{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "glycopyrronium",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "For topical use only. Qbrexza is for topical use in the underarm area only and not for use in other body areas. Qbrexza is administered by a single-use pre-moistened cloth packaged in individual pouches. Qbrexza should be applied to clean dry skin on the underarm areas only. Qbrexza should not be used more frequently than once every 24 hours. Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once.",
        "source": "US FDA label for glycopyrronium (Qbrexza), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/glycopyrronium.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety, effectiveness and pharmacokinetics of Qbrexza have been established in pediatric patients age 9 years and older for topical treatment of primary axillary hyperhidrosis [see Clinical Pharmacology ( 12.3 )] .",
        "source": "US FDA label for glycopyrronium (Qbrexza), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/glycopyrronium.json",
        "verbatim": true
      },
      {
        "text": "For topical use only. Qbrexza is for topical use in the underarm area only and not for use in other body areas. Qbrexza is administered by a single-use pre-moistened cloth packaged in individual pouches. Qbrexza should be applied to clean dry skin on the underarm areas only. Qbrexza should not be used more frequently than once every 24 hours. Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once.",
        "source": "US FDA label for glycopyrronium (Qbrexza), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/glycopyrronium.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "The safety and effectiveness of Qbrexza have not been established in pediatric patients under 9 years of age. 8.5 Geriatric Use Clinical trials of Qbrexza did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects. 8.6 Renal Impairment The elimination of glycopyrronium is severely impaired in patients with renal failure [see Clinical Pharmacology ( 12.3 )] .",
        "source": "US FDA label for glycopyrronium (Qbrexza), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/glycopyrronium.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 glycopyrronium (Qbrexza), retrieved 2026-08-29",
        "cached_file": "labels/glycopyrronium.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary There are no available data on Qbrexza use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.",
        "source": "US FDA label for glycopyrronium (Qbrexza), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/glycopyrronium.json",
        "verbatim": true
      },
      {
        "text": "In pregnant rats, daily oral administration of glycopyrrolate (glycopyrronium bromide) during organogenesis did not result in an increased incidence of gross external or visceral defects [see Data ] .",
        "source": "US FDA label for glycopyrronium (Qbrexza), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/glycopyrronium.json",
        "verbatim": true
      },
      {
        "text": "When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis, no adverse effects on embryo-fetal development were seen.",
        "source": "US FDA label for glycopyrronium (Qbrexza), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/glycopyrronium.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Female rats that were pregnant or nursing were orally dosed with glycopyrrolate daily at dosages of 0, 50, 200, or 400 mg/kg/day, beginning on day 7 of gestation, and continuing until day 20 of lactation.",
        "source": "US FDA label for glycopyrronium (Qbrexza), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/glycopyrronium.json",
        "verbatim": true
      },
      {
        "text": "Mean body weight of pups in all treatment groups was reduced compared to the control group during the period of nursing, but eventually recovered to be comparable to the control group, post-weaning.",
        "source": "US FDA label for glycopyrronium (Qbrexza), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/glycopyrronium.json",
        "verbatim": true
      },
      {
        "text": "There were no effects of maternal treatment on behavior, learning, memory, or reproductive function of pups. 8.2 Lactation Risk Summary There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.",
        "source": "US FDA label for glycopyrronium (Qbrexza), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/glycopyrronium.json",
        "verbatim": true
      }
    ]
  }
}