• RESP: Respiratory depression, respiratory arrest, suppressed cough reflex, shortness of breath
• DERM: Pruritus, rash, sweating, urticaria, flushing, hemorrhagic urticaria
• EENT: Visual disturbances, miosis
• GI: Nausea, vomiting, anorexia, constipation, dry mouth, increased biliary tract pressure and spasm, abdominal pain, abdominal cramps, diarrhea, GI distress, pancreatitis, paralytic ileus
• GU: Urinary retention or hesitancy, spasms of the urinary bladder sphincter
• MISC: Allergic reactions, edema, fatigue, weakness

• Opioid agonist; produces analgesia and sedation by binding to various opioid receptors
• Primarily metabolized by liver; CYP450: 2D6 substrate
• Excreted in urine (10% unchanged)
• Half life: Approximately 3 hrs

US Trade Name(s)

• Only generic available

US Availability

codeine sulfate (generic)

• TABS: 15, 30, 60 mg

Canadian Trade Name(s)

• Only generic available

Canadian Availability

codeine phosphate (generic)

• SYRUP: 5 mg/mL, 143 mg/30 mL
• TABS: 15, 30 mg

codeine (codeine monohydrate + codeine sulfate trihydrate )

• ETABS: 50, 100, 150, 200 mg

UK Trade Name(s)

• Only generic available

UK Availability

codeine phosphate (generic)

• TABS: 15, 30, 60 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Analgesics

Opioid Analgesics

Opioid Agonists

• CODEINE SULFATE 30 mg (Glenmark Generics Inc., USA)
• CODEINE SULFATE 60 mg (Glenmark Generics Inc., USA)
• Codeine 15 MG Oral Tablet (Roxane Laboratories, Inc)
• Codeine 30 MG Oral Tablet (Roxane Laboratories, Inc)
• Codeine 60 MG Oral Tablet (Physicians Total Care, Inc.)
• Codeine 60 MG Oral Tablet (Roxane Laboratories, Inc)