{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "amantadine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "After one week, increase to the recommended dosage of 274 mg (two 137 mg capsules) once daily at bedtime.",
        "source": "US FDA label for amantadine (GOCOVRI), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      },
      {
        "text": "After one week, increase to recommended dosage of 274 mg once daily at bedtime.",
        "source": "US FDA label for amantadine (GOCOVRI), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of GOCOVRI in pediatric patients have not been established.",
        "source": "US FDA label for amantadine (GOCOVRI), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "It is recommended to avoid sudden discontinuation of GOCOVRI [see Dosage and Administration ( 2.4 )]. 2.3 Dosing in Patients with Renal Impairment The initial and maximum recommended daily dosage of GOCOVRI for patients with renal impairment (creatinine clearance estimated by Modification of Diet in Renal Disease (MDRD) method) is provided below.",
        "source": "US FDA label for amantadine (GOCOVRI), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      },
      {
        "text": "Moderate renal impairment (30 to 59 mL/min/1.73 m 2 ) Initial dosage: 68.5 mg once daily at bedtime Maximum recommended dosage: 137 mg once daily at bedtime 1 Severe renal impairment (15 to 29 mL/min/1.73 m 2 ) 68.5 mg once daily at bedtime End Stage Renal Disease (below 15 mL/min/1.73 m 2 ) Contraindicated 2.4 Discontinuation and Missed Dose Rapid dose reduction or withdrawal of GOCOVRI may cause adverse reactions [see Warnings and Precautions ( 5.5 )].",
        "source": "US FDA label for amantadine (GOCOVRI), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      },
      {
        "text": "Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration ( 2.3 )]. 8.6 Renal Impairment GOCOVRI is contraindicated for use in patients with end-stage renal disease (creatinine clearance values lower than 15 mL/min/1.73 m 2 ).",
        "source": "US FDA label for amantadine (GOCOVRI), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for amantadine (GOCOVRI), retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary There are no adequate data on the developmental risk associated with use of amantadine in pregnant women.",
        "source": "US FDA label for amantadine (GOCOVRI), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      },
      {
        "text": "Animal studies suggest a potential risk for fetal harm with amantadine.",
        "source": "US FDA label for amantadine (GOCOVRI), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      },
      {
        "text": "In mice and rats, adverse developmental effects (embryolethality, increased incidence of malformations, and reduced fetal body weight) were observed when amantadine was administered to pregnant animals at clinically relevant doses [see Data].",
        "source": "US FDA label for amantadine (GOCOVRI), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Evaluation of parturition, lactation, and post-natal development in a limited number of litters from the mouse and rat studies described above revealed reductions in live litter size and pup weights at birth at 40 mg/kg/day in mice and 120 mg/kg/day in rats. 8.2 Lactation Risk Summary Amantadine is excreted into human milk, but amounts have not been quantified.",
        "source": "US FDA label for amantadine (GOCOVRI), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      },
      {
        "text": "There is no information on the risk to a breastfed infant.",
        "source": "US FDA label for amantadine (GOCOVRI), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      },
      {
        "text": "Amantadine may alter breast milk production or excretion [see Data].",
        "source": "US FDA label for amantadine (GOCOVRI), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/amantadine.json",
        "verbatim": true
      }
    ]
  }
}