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Health Guide

Codeine (Oral route)

Pronunciation:

KOE-deen

Dosage Forms:

  • Solution
  • Tablet, Extended Release
  • Syrup
  • Tablet

Warnings:

Oral route(Tablet)

Codeine sulfate has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of codeine sulfate, especially in children, can result in a fatal overdose of codeine. Prolonged use of codeine during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Use of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine sulfate requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Concomitant use with benzodiazepines and other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation .

Classifications:

Therapeutic—

Analgesic

Chemical—

Opioid

Uses of This Medicine:

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 with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of codeine in the pediatric population. Safety and efficacy have not been established.

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

Older adults—

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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.

Other medicines—

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
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Safinamide
  • 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.

  • Acepromazine
  • Alfentanil
  • Almotriptan
  • Alprazolam
  • Amineptine
  • Amisulpride
  • Amitriptyline
  • Amitriptylinoxide
  • Amobarbital
  • Amoxapine
  • Amphetamine
  • Anileridine
  • Aripiprazole
  • Asenapine
  • Baclofen
  • Benperidol
  • Benzphetamine
  • Bromazepam
  • Bromopride
  • Brompheniramine
  • Buprenorphine
  • Bupropion
  • Buspirone
  • Butabarbital
  • Butorphanol
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Carphenazine
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Citalopram
  • Clobazam
  • Clomipramine
  • Clonazepam
  • Clorazepate
  • Clozapine
  • Cocaine
  • Conivaptan
  • Cyclobenzaprine
  • Darunavir
  • Desipramine
  • Desmopressin
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Dezocine
  • Diazepam
  • Dibenzepin
  • Dichloralphenazone
  • Difenoxin
  • Dihydrocodeine
  • Diphenhydramine
  • Diphenoxylate
  • Dolasetron
  • Donepezil
  • Doxepin
  • Doxylamine
  • Droperidol
  • Duloxetine
  • Eletriptan
  • Enflurane
  • Escitalopram
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Fentanyl
  • Flibanserin
  • Fluoxetine
  • Fluphenazine
  • Flurazepam
  • Fluspirilene
  • Fluvoxamine
  • Fospropofol
  • Frovatriptan
  • Granisetron
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Hydroxyzine
  • Imipramine
  • Isoflurane
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Levomilnacipran
  • Levorphanol
  • Lisdexamfetamine
  • Lithium
  • Lofepramine
  • Lorazepam
  • Lorcaserin
  • Loxapine
  • Meclizine
  • Melitracen
  • Melperone
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methamphetamine
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Midazolam
  • Milnacipran
  • Mirtazapine
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Naratriptan
  • Nefazodone
  • Netupitant
  • Nicomorphine
  • Nitrazepam
  • Nitrous Oxide
  • Nortriptyline
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Palonosetron
  • Papaveretum
  • Paregoric
  • Paroxetine
  • Pentazocine
  • Pentobarbital
  • Perampanel
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenobarbital
  • Piperacetazine
  • Pipotiazine
  • Piritramide
  • Prazepam
  • Primidone
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propofol
  • Protriptyline
  • Quazepam
  • Quetiapine
  • Ramelteon
  • Remifentanil
  • Remoxipride
  • Rizatriptan
  • Secobarbital
  • Sertindole
  • Sertraline
  • Sibutramine
  • Sodium Oxybate
  • St John's Wort
  • Sufentanil
  • Sulpiride
  • Sumatriptan
  • Suvorexant
  • Tapentadol
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioridazine
  • Tianeptine
  • Tilidine
  • Tizanidine
  • Tolonium Chloride
  • Topiramate
  • Tramadol
  • Trazodone
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Trimipramine
  • Tryptophan
  • Venlafaxine
  • Vilazodone
  • Vortioxetine
  • Zaleplon
  • Ziprasidone
  • Zolmitriptan
  • Zolpidem
  • Zopiclone
  • Zotepine

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

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Addison's disease (adrenal gland problem) or
  • Alcohol abuse, history of or
  • Brain tumor or
  • Breathing or lung problems (eg, chronic obstructive pulmonary disease [COPD], cor pulmonale, hypoxia, sleep apnea) or
  • Depression, history of or
  • Drug dependence, especially narcotic abuse or dependence, or history of or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Head injuries or
  • Hypothyroidism (an underactive thyroid) or
  • Increased pressure in your head or
  • Kyphoscoliosis (curvature of spine that can cause breathing problems) or
  • Mental health problems, history of or
  • Problems with passing urine or
  • Stomach or digestion problems—Use with caution. May increase risk for more serious side effects.
  • Breathing problems (eg, asthma, hypercapnia), severe or
  • Paralytic ileus (intestinal blockage) or
  • Respiratory depression (hypoventilation or slow breathing)—Should not be used in patients with these conditions.
  • Hypotension (low blood pressure) or
  • Pancreatitis (inflammation of the pancreas) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. 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.
      • Children—Use and dose must be determined by your doctor.

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 use to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or seizure medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of these medicines while you are using 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.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

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.

For patients taking a codeine-containing medicine or any other narcotic analgesics (eg, dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

  • Contact your doctor right away if you have extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual.

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, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

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.

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.

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 of This Medicine:

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
Bloating
blurred vision
chills
cold, clammy skin
confusion
constipation
darkened urine
difficult or troubled breathing
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
indigestion
irregular, fast or slow, or shallow breathing
lightheadedness
loss of appetite
nausea
no blood pressure or pulse
no breathing
pains in the stomach, side, or abdomen, possibly radiating to the back
pale or blue lips, fingernails, or skin
redness of the face, neck, arms, and occasionally, upper chest
stopping of the heart
sweating
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
change in consciousness
chest pain or discomfort
constricted, pinpoint, or small pupils (black part of the eye)
decreased awareness or responsiveness
extreme sleepiness or unusual drowsiness
loss of consciousness
no blood pressure or pulse
severe sleepiness
slow or irregular heartbeat

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
Incidence not known
Abdominal or stomach pain or cramps
blurred or loss of vision
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 skin, or skin rash
night blindness
overbright appearance of lights
redness of the skin
sensation of spinning
shakiness
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.


Last Updated: 9/4/2017
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