{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "pentoxifylline",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "DOSAGE & ADMINISTRATION The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.",
        "source": "US FDA label for pentoxifylline (Pentoxifylline), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pentoxifylline.json",
        "verbatim": true
      },
      {
        "text": "If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day).",
        "source": "US FDA label for pentoxifylline (Pentoxifylline), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pentoxifylline.json",
        "verbatim": true
      },
      {
        "text": "DOSAGE & ADMINISTRATION The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals. While the effect of pentoxifylline extended-release tablets may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration. Digestive and central nervous system side effects are dose related.",
        "source": "US FDA label for pentoxifylline (Pentoxifylline), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pentoxifylline.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for pentoxifylline (Pentoxifylline), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/pentoxifylline.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "In patients with severe renal impairment (creatinine clearance below 30 mL/min) reduce dose to 400 mg once a day.",
        "source": "US FDA label for pentoxifylline (Pentoxifylline), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pentoxifylline.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Dosing information cannot be provided for patients with hepatic impairment.",
        "source": "US FDA label for pentoxifylline (Pentoxifylline), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pentoxifylline.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Category C: Teratogenicity studies have been performed in rats and rabbits using oral doses up to 576 mg/kg and 264 mg/kg, respectively.",
        "source": "US FDA label for pentoxifylline (Pentoxifylline), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/pentoxifylline.json",
        "verbatim": true
      },
      {
        "text": "On a weight basis, these doses are 24 and 11 times the maximum recommended human daily dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5 times the MRHD.",
        "source": "US FDA label for pentoxifylline (Pentoxifylline), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/pentoxifylline.json",
        "verbatim": true
      },
      {
        "text": "No evidence of fetal malformation was observed.",
        "source": "US FDA label for pentoxifylline (Pentoxifylline), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/pentoxifylline.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Pentoxifylline and its metabolites are excreted in human milk.",
        "source": "US FDA label for pentoxifylline (Pentoxifylline), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/pentoxifylline.json",
        "verbatim": true
      },
      {
        "text": "Because of the potential for tumorigenicity shown for pentoxifylline in rats, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.",
        "source": "US FDA label for pentoxifylline (Pentoxifylline), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/pentoxifylline.json",
        "verbatim": true
      }
    ]
  }
}