Overview
11. DESCRIPTION PIVYA tablets contain pivmecillinam (as pivmecillinam hydrochloride), a penicillin class antibacterial for oral administration. The chemical name of pivmecillinam hydrochloride is methylene 2,2-dimethylpropanoate (2S,5R,6R)-6-[[(hexahydro-1H-azepin-1-yl)methylene]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate hydrochloride.
Mechanism of Action
12. CLINICAL PHARMACOLOGY 12.1 Mechanism of Action PIVYA is an antibacterial drug [see Microbiology ( 12.4 )] . 12.2 Pharmacodynamics Like other beta-lactam antibacterial drugs, the bacteriological effect of PIVYA in the treatment of uUTI is dependent on time above minimum inhibitory concentration (MIC), which has been shown to best correlate with efficacy in animal models of infection against E. coli . 12.3 Pharmacokinetics Pivmecillinam is a pro-drug of mecillinam (the active antibacterial moiety). The pharmacokinetic information for mecillinam from published studies is summarized in Table 2.
Indications
- 1. INDICATIONS AND USAGE PIVYA is a penicillin class antibacterial indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus . ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of PIVYA and other antibacterial drugs, PIVYA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.
Common Doses
- 185 mg
Dosage
2. DOSAGE AND ADMINISTRATION The recommended dosage of PIVYA is one 185 mg tablet orally 3 times a day for 3 to 7 days as clinically indicated. ( 2.1 ) Administer PIVYA with or without food. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of PIVYA is one 185 mg tablet orally 3 times a day for 3 to 7 days as clinically indicated. Administer PIVYA with or without food [see Clinical Pharmacology ( 12.3 )] . PIVYA (pivmecillinam) is a prodrug of mecillinam (the active antibacterial agent) [see Clinical Pharmacology ( 12.3 )] . 2.
Contraindications
- 4. CONTRAINDICATIONS Serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to PIVYA or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). ( 4.1 ) Primary or secondary carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism, and other inborn errors of metabolism (e.g., methylmalonic aciduria, or propionic acidemia). ( 4.2 ) Acute porphyria. ( 4.3 ) 4.
Side Effects
- 6. ADVERSE REACTIONS The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section of labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] Carnitine Depletion [see Warnings and Precautions ( 5.3 )] Acute Porphyria [see Warnings and Precautions ( 5.4 )] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions ( 5.
Interactions
- 7. DRUG INTERACTIONS 7.1 Other Pivalate-Generating Drugs Avoid concurrent treatment with valproic acid, valproate, or other pivalate-generating drugs. If concomitant use with PIVYA is necessary, counsel patients to monitor adverse reactions associated with carnitine depletion (e.g., hypoglycemia, muscle aches, fatigue, and confusion) [see Warnings and Precautions ( 5.3 )]. Pivmecillinam is a pivalate-generating prodrug [see Clinical Pharmacology ( 12.3 )] . Pivalate can be activated to a coenzyme-A thioester in cells which is further converted to pivaloylcarnitine and excreted in urine.