Pivmecillinam

DRUG INFORMATION

  ADULT
    - 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.
      Source: US FDA label for pivmecillinam (PIVYA), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 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.
      Source: US FDA label for pivmecillinam (PIVYA), section 'dosage and
      administration', retrieved 2026-08-29
    - 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
      )] .
      Source: US FDA label for pivmecillinam (PIVYA), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of PIVYA have not been established in pediatric
      patients. Carnitine Depletion Symptomatic hypocarnitinemia has been reported in
      pediatric patients outside the United States on long term pivmecillinam therapy.
      In these cases, irritability, altered mental status, fatigue, muscle weakness, and
      vomiting have been observed.
      Source: US FDA label for pivmecillinam (PIVYA), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - The available safety information does not suggest a need for dosage adjustment
      [see Clinical Pharmacology ( 12.3 ) and Use in Specific Populations ( 8.6 )]. 8.6
      Renal Impairment Reductions in systemic elimination as well as urinary excretion
      of mecillinam are anticipated with decreases in renal function.
      Source: US FDA label for pivmecillinam (PIVYA), section 'use in specific
      populations', retrieved 2026-08-29
    - In patients with significant renal impairment or decreased muscle mass and those
      patients requiring long term antimicrobial treatment, consider alternative
      antibacterial therapies.
      Source: US FDA label for pivmecillinam (PIVYA), section 'warnings and cautions',
      retrieved 2026-08-29
    - In patients at risk for reductions in serum carnitine (e.g., patients with
      significant renal impairment or decreased muscle mass consider alternative
      antibacterial therapies.
      Source: US FDA label for pivmecillinam (PIVYA), section 'warnings and cautions',
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for pivmecillinam (PIVYA),
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Published observational studies on PIVYA use during the first
      trimester do not indicate an increased risk of major birth defects ( see Data ).
      Source: US FDA label for pivmecillinam (PIVYA), section 'pregnancy', retrieved
      2026-08-29
    - There are limited studies on PIVYA use during pregnancy that evaluate the risk of
      miscarriage and other adverse maternal or fetal outcomes.
      Source: US FDA label for pivmecillinam (PIVYA), section 'pregnancy', retrieved
      2026-08-29
    - These studies have methodological limitations hindering interpretation.
      Source: US FDA label for pivmecillinam (PIVYA), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Pivmecillinam was given orally at doses up to 582 mg/kg/day and mecillinam was
      given subcutaneously at doses up to 450 mg/kg/day (approximately 10.2-fold and
      7.9-fold higher than the maximum recommended daily human dose of PIVYA, based on
      body surface area, respectively). 8.2 Lactation Risk Summary There are
      insufficient data to exclude the presence of mecillinam in human milk.
      Source: US FDA label for pivmecillinam (PIVYA), section 'use in specific
      populations', retrieved 2026-08-29
    - When a drug is present in animal milk, it is likely to be present in human milk.
      Source: US FDA label for pivmecillinam (PIVYA), section 'use in specific
      populations', retrieved 2026-08-29
    - There are pharmacovigilance reports of adverse reactions with mecillinam exposure
      in breastfed infants, including rash and diarrhea.
      Source: US FDA label for pivmecillinam (PIVYA), section 'use in specific
      populations', retrieved 2026-08-29