Carisoprodol, aspirin, and codeine (Oral route)

Pronunciation:

kar-eye-soe-PROE-dol, AS-pir-in, KOE-deen FOS-fate

Dosage Forms:

Tablet

Warnings:

Oral route(Tablet)

Addiction, Abuse and MisuseCarisoprodol, aspirin and codeine phosphate tablets expose 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 carisoprodol, aspirin and codeine phosphate tablets, and monitor all patients regularly for the development of these behaviors and 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 product 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 DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of carisoprodol, aspirin and codeine phosphate tablets. Monitor for respiratory depression, especially during initiation of carisoprodol, aspirin and codeine phosphate tablets or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of carisoprodol, aspirin and codeine phosphate tablets, especially by children, can result in a fatal overdose of carisoprodol, aspirin and codeine phosphate tablets.Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-threatening Respiratory Depression in ChildrenLife-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. Carisoprodol, aspirin and codeine phosphate tablets are 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 carisoprodol, aspirin and codeine phosphate tablets 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 SyndromeProlonged use of carisoprodol, aspirin and codeine phosphate tablets 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 Drugs Affecting Cytochrome P450 IsoenzymesThe effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with carisoprodol, aspirin and codeine phosphate tablets requires careful consideration of the effects on codeine, and the active metabolite, morphine.Risks From Concomitant Use With Benzodiazepines Or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of carisoprodol, aspirin and codeine phosphate tablets 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 .FDA is advising that the opioid addiction medications buprenorphine or methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by health care professionals can reduce these risks .

Classifications:

Therapeutic—

Skeletal Muscle Relaxant, Centrally Acting/Analgesic Combination

Pharmacologic—

NSAID

Chemical—

Salicylate, Aspirin

Uses of This Medicine:

Carisoprodol, aspirin, and codeine combination is used to relax certain muscles in your body and relieve the discomfort caused by acute (short-term) painful muscle or bone conditions. However, this medicine does not take the place of rest, exercise, physical therapy, or other treatments that your doctor may recommend for your medical condition.

Carisoprodol is a skeletal muscle relaxant. It acts on the central nervous system (CNS) to relax the muscles. Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) that is used for pain and fever. Codeine is a narcotic analgesic (pain medicine) that acts on the CNS to relieve pain.

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—

Appropriate studies have not been performed on the relationship of age to the effects of Soma® tablets or Soma® with codeine tablets in children younger than 16 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of carisoprodol, aspirin, and codeine tablets in children younger than 18 years of age. Safety and efficacy have not been established. Use of carisoprodol, aspirin, and codeine tablets is not recommended in children younger than 12 years of age.

Carisoprodol, aspirin, and codeine combination tablets should not be used to relieve pain after surgery to remove tonsils 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 carisoprodol, aspirin, and codeine tablets in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Appropriate studies have not been performed on the relationship of age to the effects of Soma® tablets or Soma® with codeine tablets in geriatric patients. Safety and efficacy have not been established.

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
Furazolidone
Influenza Virus Vaccine, Live
Iproniazid
Isocarboxazid
Ketorolac
Linezolid
Methylene Blue
Moclobemide
Nalmefene
Naltrexone
Nialamide
Ozanimod
Phenelzine
Potassium Citrate
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
Acarbose
Aceclofenac
Acemetacin
Acenocoumarol
Acepromazine
Acetazolamide
Aclidinium
Alclometasone
Aldosterone
Alfentanil
Alipogene Tiparvovec
Almotriptan
Alosetron
Alprazolam
Alteplase, Recombinant
Amantadine
Amcinonide
Amifampridine
Amikacin
Amiloride
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amphotericin B
Amprenavir
Amtolmetin Guacil
Anagrelide
Anileridine
Anisindione
Apalutamide
Apixaban
Aprepitant
Aprobarbital
Ardeparin
Argatroban
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Asenapine
Atazanavir
Atropine
Bacitracin
Baclofen
Beclomethasone
Belladonna
Bemetizide
Bemiparin
Benazepril
Bendroflumethiazide
Benperidol
Bentazepam
Benzhydrocodone
Benzphetamine
Benzthiazide
Benztropine
Betamethasone
Betrixaban
Biperiden
Bivalirudin
Boceprevir
Bosentan
Brinzolamide
Bromazepam
Bromfenac
Bromopride
Brompheniramine
Budesonide
Bufexamac
Bumetanide
Buprenorphine
Bupropion
Buspirone
Butabarbital
Butalbital
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Canrenoate
Canrenone
Caplacizumab-yhdp
Capreomycin
Captopril
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Celecoxib
Cenobamate
Certoparin
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorpropamide
Chlorthalidone
Chlorzoxazone
Choline Salicylate
Ciclesonide
Cilostazol
Cimetidine
Cinacalcet
Ciprofloxacin
Cisplatin
Citalopram
Clarithromycin
Clemastine
Clidinium
Clobazam
Clobetasol
Clobetasone
Clocortolone
Clomipramine
Clonazepam
Clonixin
Clopamide
Clopidogrel
Clorazepate
Cloxazolam
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Cortisone
Crizotinib
Curcumin
Cyclobenzaprine
Cyclopenthiazide
Cyclopentolate
Cyclosporine
Cyclothiazide
Cyproheptadine
Dabigatran Etexilate
Dalteparin
Danaparoid
Dantrolene
Daridorexant
Darifenacin
Darunavir
Deflazacort
Delavirdine
Delorazepam
Desipramine
Desirudin
Desmopressin
Desonide
Desoximetasone
Desvenlafaxine
Dexamethasone
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diacetylmorphine
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Diclofenac
Dicumarol
Dicyclomine
Difenoxin
Diflorasone
Diflucortolone
Diflunisal
Difluprednate
Digoxin
Dihydrocodeine
Diltiazem
Dimenhydrinate
Diphenhydramine
Diphenoxylate
Dipyrone
Dolasetron
Donepezil
Dorzolamide
Dothiepin
Doxepin
Doxylamine
Dronedarone
Droperidol
Droxicam
Duloxetine
Edoxaban
Efavirenz
Elagolix
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
Fedratinib
Felbinac
Fenfluramine
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Fesoterodine
Feverfew
Fexinidazole
Flavoxate
Flibanserin
Floctafenine
Flucloronide
Fluconazole
Fludrocortisone
Flufenamic Acid
Flumethasone
Flunisolide
Flunitrazepam
Fluocinolone
Fluocinonide
Fluocortin
Fluocortolone
Fluorometholone
Fluoxetine
Fluphenazine
Flurandrenolide
Flurazepam
Flurbiprofen
Fluspirilene
Fluticasone
Fluvoxamine
Fondaparinux
Fosamprenavir
Fosaprepitant
Foscarnet
Fosinopril
Fosnetupitant
Fosphenytoin
Fospropofol
Frovatriptan
Furosemide
Gabapentin
Gabapentin Enacarbil
Gentamicin
Gepirone
Ginkgo
Glimepiride
Glipizide
Glucagon
Glyburide
Glycopyrrolate
Glycopyrronium Tosylate
Gossypol
Granisetron
Halazepam
Halcinonide
Halobetasol
Haloperidol
Halothane
Heparin
Hexobarbital
Homatropine
Hydrochlorothiazide
Hydrocodone
Hydrocortisone
Hydroflumethiazide
Hydromorphone
Hydroxytryptophan
Hydroxyzine
Hyoscyamine
Ibrutinib
Ibuprofen
Idelalisib
Imatinib
Imipramine
Indapamide
Indinavir
Indomethacin
Inotersen
Ipratropium
Isoflurane
Itraconazole
Ivacaftor
Kanamycin
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Ketoprofen
Lacosamide
Larotrectinib
Lasmiditan
Lemborexant
Lenacapavir
Lepirudin
Letermovir
Levocetirizine
Levomilnacipran
Levorphanol
Lisdexamfetamine
Lisinopril
Lithium
Lofepramine
Lofexidine
Lomitapide
Lopinavir
Loprazolam
Lorazepam
Lorcaserin
Lorlatinib
Lormetazepam
Lornoxicam
Loteprednol
Loxapine
Loxoprofen
Lumacaftor
Lumiracoxib
Macimorelin
Magnesium Oxybate
Mavacamten
Meclizine
Meclofenamate
Medazepam
Medrysone
Mefenamic Acid
Melitracen
Meloxicam
Melperone
Melphalan
Mepenzolate
Meperidine
Mephenesin
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaclazepam
Metaxalone
Metformin
Methacholine
Methadone
Methamphetamine
Methazolamide
Methdilazine
Methocarbamol
Methohexital
Methotrexate
Methotrimeprazine
Methyclothiazide
Methylprednisolone
Metoclopramide
Metolazone
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirabegron
Mirtazapine
Mitotane
Modafinil
Moexipril
Molindone
Mometasone
Moricizine
Morniflumate
Morphine
Morphine Sulfate Liposome
Nabumetone
Nadroparin
Nafcillin
Nalbuphine
Naproxen
Naratriptan
Nateglinide
Nefazodone
Nelfinavir
Neomycin
Nepafenac
Netilmicin
Netupitant
Nevirapine
Nicomorphine
Nicorandil
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Nitrazepam
Nitrous Oxide
Nordazepam
Nortriptyline
Olanzapine
Omaveloxolone
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxaprozin
Oxazepam
Oxcarbazepine
Oxitropium Bromide
Oxybutynin
Oxycodone
Oxymorphone
Oxyphenbutazone
Palbociclib
Palonosetron
Papaveretum
Paramethasone
Parecoxib
Paregoric
Parnaparin
Paromomycin
Paroxetine
Pemetrexed
Pentazocine
Pentobarbital
Pentosan Polysulfate Sodium
Pentoxifylline
Perampanel
Perazine
Periciazine
Perindopril
Perphenazine
Phenindione
Phenobarbital
Phenprocoumon
Phenylbutazone
Phenytoin
Piketoprofen
Pinazepam
Pipenzolate Bromide
Piperacetazine
Pipotiazine
Piracetam
Pirenzepine
Piretanide
Piritramide
Piroxicam
Plazomicin
Polythiazide
Posaconazole
Potassium Citrate
Potassium Oxybate
Pranoprofen
Prasugrel
Prazepam
Prednicarbate
Prednisolone
Prednisone
Pregabalin
Primidone
Prochlorperazine
Procyclidine
Proglumetacin
Promazine
Promethazine
Propantheline
Propiverine
Propofol
Propyphenazone
Proquazone
Protein C
Protriptyline
Quazepam
Quetiapine
Quinapril
Quinethazone
Quinidine
Quinine
Ramelteon
Ramipril
Ranitidine
Ranolazine
Remifentanil
Remimazolam
Remoxipride
Repaglinide
Reteplase, Recombinant
Revefenacin
Reviparin
Rifabutin
Rifampin
Rifapentine
Rimexolone
Ritonavir
Rivaroxaban
Rizatriptan
Rofecoxib
Rolapitant
Ropeginterferon Alfa-2b-njft
Salicylic Acid
Salsalate
Saquinavir
Scopolamine
Secobarbital
Secretin Human
Selumetinib
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
Sodium Salicylate
Solifenacin
Sparsentan
Spectinomycin
Spirapril
Spironolactone
St John's Wort
Stramonium
Streptomycin
Sufentanil
Sulindac
Sulodexide
Sulpiride
Sumatriptan
Suvorexant
Tacrolimus
Tapentadol
Telaprevir
Telithromycin
Temazepam
Tenofovir Alafenamide
Tenofovir Disoproxil Fumarate
Tenoxicam
Terbinafine
Terodiline
Tetrazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Thiothixene
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tilidine
Tinzaparin
Tiotropium
Tirofiban
Tizanidine
Tobramycin
Tocilizumab
Tolazamide
Tolbutamide
Tolfenamic Acid
Tolmetin
Tolonium Chloride
Tolterodine
Topiramate
Torsemide
Tramadol
Trandolapril
Trazodone
Treprostinil
Triamcinolone
Triamterene
Triazolam
Trichlormethiazide
Trifluoperazine
Trifluperidol
Triflupromazine
Trihexyphenidyl
Trimeprazine
Trimipramine
Tropicamide
Trospium
Tryptophan
Turmeric
Umeclidinium
Valdecoxib
Valproic Acid
Vancomycin
Varicella Virus Vaccine, Live
Venlafaxine
Verapamil
Vilazodone
Voriconazole
Vortioxetine
Voxelotor
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

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 disease (an adrenal problem) or
Alcohol abuse, history of or
Brain tumors or
Breathing problems (eg, COPD, hypercapnia, hypoxia, sleep apnea) or
Depression, history of or
Drug abuse or dependence, or history of or
Head injury, or history of or
Increased pressure in the head or
Mental illness, history of or
Obesity (overweight) or
Problems with passing urine or
Weakened physical condition—Use with caution. May increase risk for more serious side effects.

Aspirin-induced asthma, history of or
Asthma with nasal polyps and runny nose or
Hemophilia (bleeding problem) or
Liver damage, severe or
Lung or breathing problems (eg, asthma, respiratory depression), severe or
Porphyria (an enzyme problem) or
Reye's syndrome or
Stomach or bowel blockage (including paralytic ileus, peptic ulcer, lesions) or
Surgery, for pain after surgery in children (eg, nasopharyngeal tonsils, tonsils)
Vitamin K deficiency—Should not be used in patients with these conditions.

Gallbladder problems or
Hypotension (low blood pressure) or
Pancreatitis (swelling of the pancreas) or
Seizures, history of or
Stomach ulcers, acute or 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. If carisoprodol and codeine are taken regularly and in large amounts, they may become habit-forming and cause mental or physical dependence.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of carisoprodol, aspirin, and codeine combination. 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.

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 relaxing muscles:
- For oral dosage form (tablets):
  - Carisoprodol, aspirin, codeine:
    - Adults—1 or 2 tablets 4 times a day for 2 to 3 weeks. One tablet contains 200 milligrams (mg) carisoprodol, 325 mg aspirin, and 16 mg codeine.
    - Children 12 years of age and older—Use and dose must be determined by your doctor.
    - Children younger than 12 years of age—Should not be used in these patients.
  - Soma® with codeine:
    - Adults—1 or 2 tablets four times a day. One tablet contains 200 milligrams (mg) carisoprodol, 325 mg aspirin, and 16 mg codeine.
    - Children younger than 16 years of age—Use and dose must be determined by your child's doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of the carisoprodol, aspirin, codeine tablet, skip the missed dose and go back to your regular dosing schedule.

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 progress at regular visits, especially within the first 24 to 72 hours of treatment to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.

If your condition does not improve or becomes worse, check with your doctor. Do not use this medicine for more than 2 to 3 weeks (14 to 21 days) to treat pain unless your doctor told you to.

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.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

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

This medicine may make you dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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 will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or 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, medicine for seizures or barbiturates, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of bleeding problems if you drink 3 or more alcoholic beverages per day while you are taking aspirin. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

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: bigger, dilated, or enlarged pupils (black part of eye), blurred vision, change in consciousness, confusion, difficult or trouble breathing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, false or unusual sense of well-being, increased sensitivity of the eyes to light, irregular, fast or slow, or shallow breathing, loss of consciousness, pale or blue lips, fingernails, or skin, sweating, uncontrolled eye movements, unusual tiredness or weakness.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. You may need to gradually reduce your dose before stopping it completely. This will decrease your chance of having withdrawal symptoms, including stomach cramps, hallucinations, headache, muscle twitching, tremors, trouble sleeping, or vomiting.

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

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.

This medicine may also cause a serious allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

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).

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 using 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 or hospital emergency room 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 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 narcotics (eg, codeine) 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 give aspirin to a child or teenager who has chickenpox or flu symptoms, unless approved by a doctor. Aspirin can cause a life-threatening reaction called Reye syndrome.

Using too much of this medicine may cause 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 (eg, St John's wort) 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:

More common: Burning feeling in the chest or stomach; indigestion; stomach upset; tenderness in the stomach area

Less common: Chest tightness; cough; difficult or trouble breathing; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals; noisy breathing; shakiness and unsteady walk; unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known: Chills; cold sweats; confusion; continuing ringing or buzzing or other unexplained noise in the ears; darkening of the skin; diarrhea; difficulty with swallowing; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; fast, pounding, or irregular heartbeat or pulse; flushing or redness of the skin; hearing loss; hives, itching, skin rash; loss of appetite; painful or difficult urination; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; sore throat; sores, ulcers, or white spots on the lips or in the mouth; swollen glands; unusual bleeding or bruising; unusual tiredness or weakness; unusually warm skin

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

Symptoms of overdose: Agitation or combativeness; anxiety; black, tarry stools; bloody stools; blue lips and fingernails; change in consciousness; cold, clammy skin; confusion as to time, place, or person; coughing that sometimes produces a pink frothy sputum; decreased awareness or responsiveness; decreased urination; depression; diarrhea; difficult, fast, or noisy breathing; difficulty with sleeping; disorientation; drowsiness to profound coma; dry mouth; expressed fear of impending death; extremely high fever or body temperature; fainting; fast or deep breathing; fast, weak pulse; headache; holding false beliefs that cannot be changed by fact; inability to move the eyes; increased blinking or spasms of the eyelid; irregular, fast or slow, or shallow breathing; loss of consciousness; loss of strength or energy; mood or other mental changes; muscle cramps, pain, or weakness; nausea; pale or blue lips, fingernails, or skin; pale, clammy skin; pinpoint pupils; seeing, hearing, or feeling things that are not there; severe sleepiness; sticking out of the tongue; sunken eyes; sweating; swelling in the legs and ankles; thirst; uncontrolled twisting movements of the neck, trunk, arms, or legs; unusual drowsiness, dullness, or feeling of sluggishness; unusual excitement, nervousness, or restlessness; unusual facial expressions; vomiting; vomiting of blood or material that looks like coffee grounds; weakness of the arms and legs; wrinkled skin

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

Less common: Feeling of constant movement of self or surroundings; sensation of spinning

Rare: Deep or fast breathing with dizziness; numbness of the feet, hands, and around the mouth; irritability; shaking; trouble sleeping

Incidence not known: Constipation; constricted, pinpoint, or small pupils (black part of the eye); relaxed and calm feeling

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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