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| Clinical data | |
|---|---|
| Trade names | Selexid, Melysin, Coactabs, others |
| Other names | amdinocillin pivoxil (USANUS) |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624031 |
| License data | |
| Routes of administration | By mouth |
| ATC code | |
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| Pharmacokinetic data | |
| Bioavailability | Low |
| Protein binding | 5 to 10% (as mecillinam) |
| Metabolism | Pivmecillinam ishydrolyzed to mecillinam |
| Eliminationhalf-life | 1 to 3 hours |
| Excretion | Kidney and biliary, mostly as mecillinam |
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| CompTox Dashboard(EPA) | |
| ECHA InfoCard | 100.046.600 |
| Chemical and physical data | |
| Formula | C21H33N3O5S |
| Molar mass | 439.57 g·mol−1 |
| 3D model (JSmol) | |
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Pivmecillinam (INN), oramdinocillin pivoxil (USAN), sold under the brand nameSelexid andPivya among others, is an orally activeprodrug ofmecillinam, an extended-spectrumpenicillinantibiotic. Pivmecillinam is thepivaloyloxymethylester of mecillinam.
The most common side effects includenausea anddiarrhea.[3]
In the US, pivmecillinam isindicated for the treatment of female adults with uncomplicated urinary tract infections caused by susceptible isolates ofEscherichia coli,Proteus mirabilis, andStaphylococcus saprophyticus.[3]
Pivmecillinam is primarily active againstGram-negative bacteria, and is used primarily in the treatment of lowerurinary tract infections. In theNordic countries, it has been widely used in that indication since the 1970s.
Theadverse effect profile of pivmecillinam is similar to that of other penicillins. The most common side effects of mecillinam use arerash and gastrointestinal upset, includingnausea andvomiting.[4][5]
Prodrugs that releasepivalate anions when broken down by the body — such as pivmecillinam,pivampicillin andcefditoren pivoxil — have long been known to deplete levels ofcarnitine.[6][7] This is not due to the drug itself, but to the pivalate anion, which is mostly removed from the body by forming a conjugate with carnitine. Although short-term use of these drugs can cause a marked decrease in blood levels of carnitine,[8] it is unlikely to be of clinical significance;[7] long-term use, however, appears problematic and is not recommended.[7][9][10]
The efficacy of pivmecillinam in treating females eighteen years of age or older with uncomplicated UTIs was assessed in three controlled clinical trials comparing different pivmecillinam dosing regimens toplacebo, to another oral antibacterial drug and toibuprofen (an anti-inflammatory drug).[3] The primary measure of efficacy for the three trials was the composite response rate, which included clinical cure (resolution of the symptoms of the uncomplicated UTI that were present in participants at trial entry and no new symptoms) and microbiological response (demonstration that the bacteria cultured from participants' urine at trial entry was reduced).[3] The composite response rate was assessed approximately 8 to 14 days after participants were enrolled into the studies.[3] In the clinical trial comparing pivmecillinam to placebo, 62% of the 137 participants who received pivmecillinam achieved the composite response compared to 10% of the 134 who received placebo.[3] In the clinical trial comparing pivmecillinam to another oral antibacterial drug, 72% of the 127 participants who received pivmecillinam achieved composite response compared to 76% of the 132 who received the comparator drug.[3] In the clinical trial comparing pivmecillinam to ibuprofen, 66% of the 105 participants who received pivmecillinam achieved composite response compared to 22% of the 119 who received ibuprofen.[3]
The USFood and Drug Administration (FDA) granted the application for pivmecillinampriority review and qualified infectious disease product designations.[3] The FDA granted the approval of Pivya to Utility Therapeutics Ltd.[3]
Pivmecillinam has been proposed as thefirst-line drug of choice forempirical treatment of acutecystitis.[4][11] It has also been used to treatparatyphoid fever and shigellosis.[12]
This article incorporates text from this source, which is in thepublic domain.