# Baclofen

```text
DRUG INFORMATION

  ADULT
    - Pediatric Patients The starting screening dose for pediatric patients is the same
      as in adult patients, i.e., 50 mcg.
      Source: US FDA label for baclofen (Gablofen), section 'dosage and administration',
      retrieved 2026-08-29
    - However, for very small patients, a screening dose of 25 mcg may be tried first.
      Source: US FDA label for baclofen (Gablofen), section 'dosage and administration',
      retrieved 2026-08-29
    - For a 50 mcg bolus dose, use 1 mL of the screening syringe.
      Source: US FDA label for baclofen (Gablofen), section 'dosage and administration',
      retrieved 2026-08-29

  CHILD
    - Children should be of sufficient body mass to accommodate the implantable pump for
      chronic infusion. Please consult pump manufacturer's manual for specific
      recommendations. Safety and effectiveness in pediatric patients below the age of 4
      have not been established.
      Source: US FDA label for baclofen (Gablofen), section 'pediatric use', retrieved
      2026-08-29
    - Use Only in Medtronic SynchroMed ® Programmable Pump (or other pumps labeled for
      intrathecal administration of GABLOFEN) GABLOFEN is approved only for use with the
      Medtronic SynchroMed ® Programmable Pump or other pumps labeled for intrathecal
      administration of GABLOFEN. Refer to the manufacturer’s manual for specific
      instructions and precautions for programming the pump and/or refilling the
      reservoir.
      Source: US FDA label for baclofen (Gablofen), section 'dosage and administration',
      retrieved 2026-08-29
    - Pediatric Patients The starting screening dose for pediatric patients is the same
      as in adult patients, i.e., 50 mcg.
      Source: US FDA label for baclofen (Gablofen), section 'dosage and administration',
      retrieved 2026-08-29

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

  PREGNANCY
    - Risk Summary There are no adequate data on the developmental risk associated with
      the use of GABLOFEN in pregnant women.
      Source: US FDA label for baclofen (Gablofen), section 'pregnancy', retrieved
      2026-08-29
    - In animal studies, oral administration of baclofen to pregnant rats produced an
      increase in fetal malformations (see Data) .
      Source: US FDA label for baclofen (Gablofen), section 'pregnancy', retrieved
      2026-08-29
    - There are no animal data on developmental risk associated with baclofen
      administered via continuous intrathecal infusion.
      Source: US FDA label for baclofen (Gablofen), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - This abnormality was not seen in mice or rabbits. 8.2 Lactation Risk Summary There
      is insufficient information regarding levels of baclofen in milk of nursing
      mothers receiving GABLOFEN.
      Source: US FDA label for baclofen (Gablofen), section 'use in specific
      populations', retrieved 2026-08-29
    - There are no adequate data on the effects of GABLOFEN on the breastfed infant or
      on milk production.
      Source: US FDA label for baclofen (Gablofen), section 'use in specific
      populations', retrieved 2026-08-29
    - At recommended oral doses, baclofen is present in human milk and withdrawal
      symptoms can occur in breastfed infants when maternal administration of baclofen
      is stopped or when breastfeeding is stopped.
      Source: US FDA label for baclofen (Gablofen), section 'use in specific
      populations', retrieved 2026-08-29
```

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