{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "clindamycin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The recommended dosage of XACIATO is one applicatorful (5 g of vaginal gel containing 100 mg of clindamycin) administered once intravaginally as a single dose at any time of the day [see Clinical Studies ( 14 )] .",
        "source": "US FDA label for clindamycin (XACIATO), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/clindamycin.json",
        "verbatim": true
      },
      {
        "text": "Administer one applicatorful (5 g of gel containing 100 mg of clindamycin) once intravaginally as a single dose at any time of the day.",
        "source": "US FDA label for clindamycin (XACIATO), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/clindamycin.json",
        "verbatim": true
      },
      {
        "text": "The recommended dosage of XACIATO is one applicatorful (5 g of vaginal gel containing 100 mg of clindamycin) administered once intravaginally as a single dose at any time of the day [see Clinical Studies ( 14 )] . Place the used tube with any remaining gel and used applicator in the container box and deposit in a trash container after use [see Instructions for Use ] . XACIATO is not for ophthalmic, dermal, or oral use.",
        "source": "US FDA label for clindamycin (XACIATO), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/clindamycin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of XACIATO have been established in females aged 12 years and older for the treatment of bacterial vaginosis. Use of XACIATO for this indication is supported by the extrapolation of clinical trial data from adequate and well controlled clinical studies in adult women. The safety and effectiveness of XACIATO have not been established in pediatric patients younger than 12 years of age for the treatment of bacterial vaginosis.",
        "source": "US FDA label for clindamycin (XACIATO), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/clindamycin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for clindamycin (XACIATO), retrieved 2026-08-29",
        "cached_file": "labels/clindamycin.json",
        "verbatim": false
      }
    ],
    "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 clindamycin (XACIATO), retrieved 2026-08-29",
        "cached_file": "labels/clindamycin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Other clindamycin vaginal products have been used to treat pregnant women during the second and third trimester.",
        "source": "US FDA label for clindamycin (XACIATO), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/clindamycin.json",
        "verbatim": true
      },
      {
        "text": "XACIATO has not been studied in pregnant women.",
        "source": "US FDA label for clindamycin (XACIATO), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/clindamycin.json",
        "verbatim": true
      },
      {
        "text": "However, based on the low systemic absorption of XACIATO following the intravaginal route of administration in nonpregnant women, maternal use is not likely to result in significant fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] .",
        "source": "US FDA label for clindamycin (XACIATO), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/clindamycin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Vaginal administration of XACIATO to pregnant/lactating female rats during a pre- and post-natal development (gestation day 6 through gestation day 21) study at 2 mg clindamycin phosphate/day had no adverse effects on dams or their offspring.",
        "source": "US FDA label for clindamycin (XACIATO), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/clindamycin.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.",
        "source": "US FDA label for clindamycin (XACIATO), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/clindamycin.json",
        "verbatim": true
      }
    ]
  }
}