PIVYA 185 mg/1
Pivmecillinam · TABLET, COATED · Alembic Pharmaceuticals Inc.
PIVYA is a tablet, coated containing pivmecillinam at 185 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Inc..
Key Facts
- Brand Name
- PIVYA
- Generic Name
- Pivmecillinam
- NDC Code (Product)
62332-966- Manufacturer
- Alembic Pharmaceuticals Inc.
- Strength
- 185 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA216483
- Marketing Start
- 02/02/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 ) 1.1 Uncomplicated Urinary Tract Infections PIVYA is 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 (E. coli) , Proteus mirabilis, and Staphylococcus saprophyticus. 1.2 Usage 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered…
Dosage & Administration
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 )] . 2.2 Recommendations Regarding Missed Dose(s) If a dose of PIVYA is missed, instruct patients to take the dose as soon as possible. Do notdouble the dose to make up for the missed dose.
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 ) 4.1 Serious Hypersensitivity Reactions PIVYA is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to PIVYA or other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins) [ see Warnings and Precautions ( 5.1 ) ]. 4.2 Carnitine Deficiency PIVYA is contraindicated in patients with 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) [ see Warnings and Precautions ( 5.3 ) ]. 4.3 Acute Porphyria PIVYA is contraindicated in patients suffering from po…
Drug 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. Pivalate elimination associated with concomitant use of pivmecillinam with other pivalate-generating drugs decreases carnitine concentrations in plasma which may increase the risk of carnitine depletion-associated adverse reactions [see Warnings and Precautions ( 5.3 )] . 7.2 Methotrexate Clearance of methotrexate from the body can be reduced by concurrent use of drugs in the penicillin class, including PIVYA. Where possible, consider alternative therapy. 7.3 Drug Interference with Newborn Screening Test Treatment of a pregnant individual with PIVYA prior to delivery may cause a false positive test …
Adverse Reactions
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 ( 5.5 )] The most common adverse reactions observed in ≥2% of the patients receiving PIVYA in clinical trials are nausea and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Therapeutics at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PIVYA was evaluated in 579 adult female patients with uUTI who received PIVYA at a dose of 185 mg three times daily, or a…
Frequently Asked Questions
What is PIVYA used for?
PIVYA contains Pivmecillinam. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is PIVYA a controlled substance?
PIVYA is not classified as a controlled substance by the DEA.
What is the generic name for PIVYA?
The generic name for PIVYA is Pivmecillinam. There are no other listed brand versions of Pivmecillinam.
What is the NDC code for PIVYA 185 mg/1?
The NDC (National Drug Code) for PIVYA 185 mg/1 is 62332-966, listed by Alembic Pharmaceuticals Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)