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Acetaminophen and Propoxyphene Brand Names
Balacet | Darvocet A500 | Darvocet-N 100 | Darvocet-N 50 | Propacet
What is Acetaminophen and Propoxyphene
Acetaminophen and propoxyphene are used together to treat moderate to severe pain due to dental procedures, headache, back pain, and arthralgias and myalgias.
Acetaminophen is a non-salicylate analgesic with similar analgesic potency as NSAIDs, and propoxyphene is an oral synthetic opiate agonist structurally similar to methadone.
The combination of acetaminophen and propoxyphene produces additive analgesia as compared to the same doses of either agent alone.
Combinations containing higher doses of one or both components give progressively increasing analgesia. However, dosage escalation of this combination is limited by the side effects of propoxyphene and the toxicity and ‘ceiling effect’ of acetaminophen.
The combination of acetaminophen and opioid analgesics may achieve a ‘dose-sparing’ effect such that lower doses of both agents produce pain relief with fewer side effects.
The acetaminophen; propoxyphene napsylate combination (650mg; 100 mg and 325 mg; 50 mg) was originally FDA-approved in December 1972. A combination of acetaminophen 650 mg; propoxyphene hydrochloride 65 mg was approved in September of 1976, acetaminophen 500 mg; propoxyphene napsylate 100 mg in September 2003, and acetaminophen 325 mg; propoxyphene napsylate 100 mg in May 2004.
In the U.K., a phased withdrawal of the combination product of paracetamol and dextropropoxyphene was decided by the Medicines and Healthcare products Regulatory Agency in 2005. Cardiac abnormalities have been associated with propoxyphene use in post-marketing experience of over-dose cases and in targeted safety studies of therapeutic use conducted in 2009—2010 (see Adverse Reactions).
As a result, the FDA requested a market withdrawal of all products containing propoxyphene in November 2010 stating that propoxyphene risks outweigh its benefits.
Indications
- arthralgia
- bone pain
- dental pain
- headache
- migraine
- mild pain
- moderate pain
- myalgia
NOTE: In November 2010, the FDA requested a market withdrawal of all products containing propoxyphene stating that propoxyphene risks outweigh its benefits. Health care providers are encouraged to stop prescribing propoxyphene products and patients are encouraged to contact their prescribers for alternative therapy.
Side Effects
- abdominal pain
- acute generalized exanthematous pustulosis (AGEP)
- agranulocytosis
- anaphylactic shock
- anaphylactoid reactions
- angioedema
- anorexia
- anxiety
- arrhythmia exacerbation
- bleeding
- blurred vision
- bradycardia
- cardiac arrest
- cholestasis
- coma
- confusion
- constipation
- contact dermatitis
- diaphoresis
- dizziness
- drowsiness
- dysphoria
- edema
- elevated hepatic enzymes
- encephalopathy
- erythema
- euphoria
- exfoliative dermatitis
- fever
- flushing
- hallucinations
- headache
- heart failure
- hemolysis
- hemolytic anemia
- hepatic necrosis
- hypoprothrombinemia
- interstitial nephritis
- jaundice
- maculopapular rash
- methemoglobinemia
- myocardial infarction
- nausea
- neonatal abstinence syndrome
- neutropenia
- orthostatic hypotension
- palpitations
- pancytopenia
- physiological dependence
- pruritus
- psychosis
- purpura
- QT prolongation
- rash
- renal failure (unspecified)
- renal papillary necrosis
- renal tubular necrosis
- respiratory depression
- restlessness
- seizures
- sinus tachycardia
- syncope
- thrombocytopenia
- thrombocytosis
- tolerance
- toxic epidermal necrolysis
- urticaria
- vomiting
- withdrawal
Monitoring Parameters
- LFTs
- serum creatinine/BUN
Contraindications
- abrupt discontinuation
- acetaminophen hypersensitivity
- alcoholism
- anemia
- asthma
- bladder obstruction
- bone marrow suppression
- breast-feeding
- cardiac arrhythmias
- cardiac disease
- children
- chronic obstructive pulmonary disease (COPD)
- constipation
- diarrhea
- driving or operating machinery
- G6PD deficiency
- geriatric
- GI disease
- GI obstruction
- head trauma
- hepatic disease
- hepatitis
- hypovolemia
- ileus
- immunosuppression
- increased intracranial pressure
- infants
- infection
- inflammatory bowel disease
- labor
- lactase deficiency
- neonates
- obstetric delivery
- oliguria
- opiate agonist hypersensitivity
- potential for overdose or poisoning
- pregnancy
- prostatic hypertrophy
- pulmonary disease
- QT prolongation
- renal disease
- renal failure
- renal impairment
- respiratory depression
- seizure disorder
- substance abuse
- suicidal ideation
- tobacco smoking
- ulcerative colitis
- urethral stricture
- urinary retention
Interactions
- Abacavir; Lamivudine, 3TC; Zidovudine, ZDV
- Acetaminophen; Aspirin, ASA; Caffeine
- Acetaminophen; Butalbital
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
- Acetaminophen; Dextromethorphan; Doxylamine
- Acetaminophen; Diphenhydramine
- Acetaminophen; Hydrocodone
- Acetaminophen; Oxycodone
- Acetaminophen; Pentazocine
- Acetaminophen; Tramadol
- Acrivastine; Pseudoephedrine
- Aldesleukin, IL-2
- Aliskiren; Amlodipine
- Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
- Alogliptin; Metformin
- Alosetron
- Alpha-glucosidase Inhibitors
- Alvimopan
- Amide local anesthetics
- Amifampridine
- Amiodarone
- Amitriptyline
- Amitriptyline; Chlordiazepoxide
- Amlodipine
- Amlodipine; Atorvastatin
- Amlodipine; Benazepril
- Amlodipine; Celecoxib
- Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
- Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
- Amlodipine; Olmesartan
- Amlodipine; Telmisartan
- Amlodipine; Valsartan
- Amobarbital
- Amoxapine
- Antacids
- Anxiolytics; Sedatives; and Hypnotics
- Apomorphine
- Apraclonidine
- Aprepitant, Fosaprepitant
- Artemether; Lumefantrine
- Articaine; Epinephrine
- Aspirin, ASA
- Aspirin, ASA; Butalbital; Caffeine
- Aspirin, ASA; Butalbital; Caffeine; Codeine
- Aspirin, ASA; Caffeine; Dihydrocodeine
- Aspirin, ASA; Caffeine; Orphenadrine
- Aspirin, ASA; Carisoprodol
- Aspirin, ASA; Carisoprodol; Codeine
- Aspirin, ASA; Citric Acid; Sodium Bicarbonate
- Aspirin, ASA; Dipyridamole
- Aspirin, ASA; Omeprazole
- Aspirin, ASA; Oxycodone
- Aspirin, ASA; Pravastatin
- Atropine; Difenoxin
- Atropine; Diphenoxylate
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Azelastine
- Azelastine; Fluticasone
- Barbiturates
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Benzodiazepines
- Benzonatate
- Benzphetamine
- Bethanechol
- Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
- Bismuth Subsalicylate
- Bismuth Subsalicylate; Metronidazole; Tetracycline
- Boceprevir
- Brimonidine
- Brimonidine; Brinzolamide
- Brimonidine; Timolol
- Brompheniramine
- Brompheniramine; Carbetapentane; Phenylephrine
- Brompheniramine; Dextromethorphan; Guaifenesin
- Brompheniramine; Guaifenesin; Hydrocodone
- Brompheniramine; Hydrocodone; Pseudoephedrine
- Brompheniramine; Pseudoephedrine
- Bupivacaine
- Bupivacaine Liposomal
- Bupivacaine; Lidocaine
- Buprenorphine
- Buprenorphine; Naloxone
- Bupropion
- Bupropion; Naltrexone
- Buspirone
- Busulfan
- Butabarbital
- Butorphanol
- Canagliflozin; Metformin
- Carbamazepine
- Carbetapentane; Chlorpheniramine
- Carbetapentane; Chlorpheniramine; Phenylephrine
- Carbetapentane; Diphenhydramine; Phenylephrine
- Carbetapentane; Guaifenesin
- Carbetapentane; Guaifenesin; Phenylephrine
- Carbetapentane; Phenylephrine
- Carbetapentane; Phenylephrine; Pyrilamine
- Carbetapentane; Pseudoephedrine
- Carbetapentane; Pyrilamine
- Carbinoxamine
- Carbinoxamine; Dextromethorphan; Pseudoephedrine
- Carbinoxamine; Hydrocodone; Phenylephrine
- Carbinoxamine; Hydrocodone; Pseudoephedrine
- Carbinoxamine; Phenylephrine
- Carbinoxamine; Pseudoephedrine
- Cariprazine
- Carvedilol
- Cetirizine
- Cetirizine; Pseudoephedrine
- Cevimeline
- Charcoal
- Chlophedianol; Dexbrompheniramine
- Chlophedianol; Dexchlorpheniramine; Pseudoephedrine
- Chloral Hydrate
- Chlorcyclizine
- Chloroprocaine
- Chlorpheniramine
- Chlorpheniramine; Codeine
- Chlorpheniramine; Dextromethorphan
- Chlorpheniramine; Dextromethorphan; Phenylephrine
- Chlorpheniramine; Dihydrocodeine; Phenylephrine
- Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
- Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
- Chlorpheniramine; Hydrocodone
- Chlorpheniramine; Hydrocodone; Phenylephrine
- Chlorpheniramine; Hydrocodone; Pseudoephedrine
- Chlorpheniramine; Phenylephrine
- Chlorpheniramine; Pseudoephedrine
- Chlorpromazine
- Chlorthalidone; Clonidine
- Cholestyramine
- Choline Salicylate; Magnesium Salicylate
- Cimetidine
- Citalopram
- Class IC Antiarrhythmics
- Clemastine
- Clomipramine
- Clonidine
- Clopidogrel
- Clozapine
- Codeine; Phenylephrine; Promethazine
- Codeine; Promethazine
- Crofelemer
- Cyclizine
- Cyclobenzaprine
- Cyproheptadine
- Dapagliflozin; Metformin
- Dapsone
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Delavirdine
- Desflurane
- Desipramine
- Desmopressin
- Dexchlorpheniramine
- Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine
- Dexmedetomidine
- Dexpanthenol
- Dextromethorphan; Diphenhydramine; Phenylephrine
- Dextromethorphan; Promethazine
- Dextromethorphan; Quinidine
- Diflunisal
- Dimenhydrinate
- Diphenhydramine
- Diphenhydramine; Hydrocodone; Phenylephrine
- Diphenhydramine; Ibuprofen
- Diphenhydramine; Naproxen
- Diphenhydramine; Phenylephrine
- Dorzolamide; Timolol
- Doxepin
- Doxercalciferol
- Doxylamine
- Doxylamine; Pyridoxine
- Dronabinol
- Drospirenone; Ethinyl Estradiol
- Drospirenone; Ethinyl Estradiol; Levomefolate
- Dutasteride; Tamsulosin
- Efavirenz
- Efavirenz; Emtricitabine; Tenofovir
- Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
- Eltrombopag
- Eluxadoline
- Empagliflozin; Linagliptin; Metformin
- Empagliflozin; Metformin
- Enflurane
- Ertugliflozin; Metformin
- Escitalopram
- Esketamine
- Estrogens
- Eszopiclone
- Ethanol
- Ethinyl Estradiol
- Ethinyl Estradiol; Desogestrel
- Ethinyl Estradiol; Ethynodiol Diacetate
- Ethinyl Estradiol; Etonogestrel
- Ethinyl Estradiol; Levonorgestrel
- Ethinyl Estradiol; Levonorgestrel; Ferrous bisglycinate
- Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate
- Ethinyl Estradiol; Norelgestromin
- Ethinyl Estradiol; Norethindrone
- Ethinyl Estradiol; Norethindrone Acetate
- Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate
- Ethinyl Estradiol; Norethindrone; Ferrous fumarate
- Ethinyl Estradiol; Norgestimate
- Ethinyl Estradiol; Norgestrel
- Ethotoin
- Etomidate
- Exenatide
- Fesoterodine
- Flibanserin
- Fluoxetine
- Fluoxetine; Olanzapine
- Fluphenazine
- Fosphenytoin
- Gabapentin
- Glipizide
- Glipizide; Metformin
- Glyburide; Metformin
- Guaifenesin; Hydrocodone
- Guaifenesin; Hydrocodone; Pseudoephedrine
- Guanabenz
- Guanfacine
- Haloperidol
- Halothane
- Homatropine; Hydrocodone
- Hydantoins
- Hydrochlorothiazide, HCTZ; Methyldopa
- Hydrochlorothiazide, HCTZ; Metoprolol
- Hydrochlorothiazide, HCTZ; Propranolol
- Hydrochlorothiazide, HCTZ; Spironolactone
- Hydrocodone
- Hydrocodone; Ibuprofen
- Hydrocodone; Phenylephrine
- Hydrocodone; Potassium Guaiacolsulfonate
- Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
- Hydrocodone; Pseudoephedrine
- Hydromorphone
- Hydroxyprogesterone
- Ibuprofen; Oxycodone
- Iloperidone
- Imatinib
- Imipramine
- Indinavir
- Insulin Glargine; Lixisenatide
- Insulins
- Isavuconazonium
- Isocarboxazid
- Isoflurane
- Isoniazid, INH
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Itraconazole
- Ixabepilone
- Ketamine
- Ketoconazole
- Lamivudine, 3TC; Zidovudine, ZDV
- Lamotrigine
- Lanthanum Carbonate
- Levobupivacaine
- Levocetirizine
- Lidocaine
- Lidocaine; Prilocaine
- Linagliptin; Metformin
- Lincosamides
- Lisdexamfetamine
- Lixisenatide
- Lomitapide
- Loperamide
- Loperamide; Simethicone
- Lopinavir; Ritonavir
- Loxapine
- Lumateperone
- Lurasidone
- Magnesium Salicylate
- Magnesium Salts
- Maprotiline
- Maraviroc
- Meglitinides
- Meperidine; Promethazine
- Mephobarbital
- Mepivacaine
- Mepivacaine; Levonordefrin
- Meprobamate
- Mesoridazine
- Metformin
- Metformin; Pioglitazone
- Metformin; Repaglinide
- Metformin; Rosiglitazone
- Metformin; Saxagliptin
- Metformin; Sitagliptin
- Methadone
- Methamphetamine
- Methohexital
- Methyldopa
- Metoprolol
- Metyrapone
- Metyrosine
- Mexiletine
- Minocycline
- Mipomersen
- Mirtazapine
- Mitotane
- Molindone
- Nabilone
- Nalbuphine
- Naloxone
- Naltrexone
- Nefazodone
- Nesiritide, BNP
- Nitroglycerin
- Nortriptyline
- Octreotide
- Olanzapine
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole; Amoxicillin; Rifabutin
- Omeprazole; Sodium Bicarbonate
- Oxycodone
- Oxymorphone
- Paliperidone
- Papaverine
- Peginterferon Alfa-2b
- Pegvisomant
- Penicillin G Benzathine; Penicillin G Procaine
- Penicillin G Procaine
- Pentazocine
- Pentazocine; Naloxone
- Pentobarbital
- Perindopril; Amlodipine
- Perphenazine
- Perphenazine; Amitriptyline
- Phenelzine
- Phenobarbital
- Phenothiazines
- Phenylephrine; Promethazine
- Phenytoin
- Pimozide
- Pneumococcal Vaccine, Polyvalent
- Posaconazole
- Pramlintide
- Prasugrel
- Pregabalin
- Prilocaine
- Prilocaine; Epinephrine
- Primidone
- Procaine
- Procarbazine
- Prochlorperazine
- Promethazine
- Propranolol
- Protriptyline
- Quetiapine
- Quinidine
- Quinine
- Ranolazine
- Rasagiline
- Rifabutin
- Rifampin
- Risperidone
- Ritonavir
- Ropinirole
- Ropivacaine
- Safinamide
- Salsalate
- Saquinavir
- Secobarbital
- Segesterone Acetate; Ethinyl Estradiol
- Selegiline
- Sevoflurane
- Sildenafil
- Sodium Bicarbonate
- Sodium Oxybate
- Spironolactone
- St. John’s Wort, Hypericum perforatum
- Sulfinpyrazone
- Tamsulosin
- Tapentadol
- Telaprevir
- Telotristat Ethyl
- Terbinafine
- Tetrabenazine
- Tetracaine
- Thalidomide
- Thiazolidinediones
- Thiethylperazine
- Thiopental
- Thioridazine
- Thiothixene
- Ticagrelor
- Timolol
- Tipranavir
- Tizanidine
- tobacco
- Tolterodine
- Tramadol
- Tranylcypromine
- Trazodone
- Tricyclic antidepressants
- Trifluoperazine
- Trimethobenzamide
- Trimetrexate
- Trimipramine
- Triprolidine
- Trospium
- Valerian, Valeriana officinalis
- Vemurafenib
- Vigabatrin
- Vilazodone
- Vinblastine
- Warfarin
- Zaleplon
- Ziconotide
- Zidovudine, ZDV
- Ziprasidone
- Zolmitriptan
- Zolpidem
