Drug with two or more active ingredients
This article is about combination drugs and polypills as treatments. For two synergistic drugs chemically linked together, see
codrug . For use of multiple separate and individual drugs for treatment, see
polypharmacy .
Acombination drug is most simply defined asachemical composition of at least twodrugs combined in a singledosage form , typically as atablet orcapsule to beadministered orally , anelixir ortincture (sublingual ), aninjectable suspension (intramuscular administration orintravenous therapy ), or asuppository (rectal ). A legitimate combination drug that exceeds rigorous laboratory quality standards and isapproved for medical use is a safe option for treating multiplesymptoms ordiseases amongst various patients within a large population–and this includes combinations ofover-the-counter medicine and/or ofprescription drugs . Whenmedications are paired withsupplements [disambiguation needed , consumers can be certain of accurate dosing and ingredient labeling, as well as product quality as it would be regulated and manufactured as a medication and must meet rigorous standards of pharmaceutical quality.
Apolypill is specifically formulated as apill containing four or more active ingredients,[ 1] [ 2] compounding pharmacy in order to meet the personalized specifications deemed necessary by a patient'smedical prescription . Such specificities may include uncommon, unconventional, or unavailabledosage ,dosage form , amodified release mechanism , and necessity for a particularspeed of onset and/orduration of action . Polypills can encompass four or more of any combination ofapproved prescription drugs andover the counter drugs, and may also includenutritional supplements ,amino acids ,enzymes ,hormones ,vitamins and/oressential minerals .[ 3]
Fixed-dose combination drugs were initially developed to target a single disease, as withantiretroviral FDCs indicated for treatingAIDS andHIV .[ 4] pill burden and increasedpatient compliance by offeringaccessible and affordable ingredients, generallygeneric drugs with established therapeutic efficacy, and the ability to treat a variety of symptoms and conditions amongst a large patient population with varying treatment needs.
Current prescription combination drugs [ edit ] The combination drugs listed below are universallyavailable by prescription only , but specific circumstances regarding a given combination's legal accessibility, or any specific regulation pertinent to ingredient quality, quantities, production standards, sourcing, etc. will vary by jurisdictions, and include:[ 5]
amitriptyline (tricyclic antidepressant ) andperphenazine (typical antipsychotic ),Triavil amitriptyline andchlordiazepoxide (benzodiazepine ),Limbitrol-H India ,[ 6] [ 7] [ 8] Bangladesh amlodipine (calcium channel blocker ) andbenazepril (ACE inhibitor),Lotrel amlodipine andatorvastatin (statin ),Conduet amlodipine andcelecoxib (nonsteroidal anti-inflammatory drug ),Consensai amlodipine andlisinopril (ACE inhibitor),Lisonorm amlodipine andolmesartan (ACE inhibitor),Azor amlodipine andvalsartan (ACE inhibitor),Exforge amphetamine (stimulant ) racemic salt mixture, combining the enantiomerdextroamphetamine (sulfate anssaccharate bonds) and thestereoisomer levoamphetamine (sulfate andaspartate monohydrate bonds),Adderall Shire Pharmaceuticals ,MyDayis with slightlyvarying formulation bupropion (norepinephrine-dopamine reuptake inhibitor ) andnaltrexone (opioid antagonist ),Contrave butalbital (barbiturate ) andcaffeine (methylxanthine ,Butapap butalbital, caffeine, andaspirin (nonsteroidal anti-inflammatory ),Fiorinal butalbital, caffeine, andacetaminophen ,Fioricet butalbital, caffeine, acetaminophen, andcodeine (opioid ),Fioricet with Codeine calcipotriol/betamethasone dipropionate ,Dovobet byLEO Pharma .carbidopa/levodopa/entacapone (LCE) ,Stalevo ,Lecigon for infusion therapy in some European countrieschlordiazepoxide (benzodiazepine ) andclidinium bromide (anticholinergic ),Librax [ 9] [ 10] ephedrine (sympathomimetic ) andethylmorphine (opioid)Lephotan flupentixol (typical antipsychotic ) andmelitracen (tricyclic antidepressant ), available outside of the U.S. asDeanxit Lundbeck hydrocodone bitartrate (opioid agonist , tablet) and acetaminophen,Vicodin AbbVie contains 325 mg acetaminophen as a tablet, currently the only brand form in theUnited States .Norco is a tablet containing 300 mg acetaminophen, with limited availability in select countries.[ 11] LorTab byUCB is now solely available as asyrup in the U.S.[ 12] hydrocodone and aspirin,Azdone hydrocodone andguaifenesin (expectorant ),Obedron Flowtuss hydrocodone andibuprofen (nonsteroidal anti-inflammatory]])NSAID),Ibudone ibuprofen and acetaminophenintravenous solution ,Maxigesic IV [ 13] nirmatrelvir (antiviral ) andritonavir (antiviral), combination drug fortreatment and management of COVID-19 ),Paxlovid [ 14] omeprazole (proton pump inhibitor ),amoxicillin (antibiotic ), andrifabutin (anti-tuberculosis ),Talicia olanzapine (atypical antipsychotic ) andfluoxetine (selective serotonin reuptake inhibitor ),Symbyax oxycodone (opioid) and acetaminophen,Percocet oxycodone and aspirin,Percodan oxycodone andibuprofen (nonsteroidal anti-flammatory),Combunol phentermine (substituted amphetamine ,amphetamine derivative ) andtopiramate (antimigraine)Qsymia Vivus phenylephrine (sympathomimetic) and ketorolac (NSAID),Omidria [ 15] pseudoephedrine (sympathomimetic) andcarbinoxamine (anticholinergic),Rondec elixir [ 16] tramadol and paracetamol,Ultram Combination drugs accessible over the counter [ edit ] Combination drugs for saleover the counter (OTC) exist around the world, constituting doses that are tolerable to a mainstream consumer population. In theUnited States , items containingephedrine ,pseudoephedrine , orphenylpropanolamine can be purchased without aprescription , albeit under strict oversight and from behind the pharmacy counter, per theU.S. Federal drug law titled theCombat Methamphetamine Epidemic Act of 2005 .[ 17]
Anacin (aspirin; caffeine)tablet widely available since 1916[ 18] chlorpheniramine (first-generation antihistamine ) and phenylpropanolamine (sympathomimetic ),Vernate Injection byTutag Pharmaceuticals of New Jersey , liquid for intramuscular injection;[ 19] [ 20] [ 21] Tri-Nefrin , and a syrupelixir Altec Syrup , all available in Asia, all discontinued in U.S. by 2007. Coricidin byBayer , a line ofcough medicine combiningchlorpheniramine anddextromethorphan ; chlorpheniramine, dextromethorphan, guaifenesin, and acetaminophen isCoricidin Cold + Cough ; chlorpheniramine, phenylephrine, guaifenesin, and acetaminophen isCoricidin HBP High Blood Pressure [ 22] aspirin, caffeine, and acetaminophen,Excedrin [ 23] diphenhydramine and8-chlorotheophylline as anionic bond produce the compounddimenhydrinate ,Dramamine byGlaxoSmithKline .[ 24] [ 25] fenproporex anddiazepam ,Esbelcaps available inCentral andSouth America [ 26] fexofenadine andpseudoephedrine ,Allegra-D glucose ,fructose , andphosphoric acid ,Emetrol for Nausea guaifenesin and phenylephrine,Sudafed PE byMerck ibuprofen andfamotidine (proton pump inhibitor),Duexis [ 27] ibuprofen and diphenhydraminecitrate ,Advil PM loratadine andpseudoephedrine ,Claritin-D AstraZeneca naproxen sodium and diphenhydramine hydrochloride,Aleve PM [ 28] naproxen and pseudoephedrine,Aleve-D Toplexil Aventis , available indosage forms including tablet,tincture ,elixir andsuppository ,oxomemazine and guaifenesin, approved and available inFrance ,Algeria , andMorocco [ 29] Robitussin , a line ofcough medicine encompassing various combinations includingdextromethorphan , acetaminophen, chlorpheniramine, doxylamine succinate, and/or guaifenesin.Combination drugs under development [ edit ] Combination drugs for veterinary use [ edit ] Combinations no longer available [ edit ] Obetrol Abbott Laboratories was a mixture of methamphetamine and dextroamphetamine salts, discontinued 1973,[ 32] Oby-Rex , swapping methamphetamine forlevoamphetamine , the(s) isomer of racemic amphetamine.Tuinal AbbVie was a capsule containing amobarbital and secobarbital (double barbiturate); voluntarily discontinued by AbbVie in 2008 per widespreadsubstance abuse and decrease in prescriptions.[ 33] Phenephen byA.H. Robins combinedhyoscyamine sulfate,phenacetin , and aspirin; a separate formulation,Phenephen with Codeine contained the identical formula with the addition of codeine as a fourthactive ingredient .Pondimin ("fen-phen ") combinedfenfluramine andphentermine , discontinued 1997[ 34] Anxine [ 35] [ 36] mephenesin (muscle relaxant), 35 mgcyclobarbital , and 2.5 mg dextroamphetamineBama-Dex combined 5 mg dextroamphetamine and 400 mg meprobamate[ 37] Bontril Timed No. 1 combined 2.5 mg dextroamphetamine and 7.5 mg butabarbital[citation needed Bontril Timed No. 2 5 mg dexamphetamine and 15 mg butabarbital[ 39] Bontril Timed No. 3 10 mg dexamphetamine and 30 mg butabarbital[citation needed Bontril Timed No. 4 15 mg dexamphetamine with 60 mg butabarbital.[citation needed [ 40] Delcobese , racemic amphetamine molecule with each enantiomer bonded to sulfate andadipate , "withdrawn voluntarily in 1984, unrelated to safety or legal concerns"[ 41] Mandrax , a tablet combiningmethaqualone anddiphenhydramine (first-generation antihistamine ), only available inSouth Africa until 1993, "Lemmon (drug) " was a street name for diverted methaqualoneDexytal byEli Lilly , combination dextroamphetamine and amobarbitalelixir [dubious discuss [citation needed Mediatric combined twohormones (0.25 mgPremarin and 2.5 mgmethyltestosterone ) with 100 mgvitamin c ,b vitamins , and 1 mg methamphetamineEskatrol Smith, Kline & French combined dextroamphetamine andprochlorperazine (typical antipsychotic , discontinued 1981Daprisal tablet combined dextroamphetamine, amobarbital, and aspirinDexamyl Durophet was a racemic mixture of amphetamine salts combining combined 12.5 mg amphetamine and 400 mgmethaqualone (sedative-hypnotic ), discontinued 1984Durabond , tablet combining 8 mg chlorpheniraminetannate (first-generation antihistamine/FGA), 25 mgpyrilamine tannate (first-generation antihistamine), and "10 mgTanphetamin (racemic amphetamine tannate)""General Practice American Academy(20)" . 1959.Desbutal pentobarbital , discontinued 1973[ 32] NalerTan combined 12.5 mg dextroamphetaminetannate , 8 mg chlorpheniramine tannate, and 25 mgpyrilamine tannate (first-generation antihistamine)[ 42] [ 43] dextroamphetamine, amobarbital,methylcellulose , andnutritional supplements , brandedNexorin Obocell phosphate and 25 mgmethapyrilene phosphate (antihistamine);Obocell-TF was identical in composition with the addition of a high-viscosity methylcellulose supplement, also by Neisler and listed as "160 mgNitrin on the label)[ 44] OboTan-S: formerly SynaTan-S [ 45] [ 46] [ 47] tannate with 35 mg secobarbital[ 48] Obolip combined dextroamphetamine, phenobarbital,choline ,dimethionine , and methylcelluloseEuphoramin , 5 mg methamphetamine and 300 mgmeprobamate (non-barbiturate, barbiturate-adjacent GABergicminor tranquilizer Dysonil combined methamphetamine, pentobarbital, andsalicylamide (analgesic)Direcel combination dextroamphetamine, butabarbital,carboxymethylcellulose DuoDex , combinationbarbaloin (laxative),[ 49] GRAS [nor] effective forOTC use" upon theIARC classifying whole-leafherbal extracts ofaloe vera as "possibly carcinogenic to humans" due to presence oflatex .Phelantin combined 100 mgphenytoin (anticonvulsant), 32 mg pentobarbital, and 2.5 mg methamphetamine[ 50] Reladorm combined 100 mgcyclobarbitol and 10 mgdiazepam , previously available inRussia , discontinued 2019[ 51] Amphaplex 10 byLaderle combined 2.5 mg methamphetaminesaccharate , 2.5 mg methamphetaminehydrochloride , and 5 mg racemic amphetamine sulfate;Amphaplex 20 combined 5 mg methamphetamine saccharate, 5 mg methamphetamine hydrochloride, and 10 mg racemic amphetamine sulfate.[ 52] Amplus Now by Roehrig combined 5 mg dextroamphetamine sulfate with 5 mghydroxyzine (first-generation antihistamine)[ 53] [ 54] Amvicel combined 10 mg dextroamphetamine, 40 mgamobarbital , 15 mgphenobarbital , 30 mgnicotinamide , plusvitamins andessential minerals [ 55] Apamead combined dextroamphetamine sulfate, amobarbital, aspirin, phenacetinAmbar byWyeth Pharmaceuticals combinedmethamphetamine hydrochloride andphenobarbital ; available asAmbar Extentab inextended-release formulation Edrisal combined 160 mg aspirin, 160 mgphenacetin , 2.5 mg amphetamine sulfate;Edrisal with Codeine 160 mg aspirin, 160 mg phenacetin, 2.5 mg amphetamine sulfate, and 160 mgcodeine [citation needed Ethobral Triple-Barbiturate Tablets by Wyeth combined secobarbital,butobarbital , and phenobarbital[ 56] [ 57] Biphetamine by R.J. Strausenburgh (1964-66), byFisons (1966-79) (inscribedRJS ) containing equal parts dextroamphetamine and levoamphetamine. Later acquired by Fisons, then R.P. Rorer and rebrandedBiphetamine-T [ 58] [ 59] [ 60] [ 61] Lamital combined acetaminophen, amobarbital, and methamphetamineANOX capsule polypill combining a fixed dose of three barbiturate salts (20 mg each of phenobarbital,butabarbital , andsecobarbital ) and two amphetamine salts (7.5 mg each of methamphetamine hydrochloride and dextroamphetamine sulfate)[ 62] ANOX DiAmfet 5 modified-release dosage formulation of the above combination componentsJustification of medical use [ edit ] Most of the combination drugs which have been discontinued since the twentieth century were simultaneously indicated and utilized for treatment of various conditions, with medical use justified as part of a multifaceted, comprehensive approach to patient health care and medical treatment.Substituted amphetamines (stimulants) simultaneously functioned asappetite suppressant ,antidepressant , andeugeroic agents, also increasing mental alertness and concentration and physical stamina, while a GABAergic depressant (e.g. abarbiturate ,benzodiazepine ,antipsychotic , orquinazolone ) offeredtranquilizing ,muscle relaxant ,sedative properties to ease overstimulation, paranoia, anxiety without eliminating the stimulant's therapeutic benefits. Patients are empowered with the capability of alleviating symptoms of multiple medical conditions with the ingestion of a single dosage form, reducing the patient'spill burden and consistently showing improvedmedication compliance scores. TheAmerican Association of Orthodontists asserts that fixed-dose combinations "limit clinicians' ability to customize dosing regimens."[ 63]
Scientists formulating combination drugs face challenges in the development stages of multi-drug formulations such as compatibility issues among active ingredients and excipients affecting solubility and dissolution.[ 64] [ 65] [ 66]
Limitations of polypharmacy for multi-faceted disorders [ edit ] Obsessive-compulsive disorder ,social anxiety , andanxiety are all commonly likely tocomorbidity with tics; as such,polypharmacy necessitates secondary or even tertiary solutions to treat these aspects of theumbrella term : OCD alone is often resolvedclomipramine (atricyclic antidepressant ) anxietys with use of individualbenzodiazepines orSSRIs for the former two conditions, andfluvoxamine orclomipramine first-line treatments for OCD and related disorders, such ashoarding orcompulsive decluttering . But, whereAttention-Deficit Hyperactivity Disorder , depression, or insomnia become a primary concern to the patient, it is only through polypharmacy (in this case, adding another antidepressant or a "booster, alongside ahypnotic soporific agent, and/orpsychostimulants to both treat ADHD and counteract thesleep inertia , grogginess or hangover caused by the other evening medications).
Tourette's Syndrome is aneurological disorder , generally diagnosed and treated by aneurologist orpsychiatrist familiar withtic disorders . Tourette's most often involves chronic motor and vocal tics (described byNIH as "semi-voluntary" actions performed in response to apremonitory urge , an internal sensory phenomenon akin to a buildup of tension, only able to be alleviated upon releasing a tic.[ 67] typical antipsychotic ,pimozide , is specifically approved (as anorphan drug ) for this indication.[ 68] umbrella term that presents not just as chronic motor/physical and vocal/phonic tics; tics are nearly alwayscomorbid to symptoms ofobsessive-compulsive anxiety and/orsocial anxiety ,avoidant personality orschizoid personality ,ADHD , as well as insomnia, depression, andAsperger syndrome .clonidine andguanfacine are approved for ADHD, which often comorbid to Tourette's, but not necessarily guaranteed to reduce tics.
Illicit drug combinations [ edit ] Products sold as "powder cocaine " or "crack cocaine " are often found to contain very little, if any,coca alkaloids.ABC News has conducted severalinvestigative journalism analyses and metanalyses and have reported that the greatest concern with any illicit stimulant is that they include undetermined amounts ofdesigner drugs and/orresearch chemicals ; instead ofcocaine or pharmaceutical stimulants (e.g.amphetamines ,cocaine ) products are likely to containMDMA ,crystal meth , andcaffeine . Increasingly, the flesh-eating veterinary antibioticlevamisole has been found in "powder cocaine."[ 69]
Since the forced closure of so manypill mills in the U.S. beginning in 2007, ablack market for opioids has flourished and continuously expanded.[ 70] diacetylmorphine (Heroin) items being deceptively sold as such areadulterated by undeclared amounts of highly potentsynthetic opioids of questionable purity. Thedeath of Prince resulted from him unknowingly ingestingfentanyl in the form ofcounterfeit pills designed to resemble Percocet (oxycodone/acetaminophen ) tablets. These "pressed" pills are synthesized viaclandestine chemistry by untrained chemists and oftencut with agents including fentanyl,carfentanil , and as of September 2024,nitazenes .[ 71] [ 72]
Othercutting agents increasingly found in illicit supplies include the veterinary drugxylazine andsynthetic triazolobenzodiazepines ,bromazolam ,clobromazolam ,phenazolam , andflualprazolam .[ 73] U.S. Attorney General Pam Bondi stated a desire to regulate xylazine underU.S. federal drug law ) as aSchedule III controlled substance .[ 74] Michigan andNew York .[ 75] genericized trademark and street name for the illicit combination ofmethaqualone anddiphenhydramine , named after the pharmaceutical brand that was available by prescription inSouth Africa until 1993.[ 76] clandestine chemistry as afree base preparation, which is smoked for an intense, short-lived"high" .[ 77]
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