Pregabalin

DRUG INFORMATION

  ADULT
    - For adult indications, begin dosing at 150 mg/day.
      Source: US FDA label for pregabalin (Pregabalin), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) Dosing recommendations: INDICATION Dosing Regimen
      Maximum Dose DPN Pain ( 2.2 ) 3 divided doses per day 300 mg/day within 1 week.
      Source: US FDA label for pregabalin (Pregabalin), section 'dosage and
      administration', retrieved 2026-08-29
    - PHN ( 2.3 ) 2 or 3 divided doses per day 300 mg/day within 1 week.
      Source: US FDA label for pregabalin (Pregabalin), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Neuropathic Pain Associated with Diabetic Peripheral Neuropathy, Postherpetic
      Neuralgia, and Neuropathic Pain Associated with Spinal Cord Injury Safety and
      effectiveness in pediatric patients have not been established. Fibromyalgia Safety
      and effectiveness in pediatric patients have not been established.
      Source: US FDA label for pregabalin (Pregabalin), section 'pediatric use',
      retrieved 2026-08-29
    - For adult indications, begin dosing at 150 mg/day. For partial-onset seizure
      dosing in pediatric patients 1 month of age and older, refer to section 2.4. ( 2.2
      , 2.3 , 2.4 , 2.5 , 2.6 ) Dosing recommendations: INDICATION Dosing Regimen
      Maximum Dose DPN Pain ( 2.2 ) 3 divided doses per day 300 mg/day within 1 week.
      PHN ( 2.3 ) 2 or 3 divided doses per day 300 mg/day within 1 week. Maximum dose of
      600 mg/day.
      Source: US FDA label for pregabalin (Pregabalin), section 'dosage and
      administration', retrieved 2026-08-29
    - A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with
      fibromyalgia, ages 12 through 17 years, at pregabalin total daily doses of 75 to
      450 mg per day.
      Source: US FDA label for pregabalin (Pregabalin), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Because pregabalin is eliminated primarily by renal excretion, adjust the dose in
      adult patients with reduced renal function [see Dosage and Administration (2.7) ].
      2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults The
      maximum recommended dose of pregabalin capsules is 100 mg three times a day (300
      mg/day) in patients with creatinine clearance of at least 60 mL/min.
      Source: US FDA label for pregabalin (Pregabalin), section 'dosage and
      administration', retrieved 2026-08-29
    - In view of the dose-dependent adverse reactions, treatment with doses above 300
      mg/day is not recommended [see Adverse Reactions (6.1) ] . 2.3 Postherpetic
      Neuralgia in Adults The recommended dose of pregabalin capsules is 75 mg to 150 mg
      two times a day, or 50 mg to 100 mg three times a day (150 mg to 300 mg/day) in
      patients with creatinine clearance of at least 60 mL/min.
      Source: US FDA label for pregabalin (Pregabalin), section 'dosage and
      administration', retrieved 2026-08-29
    - Patients who do not experience sufficient pain relief after 2 to 3 weeks of
      treatment with 150 mg two times a day and who tolerate pregabalin capsules may be
      treated with up to 300 mg two times a day [see Clinical Studies (14.5) ] . 2.7
      Dosing for Adult Patients with Renal Impairment In view of dose-dependent adverse
      reactions and since pregabalin is eliminated primarily by renal excretion, adjust
      the dose in adult patients with reduced renal function.
      Source: US FDA label for pregabalin (Pregabalin), section 'dosage and
      administration', 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 pregabalin (Pregabalin),
      retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to pregabalin during pregnancy.
      Source: US FDA label for pregabalin (Pregabalin), section 'pregnancy', retrieved
      2026-08-29
    - To provide information regarding the effects of in utero exposure to pregabalin,
      physicians are advised to recommend that pregnant patients taking pregabalin
      enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
      Source: US FDA label for pregabalin (Pregabalin), section 'pregnancy', retrieved
      2026-08-29
    - This can be done by calling the toll free number 1-888-233-2334, and must be done
      by patients themselves.
      Source: US FDA label for pregabalin (Pregabalin), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Infertility Males Effects on Spermatogenesis In a randomized, double-blind,
      placebo-controlled non-inferiority study to assess the effect of pregabalin on
      sperm characteristics, healthy male subjects received pregabalin at a daily dose
      up to 600 mg (n=111) or placebo (n=109) for 13 weeks (one complete sperm cycle)
      followed by a 13-week washout period (off-drug).
      Source: US FDA label for pregabalin (Pregabalin), section 'nursing mothers',
      retrieved 2026-08-29
    - A total of 65 subjects in the pregabalin group (59%) and 62 subjects in the
      placebo group (57%) were included in the per protocol (PP) population.
      Source: US FDA label for pregabalin (Pregabalin), section 'nursing mothers',
      retrieved 2026-08-29
    - These subjects took study drug for at least 8 weeks, had appropriate timing of
      semen collections and did not have any significant protocol violations.
      Source: US FDA label for pregabalin (Pregabalin), section 'nursing mothers',
      retrieved 2026-08-29