Aspirin, caffeine, and dihydrocodeine (Oral route)

Pronunciation:

AS-pir-in, KAF-een, dye-hye-droe-KOE-deen bye-TAR-trate

Brand Names:

Synalgos-DC

Warnings:

Oral route(Capsule)

Addiction, Abuse, and Misuse:Aspirin/caffeine/dihydrocodeine bitartrate exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing aspirin/caffeine/dihydrocodeine bitartrate, and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory Depression:Serious, life-threatening, or fatal respiratory depression may occur with use of aspirin/caffeine/dihydrocodeine bitartrate. Monitor for respiratory depression, especially during initiation of aspirin/caffeine/dihydrocodeine bitartrate or following a dose increase.Accidental Ingestion:Accidental ingestion of even one dose of aspirin/caffeine/dihydrocodeine bitartrate, especially by children, can result in a fatal overdose of aspirin/caffeine/dihydrocodeine bitartrate.Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children:Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. Aspirin/caffeine/dihydrocodeine bitartrate is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of aspirin/caffeine/dihydrocodeine bitartrate in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.Neonatal Opioid Withdrawal Syndrome:Prolonged use of aspirin/caffeine/dihydrocodeine bitartrate during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 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.Interactions with Drug Affecting Cytochrome P450 Isoenzymes:The effects of concomitant use or discontinuation of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with aspirin/caffeine/dihydrocodeine bitartrate requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants:Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of aspirin/caffeine/dihydrocodeine bitartrate and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation .

Classifications:

Pharmacologic—

NSAID

Chemical—

Salicylate, Aspirin

Uses of This Medicine:

Aspirin, caffeine, and dihydrocodeine combination is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated.

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) that is used to relieve pain and reduce fever in patients. Caffeine is a CNS stimulant that is used together with pain relievers to increase their effect. It has also been used for migraine headaches. Dihydrocodeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When dihydrocodeine is used for a long time or in large doses, 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.

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—

Use of aspirin, caffeine, and dihydrocodeine combination is not recommended in children 12 years of age or younger.

Synalgos®-DC should not be used to relieve pain after surgery removal of tonsils or adenoids in 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 aspirin, caffeine, and dihydrocodeine combination in the elderly. However, elderly patients are more likely to have age-related lung, liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving aspirin, caffeine, and dihydrocodeine combination in order to avoid potentially serious side effects.

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.

Abrocitinib
Defibrotide
Dichlorphenamide
Influenza Virus Vaccine, Live
Ketorolac
Nalmefene
Naltrexone
Riociguat
Safinamide
Samidorphan
Viloxazine

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.

Abiraterone Acetate
Acarbose
Aceclofenac
Acemetacin
Acenocoumarol
Acepromazine
Acetazolamide
Alclometasone
Aldosterone
Alfentanil
Alipogene Tiparvovec
Almotriptan
Alprazolam
Alteplase, Recombinant
Amcinonide
Amifampridine
Amikacin
Amiloride
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amphotericin B
Amprenavir
Amtolmetin Guacil
Anagrelide
Anileridine
Anisindione
Apixaban
Aprepitant
Ardeparin
Argatroban
Aripiprazole
Armodafinil
Asenapine
Atazanavir
Bacitracin
Baclofen
Beclomethasone
Bemetizide
Bemiparin
Benazepril
Bendroflumethiazide
Benperidol
Benzhydrocodone
Benzphetamine
Benzthiazide
Betamethasone
Betrixaban
Bivalirudin
Boceprevir
Bosentan
Brinzolamide
Bromazepam
Bromfenac
Bromopride
Brompheniramine
Budesonide
Bufexamac
Bumetanide
Bupropion
Buspirone
Butabarbital
Calcium Oxybate
Cannabidiol
Cannabis
Caplacizumab-yhdp
Capmatinib
Capreomycin
Captopril
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Celecoxib
Certoparin
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorpropamide
Chlorthalidone
Chlorzoxazone
Choline Salicylate
Ciclesonide
Cilostazol
Cimetidine
Cinacalcet
Ciprofloxacin
Cisplatin
Citalopram
Clarithromycin
Clobazam
Clobetasol
Clobetasone
Clocortolone
Clomipramine
Clonazepam
Clonixin
Clopamide
Clopidogrel
Clorazepate
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Cortisone
Crizotinib
Curcumin
Cyclobenzaprine
Cyclopenthiazide
Cyclosporine
Cyclothiazide
Dabigatran Etexilate
Dalteparin
Danaparoid
Daridorexant
Darunavir
Deflazacort
Delavirdine
Desipramine
Desirudin
Desmopressin
Desonide
Desoximetasone
Desvenlafaxine
Dexamethasone
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Diclofenac
Dicumarol
Difenoxin
Diflorasone
Diflucortolone
Diflunisal
Difluprednate
Digoxin
Diltiazem
Diphenhydramine
Diphenoxylate
Dipyrone
Dolasetron
Donepezil
Dorzolamide
Dothiepin
Doxepin
Doxylamine
Dronedarone
Droperidol
Droxicam
Duloxetine
Edoxaban
Efavirenz
Eletriptan
Emtricitabine
Enalapril
Enalaprilat
Enflurane
Enoxaparin
Enzalutamide
Eplerenone
Eptifibatide
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethacrynic Acid
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etodolac
Etofenamate
Etoricoxib
Etozolin
Etravirine
Felbinac
Fenfluramine
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Feverfew
Flibanserin
Floctafenine
Flucloronide
Fluconazole
Fludrocortisone
Flufenamic Acid
Flumethasone
Flunisolide
Fluocinolone
Fluocinonide
Fluocortin
Fluocortolone
Fluorometholone
Fluoxetine
Fluphenazine
Flurandrenolide
Flurazepam
Flurbiprofen
Fluspirilene
Fluticasone
Fluvoxamine
Fondaparinux
Fosamprenavir
Fosaprepitant
Foscarnet
Fosinopril
Fosphenytoin
Fospropofol
Frovatriptan
Furazolidone
Furosemide
Gabapentin
Gabapentin Enacarbil
Gentamicin
Gepirone
Ginkgo
Givosiran
Glimepiride
Glipizide
Glyburide
Gossypol
Granisetron
Halazepam
Halcinonide
Halobetasol
Haloperidol
Halothane
Heparin
Hexobarbital
Hydrochlorothiazide
Hydrocodone
Hydrocortisone
Hydroflumethiazide
Hydromorphone
Hydroxytryptophan
Hydroxyzine
Ibrutinib
Ibuprofen
Idelalisib
Imatinib
Imipramine
Indapamide
Indinavir
Indomethacin
Inotersen
Iobenguane I 131
Iproniazid
Isocarboxazid
Isoflurane
Itraconazole
Ivacaftor
Kanamycin
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Ketoprofen
Lacosamide
Lasmiditan
Lemborexant
Lepirudin
Levocetirizine
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lisinopril
Lithium
Lofepramine
Lofexidine
Lomitapide
Lopinavir
Lorazepam
Lorcaserin
Lornoxicam
Loteprednol
Loxapine
Loxoprofen
Lumacaftor
Lumiracoxib
Macimorelin
Magnesium Oxybate
Meclizine
Meclofenamate
Medrysone
Mefenamic Acid
Melitracen
Meloxicam
Melperone
Melphalan
Meperidine
Mephobarbital
Meprobamate
Mesoridazine
Metaxalone
Metformin
Methadone
Methamphetamine
Methazolamide
Methdilazine
Methocarbamol
Methohexital
Methotrexate
Methotrimeprazine
Methyclothiazide
Methylene Blue
Methylprednisolone
Metoclopramide
Metolazone
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirabegron
Mirtazapine
Mitotane
Moclobemide
Modafinil
Moexipril
Molindone
Mometasone
Moricizine
Morniflumate
Morphine
Morphine Sulfate Liposome
Nabumetone
Nadroparin
Nafcillin
Naproxen
Naratriptan
Nateglinide
Nefazodone
Nelfinavir
Neomycin
Nepafenac
Netilmicin
Nevirapine
Nialamide
Nicomorphine
Nicorandil
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Nitrazepam
Nitrous Oxide
Nortriptyline
Olanzapine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxaprozin
Oxazepam
Oxcarbazepine
Oxycodone
Oxymorphone
Oxyphenbutazone
Ozanimod
Palbociclib
Palonosetron
Papaveretum
Paramethasone
Parecoxib
Paregoric
Parnaparin
Paromomycin
Paroxetine
Peginterferon Alfa-2b
Pemetrexed
Pentobarbital
Pentosan Polysulfate Sodium
Pentoxifylline
Perampanel
Perazine
Periciazine
Perindopril
Perphenazine
Phenelzine
Phenindione
Phenobarbital
Phenprocoumon
Phenylbutazone
Phenytoin
Piketoprofen
Pimozide
Piperacetazine
Pipotiazine
Piracetam
Piretanide
Piritramide
Piroxicam
Pixantrone
Plazomicin
Polythiazide
Posaconazole
Potassium Citrate
Potassium Oxybate
Pranoprofen
Prasugrel
Prazepam
Prednicarbate
Prednisolone
Prednisone
Pregabalin
Primidone
Procarbazine
Prochlorperazine
Proglumetacin
Promazine
Promethazine
Propofol
Propyphenazone
Proquazone
Protein C
Protriptyline
Quazepam
Quetiapine
Quinapril
Quinethazone
Quinidine
Quinine
Ramelteon
Ramipril
Ranitidine
Ranolazine
Rasagiline
Remifentanil
Remimazolam
Remoxipride
Repaglinide
Reteplase, Recombinant
Reviparin
Rifabutin
Rifampin
Rifapentine
Rimexolone
Ritlecitinib
Ritonavir
Rivaroxaban
Rizatriptan
Rofecoxib
Rolapitant
Ropeginterferon Alfa-2b-njft
Salicylic Acid
Salsalate
Saquinavir
Scopolamine
Secobarbital
Selegiline
Selumetinib
Sertindole
Sertraline
Sibutramine
Sildenafil
Sodium Oxybate
Sodium Salicylate
Spectinomycin
Spirapril
Spironolactone
St John's Wort
Streptomycin
Sufentanil
Sulindac
Sulodexide
Sulpiride
Sumatriptan
Suvorexant
Tacrolimus
Tapentadol
Telaprevir
Telithromycin
Temazepam
Tenofovir Alafenamide
Tenofovir Disoproxil Fumarate
Tenoxicam
Terbinafine
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Thiothixene
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tilidine
Tinzaparin
Tirofiban
Tizanidine
Tobramycin
Tocilizumab
Tolazamide
Tolbutamide
Tolfenamic Acid
Tolmetin
Tolonium Chloride
Topiramate
Torsemide
Tramadol
Trandolapril
Tranylcypromine
Trazodone
Treprostinil
Triamcinolone
Triamterene
Triazolam
Trichlormethiazide
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Trimipramine
Tryptophan
Turmeric
Valdecoxib
Valproic Acid
Vancomycin
Varicella Virus Vaccine, Live
Venlafaxine
Verapamil
Vilazodone
Voriconazole
Vortioxetine
Warfarin
Xipamide
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine
Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol
Atenolol
Betaxolol
Bisoprolol
Carteolol
Carvedilol
Celiprolol
Delapril
Esmolol
Imidapril
Labetalol
Levobunolol
Metipranolol
Metoprolol
Nadolol
Nebivolol
Nitroglycerin
Oxprenolol
Penbutolol
Pindolol
Probenecid
Propranolol
Sotalol
Streptokinase
Tamarind
Temocapril
Tenecteplase
Timolol

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 is usually not recommended, 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
Grapefruit Juice
Tobacco

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, or history of or
Brain , tumor, history of or
Breathing or lung problems (eg, COPD, sleep apnea, respiratory depression) or
Cor pulmonale (serious heart condition) or
Depression, history of or
Drug dependence, especially with narcotic abuse or dependence, or history of or
Head injuries, history of or
Hyperkalemia (high potassium levels in the blood) or
Increased pressure in the head or
Mental health problems, history of or
Obesity (overweight) or
Weakened physical condition—Use with caution. May increase risk for more serious side effects.

Bleeding problems or
Hypotension (low blood pressure) or
Pancreatitis swelling of the pancreas) or
Stomach or bowel problems (eg, peptic ulcer disease, bleeding), active or history of or
Seizures, history of—Use with caution. May make these conditions worse.

Dehydration or
Hypovolemia—Must be corrected first before using this medicine.

Hemophilia (bleeding problem) or
Reye's syndrome or
Severe asthma, asthma with nasal polyps and runny nose, trouble breathing, or other lung problems or
Stomach or bowel blockage (including paralytic ileus) or
Surgery (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with these conditions.

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.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of aspirin, caffeine, and dihydrocodeine combination. This medicine comes 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.

Take this medicine with food or a full glass of water to prevent stomach upset.

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 (capsules):
- For moderate to moderately severe pain:
  - Adults—Two capsules every 4 hours as needed.
  - Children 12 years of age and older—Use and dose must be determined by your doctor.
  - Children younger than 12 years of age—Use is not recommended.

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.

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 web site 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 While Using This Medicine:

It is very important that your doctor check your or your child's progress while 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 and urine 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) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

Check with your doctor before taking any of these medicines while you are using this medicine. The use of alcohol or other medicines that affect the CNS with codeine may worsen the side effects of this medicine, such as 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, 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.

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.

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.

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 the dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroids or a blood thinner).

Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of serious skin reaction including drug reaction with eosinophilia and systemic symptoms (DRESS).

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

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.

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 for more than 4 hours at a time.
Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") right away 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.

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.

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 hallucinations, stomach or muscle cramps, tremors, or unusual behavior.

Using this medicine while you are pregnant, especially during the later part of pregnancy 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.

Check with your doctor right away if you or your child 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) or may cause a delay in ovulation for women and may affect their ability 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: Agitation; anxiety; bleeding gums; bloating; bloody or black, tarry stools; bloody or cloudy urine; blue lips and fingernails; blurred vision; chest pain or discomfort; chills; cold sweats; confusion; constipation; continuing ringing or buzzing or other unexplained noise in the ears; cool, pale skin; coughing that sometimes produces a pink frothy sputum; dark urine; darkening of the skin; depression; diarrhea; difficult, fast, noisy breathing; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; drowsiness; dry mouth; fast, pounding, or irregular heartbeat or pulse; fast, slow, or irregular heartbeat; fever; flushed, dry skin; fruit-like breath odor; general tiredness and weakness; greatly decreased frequency of urination or amount of urine; headache; headache, sudden and severe; hearing loss; heartburn; increased hunger; increased sweating; increased thirst; increased urination; indigestion; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals; light-colored stools; loss of appetite; loss of consciousness; muscle cramps, spasms, pain, weakness, or stiffness; muscle tremors; nausea; nervousness; nightmares; numbness and tingling of the face, lips, hands, and feet; overactive reflexes; pains in the stomach, side, or abdomen, possibly radiating to the back; pinpoint red spots on the skin; poor coordination; rapid, deep breathing; restlessness; seizures; severe stomach pain; shakiness; shivering; skin rash; slurred speech; stomach pain, cramping, or burning; sunken eyes; swelling in the legs, feet, or ankles; trembling or shaking; trouble with breathing; twitching; unexplained weight loss; unusual bleeding or bruising; unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness; upper right abdominal or stomach pain; vomiting; vomiting of blood or material that looks like coffee grounds; vomiting, severe or continuous; weakness or heaviness of the legs; wrinkled skin; yellow eyes or skin

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

Symptoms of overdose: Chest pain or discomfort; cold and clammy skin; coughing that sometimes produces a pink frothy sputum; difficult, fast, noisy breathing; extreme sleepiness; increased sweating; irregular, fast or slow, or shallow breathing; lightheadedness, dizziness or fainting; pale or blue lips, fingernails, or skin; sleepiness or unusual drowsiness; 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:

Incidence not known: Belching; clumsiness; low body temperature; sleepiness; weak or feeble pulse; weight gain

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: 11/16/2023

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