Class: Opiate Agonists
Note: This monograph also contains information on Codeine Phosphate, Codeine Sulfate
VA Class: CN101
Chemical Name: (5α,6α)-7,8-Didehydro-4,5-epoxy-3-methoxy-17-methyl-morphan-6-ol monohydrate
Molecular Formula: C18H21NO3•H2OC18H21NO3•H3PO4•½H2O
CAS Number: 6059-47-8
Brands: Ambenyl, Bromanyl, BenzaClin, Brontex, Capital and Codeine, Cheracol with Codeine, Codimal PH, Colrex Compound, Cycofed Expectorant Pediatric, Decohistine DH, Dihistine DH Elixir, Duac, Fioricet with Codeine, Fiorinal with Codeine, Gani-Tuss NR, Guiatuss AC, Guiatussin with Codeine, HaNew Riversin, KG-Fed Pediatric Expectorant, Mytussin AC, Novahistine DH, Nucofed, Nucotuss Pediatric, Pediacof, Phenergan VC with Codeine, Phenhist DH with Codeine Modified Formula, Prometh VC with Codeine Phosphate, Robafen AC, Robitussin A-C, Ryna-C, Ryna-CX, Soma Compound with Codeine, Triacin-C, Tussar SF, Tussar-2 Syrup, Tussi-Organidin NR, Tussi-Organidin-S NR, Tylenol with Codeine
Introduction
Opiate agonist; phenanthrene derivative.a b
Uses for Codeine
Pain
Symptomatic relief of mild to moderate pain that is not relieved by a non-opiate analgesic.b d e f
Combinations of codeine and aspirin or acetaminophen may produce additive analgesic effects because of differing mechanisms of action.b
Cough
Symptomatic relief of nonproductive cough, alone or in combination with other antitussives or expectorants.a
Codeine Dosage and Administration
Administration
Oral Administration
Administer orally.a b
Dispense a calibrated measuring device with cough preparations intended for children 2–5 years of age.103
Dosage
Available as codeine phosphate and codeine sulfate; dosage expressed in terms of the salt.d e g
Pediatric Patients
Cough
Oral
Usual Pediatric Antitussive Dosages
Age
|
Daily Dosage
|
|---|
2–5 years
|
1 mg/kg daily in 4 equally divided doses every 4–6 hours100 101 103
|
6–11 years
|
5–10 mg every 4–6 hours100 101 103
|
≥12 years
|
10–20 mg every 4–6 hoursa
|
Alternatively, use the following dosages as a guide based on average body weight; reduce dosage for low-weight children.100
Antitussive Dosages for Pediatric Patients Based on Weight100
Age
|
Daily Dosage
|
|---|
2 years (averaging 12 kg)
|
3 mg every 4–6 hours (maximum 12 mg daily)
|
3 years (averaging 14 kg)
|
3.5 mg every 4–6 hours (maximum 14 mg daily)
|
4 years (averaging 16 kg)
|
4 mg every 4–6 hours (maximum 16 mg daily)
|
5 years (averaging 18 kg)
|
4.5 mg every 4–6 hours (maximum 18 mg daily)
|
Pain
Oral
3 mg/kg or 100 mg/m2 daily in 6 divided doses.b Alternatively, 0.5 mg/kg or 15 mg/m2 every 4–6 hours.b f
Adults
Cough
Oral
10–20 mg every 4–6 hours.a
Pain
Oral
30 mg every 4 hours as needed; usual dosage range is 15–60 mg every 4 hours as needed.b d e
Nonopiate-containing analgesic fixed combinations: Nonopiate component may limit dosage of opiate component.117 119 120 121 Nonopiate analgesics are available in various fixed ratios with codeine and also are available in many other prescription and OTC preparations; ensure that therapy is not duplicated and that nonopiate dosage does not exceed maximum recommended dosages.117 118 119 121
Prescribing Limits
Pediatric Patients
Cough
Oral
Maximum Daily Antitussive Dosages for Pediatric Patients
Age
|
Maximum Daily Dosage
|
|---|
2 years (averaging 12 kg)
|
12 mg100
|
3 years (averaging 14 kg)
|
14 mg 100
|
4 years (averaging 16 kg)
|
16 mg 100
|
5 years (averaging 18 kg)
|
18 mg 100
|
6–11 years
|
60 mg a
|
≥12 years
|
120 mg a
|
Adults
Cough
Oral
Maximum 120 mg daily.a
Special Populations
Geriatric Patients
Reduce dosage in older patients.a b
Ultra-rapid Metabolizers of CYP2D6 Substrates
Use lowest effective dosage for shortest period of time.104 105 106 113 (See Special Populations under Pharmacokinetics.)
Cautions for Codeine
Contraindications
Warnings/Precautions
Warnings
CNS Depression
Performance of activities requiring mental alertness and physical coordination may be impaired.a c d e f
Concurrent use of other CNS depressants may potentiate CNS depression.d e (See Specific Drugs under Interactions.)
Abuse Potential
Possible tolerance, psychologic dependence, and physical dependence following prolonged administration.a Abuse potential similar to that of morphine.d e f
Sulfite Sensitivity
Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.f
General Precautions
Increased Intracranial Pressure or Head Trauma
Potential for increased respiratory depressant effects and elevation of CSF pressure in patients with increased intracranial pressure, head trauma, or other intracranial lesions.c d e f
Adverse effects of opiates may obscure the existence, extent, or course of intracranial pathology.d e f g
Acute Abdominal Conditions
Administration may complicate assessment of patients with acute abdominal conditions.c d e f
Respiratory Depression
Possible dose-related respiratory depressionc d e (occurs infrequently with oral antitussive doses).a
Potential for increased viscosity of bronchial secretions and suppression of cough reflex, with subsequent respiratory insufficiency, in patients with asthma or pulmonary emphysema who indiscriminately use antitussives.a
Postoperative Patients
Suppression of cough reflex following thoracotomy or laparotomy may lead to postoperative retention of secretions; cautious use recommended.a
Debilitated and Special Risk Patients
Use with caution in debilitated patients and in those with hypothyroidism, Addison’s disease, and prostatic hypertrophy or urethral stricture.a d e f
Fixed-combination Preparations
When used in fixed combination with other drug(s), consider the cautions, precautions, and contraindications associated with the other drug(s).b
Specific Populations
Pregnancy
Category C.f
Lactation
Distributed into milk. a Use with caution in nursing women who are known or suspected ultra-rapid metabolizers of CYP2D6 substrates; opioid toxicity resulting in neonatal death reported in the nursing infant of mother receiving codeine; mother was an ultra-rapid metabolizer of codeine.104 105 106 107 113 (See Metabolism and see Special Populations under Pharmacokinetics.)
The FDA-approved AmpliChip CYP450 Test can be used to identify CYP2D6 genotype.106 111 113 Testing alone may not adequately predict risk of adverse reactions and should not substitute for clinical judgment.104 If codeine is used in nursing women, administer lowest effective dosage for shortest possible time; closely monitor for opioid toxicity in both mother and infant.104 105 106 113
Pediatric Use
Safety for the management of mild to moderate pain not established in children <3 years of age.d e f
Use as antitussive not recommended in children <2 years of age; possible respiratory arrest, coma, and death due to increased susceptibility to respiratory depressant effects.a
Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.115 116 Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.115 Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.
Geriatric Use
Use with caution.d e f g (See Geriatric Patients under Dosage and Administration.)
Hepatic Impairment
Use with caution in patients with severe hepatic impairment.d e f g
Renal Impairment
Use with caution in patients with severe renal impairment.d e f
Common Adverse Effects
When used for pain relief (particularly in ambulatory patients not experiencing severe pain): lightheadedness, dizziness, sedation, nausea, vomiting, sweating.d e f
When used at antitussive doses: nausea, vomiting, constipation (with repeated doses), dizziness, sedation, palpitation, pruritus.a
Interactions for Codeine
Specific Drugs
Drug
|
Interaction
|
Comments
|
|---|
Anticholinergic agents
|
Possible paralytic ileusf
|
|
Antidepressants, MAO inhibitors and tricyclics
|
Potentiation of antidepressant effectc
|
Use with caution; reduce dosage of codeinec
|
CNS depressants (e.g., opiate agonists, general anesthetics, tranquilizers, phenothiazines, sedatives/hypnotics, alcohol)
|
Additive CNS effectsa d e f
|
Reduce dosage of one or both agentsd e f
|
Codeine Pharmacokinetics
Absorption
Bioavailability
Well absorbed following oral administration.a b e f g
Onset
Onset occurs in 15–30 minutes.a b Peak analgesic effects occur within 2 hours;g peak antitussive effects within 1–4 hours.i
Duration
Analgesic effects persist for 4–6 hours.b g Antitussive effects may persist for 4 hours.i
Distribution
Extent
Rapidly distributed into various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen, and kidney.g Distributed into milk.b Readily crosses the placenta.c
Protein Binding
Not bound to plasma proteins.g
Elimination
Metabolism
Metabolized in liver, principally by CYP3A4 and to a lesser extent (10%) by CYP2D6 to O-demethylated morphine, the active metabolite.b 108 109 110 112
Metabolism of codeine influenced by CYP2D6 polymorphism; genetic differences in drug metabolism affect drug response.108 109 110 112 114 Individuals may be described as poor, extensive, or ultra-rapid metabolizers of CYP2D6 substrates.108 109 110 112 114
Elimination Route
Excreted mainly in urine with negligible amounts of codeine and its metabolites found in feces.b g
Half-life
About 2.5–3 hours.f g
Special Populations
Individuals who carry the genotype associated with ultra-rapid metabolism of CYP2D6 substrates (approximately 1–7% of Caucasians, 10–30% of Ethiopians and Saudi Arabians) convert codeine to morphine more rapidly and completely than other individuals; ultra-rapid metabolizers are likely to have higher than expected serum concentrations of morphine.107 108 110 112 114
Stability
Storage
Oral
Tablets
Tight, light-resistant containers at <40°C (preferably 15–30°C).b
Solution
Tight, light-resistant containers at <40°C (preferably 15–30°C).h Protect from freezing.h
ActionsActions
Principal pharmacologic effects are on CNS and intestines.c d e
Mild analgesic effect.b d e f Acts at several sites within the CNS involving several systems of neurotransmitters to produce analgesia; precise mechanism of action not fully elucidated.c
Suppresses cough reflex by direct effect on cough center in medulla of brain.a
Exerts drying effect on respiratory tract mucosa and increases viscosity of bronchial secretions.a
Antitussive activity is less than that of morphine (on a weight basis).a
Advice to Patients
Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.d e f
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as alcohol consumption and any concomitant diseases.d e f Importance of limiting alcohol intake.f
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.d e f
Risk of morphine toxicity in nursing infants of mothers taking codeine who are ultra-rapid metabolizers of codeine.104 105 106 113 Importance of monitoring infants for manifestations of morphine overdose (e.g., sedation, difficulty breathing, hypotonia, poor feeding); immediately seek medical attention if any symptoms develop.104 105 113
Importance of advising patients of other important precautionary information.d e (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Subject to control under the Federal Controlled Substances Act of 1970.d e
Codeine
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Bulk
|
Crystals
|
|
|
|
Codeine Phosphate
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Bulk
|
Powder
|
|
|
|
Oral
|
Solution
|
15 mg/5 mL
|
Codeine Phosphate Oral Solution ( C-II)
|
|
|
Tablets, soluble
|
30 mg
|
Codeine Phosphate Soluble Tablets ( C-II)
|
|
|
|
60 mg
|
Codeine Phosphate Soluble Tablets ( C-II)
|
|
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Acetaminophen and Codeine Phosphate
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Oral
|
Solution
|
120 mg/5 mL Acetaminophen and Codeine Phosphate 12 mg/5 mL*
|
Tylenol with Codeine Elixir ( C-V)
|
Ortho-McNeil
|
|
Suspension
|
120 mg/5 mL Acetaminophen and Codeine Phosphate 12 mg/5 mL
|
Capital and Codeine ( C-V)
|
Amarin
|
|
Tablets
|
300 mg Acetaminophen and Codeine Phosphate 15 mg*
|
|
|
|
|
300 mg Acetaminophen and Codeine Phosphate 30 mg*
|
Tylenol with Codeine ( C-III)
|
Ortho-McNeil
|
|
|
300 mg Acetaminophen and Codeine Phosphate 60 mg*
|
Tylenol with Codeine ( C-III)
|
Ortho-McNeil
|
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Aspirin and Codeine Phosphate (Co-codaprin)
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Oral
|
Tablets
|
325 mg Aspirin and Codeine Phosphate 30 mg*
|
Aspirin and Codeine Phosphate Tablets ( C-III)
|
|
|
|
325 mg Aspirin and Codeine Phosphate 60 mg*
|
Aspirin and Codeine Phosphate Tablets ( C-III)
|
|
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Guaifenesin and Codeine Phosphate
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Oral
|
Solution
|
75 mg/5 mL Guaifenesin and Codeine Phosphate 2.5 mg/5 mL
|
Brontex ( C-V)
|
Kenwood
|
|
|
100 mg/5 mL Guaifenesin and Codeine Phosphate 10 mg/5 mL*
|
Cheracol with Codeine Syrup ( C-V)
|
Lee Pharmaceuticals
|
|
|
|
Gani-Tuss NR ( C-V)
|
Cypress
|
|
|
|
Guiatuss AC Syrup ( C-V)
|
Alpharma, IVAX
|
|
|
|
Guiatussin with Codeine ( C-V)
|
Rugby
|
|
|
|
HaNew Riversin AC ( C-V)
|
Halsey
|
|
|
|
Mytussin AC Cough Syrup ( C-V;)
|
Morton Grove Pharmaceuticals
|
|
|
|
Robafen AC Syrup ( C-V)
|
Major
|
|
|
|
Robitussin A-C Syrup ( C-V)
|
Robins
|
|
|
|
Tussi-Organidin NR ( C-V)
|
Wallace
|
|
|
|
Tussi-Organidin-S NR ( C-V; with graduated oral syringe)
|
Wallace
|
|
Tablets
|
300 mg Guaifenesin and Codeine Phosphate 10 mg
|
Brontex ( C-III)
|
Kenwood
|
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Other Codeine Phosphate Combinations
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Oral
|
Capsules
|
30 mg with Acetaminophen 325 mg, Butalbital 50 mg, and Caffeine 40 mg
|
Fioricet with Codeine ( C-III)
|
Watson
|
|
|
16 mg with Acetaminophen 325 mg, Chlorpheniramine Maleate 2 mg and Phenylephrine Hydrochloride 10 mg
|
Colrex Compound ( C-III)
|
Numark
|
|
|
30 mg with Aspirin 325 mg, Butalbital 50 mg, and Caffeine 40 mg*
|
Fiorinal with Codeine ( C-III)
|
Watson
|
|
|
20 mg with Pseudoephedrine Hydrochloride 60 mg
|
Nucofed ( C-III)
|
Monarch
|
|
Solution
|
5 mg/5 mL with Chlorpheniramine Maleate 0.75 mg/5 mL, Phenylephrine Hydrochloride 2.5 mg/5 mL, and Potassium Iodide 75 mg/5 mL
|
Pediacof Cough Syrup ( C-V)
|
Sanofi-Synthelabo
|
|
|
10 mg/5 mL with Bromodiphenhydramine Hydrochloride 12.5 mg/5 mL
|
Ambenyl Cough Syrup ( C-V)
|
Forest
|
|
|
|
Bromanyl Cough Syrup ( C-V)
|
Alpharma, Moore
|
|
|
|
Bromodiphenhydramine Hydrochloride and Codeine Phosphate Cough Syrup ( C-V)
|
|
|
|
10 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL, and Pseudoephedrine Hydrochloride 30 mg/5 mL
|
Decohistine DH ( C-V)
|
Morton Grove
|
|
|
|
Dihistine DH Elixir ( C-V)
|
Alpharma, IVAX, Moore
|
|
|
|
Novahistine DH ( C-V)
|
GlaxoSmithKline
|
|
|
|
Phenhist DH with Codeine Modified Formula ( C-V)
|
Rugby
|
|
|
|
Ryna-C ( C-V)
|
Wallace
|
|
|
10 mg/5 mL with Guaifenesin 100 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL
|
Cycofed Expectorant Pediatric ( C-V)
|
Cypress
|
|
|
|
Decohistine Expectorant ( C-V)
|
Morton Grove
|
|
|
|
Dihistine Expectorant ( C-V)
|
Alpharma, Moore
|
|
|
|
Guaifenesin DAC ( C-V)
|
Cypress
|
|
|
|
Guiatuss DAC Syrup ( C-V)
|
Alpharma, IVAX, Moore
|
|
|
|
Guiatussin DAC Syrup ( C-V)
|
Rugby
|
|
|
|
HaNew Riversin DAC ( C-V)
|
Halsey
|
|
|
|
KG-Fed Pediatric Expectorant Syrup ( C-V)
|
King
|
|
|
|
Mytussin DAC ( C-V)
|
Morton Grove
|
|
|
|
Novahistine Expectorant with Codeine ( C-V)
|
GlaxoSmithKline
|
|
|
|
Nucofed Pediatric Expectorant Syrup ( C-V)
|
Monarch
|
|
|
|
Nucotuss Pediatric Expectorant ( C-V)
|
Alpharma
|
|
|
|
Robitussin-DAC ( C-V)
|
Robins
|
|
|
|
Ryna-CX ( C-V)
|
Wallace
|
|
|
|
Tussar SF Syrup ( C-V)
|
Aventis
|
|
|
|
Tussar-2 Syrup ( C-V)
|
Aventis
|
|
|
10 mg/5 mL with Phenylephrine Hydrochloride 5 mg/5 mL and Promethazine Hydrochloride 6.25 mg/5 mL
|
Phenergan VC with Codeine Syrup ( C-V)
|
Wyeth
|
|
|
|
Promethazine VC with Codeine Syrup ( C-V)
|
|
|
|
|
Prometh VC with Codeine Phosphate Cough Syrup ( C-V)
|
Alpharma
|
|
|
10 mg/5 mL with Phenylephrine Hydrochloride 5 mg/5 mL and Pyrilamine Maleate 8.33 mg/5 mL
|
Codimal PH Syrup ( C-V)
|
Schwarz
|
|
|
10 mg/5 mL with Promethazine Hydrochloride 6.25 mg/5 mL*
|
Phenergan with Codeine Syrup ( C-V)
|
Wyeth
|
|
|
10 mg/5 mL with Pseudoephedrine Hydrochloride 30 mg/5 mL and Triprolidine Hydrochloride 1.25 mg/5 mL*
|
Triacin-C Cough Syrup ( C-V)
|
Alpharma, Moore
|
|
|
20 mg/5 mL with Guaifenesin 200 mg/5 mL and Pseudoephedrine Hydrochloride 60 mg/5 mL
|
Cycofed Expectorant ( C-III)
|
Cypress
|
|
|
|
KG-Fed Expectorant Syrup ( C-III)
|
King
|
|
|
|
Nucofed Expectorant ( C-III)
|
Monarch
|
|
|
|
Nucotuss Expectorant ( C-III)
|
Alpharma
|
|
|
20 mg/5 mL with Pseudoephedrine Hydrochloride 60 mg/5 mL
|
KG-Fed Syrup ( C-III)
|
King
|
|
|
|
Nucofed Syrup ( C-III)
|
Monarch
|
|
Tablets
|
16 mg with Aspirin 325 mg and Carisoprodol 200 mg*
|
Soma Compound with Codeine ( C-III)
|
Wallace
|
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Codeine Sulfate
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Bulk
|
Powder*
|
|
|
|
Oral
|
Tablets
|
15 mg*
|
Codeine Sulfate Tablets ( C-II)
|
|
|
|
30 mg*
|
Codeine Sulfate Tablets ( C-II)
|
|
|
|
60 mg*
|
Codeine Sulfate Tablets ( C-II)
|
|
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 05/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Acetaminophen-Codeine 120-12MG/5ML Solution (MORTON GROVE PHARMACEUTICALS): 240/$19.99 or 720/$35.97
Acetaminophen-Codeine #2 300-15MG Tablets (TEVA PHARMACEUTICALS USA): 30/$14.99 or 60/$19.97
Acetaminophen-Codeine #3 300-30MG Tablets (MALLINCKRODT PHARM): 30/$15.99 or 60/$20.98
Acetaminophen-Codeine #4 300-60MG Tablets (MALLINCKRODT PHARM): 30/$17.99 or 90/$33.97
Carisoprodol-Aspirin-Codeine 200-325-16MG Tablets (SANDOZ): 30/$83.37 or 90/$240.03
Cheratussin AC 100-10MG/5ML Syrup (QUALITEST): 480/$15.99 or 1440/$25.97
Cheratussin AC 100-10MG/5ML Syrup (QUALITEST): 118/$11.99 or 354/$19.97
Cheratussin DAC 30-10-100MG/5ML Solution (QUALITEST): 480/$35.99 or 960/$60.97
Codeine Sulfate 30MG Tablets (ROXANE): 20/$19.99 or 30/$26.98
Mytussin DAC 30-10-100MG/5ML Solution (MORTON GROVE PHARMACEUTICALS): 473/$39.66 or 1419/$118.98
Promethazine-Codeine 6.25-10MG/5ML Syrup (QUALITEST): 473/$29.99 or 1419/$83.38
Tylenol with Codeine #4 300-60MG Tablets (MCNEIL): 30/$45.99 or 90/$119.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 01, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
Only references cited for selected revisions after 1984 are available electronically.
100. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; tentative final monograph for OTC antitussive drug products. [21 CFR Part 341] Fed Regist. 1983; 43:48576-95.
101. Committee on Drugs, American Academy of Pediatrics. Use of codeine- and dextromethorphan-containing cough syrups in pediatrics. Pediatrics. 1978; 62:118-22. [IDIS 112027] [PubMed 683771]
102. von Muhlendahl KE, Krienke EG, Scherf-Rahne B et al. Codeine intoxication in childhood. Lancet. 1976; 2:303-5. [PubMed 59870]
103. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for OTC antitussive drug products [21 CFR Parts 310, 341, and 369] Fed Regist. 1987; 52:30042-57.
104. Food and Drug Administration. FDA public health advisory: use of codeine by some breastfeeding mothers may lead to life-threatening side effects in nursing babies. Rockville, MD; 2007 Aug 17. From FDA website.
105. Food and Drug Administration. FDA Alert: Use of codeine products in nursing mothers. 2007 Aug 17. From FDA website.
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