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Codeine Sulfate

Pronunciation

Class: Opiate Agonists
Note: This monograph also contains information on Codeine, Codeine Phosphate
VA Class: CN101
Chemical Name: (5α,6α)-7,8-Didehydro-4,5-epoxy-3-methoxy-17-methyl-morphan-6-ol phosphate
Molecular Formula: C18H21NO3•H3PO4•½H2O
CAS Number: 41444-62-6
Brands: Ala-Hist AC (combination), Ascomp with Codeine (combination), Capital and Codeine, Cheratussin AC (combination), Cheratussin DAC (combination), Codar AR (combination), Codar D (combination), Codar GF (combination), EndaCof- C (combination), Fioricet with Codeine, Fiorinal with Codeine, Guaiatussin AC, Lortuss EX (combination), Neo AC (combination), Poly-tussin, Poly-tussin AC (combination), Poly-tussin D (combination), Pro-Clear AC (combination), Pro-Red AC (combination), Robafen AC, Rydex (combination), Soma Compound with Codeine, Statuss Green (combination), Triacin-C, Tricode AR (combination), Tricode GF (combination), Tylenol with Codeine, Z-Tuss AC (combination), Z-Tuss E (combination)

Warning(s)

  • Ultrarapid Metabolism of Codeine to Morphine
  • Respiratory depression and death associated with codeine use for postoperative pain management following tonsillectomy and/or adenoidectomy reported in children who were ultrarapid metabolizers of CYP2D6 substrates.122 123 124 130 (See Pediatric Use under Cautions and see Elimination under Pharmacokinetics.)

  • Contraindicated in children for the management of postoperative pain following tonsillectomy and/or adenoidectomy.122 123 124 130

Introduction

Opiate agonist; phenanthrene derivative.a b

Uses for Codeine Sulfate

Pain

Symptomatic relief of mild to moderately severe pain122 123 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 Sulfate 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.10103

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 hours10100 10101 10103

6–11 years

5–10 mg every 4–6 hours10100 10101 10103

≥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.10100

Antitussive Dosages for Pediatric Patients Based on Weight10100

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

Individualize initial dosage, taking into account patient's prior opiate use; concurrent drug therapy; degree of opiate tolerance; medical condition; type and severity of pain; and risk factors for addiction, abuse, and misuse.122 123

Prescribing Limits

Pediatric Patients

Cough
Oral
Maximum Daily Antitussive Dosages for Pediatric Patients

Age

Maximum Daily Dosage

2 years (averaging 12 kg)

12 mg10100

3 years (averaging 14 kg)

14 mg 10100

4 years (averaging 16 kg)

16 mg 10100

5 years (averaging 18 kg)

18 mg 10100

6–11 years

60 mg a

≥12 years

120 mg a

Adults

Cough
Oral

Maximum 120 mg daily.a

Pain
Oral

Maximum 360 mg daily.122 123

Special Populations

Geriatric Patients

Reduce dosage in older patients.a b

Ultrarapid 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 Sulfate

Contraindications

  • Known hypersensitivity to codeine or any ingredient in the formulation.c d e f

  • In children for the management of postoperative pain following tonsillectomy and/or adenoidectomy.122 123 124 130

  • Some manufacturers state codeine is contraindicated in patients with known or suspected paralytic ileus.122 123

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

Adrenal Insufficiency

Adrenal insufficiency reported in patients receiving opiate agonists or opiate partial agonists.400 Manifestations are nonspecific and may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and hypotension.400

If adrenal insufficiency is suspected, perform appropriate laboratory testing promptly and provide physiologic (replacement) dosages of corticosteroids; taper and discontinue the opiate agonist or partial agonist to allow recovery of adrenal function.400 If the opiate agonist or partial agonist can be discontinued, perform follow-up assessment of adrenal function to determine if corticosteroid replacement therapy can be discontinued.400 In some patients, switching to a different opiate improved symptoms.400

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

Hypogonadism

Hypogonadism or androgen deficiency reported in patients receiving long-term opiate agonist or opiate partial agonist therapy;400 401 402 403 404 causality not established.400 Manifestations may include decreased libido, impotence, erectile dysfunction, amenorrhea, or infertility.400 Perform appropriate laboratory testing in patients with manifestations of hypogonadism.400

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 ultrarapid metabolizers of CYP2D6 substrates; opiate toxicity resulting in neonatal death reported in the nursing infant of mother receiving codeine; mother was an ultrarapid 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 opiate toxicity in both mother and infant.104 105 106 113

Pediatric Use

Manufacturers state safety and efficacy of single-entity codeine preparations for the management of mild to moderately severe pain not established in pediatric patients <18 years of age;122 123 safety in fixed combination with acetaminophen for the management of mild to moderate pain not established in children <3 years of age.130 If codeine is used for management of pain (excluding postoperative pain following tonsillectomy and/or adenoidectomy), administer lowest effective dosage for shortest possible time; closely monitor for opiate toxicity.124 130

Use as an analgesic contraindicated in children following tonsillectomy and/or adenoidectomy.122 123 124 130 Serious adverse events, including deaths, reported in this setting in children with confirmed or suspected ultrarapid or extensive metabolism of CYP2D6 substrates; children with obstructive sleep apnea may be at particular risk.122 123 124 125 126 127 130 (See Boxed Warnings and see Elimination under Pharmacokinetics.) Some experts and FDA recommend alternate analgesics (e.g., nonopiate analgesics, opiates not substantially metabolized by CYP2D6) for postoperative pain management in children undergoing tonsillectomy and/or adenoidectomy.124 128 129

FDA is evaluating the safety of codeine for the management of cough and cold in children <18 years of age following a European Medicines Agency (EMA) decision that codeine must not be used for cough and cold in children <12 years of age and is not recommended for this use in children 12–18 years of age with asthma or other chronic respiratory conditions.10125 10126 FDA will notify healthcare professionals of its conclusions and recommendations when the review is complete, or when the agency has additional information to report.10125

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.10115 10116 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 Sulfate

Drugs Associated with Serotonin Syndrome

Risk of serotonin syndrome when used with other serotonergic drugs.400 May occur at usual dosages.400 Symptom onset generally occurs within several hours to a few days of concomitant use, but may occur later, particularly after dosage increases.400 (See Advice to Patients.)

If concomitant use of other serotonergic drugs is warranted, monitor patients for serotonin syndrome, particularly during initiation of therapy and dosage increases.400

If serotonin syndrome is suspected, discontinue codeine, other opiate therapy, and/or any concurrently administered serotonergic agents.400

Specific Drugs

Drug

Interaction

Comments

Anticholinergic agents

Possible paralytic ileusf

Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline), SNRIs (e.g., desvenlafaxine, duloxetine, milnacipran, venlafaxine), tricyclic antidepressants (TCAs), mirtazapine, nefazodone, trazodone, vilazodone

Risk of serotonin syndrome400

TCAs: Opiates may potentiate antidepressant effectc

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, the antidepressant, and/or any concurrently administered opiates or serotonergic agents400

TCAs: Use with caution; reduce dosage of codeinec

Antiemetics, 5-HT3 receptor antagonists (e.g., dolasetron, granisetron, ondansetron, palonosetron)

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, the 5-HT3 receptor antagonist, and/or any concurrently administered opiates or serotonergic agents400

Buspirone

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, buspirone, and/or any concurrently administered opiates or serotonergic agents400

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

Cyclobenzaprine

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, cyclobenzaprine, and/or any concurrently administered opiates or serotonergic agents400

Dextromethorphan

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, dextromethorphan, and/or any concurrently administered opiates or serotonergic agents400

5-HT1 receptor agonists (triptans; e.g., almotriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan)

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, the triptan, and/or any concurrently administered opiates or serotonergic agents400

Lithium

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, lithium, and/or any concurrently administered opiates or serotonergic agents400

MAO inhibitors (e.g., isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, tranylcypromine)

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, the MAO inhibitor, and/or any concurrently administered opiates or serotonergic agents400

St. John’s wort (Hypericum perforatum)

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, St. John’s wort, and/or any concurrently administered opiates or serotonergic agents400

Tryptophan

Risk of serotonin syndrome400

If concomitant use warranted, monitor for serotonin syndrome, particularly during initiation of therapy and dosage increases400

If serotonin syndrome suspected, discontinue codeine, tryptophan, and/or any concurrently administered opiates or serotonergic agents400

Codeine Sulfate 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 ultrarapid 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 ultrarapid 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; ultrarapid 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

Actions

  • 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

  • Potential risk of serotonin syndrome with concurrent use of codeine and other serotonergic agents.400 Importance of immediately contacting clinician if manifestations of serotonin syndrome (e.g., agitation, hallucinations, tachycardia, labile BP, fever, excessive sweating, shivering, shaking, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea) develop.400

  • Potential risk of adrenal insufficiency.400 Importance of contacting clinician if manifestations of adrenal insufficiency (e.g., nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, hypotension) develop.400

  • 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 ultrarapid metabolizers of codeine.104 105 106 113 Importance of monitoring infants for manifestations of opiate overdosage (e.g., sedation, difficulty breathing, hypotonia, poor feeding); immediately seek medical attention if any symptoms develop.104 105 113

  • Risk of morphine toxicity in children who are ultrarapid metabolizers of codeine and undergoing tonsillectomy and/or adenoidectomy.122 123 124 125 126 127 130 Importance of not giving codeine to children for postoperative pain management following tonsillectomy and/or adenoidectomy.122 123 124 130 Importance of monitoring children receiving codeine for other indications for respiratory depression.130

  • Risk of respiratory depression in children receiving codeine for the management of cough and cold.10125 10126 Importance of monitoring children receiving codeine for clinical manifestations of morphine toxicity (e.g., shallow, difficult, or noisy breathing; confusion; unusual sleepiness); immediately seek medical attention for the child if symptoms develop.10125

  • Possible risk (although causality not established) of hypogonadism or androgen deficiency with long-term opiate agonist or partial agonist use.400 Importance of informing clinician if decreased libido, impotence, erectile dysfunction, amenorrhea, or infertility occurs.400

  • 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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Subject to control under the Federal Controlled Substances Act of 1970.d e

Codeine Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Crystals

Bulk

Powder

* 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*

Acetaminophen and Codeine Phosphate Oral Solution (C-V)

Suspension

120 mg/5 mL Acetaminophen and Codeine Phosphate 12 mg/5 mL

Capital and Codeine (C-V)

Valeant

Tablets

300 mg Acetaminophen and Codeine Phosphate 15 mg*

Acetaminophen and Codeine Phosphate Tablets (C-III)

300 mg Acetaminophen and Codeine Phosphate 30 mg*

Acetaminophen and Codeine Phosphate Tablets (C-III)

Tylenol with Codeine No. 3 (C-III)

Janssen

300 mg Acetaminophen and Codeine Phosphate 60 mg*

Acetaminophen and Codeine Phosphate Tablets (C-III)

Tylenol with Codeine No. 4 (C-III)

Janssen

* 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

100 mg/5 mL Guaifenesin and Codeine Phosphate 10 mg/5 mL*

Cheratussin AC (C-V)

Qualitest

Guaiatussin AC (C-V)

Hi-Tech

Guaifenesin AC Cough Syrup (C-V)

Guaifenesin and Codeine Phosphate Oral Solution (C-V)

Robafen AC (C-V)

Major

200 mg/5 mL Guaifenesin and Codeine Phosphate 8 mg/5 mL

Codar GF (C-V)

Respa

* 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 300 mg, Butalbital 50 mg, and Caffeine 40 mg*

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules (C-III)

Fioricet with Codeine (C-III)

Actavis

30 mg with Acetaminophen 325 mg, Butalbital 50 mg, and Caffeine 40 mg*

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules (C-III)

30 mg with Aspirin 325 mg, Butalbital 50 mg, and Caffeine 40 mg*

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules (C-III)

Fiorinal with Codeine (C-III)

Actavis

Solution

6.33 mg/5 mL with Brompheniramine Maleate 1.33 mg/5 mL and Pseudoephedrine Hydrochloride 10 mg/5 mL

Rydex (C-V)

Centurion

8 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL

Codar AR (C-V)

Respa

8 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Tricode AR (C-V)

Respa

8 mg/5 mL with Guaifenesin 200 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Tricode GF (C-V)

Respa

8 mg/5 mL with Pseudoephedrine Hydrochloride 30 mg/5 mL

Codar D (C-V)

Respa

9 mg/5 mL with Chlorcyclizine Hydrochloride 12.5 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Statuss Green (C-V)

Magna

9 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL

Z-Tuss AC (C-V)

Magna

9 mg/5 mL with Dexchlorpheniramine Maleate 1 mg/5 mL and Phenylephrine Hydrochloride 5 mg/5 mL

Pro-Red AC (C-V)

Pro-Pharma

9 mg/5 mL with Guaifenesin 200 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Z-Tuss E (C-V)

Magna

9 mg/5 mL with Pyrilamine Maleate 8.33 mg/5 mL

Pro-Clear AC (C-V)

Pro-Pharma

10 mg/5 mL with Brompheniramine Maleate 4 mg/5 mL and Phenylephrine Hydrochloride 7.5 mg/5 mL

Poly-tussin AC (C-V)

Poly

10 mg/5 mL with Chlorcyclizine Hydrochloride 9.375 mg/5 mL

Poly-tussin (C-V)

Poly

10 mg/5 mL with Chlorcyclizine Hydrochloride 9.375 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Poly-tussin D (C-V)

Poly

10 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL

EndaCof-C (C-V)

Larken

10 mg/5 mL with Guaifenesin 100 mg/5 mL and Pseudoephedrine Hydrochloride 22.5 mg/5 mL

Lortuss EX (C-V)

Poly

10 mg/5 mL with Guaifenesin 100 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL*

Cheratussin DAC (C-V)

Qualitest

Guaifenesin DAC Syrup (C-V)

10 mg/5 mL with Phenylephrine Hydrochloride 5 mg/5 mL and Promethazine Hydrochloride 6.25 mg/5 mL*

Promethazine VC with Codeine Syrup (C-V)

10 mg/5 mL with Phenylephrine Hydrochloride 7.5 mg/5 mL

Ala-Hist AC (C-V)

Poly

10 mg/5 mL with Promethazine Hydrochloride 6.25 mg/5 mL*

Promethazine Hydrochloride with Codeine Phosphate Oral Solution (C-V)

10 mg/5 mL with Pseudoephedrine Hydrochloride 30 mg/5 mL and Pyrilamine Maleate 15 mg/5 mL

Neo AC (C-V)

Laser

10 mg/5 mL with Pseudoephedrine Hydrochloride 30 mg/5 mL and Triprolidine Hydrochloride 1.25 mg/5 mL

Triacin-C (C-V)

STI Pharma

Tablets

16 mg with Aspirin 325 mg and Carisoprodol 200 mg*

Carisoprodol, Aspirin, and Codeine Phosphate Tablets (C-III)

Soma Compound with Codeine (C-III)

Meda

Also commercially available in combination with other antihistamines, decongestants, and expectorants.

* 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

Solution

30 mg/5 mL*

Codeine Sulfate Oral Solution (C-II)

Tablets

15 mg*

Codeine Sulfate Tablets (C-II)

30 mg*

Codeine Sulfate Tablets (C-II)

60 mg*

Codeine Sulfate Tablets (C-II)

AHFS DI Essentials. © Copyright 2016, Selected Revisions November 30, 2016. 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.

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106. Food and Drug Administration. Codeine products used by nursing mothers. Medwatch alert. Rockville, MD; 2007 Aug 17. From FDA website.

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111. Roche Molecular Systems, Inc. AmpliChip CYP450 Test for in vitro diagnostic use. Branchburg, NJ; 2007 July.

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