Adult Dosing

Mild-moderate severe pain

• 15-60 mg codeine PO q4 hr
• Max: 360 mg/day, 4 g/day acetaminophen

• Administer with food
• Codeine doses >60 mg are rarely more effective or well-tolerated in opioid-naive patients
• Adjust dosage according to severity of pain and response of the patient

Pediatric Dosing

Mild-moderate severe pain

• 3-6 yrs: 5 mL soln PO tid or qid; Alt: 0.5-1 mg/kg codeine PO tid or qid
• Max: 60 mg/dose codeine; 1 g/dose, 75 mg/kg/day up to 4 g/day of acetaminophen
• 7-12 yrs: 10 mL soln PO tid or qid; Alt: 0.5-1 mg/kg codeine PO tid or qid
• Max: 60 mg/dose codeine; 1 g/dose, 75 mg/kg/day up to 4 g/day of acetaminophen
• 13-16 yrs: 15-60 mg codeine PO q4 hr; alt: 0.5-1 mg/kg codeine PO q4-6 hr; 15 mL PO q4-6 hr

• Administer with food
• Safety and effectiveness in pediatric patients <3 yrs of age has not been established
• Codeine doses >60 mg are rarely more effective or well-tolerated in opioid-naive patients
• Adjust dosage according to severity of pain and response of the patient

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relief of mild-moderate severe pain

• Hypersensitivity to any of the ingredients of the product
• Respiratory depression
• Paralytic ileus

• N/A

Renal Dose Adjustment

• Renal impairment: Consider lower doses; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Consider lower doses; dose adjustments not defined

See Supplemental Patient Information

• Severe exaggeration of respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure have occurred in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure
• Narcotics are associated with adverse reactions which obscures the clinical course of patients with head injuries and acute abdominal conditions
• Higher-than-normal levels of morphine have occurred in blood of ultra-rapid metabolizers resulting in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Select lowest effective dose for the shortest period of time and inform patients about risks and the signs of morphine overdose

Cautions: Use cautiously in

• Severe renal impairment
• Severe hepatic impairment
• Head injury
• Increased ICP
• Seizure disorder
• CNS depression
• Hypothyroidism
• Addison’s disease
• Pulmonary impairment
• Biliary disease
• Acute abdomen
• GI obstruction
• G6PD deficiency
• Prostatic hypertrophy
• GU obstruction
• Urethral stricture
• History of drug/alcohol abuse
• Ultra-rapid CYP2D6 metabolizers
• Geriatrics
• Debilitated patients

Supplemental Patient Information

• Codeine component of this combination drug is associated with impairment of mental and/or physical abilities required for the performance of potentially hazardous activities such as driving a car or operating machinery; advise patients to avoid such tasks
• Advise patients to avoid use of alcohol and other CNS depressants in conjuction with this combination drug

Pregnancy Category:C

Breastfeeding: Acetaminophen is good choice for analgesia as well as for fever reduction in nursing mothers. Amounts excreted in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare. Codeine is associated with drowsiness in breastfeed infants. Newborn infants seem to be particularly sensitive to the effects of even small dosages, particularly in the first week of life. Both acetaminophen and codeine literature suggests that maternal medication is 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 LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT). This drug is compatible and considered safe with breastfeeding based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 21 February 2011). Manufacturer advises to make a decision for discontinuing the drug, taking into account the importance of the drug to the mother.

• RESP: Respiratory depression
• CNS: CNS depression, increased ICP, abuse, euphoria, dysphoria dizziness, lightheadedness, sedation
• GI: Hepatotoxicity, paralytic ileus, biliary spasm, constipation, nausea, vomiting, abdominal pain
• HEMA: Hemolytic anemia, pancytopenia, thrombocytopenia, leukopenia, neutropenia
• DERM: Pruritus, rash
• GU: Urinary retention
• MISC: Angioedema, anaphylaxis, dependency/abuse

Acetaminophen

• Analgesic, antipyretic; increases the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1 and COX-2, enzymes involved in prostaglandin (PG) synthesis, reduces fever through direct action on hypothalamic heat-regulating center
• Rapid and almost complete absorption
• Metabolized by liver; CYP450: CYP2E1, CYP1A2
• Excreted in urine (5-10% unchanged)
• Half-life: 2-4 hrs

Codeine

• 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: Approx. 3 hrs

US Trade Name(s)

• Tylenol with codeine no.3
• Tylenol with codeine no.4

US Availability

acetaminophen/codeine (generic)

• SOLN: [120 mg/5 mL]/[12 mg/5 mL]
• TABS:
• 300 mg/15 mg
• 300 mg/30 mg
• 300 mg/60 mg
• 650 mg/30 mg
• 650 mg/60 mg

Tylenol with codeine no.3 (acetaminophen/codeine)

• TABS: 300 mg/30 mg

Tylenol with codeine no.4 (acetaminophen/codeine)

• TABS: 300 mg/60 mg

Canadian Trade Name(s)

• Acet-codeine 30
• Acet-codeine 60
• Lenoltec no. 4
• Tylenol with codeine no. 4

Canadian Availability

acetaminophen/codeine (generic)

• ELIXIR: [160 mg/5 mL]/[8 mg/5 mL]
• TABS:
• 300 mg/30 mg
• 300 mg/60 mg

Acet-codeine 30 (acetaminophen/codeine)

• TABS: 300 mg/30 mg

Acet-codeine 60 (acetaminophen/codeine)

• TABS: 300 mg/60 mg

Procet 30, Triatec-30 (acetaminophen/codeine)

• TABS: 300 mg/30 mg

Lenoltec no. 4, Tylenol with codeine no. 4(acetaminophen/codeine)

• TABS: 300 mg/60 mg

Tylenol with codeine

• ELIXIR: [160 mg/5 mL]/[8 mg/5 mL]

UK Trade Name(s)

• Co-Codamol
• Copaz
• Codipar
• Co-codamol
• Kapake
• Feminax period pain capsules
• Medocodene
• Migraine relief
• Paracodol
• Migraleve yellow
• Solpadol
• Tylex
• Zapain

UK Availability

Co-Codamol (acetaminophen/codeine)

• EFFER TABS:
• 500 mg/8 mg
• 500 mg/30 mg

• TABS:
• 500 mg/8 mg
• 500 mg/30 mg

• SOLUBLE TABS: 500 mg/8 mg

Copaz, Codipar, Co-codamol, Kapake (acetaminophen/codeine)

• TABS: 500 mg/15 mg

Feminax period pain capsules (acetaminophen/codeine)

• CAPS: 500 mg/8 mg

Medocodene (acetaminophen/codeine)

• TABS: 500 mg/30 mg

Migraine relief, Paracodol, (acetaminophen/codeine)

• CAPS: 500 mg/8 mg

Migraleve yellow, Paracodol (acetaminophen/codeine)

• TABS: 500 mg/8 mg

Solpadol (acetaminophen/codeine)

• CAPS: 500 mg/30 mg
• TABS: 500 mg/30 mg
• EFFER TABS: 500 mg/30 mg

Tylex (acetaminophen/codeine)

• CAPS: 500 mg/30 mg
• EFFER TABS: 500 mg/30 mg

Zapain (acetaminophen/codeine)

• TABS: 500 mg/30 mg

Australian Trade Name(s)

• Chemist own pain tablets
• Codalgin
• Codapane
• Panamax Co
• Codalgin forte
• Codapane forte
• Comfarol forte
• Dolaforte
• Panadeine forte
• Prodeine forte
• Febridol plus
• Mersyndol day strength
• Pain stop for children-day time pain reliever
• Panadeine
• Panadeine extra
• Prodeine- 15

Australian Availability

acetaminophen/codeine (generic)

• TABS: 500 mg/30 mg

Chemist own pain tablets (acetaminophen/codeine)

• TABS:
• 500 mg/30 mg
• 500 mg/9.6 mg

Codalgin, Codapane, Panamax Co (acetaminophen/codeine)

• TABS: 500 mg/8 mg

Codalgin forte, Codapane forte, Comfarol forte, Dolaforte, Panadeine forte, Prodeine forte (acetaminophen/codeine)

• TABS: 500 mg/30 mg

Febridol plus (acetaminophen/codeine)

• TABS: 500 mg/10 mg

Mersyndol day strength (acetaminophen/codeine)

• TABS: 500 mg/9.6 mg

Pain stop for children-day time pain reliever (acetaminophen/codeine)

• SYRUP: [120 mg/5 mL]/[5 mg/5 mL]

Panadeine (acetaminophen/codeine)

• TABS: 500 mg/8 mg

Panadeine extra, Prodeine-15 (acetaminophen/codeine)

• TABS: 500 mg/15 mg

[Outline]

Analgesics

Narcotic Analgesic Combinations

Pricing data from www.DrugStore.com in U.S.A.

• Acetaminophen-Codeine #2 300-15 MG TABS [Bottle] (TEVA PHARMACEUTICALS USA)
  30 mg = $14.99
  60 mg = $19.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• APAP 300 MG / codeine 60 MG Oral Tablet (American Health Packaging)
• APAP 300 MG / codeine 60 MG Oral Tablet (Andrx Pharmaceuticals, Inc.)
• APAP 300 MG / codeine 60 MG Oral Tablet (Apotheca, Inc.)
• APAP 300 MG / codeine 60 MG Oral Tablet (BARR LABORATORIES, INC.)
• APAP 300 MG / codeine 60 MG Oral Tablet (Mallinckrodt, Inc.)
• APAP 300 MG / codeine 60 MG Oral Tablet (Mikart, Inc.)
• APAP 300 MG / codeine 60 MG Oral Tablet (Mutual Pharmaceutical Company)
• APAP 300 MG / codeine 60 MG Oral Tablet (Physicians Total Care, Inc.)
• APAP 300 MG / codeine 60 MG Oral Tablet (Qualitest Pharmaceuticals)
• APAP 300 MG / codeine 60 MG Oral Tablet (Ranbaxy Pharmaceuticals Inc.)
• APAP 300 MG / codeine 60 MG Oral Tablet (Rebel Distributors Corp.)
• APAP 300 MG / codeine 60 MG Oral Tablet (TEVA PHARMACEUTICALS USA)
• APAP 300 MG / codeine 60 MG Oral Tablet (bryant ranch prepack)
• APAP 300 MG / codeine phosphate 15 MG Oral Tablet (Andrx Pharmaceuticals, Inc.)
• APAP 300 MG / codeine phosphate 15 MG Oral Tablet (Apotheca, Inc.)
• APAP 300 MG / codeine phosphate 15 MG Oral Tablet (BARR LABORATORIES, INC.)
• APAP 300 MG / codeine phosphate 15 MG Oral Tablet (Mallinckrodt, Inc.)
• APAP 300 MG / codeine phosphate 15 MG Oral Tablet (Mutual Pharmaceutical Company)
• APAP 300 MG / codeine phosphate 15 MG Oral Tablet (Physicians Total Care, Inc.)
• APAP 300 MG / codeine phosphate 15 MG Oral Tablet (Qualitest Pharmaceuticals)
• APAP 300 MG / codeine phosphate 15 MG Oral Tablet (TEVA PHARMACEUTICALS USA)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (American Health Packaging)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (Andrx Pharmaceuticals, Inc.)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (Apotheca, Inc.)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (BARR LABORATORIES, INC.)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (Contract Pharmacy Services-PA)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (Mallinckrodt, Inc.)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (McKesson Packaging Services Business Unit of McKesson Corporation)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (Mikart, Inc.)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (Mutual Pharmaceutical Company)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (Physicians Total Care, Inc.)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (Qualitest Pharmaceuticals)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (Ranbaxy Pharmaceuticals Inc.)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (Rebel Distributors Corp.)
• APAP 300 MG / codeine phosphate 30 MG Oral Tablet (TEVA PHARMACEUTICALS USA)
• Acetaminophen 650 MG / Codeine 30 MG Oral Tablet (MIKART, INC.)
• Acetaminophen 650 MG / Codeine 60 MG Oral Tablet (MIKART, INC.)
• Acetaminophen 650 MG / Codeine 60 MG Oral Tablet (UAD LABORATORIES)
• Codrix 500/15 Oral Tablet (Andrx Laboratories, Inc.)
• Codrix 500/30 Oral Tablet (Andrx Laboratories, Inc.)
• Codrix 500/60 Oral Tablet (Andrx Laboratories, Inc.)
• Tylenol #3 Oral Tablet (OMP DIVISION, ORTHO-McNEIL PHARMACEUTICAL, INC.)
• Tylenol #4 Oral Tablet (OMP DIVISION, ORTHO-McNEIL PHARMACEUTICAL, INC.)