Codeine Phosphate

Name: Codeine Phosphate

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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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

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

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)

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