Codeine (Oral Route) Proper Use

Description and Brand Names

Drug information provided by: Merative, Micromedex®

Canadian Brand Name

Codeine Contin

Descriptions

Codeine is used to relieve mild to moderate pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). This medicine acts on the central nervous system (CNS) to relieve pain.

When codeine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

This product is available in the following dosage forms:

Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of codeine in the pediatric population. It should not be used in children younger than 12 years of age. Safety and efficacy have not been established.

Codeine sulfate tablets should not be used to relieve pain after surgery removal of tonsils or adenoids in any children 12 to 18 years of age. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of codeine in the elderly. However, elderly patients are more likely to have confusion and drowsiness, and age-related lung, liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving codeine in order to avoid potentially serious side effects.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Furazolidone
Iproniazid
Isocarboxazid
Linezolid
Methylene Blue
Moclobemide
Nalmefene
Naltrexone
Nialamide
Ozanimod
Phenelzine
Procarbazine
Rasagiline
Safinamide
Samidorphan
Selegiline
Toloxatone
Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir
Abiraterone Acetate
Acepromazine
Aclidinium
Alfentanil
Almotriptan
Alosetron
Alprazolam
Amantadine
Amifampridine
Amiloride
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Anileridine
Apalutamide
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Asenapine
Atazanavir
Atropine
Baclofen
Belladonna
Bemetizide
Bendroflumethiazide
Benperidol
Bentazepam
Benzhydrocodone
Benzphetamine
Benzthiazide
Benztropine
Biperiden
Boceprevir
Bosentan
Bromazepam
Bromopride
Brompheniramine
Bumetanide
Buprenorphine
Bupropion
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Canrenoate
Canrenone
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Celecoxib
Cenobamate
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorthalidone
Chlorzoxazone
Cimetidine
Cinacalcet
Ciprofloxacin
Citalopram
Clarithromycin
Clemastine
Clidinium
Clobazam
Clomipramine
Clonazepam
Clopamide
Clopidogrel
Clorazepate
Cloxazolam
Clozapine
Cobicistat
Cocaine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclopenthiazide
Cyclopentolate
Cyclosporine
Cyclothiazide
Cyproheptadine
Daridorexant
Darifenacin
Darunavir
Delavirdine
Delorazepam
Desipramine
Desmopressin
Desvenlafaxine
Dexamethasone
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diacetylmorphine
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Dicyclomine
Difenoxin
Dihydrocodeine
Diltiazem
Dimenhydrinate
Diphenhydramine
Diphenoxylate
Dolasetron
Donepezil
Doxepin
Doxylamine
Dronedarone
Droperidol
Duloxetine
Efavirenz
Elagolix
Eletriptan
Enflurane
Enzalutamide
Eplerenone
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethacrynic Acid
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etozolin
Etravirine
Fedratinib
Fenfluramine
Fentanyl
Fesoterodine
Fexinidazole
Flavoxate
Flibanserin
Fluconazole
Flunitrazepam
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Fosamprenavir
Fosaprepitant
Fosnetupitant
Fosphenytoin
Fospropofol
Frovatriptan
Furosemide
Gabapentin
Gabapentin Enacarbil
Gepirone
Glycopyrrolate
Glycopyrronium Tosylate
Granisetron
Halazepam
Haloperidol
Halothane
Hexobarbital
Homatropine
Hydrochlorothiazide
Hydrocodone
Hydroflumethiazide
Hydromorphone
Hydroxytryptophan
Hydroxyzine
Hyoscyamine
Idelalisib
Imatinib
Imipramine
Indapamide
Indinavir
Ipratropium
Isoflurane
Itraconazole
Ivacaftor
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Lacosamide
Larotrectinib
Lasmiditan
Lemborexant
Lenacapavir
Letermovir
Levocetirizine
Levomilnacipran
Levorphanol
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lomitapide
Lopinavir
Loprazolam
Lorazepam
Lorcaserin
Lorlatinib
Lormetazepam
Loxapine
Lumacaftor
Magnesium Oxybate
Mavacamten
Meclizine
Medazepam
Melitracen
Melperone
Mepenzolate
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaclazepam
Metaxalone
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methyclothiazide
Metoclopramide
Metolazone
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirabegron
Mirtazapine
Mitotane
Modafinil
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Nafcillin
Nalbuphine
Naratriptan
Nefazodone
Nelfinavir
Netupitant
Nevirapine
Nicomorphine
Nilotinib
Nitrazepam
Nitrous Oxide
Nordazepam
Nortriptyline
Olanzapine
Oliceridine
Omaveloxolone
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxcarbazepine
Oxitropium Bromide
Oxybutynin
Oxycodone
Oxymorphone
Palbociclib
Palonosetron
Papaveretum
Paregoric
Paroxetine
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenobarbital
Phenytoin
Pinazepam
Pipenzolate Bromide
Piperacetazine
Pipotiazine
Pirenzepine
Piretanide
Piritramide
Polythiazide
Posaconazole
Potassium Oxybate
Prazepam
Prednisone
Pregabalin
Primidone
Prochlorperazine
Procyclidine
Promazine
Promethazine
Propantheline
Propiverine
Propofol
Protriptyline
Quazepam
Quetiapine
Quinethazone
Quinidine
Quinine
Ramelteon
Ranitidine
Ranolazine
Remifentanil
Remimazolam
Remoxipride
Rifabutin
Rifampin
Rifapentine
Ritonavir
Rizatriptan
Rolapitant
Ropeginterferon Alfa-2b-njft
Saquinavir
Scopolamine
Secobarbital
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
Solifenacin
Spironolactone
St John's Wort
Stramonium
Sufentanil
Sulpiride
Sumatriptan
Suvorexant
Tapentadol
Telaprevir
Telithromycin
Temazepam
Terbinafine
Terodiline
Tetrazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Thiothixene
Tianeptine
Tilidine
Tiotropium
Tizanidine
Tolonium Chloride
Tolterodine
Topiramate
Torsemide
Tramadol
Trazodone
Triamterene
Triazolam
Trichlormethiazide
Trifluoperazine
Trifluperidol
Triflupromazine
Trihexyphenidyl
Trimeprazine
Trimipramine
Tropicamide
Trospium
Tryptophan
Umeclidinium
Venlafaxine
Verapamil
Vilazodone
Voriconazole
Vortioxetine
Voxelotor
Xipamide
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine
Zuranolone

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of codeine. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

This medicine is taken only when needed, so there are no special instructions for a missed dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For mild to moderate pain:
  - Adults—At first, 15 to 60 milligrams (mg) every 4 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 360 mg per day.
  - Children 12 to 18 years of age—Use and dose must be determined by your doctor.
  - Children younger than 12 years of age—Should not be used in these patients.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Codeine can cause serious unwanted effects if taken by adults, children, or pets who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it. Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA website for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions

It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with codeine may worsen the side effects of this medicine, including dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Signs of an overdose include: cold, clammy skin, coughing that sometimes produces a pink frothy sputum, dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

This medicine may make you dizzy, drowsy, confused, or disoriented. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, including anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect. Do not give this medicine to:

Children younger than 12 years of age.
Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects.

For nursing mothers taking this medicine:

Talk to your doctor if you have any questions about taking codeine or about how this medicine may affect your baby.
Call your doctor if you become extremely tired and have difficulty caring for your baby.
Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time.
Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Agitation
bloating
blurred vision
chills
cold, clammy skin
confusion
constipation
cough
darkened urine
darkening of the skin
diarrhea
difficult or trouble breathing
difficulty swallowing
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fainting
fast, irregular, pounding, or racing heartbeat or pulse
fast, weak pulse
feeling of warmth
fever
hives, itching
indigestion
irregular, fast or slow, or shallow breathing
lightheadedness
loss of appetite
nausea
no blood pressure or pulse
no breathing
overactive reflexes
pains in the stomach, side, or abdomen, possibly radiating to the back
pale or blue lips, fingernails, or skin
poor coordination
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness of the face, neck, arms, and occasionally, upper chest
restlessness
shivering
stopping of the heart
sweating
talking or acting with excitement you cannot control
tightness in the chest
trembling or shaking
twitching
unconsciousness
unusual tiredness or weakness
vomiting
yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Bluish lips or skin
chest pain or discomfort
cold, clammy skin
constricted, pinpoint, or small pupils (black part of the eye)
coughing that sometimes produces a pink frothy sputum
decreased awareness or responsiveness
extreme sleepiness or unusual drowsiness
increased sweating
irregular, fast or slow, or shallow breathing
pale or blue lips, fingernails, or skin
slow or irregular heartbeat
swelling in the legs and ankles

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Drowsiness
relaxed and calm feeling

Incidence not known

Diarrhea
disturbed color perception
double vision
dry mouth
false or unusual sense of well-being
fear or nervousness
feeling of constant movement of self or surroundings
halos around lights
headache
hives or welts, itching, or skin rash
night blindness
overbright appearance of lights
redness of the skin
sensation of spinning
shakiness
stomach pain or cramps
trouble sleeping
tunnel vision
weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Portions of this document last updated: April 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/codeine-oral-route/proper-use/drg-20074022

Codeine (Oral Route)

Description and Brand Names

Canadian Brand Name

Descriptions

Before Using

Allergies

Pediatric

Geriatric

Breastfeeding

Drug Interactions

Other Interactions

Other Medical Problems

Proper Use

Dosing

Missed Dose

Storage

Precautions

Side Effects

Incidence not known

Symptoms of overdose

More common

Incidence not known

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