Butalbital, aspirin, caffeine, and codeine (Oral route)

Pronunciation:

bue-TAL-bi-tal, AS-pir-in, KAF-een, KOE-deen FOS-fate

Brand Names:

Ascomp w/Codeine
Fiorinal w/Codeine
Fiorinal-C 1/2
Fiorinal-C 1/4
Teva-Tecnal C1/2
Teva-Tecnal C1/4
Trianal C1/2
Trianal C1/4

Dosage Forms:

Capsule

Warnings:

Oral route(Capsule)

Addiction, Abuse, and Misuse:Butalbital/aspirin/caffeine/codeine phosphate 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 codeine sulfate, 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 butalbital/aspirin/caffeine/codeine phosphate. Monitor for respiratory depression, especially during initiation of butalbital/aspirin/caffeine/codeine phosphate or following a dose increase.Accidental Ingestion:Accidental ingestion of even one dose of butalbital/aspirin/caffeine/codeine phosphate, especially by children, can result in a fatal overdose of butalbital/aspirin/caffeine/codeine phosphate.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 butalbital/aspirin/caffeine/codeine phosphate 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.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. Butalbital/aspirin/caffeine/codeine phosphate 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 butalbital/aspirin/caffeine/codeine phosphate in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeineNeonatal Opioid Withdrawal Syndrome:Prolonged use of butalbital/aspirin/caffeine/codeine phosphate 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 butalbital/aspirin/caffeine/codeine phosphate requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine .

Classifications:

Therapeutic—

Opioid/Barbiturate Combination

Pharmacologic—

Barbiturate

Chemical—

Salicylate, Aspirin

Uses of This Medicine:

Butalbital, aspirin, caffeine, and codeine combination is used to relieve symptoms of tension (or muscle contraction) headaches. Extended and repeated use of this product is not recommended.

Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.

Aspirin is used to relieve pain and reduce fever in patients. It belongs to the group of medicines known as salicylates and acts on the immune system to reduce inflammation. It is also known as an anti-inflammatory analgesic.

Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. Codeine belongs to the group of medicine called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When butalbital or codeine is used for a long time or in large doses, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects when you suddenly stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

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 butalbital, aspirin, caffeine, and codeine combination in the pediatric population. It should not be used in children younger than 12 years of age. Safety and efficacy have not been established.

Fiorinal® with codeine should not be used to relieve pain after surgery removal of 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 butalbital, aspirin, caffeine, and codeine 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 this medicine.

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
Procarbazine
Rasagiline
Riociguat
Safinamide
Samidorphan
Selegiline
Toloxatone
Tranylcypromine
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.

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
Barbital
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
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Canrenoate
Canrenone
Caplacizumab-yhdp
Capmatinib
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
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
Doxorubicin
Doxorubicin Hydrochloride Liposome
Doxylamine
Dronedarone
Droperidol
Drospirenone
Droxicam
Duloxetine
Edoxaban
Efavirenz
Elagolix
Eletriptan
Emtricitabine
Enalapril
Enalaprilat
Enflurane
Enoxaparin
Enzalutamide
Eplerenone
Eptifibatide
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Eterobarb
Ethacrynic Acid
Ethchlorvynol
Ethinyl Estradiol
Ethopropazine
Ethylmorphine
Etodolac
Etofenamate
Etonogestrel
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
Givosiran
Glimepiride
Glipizide
Glyburide
Glycopyrrolate
Glycopyrronium Tosylate
Gossypol
Granisetron
Halazepam
Halcinonide
Halobetasol
Haloperidol
Halothane
Heparin
Heptabarbital
Hexobarbital
Homatropine
Hydrochlorothiazide
Hydrocodone
Hydrocortisone
Hydroflumethiazide
Hydromorphone
Hydroxytryptophan
Hydroxyzine
Hyoscyamine
Ibrutinib
Ibuprofen
Idelalisib
Imatinib
Imipramine
Indapamide
Indinavir
Indomethacin
Inotersen
Iobenguane I 131
Ipratropium
Isocarboxazid
Isoflurane
Itraconazole
Ivacaftor
Kanamycin
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Ketoprofen
Lacosamide
Larotrectinib
Lasmiditan
Lemborexant
Lenacapavir
Lepirudin
Letermovir
Levocetirizine
Levomilnacipran
Levorphanol
Linezolid
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
Methadone
Methamphetamine
Methazolamide
Methdilazine
Methocarbamol
Methohexital
Methotrexate
Methotrimeprazine
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Methylene Blue
Methylprednisolone
Metoclopramide
Metolazone
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirabegron
Mirtazapine
Mitotane
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Moexipril
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Moricizine
Morniflumate
Morphine
Morphine Sulfate Liposome
Nabumetone
Nadroparin
Nafcillin
Nalbuphine
Naproxen
Naratriptan
Nateglinide
Nefazodone
Nelfinavir
Neomycin
Nepafenac
Netilmicin
Netupitant
Nevirapine
Nicomorphine
Nicorandil
Nifedipine
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Nitrazepam
Nitrous Oxide
Nordazepam
Norethindrone
Norgestimate
Norgestrel
Nortriptyline
Olanzapine
Oliceridine
Omaveloxolone
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxaprozin
Oxazepam
Oxcarbazepine
Oxitropium Bromide
Oxybutynin
Oxycodone
Oxymorphone
Oxyphenbutazone
Ozanimod
Palbociclib
Palonosetron
Papaveretum
Paramethasone
Parecoxib
Paregoric
Parnaparin
Paromomycin
Paroxetine
Pemetrexed
Pentazocine
Pentobarbital
Pentosan Polysulfate Sodium
Pentoxifylline
Perampanel
Perazine
Periciazine
Perindopril
Perphenazine
Phenelzine
Phenindione
Phenobarbital
Phenprocoumon
Phenylbutazone
Phenytoin
Piketoprofen
Pinazepam
Pipenzolate Bromide
Piperacetazine
Piperaquine
Pipotiazine
Piracetam
Pirenzepine
Piretanide
Piritramide
Piroxicam
Pixantrone
Plazomicin
Polythiazide
Posaconazole
Potassium Citrate
Potassium Oxybate
Pranoprofen
Prasugrel
Prazepam
Prednicarbate
Prednisolone
Prednisone
Pregabalin
Primidone
Procarbazine
Prochlorperazine
Procyclidine
Proglumetacin
Promazine
Promethazine
Propantheline
Propiverine
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
Safinamide
Salicylic Acid
Salsalate
Saquinavir
Scopolamine
Secobarbital
Selegiline
Selumetinib
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
Sodium Salicylate
Solifenacin
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
Tolazamide
Tolbutamide
Tolfenamic Acid
Tolmetin
Tolonium Chloride
Tolterodine
Topiramate
Torsemide
Tramadol
Trandolapril
Tranylcypromine
Trazodone
Treprostinil
Triamcinolone
Triamterene
Triazolam
Trichlormethiazide
Trifluoperazine
Trifluperidol
Triflupromazine
Trihexyphenidyl
Trimeprazine
Trimipramine
Tropicamide
Trospium
Tryptophan
Turmeric
Ulipristal
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
Ospemifene
Oxprenolol
Penbutolol
Pindolol
Prednisone
Probenecid
Propranolol
Sotalol
St John's Wort
Streptokinase
Tamarind
Temocapril
Tenecteplase
Timolol
Warfarin

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
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 (an adrenal problem) or
Alcohol abuse, or history of or
Brain tumor, history of or
Breathing problems (eg, COPD, hypercapnia, hypoxia, sleep apnea) or
Cor pulmonale (serious heart condition) or
Depression, or history of or
Drug dependence, especially with narcotic abuse or dependence, or history of or
Enlarged prostate or
Head injury, or history of or
Hypothyroidism (underactive thyroid) or
Increased pressure in the head or
Obesity (overweight) or
Stomach or digestion problems or
Trouble urinating or
Weakened physical condition—Use with caution. May increase risk for more serious side effects.

Asthma with nasal polyps and rhinitis, history of or
Hemophilia (bleeding problem) or
Hypoprothrombinemia (low prothrombin in the blood) or
Liver damage, severe or
Lung or breathing problems (eg, asthma, respiratory depression), severe or
Porphyria (enzyme problem) or
Reye's syndrome or
Stomach or bowel problems (eg, paralytic ileus, peptic ulcer, lesions) or
Surgery (eg, nasopharyngeal tonsils, tonsils) or
Thrombasthenia (a platelet disorder) or
Thrombocytopenia (low platelets in the blood) or
Vitamin K deficiency or
von Willebrand's disease (blood clotting disorder)—Should not be used in patients with these conditions.

Chicken pox or
Flu—Use with caution. May increase risk of having a condition called Reye's syndrome.

Gallbladder problems or
Hypotension (low blood pressure) or
Pancreatitis (swelling of the pancreas) or
Seizures, history of or—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 too much of this medicine is taken for a long time, it 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 butalbital, aspirin, caffeine, 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.

Drink plenty of fluids to help avoid constipation.

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 tension headaches:
  - Adults—1 or 2 capsules every 4 hours as needed. Do not take more than 6 capsules per day.
  - 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.

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.

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 take 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.

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

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.

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 using 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 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.

Aspirin may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, hives, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth 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. Call your doctor for instructions.

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 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).

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.

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).

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using 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: cold, clammy skin, coughing that sometimes produces a pink frothy sputum, seizures, 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, swelling in the legs and ankles, or trouble sleeping.

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.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by 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 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:

Rare: Back, leg, or stomach pains; black, tarry stools; bleeding gums; blistering, peeling, or loosening of the skin; bloody urine; blurred vision; chest pain or tightness; chills; confusion; cough; dark urine; decreased frequency or amount of urine; diarrhea; difficulty breathing; difficulty swallowing; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; fast, irregular, pounding, or racing heartbeat or pulse; fever; general tiredness and weakness; headache; hives, itching, or skin rash; increased thirst; joint or muscle pain; light-colored stools; lower back or side pain; nausea; nosebleeds; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; red skin lesions, often with a purple center; red, irritated eyes; shakiness in the legs, arms, hands, or feet; sores, ulcers, or white spots in the mouth or on the lips; sweating; swelling of the face, fingers, or lower legs; trembling or shaking of the hands or feet; upper right abdominal or stomach pain; vomiting; vomiting blood; weight gain; yellow eyes and skin

Incidence not known: Agitation; bloody nose; confusion; constricted, pinpoint, or small pupils (black part of the eye); darkening of the skin; loss of appetite; mental depression; overactive reflexes; poor coordination; restlessness; seeing, hearing, or feeling things that are not there; shivering; trouble sleeping; twitching; unusual tiredness or weakness

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

Symptoms of overdose: Cold and clammy skin; confusion as to time, place, or person; continuing ringing or buzzing or other unexplained noise in the ears; coughing that sometimes produces a pink frothy sputum; difficult or trouble breathing; drowsiness; extremely high fever or body temperature; hearing loss; holding false beliefs that cannot be changed by fact; increased sweating; irregular, fast or slow, or shallow breathing; loss of consciousness; muscle cramps; pale or blue lips, fingernails, or skin; pinpoint pupils (black part of the eyes); restlessness; seeing, hearing, or feeling things that are not there; seizures; swelling in the legs and ankles; trouble sleeping; unusual bleeding or bruising

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:

Rare: Anxiety; blurred vision; burning, tingling, numbness, or pain in the hands, arms, feet, or legs; confusion about identity, place, and time; constricted, pinpoint, or small pupils (black part of the eye); deep or fast breathing with dizziness; depression; difficulty having a bowel movement; dry mouth; feeling of constant movement of self or surroundings; feeling of warmth; feeling that others are watching you or controlling your behavior; feeling that others can hear your thoughts; heartburn; high energy; irregular heartbeat; irritability; loss in sexual ability, desire, drive, or performance; numbness of the feet, hands, and around mouth; pain in the legs; redness of the face, neck, arms, and occasionally, upper chest; sensation of spinning; severe mood or mental changes; shaking; sleepiness; sluggishness; slurred speech; trouble sitting still; unexplained weight loss; unusual behavior; weakness

Incidence not known: Decreased interest in sexual intercourse; inability to have or keep an erection; loss in sexual ability, desire, drive, or performance

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: 4/24/2024

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