Codeine Phosphate
Name: Codeine Phosphate
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Overdose
Signs and Symptoms
Codeine is metabolized to morphine and its effects are similar to those of morphine and other opiate analgesics. Respiratory depression, sedation and miosis and common symptoms of overdose. Other symptoms include nausea, vomiting, skeletal muscle flaccidity, bradycardia, hypotension, and cool, clammy skin. Apnea and death may ensue; children have had apnea after doses as small as 5 mg/kg. Noncardiac pulmonary edema may develop opioid overdose, and monitoring of heart filling pressure may be helpful.
Treatment
To obtain up-to-date information about the treatment of overdose, a good resource is your Certified Regional Control Center. Telephone numbers of certified poison control centers are listed in the beginning of Physicians GenRx. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.
Naloxone antagonizes most effects of codeine. Protect the airway as Naloxone may induce vomiting. Naloxone has a shorter duration of action than codeine; repeated doses may be needed. In patients who abuse opioids chronically, a withdrawal syndrome may be manifest on administration of naloxone. This may include yawning, tearing, restlessness, sweating, dilated pupils, piloerection, vomiting, diarrhea, and abdominal cramps. This syndrome usually abates quickly as the effect of naloxone dissipates.
Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.
Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of codeine phosphate.
What is the most important information i should know about codeine ()?
Codeine may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.
Never take codeine in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how codeine will affect you.
Do not stop using codeine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using codeine.
What should i discuss with my healthcare provider before taking codeine ()?
Do not use this medication if you have ever had an allergic reaction to a narcotic medicine (examples include codeine, methadone, morphine, OxyContin, Darvocet, Percocet, Vicodin, Lortab, and many others). You should also not take codeine if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus.
Codeine may be habit forming and should be used only by the person for whom it was prescribed. Never share codeine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
To make sure you can safely take codeine, tell your doctor if you have any of these other conditions:
- asthma, COPD, sleep apnea, or other breathing disorders;
- liver or kidney disease;
- underactive thyroid;
- curvature of the spine;
- a history of head injury or brain tumor;
- epilepsy or other seizure disorder;
- low blood pressure;
- gallbladder disease;
- a pancreas disorder;
- an intestinal disorder;
- Addison's disease or other adrenal gland disorders;
- enlarged prostate, urination problems;
- mental illness; or
- a history of drug or alcohol addiction.
FDA pregnancy category C. It is not known whether codeine will harm an unborn baby. Codeine may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using codeine.
Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Older adults may be more sensitive to the effects of this medicine.
What should i avoid while taking codeine ()?
Do not drink alcohol while you are taking codeine. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.
Codeine may impair your thinking or reactions. Avoid driving or operating machinery until you know how codeine will affect you.
Where can i get more information?
Your pharmacist can provide more information about codeine.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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Uses for Codeine Phosphate
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
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 Phosphate 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
TabletsTight, light-resistant containers at <40°C (preferably 15–30°C).b
SolutionTight, light-resistant containers at <40°C (preferably 15–30°C).h Protect from freezing.h
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
| 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
| 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
| 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
| 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
| 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) |